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re Ark therapeutics -- News
Ark makes significant advances with EG013 and EG014 preclinical programmes
19 May 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") today provides an update on two of its preclinical programmes, EG013 and EG014. In November 2007, Ark raised £35.4 million net through a Placing and Open Offer to allow investment in a number of advanced preclinical programmes within its gene-based medicine portfolio that had promising results and the potential to move rapidly into the clinic.
EG013 is a Trinam® variant VEGF based gene medicine under development for fetal growth restriction, an often terminal condition where insufficient blood supply via the placenta results in serious growth retardation, leading to premature death or undesired termination of a baby in an otherwise healthy mother or long term neurological problems in surviving infants. The problem is usually first diagnosed about 20 weeks into pregnancy and at present there is no effective treatment.
Results from the first trial in a preclinical model of blood flow to the placenta have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, an improvement that is believed adequate to treat the condition. The latest results of the second set of experiments have shown that the significantly increased blood flow after treatment with EG013 is maintained out to 50 days. If confirmed in human studies, a therapy with this magnitude and duration of effect could allow the fetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Preliminary biodistribution results using immunohistochemical techniques have indicated that there is no transfer of the gene into the fetus.
Fetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe and is an extremely distressing condition. The work is being undertaken as a collaboration between Ark's scientists at University College, London (UCL) and the UCL Department of Obstetrics and Gynaecology. An abstract describing the work was recently presented at an American Society of Gynaecological Investigation where it won a President's Investigator award.
Commenting on the results, Professor Donald Peebles, Professor of Obstetrics and Fetal Medicine at UCL undertaking the work, said: "The results from this second set of experiments are again very encouraging. The robust science behind the gene-based product led us to believe we would see this effect but it is always exciting to have the theory confirmed. In common with many of the new types of advanced biologics treatments that are coming through, it looks as if we may be on the verge of a major treatment breakthrough in an extremely distressing medical condition."
EG014 is Ark's gene derived small molecule anti-cancer programme centred around the neuropilin 1 (NP1) receptor. Previously reported preclinical results from Ark's early leads have shown that blocking of the NP1 receptor has a triple effect, killing tumour cells, reducing blood flow to tumours and inhibiting metastatic spread of the cancer. Work this year using advanced crystallography and computational chemical modelling has led to the recent discovery and understanding of the precise NP1 receptor pocket structure and molecular binding site characteristics. Additionally Ark has completed development of novel fast screening assays, highly specific to the above mentioned receptor. These developments are significant advances which now direct Ark's chemistry to optimise the existing leads.
Commenting on this, Professor John Martin, Chief Scientific Officer at Ark, said: "The previous preclinical results with NP1 indicated its potential as a broad treatment for cancer. This precise finding had eluded us for a number of months and we are delighted to have made this discovery in such a precise and detailed manner. This allows us to continue what we believe is the last stage of our lead optimisation work in a controlled and systematic way to give us compounds with the right potency and binding specificity to take into the clinic."
Nigel Parker, CEO at Ark, added: "In the second half of last year we received strong support to progress a number of preclinical programmes and we are very pleased to report this steady and solid progress by our research groups in two of the projects. It is extremely exciting for us to see this breakthrough science move forward and the progress confirms our view that advanced molecular medicine has the potential to offer breakthrough treatments in areas of serious unmet clinical needs. We look forward to updating the market on progress with these and our other preclinical projects in due course."
re Ark therapeutics -- Update
http://finance.yahoo.com/q?s=akt.l
Ark Therapeutics Group plc
Interim Management Statement
16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August 2008.
The overall performance of the business during the period has been in line with the Board's expectations.
Highlights
* Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
* Good progress made towards start of Phase III trials for Trinam® and VitorTM
* Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
* Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
* Finnish manufacturing facility completes validation review to USA standards
* Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
* Neuropad® in-licensed and launched in the UK
Clinical Programmes
In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.
Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.
Pre-clinical Programmes
The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.
Woundcare
The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further confidence for the future success of this business.
Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning licensing of other intellectual property in Ark's portfolio.
Cash
As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December 2007.
Nigel Parker, CEO of Ark, commented:
"The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set."
re Ark therapeutics -- Update
http://finance.yahoo.com/q?s=akt.l
Ark Therapeutics Group plc
Interim Management Statement
16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August 2008.
The overall performance of the business during the period has been in line with the Board's expectations.
Highlights
* Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
* Good progress made towards start of Phase III trials for Trinam® and VitorTM
* Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
* Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
* Finnish manufacturing facility completes validation review to USA standards
* Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
* Neuropad® in-licensed and launched in the UK
Clinical Programmes
In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.
Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.
Pre-clinical Programmes
The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.
Woundcare
The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further confidence for the future success of this business.
Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning licensing of other intellectual property in Ark's portfolio.
Cash
As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December 2007.
Nigel Parker, CEO of Ark, commented:
"The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set."
re HIV & HCV first-in-class drug...Breakout
Biotron Limited (Bit.ax)
Marketcap: 22 million US$
Price : 0,22 A$
up 29%
http://finance.yahoo.com/q?s=bit.ax&x=0&y=0
re HIV & HCV first-in-class drug..Undiscovered Stock
Biotron Limited (Bit.ax)
Marketcap: 17 million US$
HIV trial start Phase 1b/2a in 2Q 2008 results in 3Q 2008
HCV trial start Phase 1b/2a in 2Q 2008 results in 3Q 2008
Shareholder Update 9 may 2008
Dear Shareholder
Welcome to this edition of Biotron’s newsletter, BITNews. These first few months of 2008 have seen turmoil in the stock market, and Biotron has not escaped the general downturn. The Directors believe that the current share price does not reflect the intrinsic value of the Company’s technologies.
Biotron continues with a robust drug development program which shows every promise of achieving commercial success. Since completing the Phase I clinical trial in healthy volunteers in late 2007, we have been compiling the drug data packages that will support two new trials – one in HIV-positive and one in HCV-positive patients. These are highly detailed documents that are required for submission to relevant ethics and regulatory authorities. Preparation of these data packages is now complete, which is a substantial milestone for the Company
During the first quarter of this year the Company has been in extensive consultation with international and national clinical advisors who have specific expertise in the design of trials of new drugs in patients. Biotron’s lead drug, BIT225, is a new class of drug with a new mode of action. It is critical that the trials are designed correctly to ensure the required outcomes can be achieved. The data from these trials will be used to support on-going development of BIT225, and critically, will be the major item that maximises their value to a multinational pharmaceutical company. Correctly designed and implemented trials will benefit shareholders as returns to the Company from a commercial deal will be maximised.
The other key reason for ensuring the trials are correctly designed is to maximise patient recruitability. Defining inclusion and exclusion criteria for trial participants – such as stage of disease, past treatment, current co-treatment, unrelated diseases, age and gender – determine how quickly we will be able to recruit sufficient patients and complete the trial. Delaying commencement of the trials while these criteria are determined is preferable to commencing a poorly-designed trial with slow recruitment and significantly prolonged outcomes.
At time of writing, final versions of trial protocols have been prepared, and will shortly be submitted to ethics and regulatory authorities. We anticipate receiving approvals to commence these trials before mid-year.
In December 2007 Biotron initiated and completed a Share Purchase Plan (SPP) to raise additional capital for clinical development of its antiviral programs. The issue of 14,700,000 shares to raise $2.5 million was underwritten by Martin Place Securities Pty Limited. The Directors would like to thank all those shareholders who supported the Company by participating in this recent capital raising.
Extended Safety Doses for BIT225
Biotron recently completed an additional higher dosage of BIT225 in healthy volunteers. This was done as an extension to the Phase I trial that was completed late last year. The higher dose was given as no dose-limiting toxicities were noted during dosing at the lower levels. This higher dose of 600mg BIT225 was well tolerated and results have further strengthened the data package that will support the proposed trials in HIV+ and HCV+ patients.
Presentation of Phase I Study to International Experts
In December 2007 Biotron presented the results of the Phase I clinical trial of BIT225 to an international audience of clinicians, researchers, scientists and pharmaceutical company representatives from around the world assembled at the HCV DART 2007 conference, Maui, Hawaii.
At the same meeting, Biotron presented a second paper on BIT225, with data showing that BIT225 significantly improves the activity of the current leading HCV therapies in an in vitro model system. Studies performed in the USA have shown BIT225 is highly synergistic in a triple combination with two of the most common HCV therapies in use today - ribavirin and interferon-á. The addition of BIT225 to ribavirin and interferon-á increased the level of inhibition of viral replication from 70% with the two other drugs to 100% when BIT225 was added to the mix. The potency of BIT225 was increased tenfold in this triple combination, compared to its activity on its own, with only one tenth the amount of BIT225 needed to achieve this excellent result in combination compared to on its own. The data indicate that BIT225 has the potential to be used in combination therapy to achieve a higher level of antiviral activity against HCV than is currently possible, while improving the potency of each of the drugs in the combination.
The two papers generated significant interest and discussion by the international antiviral drug community.
Further evidence of this interest was the invitation extended to Biotron to present at another international conference in March 2008. The 5th Anti-Infectives Partnering & Deal Making Summit , held in Philadelphia, PA, USA, was an infectious disease partnering and business development conference that gives global biotechnology and pharmaceutical companies an opportunity to network with high-level executives from top pharma and various biotech/ pharmaceutical companies, as well as explore potential collaborations, and discuss relevant anti-infective issues and deals that affect the industry. Biotron presented a paper on BIT225 to an audience of experts from leading organizations such as AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Global Alliance for TB Drug Development, GlaxoSmithKline, Human Genome Sciences, Merck, Novartis, Wyeth, and many more.
BIO2008, San Diego
In June Biotron will be attending the annual international biotechnology partnering conference, BIO2008 in San Diego. This conference provides an excellent opportunity to showcase Biotron’s antiviral drug programs to an international audience, and Biotron will participate in one-on-one meetings with business executives from US and European companies. This provides an opportunity to further advance discussions with potential partners.
Thank you for your continuing support
re Nuvo Research -- A big opportunity ???
Insider Activity
http://canadianinsider.ca/coReport/allTransactions.php?ticker=nri
iling Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Mar 06/08 Mar 04/08 GALER, BRADLEY STUART Direct Ownership Common Shares 30 - Acquisition under a purchase/ownership plan 136,145 $0.097
Mar 06/08 Mar 04/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 111,270 $0.106
Mar 06/08 Mar 04/08 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Acquisition in the public market 100,000 $0.100
Feb 29/08 Feb 26/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 400,000 $0.106
Feb 29/08 Feb 26/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 290,000 $0.107
Jan 10/08 Dec 31/07 GALER, BRADLEY STUART Direct Ownership Common Shares 97 - Other 682,592 $0.135
Dec 19/07 Dec 18/07 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Disposition in the public market -40,000 $0.090
Dec 19/07 Dec 17/07 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Disposition in the public market -10,000 $0.090
Dec 19/07 Dec 17/07 Dobranowski, Anthony Edward Indirect Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.090
"Pennsaid on track to be best in class FDA approved topical NSAID for osteo-arthritis"
Nuvo Research (NRI.TO)
Marketcap: 35 Million C$
Cash: 19,1 Million C$
Price: 0,12 C$
Please read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf
Nuvo announces first quarter 2008 financial results
Thursday May 1, 7:00 am ET
http://biz.yahoo.com/cnw/080501/nuvo_q1_2008_results.html?.v=1
Key Corporate Developments:
- Pennsaid product sales more than tripled to $1.7 million;
- Successful launch continued in Greece with Pennsaid capturing over
30% of its market during the first quarter, placing it first in
its class by revenue;
- The Company continued to make substantial progress regarding the
studies to be provided to the FDA to address the conditions raised
in the Approvable Letter for Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID) used to treat the pain and
stiffness associated with knee osteoarthritis (OA); and,
- The Company believes it will be in a position to file a complete
resubmission of its Pennsaid application to the FDA in early 2009
and be eligible to receive final marketing approval six months
later.
"We are extremely optimistic about Nuvo's future. We have a post-Phase III
product that is unlicensed for the large and growing U.S. OA market and we
remain confident that we will be in a position to file a complete resubmission
of our application for Pennsaid approval in early 2009," said Henrich
Guntermann, President and Chief Executive Officer, "In addition, our high
throughput screening and MMPE technology is creating a promising pipeline of
transdermal drug candidates."
Fighting arthritis with exercise and Pennsaid
Provided by: Sun Media
'Why are you using Celebrex, an oral nonsteroidal anti-inflammatory drug (NSAID) to treat arthritis of your knee when a safer medication, Pennsaid, is available? And a new report from Boston will also help to ease your pain."
This is the advice I recently gave my tennis partner.
Several years ago in my book, The Healthy Barmaid, I told the story of a patient whose arthritic fingers were improved by playing the piano. For years, I've been convinced that many people would not require hip and knee replacements if they used their legs more.
Ad
But a report from Boston claims that once arthritis sets in, walking isn't the entire answer. Dr. Ronenn Roubenoff, a rheumatologist at Tuft's University, says it also depends on the type of exercise.
He claims that few people realize the enormous pressures to which the joints are subjected. Amazingly, for every pound we weigh, a single step creates three pounds of pressure across the knees and hips.
VICIOUS CYCLE
This can be a problem therefore when the doctor says, "You've got to walk more." Rather than helping the pain, the knee hurts more and patients stop walking. This creates a vicious cycle. Inactivity leads to further weight gain, and more pressure on the knees causes more pain. It's a lose-lose situation.
Dr. Roubenoff says specific exercise is needed to strengthen the muscles which act like the shock absorbers of a car. We know we feel every bump in the road if our car's shock absorbers wear out. And this is what happens to joints if muscles are weak.
Fortunately Dr. Roubenoff's program needs no expensive equipment nor the worry of Draconian exercise. Leg muscles are strengthened by simply sitting in a chair and repeatedly getting up and down.
Another exercise involves placing increasing weights on the extended leg while sitting in a chair and moving the knee up and down. Dr. Roubenoff's patients were asked to do this twice a week.
By the end of 16 weeks, his patients had increased muscle strength by 71%. Now many could walk up and down stairs, sleep better and pain was decreased by 43%.
However, to achieve this end, Dr. Roubenoff insisted it's mandatory to push muscles beyond their current limits. This is what eventually makes the muscles more powerful. And if patients have the motivation to do so, they do not have to blindly accept the diagnosis of chronic arthritic pain.
A recent Harvard study, however, reported that rheumatoid specialists only recommended exercise in 50% of cases of rheumatoid arthritis. And a study in Canada showed that family doctors prescribed exercise to only one-third of patients with arthritis of the knee.
Today, many patients are taking Celebrex, Vioxx and other oral NSAIDs to treat arthritis of the knee. But these drugs can cause serious complications such as gastro-intestinal bleeding. It's estimated that 1,900 patients die in Canada every year due to these drugs.
This is a high price to pay for pain relief --and I have no desire to lose a tennis partner. That's why I told my friend not to take this chance and to use muscle-strengthening exercises and the new locally applied Pennsaid.
Pennsaid is a non-steroidal anti-inflammatory solution initially applied to the surface of the knee four times a day. Since it's locally applied, the likelihood of serious side-effects is decreased markedly. Equally important, studies show that it is as effective in controlling symptoms of osteoarthritis as the oral NSAIDs.
The most common side-effect of Pennsaid is a skin rash. But this problem pales in comparison to losing your life or possibly developing kidney and liver problems with the oral NSAIDs.
Doctors and patients have been waiting a long time for a safer product to treat osteo-arthritis. Pennsaid, a prescription drug, fills that need and is a godsend for arthritic patients.
Gene-based Brain Cancer Drug--P3 results in July
Ark therapeutics (AKT.L)
Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p
up again
http://finance.yahoo.com/q?s=akt.l
HIGHLIGHTS
Cerepro(R) * Phase III study completes recruitment
* Two successful Data Safety and Monitoring Board ("DSMB")
meetings advise no major safety concerns and recommend
trial continuation
* Clearance from the EMEA of historically difficult
technical barriers represents major breakthrough for
Cerepro(R) and the new gene-based therapeutic area
overall
Trinam(R) * Special Protocol Assistance (SPA) opened for Phase III
trial
* US Recombinant DNA Advisory Committee (RAC) gives early
clearance for Phase III trial, expected to commence in
H1 2008
VitorTM * Successful pre-Phase III FDA and EMEA scientific advice
meetings. Pilot Phase III trial expected to commence
H1 2008
Pre-clinical * Three gene-based products being prepared for Phase
I/IIa trials
* Ark Therapeutics-led consortium awarded Euro2.5m European
Commission grant for baculoviral vectors research
* Scavidin(R) demonstrates pre-clinical effectiveness in
third cancer model
Wound care * Wound care portfolio strengthened with the addition of
Kerraped(R)
Corporate/ * Formal grant of key patent for stroke in Europe
Commercial * Placing and Open Offer completed in November, raising
£35.4m net of expenses
* Cash and money market investments of £65.1m at 31
December 2007 (£48.4m at 31 December 2006)
Post-period events * January 2008 DSMB meeting confirms timing of preliminary
results from Phase III Cerepro(R) trial due Q3 2008
* Acquisition of Lymphatix Oy strengthens gene research
technology and secures licences for VEGF C and VEGF
D genes
* Finnish manufacturing facility completes validation
review to USA standards
* Neuropad(R) in-licensed and launched in the UK
(see separate press release)
Pipeline Review
Pharmaceuticals
Cerepro(R)
Throughout 2007 we continued to manufacture commercial grade batches of Cerepro
(R) to the rigorous standards agreed with the EMEA. In the first half we
pioneered the process controls necessary for approval of adenoviral gene
medicines in Europe and we believe that the patents for these will, once
granted, help maintain our leading position for both Cerepro(R) and in this area
overall. At the end of 2006 the DSMB had reviewed the first 133 patients
recruited into the Cerepro(R) Phase III corroborative study and recommended the
study continue as planned. In early Q2 we completed recruitment of the full 250
patients and in July the DSMB again recommended continuation of the study. Also
in Q2, the EMEA concluded its first review of our application for conditional
marketing approval which we filed on the basis of the existing Phase II trials.
The EMEA concluded that whilst the critical chemistry and manufacturing controls
(CMC), pre-clinical and environmental sections appeared satisfactory and the
safety profile appeared acceptable, an approval based on efficacy from a limited
number of treated patients was insufficient for a new class of drug despite it
being an Orphan Drug. Additional proof of efficacy from the ongoing Phase III
corroborative study was requested by the EMEA as necessary for an approval.
Being cleared through the three key technical CMC, pre-clinical and
environmental sections of the marketing application is a major breakthrough for
Ark and for the biotech sector overall. It has effectively established that,
providing satisfactory clinical data exists, this type of gene medicine is an
approvable platform.
Consequently, since the conditional approval route was no longer the correct
process for an approval based on a full trials programme, the Company withdrew
its application and will apply for a full licence once the results of the
corroborative study are available. Following the January 2008 DSMB meeting,
these are scheduled for Q3 2008.
VitorTM
Following a successful pre-Phase III meeting with the EMEA and the FDA, the
Company applied for Special Protocol Assistance ("SPA") from the FDA. Once
granted, SPA allows the final Phase III programme to be designed with the US
regulators such that, if successful, a rapid review process takes place. Whilst
SPA can delay commencement of the Phase III programme, it usually achieves a
greater time-saving during the approval process and reduces the risk of a
programme design problem preventing an approval. The SPA process opened in Q2
and, following a number of consultation and review meetings with the FDA, the
Company decided to run a pilot Phase III to obtain extra data not available from
early studies, prior to concluding the SPA. Whilst this has delayed the start
of the Phase III programme by around a year, Ark believes this sensible and
cautious approach is correct to ensure the appropriate Phase III programme is
conducted. Recruitment of the first patient is expected H1 2008.
Trinam(R)
The end of Phase II meeting with the FDA in 2006 resulted in Ark being offered
SPA for the Phase III development. In the first half of the year we filed the
relevant applications to the US recombinant advisory committee ("RAC") and to
the FDA to open the SPA. We were encouraged that attitudes to gene medicine in
the US had also advanced when rapid clearance for the Trinam Phase III was given
by RAC mid year, without the need for an oral hearing. The SPA progressed
steadily during the rest of the year and we conducted a further pre-clinical
study, as requested by the FDA, to expand the number of operative procedures for
which Trinam(R) might be used. Whilst we had hoped to conclude the SPA in 2007,
the outbreak of foot and mouth disease in the UK stopped animal movements and
caused us a three month delay, but work was completed at the end of the year and
the SPA process is expected to conclude shortly.
Pre-clinical Research
Our pre-clinical programmes have shown considerable advancement in 2007 and we
have increasingly focused our efforts on the DNA-based areas of our research
where our skill base and resources are world-leading. In January 2007 we held
our first R&D day for analysts and investors at our Kuopio facility. The day
was well attended and gave us the opportunity to show the size and scope of our
new research and manufacturing facilities and to introduce the results of some
of our most promising research programmes. These are advancing the way DNA can
be used as highly selective medicines in conditions where existing treatments
and old pharmaceutical chemistry based approaches are inadequate. We were very
pleased with the positive response from attendees and the coverage which we
received.
In February we announced a Euro2.5m consortium grant to undertake pioneering work
in the use of insect-derived baculoviruses to further their use in the gene
medicine area. Further pre-clinical proof-of-principle results were obtained
mid year for our Scavidin(R) product which showed efficacy in a third cancer
model, giving us confidence to plan the final pre-clinical work and associated
GMP manufacturing to take the product into clinical development. In Q3 we
showed for the first time the extremely exciting results for our VEGF work in
the ischaemic myocardium using the same adenoviral delivery technology as in
Cerepro(R) and Trinam(R). In Q4 we also showed the market further pre-clinical
results for our DNA-based medicines in the areas of foetal growth restriction,
wound healing and coronary artery bypass graft. These are all serious areas of
unmet clinical need, in which our understanding of the disease at the molecular
biology level is enabling us to develop second generation gene medicine products
where the therapeutic gene can be optimised to the problem and be delivered via
our established adenoviral platform.
Late in the year we concluded negotiations with Lymphatix Oy, a Helsinki-based
private biotech company and acquired the business in an all-share transaction at
the start of 2008. This acquisition has given us access to certain scientific
technologies to speed up our pre-clinical programmes, as well as a licence to
the angiogenic and lymphangiogenic applications for VEGF-D and C.
We are also moving towards lead optimisation with our Neuropilin-1 antagonist
programme and our targeted vector and earlier gene science research continues to
advance. Our goal is to move three of our most promising pre-clinical products
through to the first human studies, to gain key first efficacy data in the
target disease.
The strength and quality of our pre-clinical science was reinforced this year by
the European Euro2.5m baculovirus grant, where our application achieved one of the
highest scores possible in review, and by the successful Q4 fundraising where
significant proceeds were raised to progress the pre-clinical gene-based
programmes.
Patent Portfolio Update
In 2007 Ark had 36 new patents granted including the important "ACE stroke"
patent for Europe. We filed 14 new applications and, in accordance with our
constant review policy, abandoned 12 which we felt had no clear commercial
value. At present Ark has 186 patents granted and 160 pending applications and
we continue to demonstrate success in overcoming the various objections and
oppositions in the prosecution process. In the latter part of 2007 we filed
applications covering manufacturing processes which, if granted, would give our
gene-based products protection until 2027.
Wound Care Business
Combined sales of our wound care products showed good growth in 2007. Overall,
our ex-warehouse sales averaged an increase of 66% over 2006. Whilst our wound
care business is still relatively small, we are pleased with the growth and we
believe we are seeing some signs that the NHS is beginning to move from a
containment mode towards an optimisation mode where Ark's new product range,
which stands up to the latest health economic scrutiny, should do well.
Late in the period we introduced Kerraped(R), a special medical shoe which
off-loads pressure from the areas of the foot most prone to diabetic ulcers.
This is the first product of this class to receive reimbursement in the UK.
Early signs are that the market has received the product enthusiastically and
first sales occurred at the very end of the year. Very recently, we have
introduced the Neuropad(R) diagnostic test, to detect peripheral autonomic
neuropathy in the feet of diabetic patients, to UK podiatrists and we will
continue to add further new products to the business to build scale in this
challenging UK healthcare environment.
Summary and Outlook
In 2007 we made substantial progress. The pioneering work on regulatory
standards for gene therapy, progressing our other leads towards Phase III and
the grant of the European stroke patent are some of the most important
achievements in the history of the Company. This success, together with our
pre-clinical progress, catalysed the Placing and Open Offer which has allowed us
to strengthen considerably our balance sheet, thus securing the next stage of
the Company's development and building on our leading position in the gene
therapy area.
During 2008 we expect to maintain this momentum. Our manufacturing facility
recently achieved US production validation standards. Trinam(R) and VitorTM are
expected to enter Phase III studies and we will report the results of the
Cerepro(R) Phase III study. We already have the sales and marketing plan for
launch in place and key managers identified. 2008 should also bring further
developments in the commercialisation of our stroke patent and we expect to
introduce further wound care products to market in the UK. With the Lymphatix
acquisition and strong cash reserves we also expect to make significant progress
with the late stage pre-clinical programmes, moving them towards Phase I/IIa
development in consultation with regulators. We are very excited by our
achievements in 2007 and, whilst there are still some major challenges ahead, we
look forward to translating these plans into reality with confidence.
Nuvo Research -- A big opportunity ???
All comments are welcome
Pennsaid on track to be best in class FDA approved topical NSAID for osteo-arthritis
Nuvo Research (NRI.TO)
Marketcap: 35 Million C$
Cash: 19,1 Million C$
Price: 0,12 C$
Please read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf
Nuvo announces first quarter 2008 financial results
Thursday May 1, 7:00 am ET
http://biz.yahoo.com/cnw/080501/nuvo_q1_2008_results.html?.v=1
Key Corporate Developments:
- Pennsaid product sales more than tripled to $1.7 million;
- Successful launch continued in Greece with Pennsaid capturing over
30% of its market during the first quarter, placing it first in
its class by revenue;
- The Company continued to make substantial progress regarding the
studies to be provided to the FDA to address the conditions raised
in the Approvable Letter for Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID) used to treat the pain and
stiffness associated with knee osteoarthritis (OA); and,
- The Company believes it will be in a position to file a complete
resubmission of its Pennsaid application to the FDA in early 2009
and be eligible to receive final marketing approval six months
later.
"We are extremely optimistic about Nuvo's future. We have a post-Phase III
product that is unlicensed for the large and growing U.S. OA market and we
remain confident that we will be in a position to file a complete resubmission
of our application for Pennsaid approval in early 2009," said Henrich
Guntermann, President and Chief Executive Officer, "In addition, our high
throughput screening and MMPE technology is creating a promising pipeline of
transdermal drug candidates."
Fighting arthritis with exercise and Pennsaid
Provided by: Sun Media
'Why are you using Celebrex, an oral nonsteroidal anti-inflammatory drug (NSAID) to treat arthritis of your knee when a safer medication, Pennsaid, is available? And a new report from Boston will also help to ease your pain."
This is the advice I recently gave my tennis partner.
Several years ago in my book, The Healthy Barmaid, I told the story of a patient whose arthritic fingers were improved by playing the piano. For years, I've been convinced that many people would not require hip and knee replacements if they used their legs more.
Ad
But a report from Boston claims that once arthritis sets in, walking isn't the entire answer. Dr. Ronenn Roubenoff, a rheumatologist at Tuft's University, says it also depends on the type of exercise.
He claims that few people realize the enormous pressures to which the joints are subjected. Amazingly, for every pound we weigh, a single step creates three pounds of pressure across the knees and hips.
VICIOUS CYCLE
This can be a problem therefore when the doctor says, "You've got to walk more." Rather than helping the pain, the knee hurts more and patients stop walking. This creates a vicious cycle. Inactivity leads to further weight gain, and more pressure on the knees causes more pain. It's a lose-lose situation.
Dr. Roubenoff says specific exercise is needed to strengthen the muscles which act like the shock absorbers of a car. We know we feel every bump in the road if our car's shock absorbers wear out. And this is what happens to joints if muscles are weak.
Fortunately Dr. Roubenoff's program needs no expensive equipment nor the worry of Draconian exercise. Leg muscles are strengthened by simply sitting in a chair and repeatedly getting up and down.
Another exercise involves placing increasing weights on the extended leg while sitting in a chair and moving the knee up and down. Dr. Roubenoff's patients were asked to do this twice a week.
By the end of 16 weeks, his patients had increased muscle strength by 71%. Now many could walk up and down stairs, sleep better and pain was decreased by 43%.
However, to achieve this end, Dr. Roubenoff insisted it's mandatory to push muscles beyond their current limits. This is what eventually makes the muscles more powerful. And if patients have the motivation to do so, they do not have to blindly accept the diagnosis of chronic arthritic pain.
A recent Harvard study, however, reported that rheumatoid specialists only recommended exercise in 50% of cases of rheumatoid arthritis. And a study in Canada showed that family doctors prescribed exercise to only one-third of patients with arthritis of the knee.
Today, many patients are taking Celebrex, Vioxx and other oral NSAIDs to treat arthritis of the knee. But these drugs can cause serious complications such as gastro-intestinal bleeding. It's estimated that 1,900 patients die in Canada every year due to these drugs.
This is a high price to pay for pain relief --and I have no desire to lose a tennis partner. That's why I told my friend not to take this chance and to use muscle-strengthening exercises and the new locally applied Pennsaid.
Pennsaid is a non-steroidal anti-inflammatory solution initially applied to the surface of the knee four times a day. Since it's locally applied, the likelihood of serious side-effects is decreased markedly. Equally important, studies show that it is as effective in controlling symptoms of osteoarthritis as the oral NSAIDs.
The most common side-effect of Pennsaid is a skin rash. But this problem pales in comparison to losing your life or possibly developing kidney and liver problems with the oral NSAIDs.
Doctors and patients have been waiting a long time for a safer product to treat osteo-arthritis. Pennsaid, a prescription drug, fills that need and is a godsend for arthritic patients.
Gene-based Brain Cancer Drug --P3 results in July
This stock is significantly undervalued ...
Ark therapeutics (AKT.L)
Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p
Pipeline:
http://www.arktherapeutics.com/main/research_development.php?content=product_portfolio
----
Cerepro (malignant glioma) final Phase III results in July 08
about Cerepro
http://www.arktherapeutics.com/main/products.php?content=products_cerepro
Trinam (haemodialysis access) start Phase III in 1H 08
about Trinam
http://www.arktherapeutics.com/main/products.php?content=products_trinam
Vitor (cachexia) start Phase III in 1H 08
about Vitor
http://www.arktherapeutics.com/main/products.php?content=products_vitor
-------
Exciting times for Ark Therapeutics
Created:11 March 2008
Written by:Richard Hemming
The much anticipated data for Ark Therapeutics’ brain cancer drug, Cerepro, is due at the end of July and chief executive Nigel Parker knows what is at stake: “Once we get an approval of Cerepro the future of this company is assured.”
Nomura Code analyst Samir Devani puts the likelihood of success of the Phase III trial at 50 per cent. A failure would see a 50 per cent fall in the share price, but success is likely to see the share price north of 200p, he says.
Ark raised over £35.4m in a placing and open offer at 105p a share last November, and the company is building up a stronger early and late stage pipeline. But investors’ confidence will be increased by Dr Parker’s belief that the compelling results for Cerepro seen in Phase II - versus patients on standard treatment - will occur again in the bigger Phase III trials.
Elsewhere, Trinam, a treatment for blood vessel blockages in dialysis patients and Vitor, for cancer-related muscle wastage, are both entering Phase III trials this half.
Nomura Code expects a loss per share of 10.9p in 2008 and has a fair value of 130-140p on the shares.
------------------------------------------
Gene therapy for high-grade glioma with an adenoviral vector containing the Herpes Simplex virus thymidine kinase gene (Cerepro™): From pre clinical studies to a randomised phase II survival study
Objective
The aim of these studies was to evaluate the efficacy and safety of CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with intravenous Ganciclovir in pre clinical animal model as in patients with operable high grade glioma. Our randomised, controlled, phase II study involved 36 patients with operable primary or recurrent high-grade glioma.
Methods
Patients were randomised in phase II study either to receive CereproTM (3x1010 pfu) by local injection into the walls of the tumor cavity at the time of tumour resection, followed by intravenous ganciclovir, 5mg/kg twice daily for 14 days (n=17) or standard care consisting of radical excision (n=19). Patients in both groups with primary tumours received postoperative radiotherapy.
Results
In the phase II study, there was an increased mean survival from 39.0±19.7 (SD) in control group to 70.652.9 weeks in the treatment group (p=0.0095) following CereproTM therapy. Median survival increased from 37.7 to 62.4 weeks. The percentage increase in mean survival was 81% and median survival was 65%. This therapy was well tolerated according to adverse events, clinical chemistry, haematology and immunology. There was no evidence of any deterioration in quality of life or increased use of concomitant medications.
Conclusions
CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with ganciclovir is a novel, safe, promising therapy for operable malignant glioma.
Presentations (please read the March 2008 presentation)
http://investors.arktherapeutics.com/presentations
More Infos
http://www.iii.co.uk/investment/detail?code=cotn:AKT.L&display=news&it=le
Gene-based Brain Cancer Drug--P3 results in July
Ark therapeutics (AKT.L)
Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p
Pipeline:
http://www.arktherapeutics.com/main/research_development.php?content=product_portfolio
Exciting times for Ark Therapeutics
Created:11 March 2008
Written by:Richard Hemming
The much anticipated data for Ark Therapeutics’ brain cancer drug, Cerepro, is due at the end of July and chief executive Nigel Parker knows what is at stake: “Once we get an approval of Cerepro the future of this company is assured.”
Nomura Code analyst Samir Devani puts the likelihood of success of the Phase III trial at 50 per cent. A failure would see a 50 per cent fall in the share price, but success is likely to see the share price north of 200p, he says.
Ark raised over £35.4m in a placing and open offer at 105p a share last November, and the company is building up a stronger early and late stage pipeline. But investors’ confidence will be increased by Dr Parker’s belief that the compelling results for Cerepro seen in Phase II - versus patients on standard treatment - will occur again in the bigger Phase III trials.
Elsewhere, Trinam, a treatment for blood vessel blockages in dialysis patients and Vitor, for cancer-related muscle wastage, are both entering Phase III trials this half.
Nomura Code expects a loss per share of 10.9p in 2008 and has a fair value of 130-140p on the shares.
------------------------------------------
Gene therapy for high-grade glioma with an adenoviral vector containing the Herpes Simplex virus thymidine kinase gene (Cerepro™): From pre clinical studies to a randomised phase II survival study
Text
Objective
The aim of these studies was to evaluate the efficacy and safety of CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with intravenous Ganciclovir in pre clinical animal model as in patients with operable high grade glioma. Our randomised, controlled, phase II study involved 36 patients with operable primary or recurrent high-grade glioma.
Methods
Patients were randomised in phase II study either to receive CereproTM (3x1010 pfu) by local injection into the walls of the tumor cavity at the time of tumour resection, followed by intravenous ganciclovir, 5mg/kg twice daily for 14 days (n=17) or standard care consisting of radical excision (n=19). Patients in both groups with primary tumours received postoperative radiotherapy.
Results
In the phase II study, there was an increased mean survival from 39.0±19.7 (SD) in control group to 70.652.9 weeks in the treatment group (p=0.0095) following CereproTM therapy. Median survival increased from 37.7 to 62.4 weeks. The percentage increase in mean survival was 81% and median survival was 65%. This therapy was well tolerated according to adverse events, clinical chemistry, haematology and immunology. There was no evidence of any deterioration in quality of life or increased use of concomitant medications.
Conclusions
CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with ganciclovir is a novel, safe, promising therapy for operable malignant glioma.
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28839708
Presentations
http://investors.arktherapeutics.com/presentations
More Infos
http://www.iii.co.uk/investment/detail?code=cotn:AKT.L&display=news&it=le
Strong Growth for Arixtra
Last quarter in brackets
US US$38 ($US32m) up 19%
Europe US$28m (US$22m) up 27%
RoW US$4m (US$4m)
Good growth in a quarter again.
gsk's comments:
New growth drivers
Arixtra, for deep vein thrombosis and pulmonary embolism, delivered strong growth with sales up 70% to
£35 million. Sales grew in Europe (up 33% to £14 million) following approval last year for the treatment of
specific acute coronary syndromes (ACS). In the USA, GSK is in on-going discussions with the FDA
regarding a potential ACS indication.
27 March 2008
Alchemia’s generic fondaparinux a potential beneficiary of heparin product recalls.
The company has received numerous enquiries from investors regarding the recent publicity concerning patient reactions to heparins and the recall of those products in local and overseas markets. Adverse events such as anaphylaxis (acute allergic reactions) and low blood pressure have been reported in hundreds of patients who have received unfractionated heparin in the US. The FDA has also reported over 20 deaths, several linked to the adverse heparin reaction.
The heparin market is comprised of three classes of products: unfractionated heparins (heparin), an animal derived compound; Low Molecular Weight Heparins (LMWH) e.g. Lovenox®, which are modified forms of unfractionated heparin and are, therefore, also animal derived; and the synthetic heparin (fondaparinux) Arixtra®, which is a completely synthetic compound. Whilst the contamination currently affects unfractionated heparin only, it should be noted LMWH’s are also under investigation. Fondaparinux is the only drug in the heparin market which is not animal derived being completely synthetic, comprising a single purified chemical substance.
Alchemia’s CEO, Dr Pete Smith stated that in numerous studies it has been found that Arixtra® (fondaparinux) offers superior safety and efficacy over both unfractionated heparin and LMWH’s without the possibility of contamination. “We would expect that GSK’s sales of Arixtra® will benefit from the adverse publicity surrounding its competitors and that this will increase the sales potential of our generic version.” Dr Smith added, “Development of our product remains on track with the potential for approval before the end of 2008 and sales commencing early in 2009.”
The global heparin market is currently worth approximately $US4.6 billion of which $US400 million is unfractionated heparin, about $US4 billion is LMWH, with the only currently available synthetic heparin, Arixtra®, earning about $US200 million in 2007 an increase of 87% over 2006 sales.
Alchemia has the only generic version of Arixtra
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28043443
Ark Therapeutics - Leader in Gene Therapy
Ark therapeutics (AKT.L)
Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p
Exciting times for Ark Therapeutics
Created:11 March 2008
Written by:Richard Hemming
The much anticipated data for Ark Therapeutics’ brain cancer drug, Cerepro, is due at the end of July and chief executive Nigel Parker knows what is at stake: “Once we get an approval of Cerepro the future of this company is assured.”
Nomura Code analyst Samir Devani puts the likelihood of success of the Phase III trial at 50 per cent. A failure would see a 50 per cent fall in the share price, but success is likely to see the share price north of 200p, he says.
Ark raised over £35.4m in a placing and open offer at 105p a share last November, and the company is building up a stronger early and late stage pipeline. But investors’ confidence will be increased by Dr Parker’s belief that the compelling results for Cerepro seen in Phase II - versus patients on standard treatment - will occur again in the bigger Phase III trials.
Elsewhere, Trinam, a treatment for blood vessel blockages in dialysis patients and Vitor, for cancer-related muscle wastage, are both entering Phase III trials this half.
Nomura Code expects a loss per share of 10.9p in 2008 and has a fair value of 130-140p on the shares.
HIGHLIGHTS
Cerepro(R) * Phase III study completes recruitment
* Two successful Data Safety and Monitoring Board ("DSMB")
meetings advise no major safety concerns and recommend
trial continuation
* Clearance from the EMEA of historically difficult
technical barriers represents major breakthrough for
Cerepro(R) and the new gene-based therapeutic area
overall
Trinam(R) * Special Protocol Assistance (SPA) opened for Phase III
trial
* US Recombinant DNA Advisory Committee (RAC) gives early
clearance for Phase III trial, expected to commence in
H1 2008
VitorTM * Successful pre-Phase III FDA and EMEA scientific advice
meetings. Pilot Phase III trial expected to commence
H1 2008
Pre-clinical * Three gene-based products being prepared for Phase
I/IIa trials
* Ark Therapeutics-led consortium awarded Euro2.5m European
Commission grant for baculoviral vectors research
* Scavidin(R) demonstrates pre-clinical effectiveness in
third cancer model
Wound care * Wound care portfolio strengthened with the addition of
Kerraped(R)
Corporate/ * Formal grant of key patent for stroke in Europe
Commercial * Placing and Open Offer completed in November, raising
£35.4m net of expenses
* Cash and money market investments of £65.1m at 31
December 2007 (£48.4m at 31 December 2006)
Post-period events * January 2008 DSMB meeting confirms timing of preliminary
results from Phase III Cerepro(R) trial due Q3 2008
* Acquisition of Lymphatix Oy strengthens gene research
technology and secures licences for VEGF C and VEGF
D genes
* Finnish manufacturing facility completes validation
review to USA standards
* Neuropad(R) in-licensed and launched in the UK
(see separate press release)
Pipeline Review
Pharmaceuticals
Cerepro(R)
Throughout 2007 we continued to manufacture commercial grade batches of Cerepro
(R) to the rigorous standards agreed with the EMEA. In the first half we
pioneered the process controls necessary for approval of adenoviral gene
medicines in Europe and we believe that the patents for these will, once
granted, help maintain our leading position for both Cerepro(R) and in this area
overall. At the end of 2006 the DSMB had reviewed the first 133 patients
recruited into the Cerepro(R) Phase III corroborative study and recommended the
study continue as planned. In early Q2 we completed recruitment of the full 250
patients and in July the DSMB again recommended continuation of the study. Also
in Q2, the EMEA concluded its first review of our application for conditional
marketing approval which we filed on the basis of the existing Phase II trials.
The EMEA concluded that whilst the critical chemistry and manufacturing controls
(CMC), pre-clinical and environmental sections appeared satisfactory and the
safety profile appeared acceptable, an approval based on efficacy from a limited
number of treated patients was insufficient for a new class of drug despite it
being an Orphan Drug. Additional proof of efficacy from the ongoing Phase III
corroborative study was requested by the EMEA as necessary for an approval.
Being cleared through the three key technical CMC, pre-clinical and
environmental sections of the marketing application is a major breakthrough for
Ark and for the biotech sector overall. It has effectively established that,
providing satisfactory clinical data exists, this type of gene medicine is an
approvable platform.
Consequently, since the conditional approval route was no longer the correct
process for an approval based on a full trials programme, the Company withdrew
its application and will apply for a full licence once the results of the
corroborative study are available. Following the January 2008 DSMB meeting,
these are scheduled for Q3 2008.
VitorTM
Following a successful pre-Phase III meeting with the EMEA and the FDA, the
Company applied for Special Protocol Assistance ("SPA") from the FDA. Once
granted, SPA allows the final Phase III programme to be designed with the US
regulators such that, if successful, a rapid review process takes place. Whilst
SPA can delay commencement of the Phase III programme, it usually achieves a
greater time-saving during the approval process and reduces the risk of a
programme design problem preventing an approval. The SPA process opened in Q2
and, following a number of consultation and review meetings with the FDA, the
Company decided to run a pilot Phase III to obtain extra data not available from
early studies, prior to concluding the SPA. Whilst this has delayed the start
of the Phase III programme by around a year, Ark believes this sensible and
cautious approach is correct to ensure the appropriate Phase III programme is
conducted. Recruitment of the first patient is expected H1 2008.
Trinam(R)
The end of Phase II meeting with the FDA in 2006 resulted in Ark being offered
SPA for the Phase III development. In the first half of the year we filed the
relevant applications to the US recombinant advisory committee ("RAC") and to
the FDA to open the SPA. We were encouraged that attitudes to gene medicine in
the US had also advanced when rapid clearance for the Trinam Phase III was given
by RAC mid year, without the need for an oral hearing. The SPA progressed
steadily during the rest of the year and we conducted a further pre-clinical
study, as requested by the FDA, to expand the number of operative procedures for
which Trinam(R) might be used. Whilst we had hoped to conclude the SPA in 2007,
the outbreak of foot and mouth disease in the UK stopped animal movements and
caused us a three month delay, but work was completed at the end of the year and
the SPA process is expected to conclude shortly.
Pre-clinical Research
Our pre-clinical programmes have shown considerable advancement in 2007 and we
have increasingly focused our efforts on the DNA-based areas of our research
where our skill base and resources are world-leading. In January 2007 we held
our first R&D day for analysts and investors at our Kuopio facility. The day
was well attended and gave us the opportunity to show the size and scope of our
new research and manufacturing facilities and to introduce the results of some
of our most promising research programmes. These are advancing the way DNA can
be used as highly selective medicines in conditions where existing treatments
and old pharmaceutical chemistry based approaches are inadequate. We were very
pleased with the positive response from attendees and the coverage which we
received.
In February we announced a Euro2.5m consortium grant to undertake pioneering work
in the use of insect-derived baculoviruses to further their use in the gene
medicine area. Further pre-clinical proof-of-principle results were obtained
mid year for our Scavidin(R) product which showed efficacy in a third cancer
model, giving us confidence to plan the final pre-clinical work and associated
GMP manufacturing to take the product into clinical development. In Q3 we
showed for the first time the extremely exciting results for our VEGF work in
the ischaemic myocardium using the same adenoviral delivery technology as in
Cerepro(R) and Trinam(R). In Q4 we also showed the market further pre-clinical
results for our DNA-based medicines in the areas of foetal growth restriction,
wound healing and coronary artery bypass graft. These are all serious areas of
unmet clinical need, in which our understanding of the disease at the molecular
biology level is enabling us to develop second generation gene medicine products
where the therapeutic gene can be optimised to the problem and be delivered via
our established adenoviral platform.
Late in the year we concluded negotiations with Lymphatix Oy, a Helsinki-based
private biotech company and acquired the business in an all-share transaction at
the start of 2008. This acquisition has given us access to certain scientific
technologies to speed up our pre-clinical programmes, as well as a licence to
the angiogenic and lymphangiogenic applications for VEGF-D and C.
We are also moving towards lead optimisation with our Neuropilin-1 antagonist
programme and our targeted vector and earlier gene science research continues to
advance. Our goal is to move three of our most promising pre-clinical products
through to the first human studies, to gain key first efficacy data in the
target disease.
The strength and quality of our pre-clinical science was reinforced this year by
the European Euro2.5m baculovirus grant, where our application achieved one of the
highest scores possible in review, and by the successful Q4 fundraising where
significant proceeds were raised to progress the pre-clinical gene-based
programmes.
Patent Portfolio Update
In 2007 Ark had 36 new patents granted including the important "ACE stroke"
patent for Europe. We filed 14 new applications and, in accordance with our
constant review policy, abandoned 12 which we felt had no clear commercial
value. At present Ark has 186 patents granted and 160 pending applications and
we continue to demonstrate success in overcoming the various objections and
oppositions in the prosecution process. In the latter part of 2007 we filed
applications covering manufacturing processes which, if granted, would give our
gene-based products protection until 2027.
Wound Care Business
Combined sales of our wound care products showed good growth in 2007. Overall,
our ex-warehouse sales averaged an increase of 66% over 2006. Whilst our wound
care business is still relatively small, we are pleased with the growth and we
believe we are seeing some signs that the NHS is beginning to move from a
containment mode towards an optimisation mode where Ark's new product range,
which stands up to the latest health economic scrutiny, should do well.
Late in the period we introduced Kerraped(R), a special medical shoe which
off-loads pressure from the areas of the foot most prone to diabetic ulcers.
This is the first product of this class to receive reimbursement in the UK.
Early signs are that the market has received the product enthusiastically and
first sales occurred at the very end of the year. Very recently, we have
introduced the Neuropad(R) diagnostic test, to detect peripheral autonomic
neuropathy in the feet of diabetic patients, to UK podiatrists and we will
continue to add further new products to the business to build scale in this
challenging UK healthcare environment.
Summary and Outlook
In 2007 we made substantial progress. The pioneering work on regulatory
standards for gene therapy, progressing our other leads towards Phase III and
the grant of the European stroke patent are some of the most important
achievements in the history of the Company. This success, together with our
pre-clinical progress, catalysed the Placing and Open Offer which has allowed us
to strengthen considerably our balance sheet, thus securing the next stage of
the Company's development and building on our leading position in the gene
therapy area.
During 2008 we expect to maintain this momentum. Our manufacturing facility
recently achieved US production validation standards. Trinam(R) and VitorTM are
expected to enter Phase III studies and we will report the results of the
Cerepro(R) Phase III study. We already have the sales and marketing plan for
launch in place and key managers identified. 2008 should also bring further
developments in the commercialisation of our stroke patent and we expect to
introduce further wound care products to market in the UK. With the Lymphatix
acquisition and strong cash reserves we also expect to make significant progress
with the late stage pre-clinical programmes, moving them towards Phase I/IIa
development in consultation with regulators. We are very excited by our
achievements in 2007 and, whilst there are still some major challenges ahead, we
look forward to translating these plans into reality with confidence.
Alizyme PLC
Marketcap : 84 million GBP = 166,8 million US$
Cash: 16 million GBP = 31,3 million US$
Price: 39,75 p
Pipeline :
http://www.alizyme.com/alizyme/products/overview/
Presentation March 2008 << a must read
http://www.alizyme.com/alizyme/uploads/reports/Prelims2008FI…
Cetilistat (obesity + diabetes) start Phase III in 08
Renzapride (irritable bowel syndrome)1st Phase III results in April 08
Colal-Pred (ulcerative colitis) Phase III results in July and
MAA filing in 4Q 08
ATL-104 (mucositis) start Phase IIb in 08
28 March 08:
BROKERWATCH Alizyme upgraded to 'Buy' from 'Hold' at Investec
LONDON (Thomson Financial) - Investec Securities has upgraded Alizyme to 'Buy' from 'Hold',saying it believes the wait for a major partnering deal is 'almost over'.
The broker said it hopes that the company's obesity drug Cetilistat will deliver a licensing deal in the short term, and adds that the company's Irritable Bowel Syndrome drug Renzapride may also be outlicensed in the next 12 months.
It adds that further value may come from the imminent results from late stage trials on Renzapride, due to report in April, and the ulcerative colitis treatment COLAL-PRED, which it expects to be positive.
In a note to clients, the broker says it expects the company will not be coming back to the market for more cash for at least two years, pointing out that Alizyme has promised no more major R&D for at least two years without it being funded by a development partner.
re :Alchemia (synthetic heparin) update
up 30% last week
http://finance.yahoo.com/q?s=acl.ax&x=42&y=11
27-Mar-2008
Alchemia’s generic fondaparinux a potential beneficiary of heparin product recalls.
http://www.alchemia.com.au/irm/content/home.html
Alchemia Limited
Alchemia ASX symbol : ACL.AX (Australia)
Alchemia ADR symbol : AEMAY.PK ( Pink Sheets)
Marketcap : 55,9 million A$ ( 52,4 Million US$)
Cash : 20,3 million A$ ( 19 Million US$)
Price : 0,35 A$
Shares on issue: 159,851,513
Options on issue :6,768,931
Top 20 own :62% (3/3/2008)
Employees : 50
Top 20 Shareholders - at 3/3/08
http://www.alchemia.com.au/IRM/Company/ShowPage.aspx?CPID=1216
Insider Transactions
http://au.finance.yahoo.com/q/ait?s=ACL.AX
13 Feb 2008
CEO Peter Smith bought 500.000 shares at 50 cent
13 March 2008
Director Carlo Montagner bought 15.000 shares at 37,5 cent
Pipeline :
http://www.alchemia.com.au/irm/content/pipeline.html
Analyst Reports :
http://www.alchemia.com.au/irm/content/investor_analystreports.html
Alchemia Announces Successful Pre-IND Meeting With the US FDA
http://biz.yahoo.com/bw/080201/20080201005188.html?.v=1
Alchemia announces positive final data from HyCAMP Phase II
http://salesandmarketingnetwork.com/news_release.php?ID=2018509
Transcript of Interview with Alchemia's CEO 15 February 2008
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00812620ACL
Appointment of Dr Reddy's Laboratories Limited RDY as its marketing partner for synthetic heparin (fondaparinux sodium).
http://investor.biospace.com/biospace?GUID=1898426&Page=MEDIAVIEWER
Alchemia Announces Appointment of Non Executive Director
Fri Mar 7, 8:01 AM
http://ca.news.finance.yahoo.com/s/07032008/34/biz-finance-news-alchemia-announces-appointment-non-executive-director.html
Alchemia Approaching Several Key Milestones in 2008
Tuesday February 26, 8:00 am ET
BRISBANE, Australia--(BUSINESS WIRE)--Alchemia Limited (ASX:ACL - News) today announced its half year results for the six months ended 31 December 2007.
Dr Peter Smith, Alchemia´s Chief Executive Officer and Managing Director, today set out the significant progress the Company had made over the reporting period to advance and de-risk the Company´s drug discovery and delivery platforms, through the completion of a number of highly important initiatives and milestones. The major highlights for the period include:
1.
Fondaparinux Program on Track to Deliver in 2009
Generic fondaparinux remains on track for approval around the end of calendar year ("CY") 2008, subject to review times at the US Food and Drug Administration (FDA).
-- Strong growth in Arixtra(R) sales up 87% to US$200 million, from US$107 million in CY 2006. Once the FDA issue their final letter of approval for the ACS indication (an approvable letter for ACS (acute coronary syndromes) was issued early in 2007) this is likely to have a positive impact on US sales of Arixtra.
-- Alchemia remains confident that its fondaparinux will be the sole generic version of Arixtra.
-- As the only synthetic molecule in the heparin market, generic fondaparinux will not meet the same regulatory hurdles that have delayed other generic heparins of animal origin at the FDA.
2.
HyACT Technology Closer to Market
In early 2008 the Company announced the results of its successful pre-IND meeting with the FDA for the design of the pivotal Phase III study for HA-irinotecan. This important milestone significantly de-risks the program and increases the potential opportunities for partnering and financing. The Company expects to file an IND (Investigational New Drug Application) to commence pivotal clinical trials of HA-irinotecan later this financial year.
3.
Other Highlights
In addition Dr Smith noted the following key achievements:
-- Development of the VAST(TM) 'Universal Library' (UL) remains on track for completion in 2009. The UL will comprise in excess of 10,000 drug-like VAST(TM) molecules and is designed to target the therapeutically rich area of G-protein coupled receptors, GPCRs.
-- The Company has undertaken successful screens against several targets for two international drug development companies using the Company's VAST(TM) compounds, with great success and is currently developing focussed libraries for those companies.
-- Receipt of a key HyACT(R) patent granted in Europe which underpins the HyACT(R) technology and the HA-irinotecan product.
Dr Smith was also delighted with the depth and calibre of the industry experts attracted to the Company's Clinical Advisory Board (CAB) and Scientific Advisory Board (SAB). The CAB comprises experts with research and clinical experience in the field of oncology, and advises on the clinical development of HyACT(R) products. The SAB advises on disease targets for Alchemia's drug discovery technology VAST(TM).
4.
Finances
For the six months to 31 December 2007 Alchemia incurred a net loss after tax of $5.1 million (2006: $6.9 million).
Total revenue for the period was $1.2 million, down from the previous period (2006: $2 million). This decrease is due to the receipt of lower grant revenue and other income. Grant revenue was down due to lower income received from a Federal Government Commercial Ready Grant for the ACL16907 anticancer program.
Operating expenditure of $6.5 million was lower than the corresponding period (2006: $9.1 million), principally because of the reduction in R&D expenditure for the period to $1.3 million compared with the previous period (2006: $3.9 million). This is mainly due to the assumption of fondaparinux manufacturing costs by Dr Reddys.
In July the Company successfully completed a private placement of 19 million shares which raised $14.7 million (net). US institutional interest in this raise was strong and resulted in over 12 million of the shares being placed into that market. The capital raising has significantly strengthened Alchemia's balance sheet, with cash at December 31 of $20.3 million. This should provide sufficient funding to see the company through to receipt of fondaparinux revenues in 2009.
5.
The 2008 Outlook
Commenting on the outlook for the remainder of the financial year Dr Smith noted that the company has a number of significant milestones ahead. "We will continue to report on our progress with our oncology platform, including preparations for Phase III clinical trials for HA-irinotecan, partnering and development of other HyACT(R) based products. For commercial reasons we are unable to give precise guidance on the ANDA filing date for generic fondaparinux but expect this event to substantially increase interest in the stock."
-------
MARC SINATRAS BIOGUIDE: ALCHEMIA
Overview: When Alchemia arrived on the ASX it had two primary assets, its synthetic heparin program and its Vast drug design platform. In 2006, Alchemia acquired Meditech Research, adding the Hyact (from hyaluronic acid) drug delivery portfolio.
With its heparin product close to market, outstanding phase II results from Meditech´s former lead product and two quality platform technologies, Alchemia should be one of the most exciting companies around. Instead its share price, at 50 cents, is languishing near all time lows.
How does Alchemia prick investor interest? What do they need to do to be identified as company likely to generate exciting returns?
Directors: Non-executive chairman, Mel Bridges; chief executive officer, Dr Pete Smith; non-executive directors, Prof Peter Andrews, Dr Julian Clark, Dr Tracie Ramsdale, Nerolie Withnall.
The make-up of the board appears more dependent on Alchemia´s past than it does on its future and, consequently, desirable areas of expertise are missing (see below).
Product Development Programs:
1) Fondaparinux - A generic of Glaxosmithkline´s Arixtra, which is used for the prevention and treatment of deep vein thrombosis. Alchemia will receive a minimum 50 percent of the profit on sales by Dr Reddy´s Laboratories, their manufacturing and North American marketing partner. FDA approval for fondaparinux is expected in late 2008.
2) Hyact drug delivery technology - Works on the premise that many cancers express hyaluronic acid receptors and that existing chemotherapeutics entrapped in hyaluronic acid will target these cancers, leading to better safety and effectiveness.
(i) HA-Irinotecan (formerly, Hycamp) Combines HA and Pfizer´s Camptosar (irinotecan). It has been shown to significantly increase progression free survival in metastatic colorectal cancer patients compared to irinotecan alone. Only one further trial is required before the FDA will accept a new drug application. This trial should begin before 2009 and be completed in three years.
(ii) Hydox and Hyfive are combinations of HA with doxorubicin and 5-fluorouracil, respectively. Both have successfully completed phase I/IIa studies. Development plans for these products are being reviewed.
3) Vast drug development platform - versatile assembly on a sugar template (Vast) new chemical entities are created though the addition of drug-like binding groups to a carbohydrate spine in a defined manner. The performance of initial entities can be used to develop superior ones. VAST is the subject of collaborations with Euroscreen, where leads for two g-protein-coupled receptors have been identified, and with Tetraq, where hits against various opioid receptors have been obtained.
4) Novel antibiotic program - Development of antibiotics that act via a unique mechanism. Results of further preclinical testing are due in the current quarter.
Significant Product Markets: The heparin market was $US4.2 billion dollars in 2006. Various drugs crowd this market, but it is dominated by the low molecular weight heparin, Lovenox (enoxaparin). It had sales of $US3.0 billion in 2006. Sales of Arixtra were $US190 million in 2007. Several new drugs in development have the advantage of being oral. These include the highly anticipated Xarelto (rivaroxaban) from Johnson & Johnson and Bayer, which has outperformed Lovenox in comparative trials. US filing for Xarelto is expected in 2008, while EU filing occurred in 2007.
The colorectal cancer drugs market was $US7.0 billion in 2006. Irinotecan is one of seven approved drugs for patients with metastatic colorectal cancer. Its sales were $US$910 million in 2005 and $US903 million in 2006. In terms of product development, there are numerous compounds in phase II studies, while both Astra Zeneca and Pfizer have compounds in phase III trials. Other companies are combining substances with irinotecan to try and improve safety and efficacy, but Alchemia is the furthest ahead.
Verdict: Alchemia´s fondaparinux should create reasonable cash flows. It is not an easy drug to make and given Alchemia´s manufacturing patents, further generic competition is unlikely. This should allow margins to be maintained. Xarelto is likely to take significant market share from the injectable heparins. However, major pre-operatiion and post-operation markets exist where injectable heparins will be preferred. Fondaparinux should do well in these markets, given its superiority to Lovenox in clinical trials.
HA-irinotecan looks especially promising given the extremely good phase II trial results obtained recently and that only one more trial will be required before registration. Considering the current sales of Camptosar and despite the current and expected future tightening in the market for metastatic colorectal cancer drugs, HA-irinotecan could yield some very significant, low-risk cash flows.
Alchemia already possesses the technology to become an exciting company, but I am not sure its directors have the skill set to make it one. Both Hyact and Vast present an enormous array of opportunities, but without the experience to quickly and accurately choose the best opportunities for each, time will be lost and mistakes made.
The Euroscreen and Tetraq collaborations are evidence that Alchemia is getting its strategy right, while their high quality advisory boards give them access to considerable experience. Nonetheless, the injection of a big dose of experience with international pharmaceutical platform-development strategy to the board should improve the speed and efficiency with which Alchemia´s technologies are commercialized and, consequently, impress upon investors how much value there is in them.
Despite these needed changes, I believe Alchemia is one of the most undervalued ASX listed life science companies, as reflected in my valuation of $1.61 a share.
Alchemia (synthetic heparin)<<< Good News
Marketcap : 55,9 million A$ ( 52,4 Million US$)
Cash : 20,3 million A$ ( 19 Million US$)
Price : 0,35 A$
up in australia
http://au.finance.yahoo.com/q?s=ACL.AX&x=239&y=11
27 March 2008
Alchemia’s generic fondaparinux a potential beneficiary of heparin product recalls.
The company has received numerous enquiries from investors regarding the recent publicity concerning patient reactions to heparins and the recall of those products in local and overseas markets. Adverse events such as anaphylaxis (acute allergic reactions) and low blood pressure have been reported in hundreds of patients who have received unfractionated heparin in the US. The FDA has also reported over 20 deaths, several linked to the adverse heparin reaction.
The heparin market is comprised of three classes of products: unfractionated heparins (heparin), an animal derived compound; Low Molecular Weight Heparins (LMWH) e.g. Lovenox®, which are modified forms of unfractionated heparin and are, therefore, also animal derived; and the synthetic heparin (fondaparinux) Arixtra®, which is a completely synthetic compound. Whilst the contamination currently affects unfractionated heparin only, it should be noted LMWH’s are also under investigation. Fondaparinux is the only drug in the heparin market which is not animal derived being completely synthetic, comprising a single purified chemical substance.
Alchemia’s CEO, Dr Pete Smith stated that in numerous studies it has been found that Arixtra® (fondaparinux) offers superior safety and efficacy over both unfractionated heparin and LMWH’s without the possibility of contamination. “We would expect that GSK’s sales of Arixtra® will benefit from the adverse publicity surrounding its competitors and that this will increase the sales potential of our generic version.” Dr Smith added, “Development of our product remains on track with the potential for approval before the end of 2008 and sales commencing early in 2009.”
The global heparin market is currently worth approximately $US4.6 billion of which $US400 million is unfractionated heparin, about $US4 billion is LMWH, with the only currently available synthetic heparin, Arixtra®, earning about $US200 million in 2007 an increase of 87% over 2006 sales.
Reference to announcements by the Australian Therapeutic Goods Administration and the US Food and Drug Administration on this matter can be viewed at:
TGA ref
http://www.tga.gov.au/alerts/medicines/heparin.htm
FDA ref
http://www.fda.gov/cder/drug/advisory/heparin.htm
Stem Cell Therapeutics--Great Interview
Marketcap: 26 million C$
Cash: 15 million C$
Price: 0,26 C$
After a successful phase II, Stem Cell Therapeutics is confident that it can regenerate the same results in new Canadian trials. BNN interviews Alan Moore, president and CEO, Stem Cell Therapeutics.
http://broadband.bnn.ca/bnn/?sid=205&vid=40429 <<click to listen
Homepage
http://www.stemcellthera.com/
Alchemia (synthetic heparin)for anyone interested
Alchemia Limited
Alchemia ASX symbol : ACL.AX (Australia)
Alchemia ADR symbol : AEMAY.PK ( Pink Sheets)
Marketcap : 55,9 million A$ ( 52,4 Million US$)
Cash : 20,3 million A$ ( 19 Million US$)
Price : 0,35 A$
Shares on issue: 159,851,513
Options on issue :6,768,931
Top 20 own :62% (3/3/2008)
Employees : 50
Top 20 Shareholders - at 3/3/08
http://www.alchemia.com.au/IRM/Company/ShowPage.aspx?CPID=1216
Insider Transactions
http://au.finance.yahoo.com/q/ait?s=ACL.AX
13 Feb 2008
CEO Peter Smith bought 500.000 shares at 50 cent
13 March 2008
Director Carlo Montagner bought 15.000 shares at 37,5 cent
Pipeline :
http://www.alchemia.com.au/irm/content/pipeline.html
Analyst Reports :
http://www.alchemia.com.au/irm/content/investor_analystreports.html
Alchemia Announces Successful Pre-IND Meeting With the US FDA
http://biz.yahoo.com/bw/080201/20080201005188.html?.v=1
Alchemia announces positive final data from HyCAMP Phase II
http://salesandmarketingnetwork.com/news_release.php?ID=2018509
Transcript of Interview with Alchemia's CEO 15 February 2008
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00812620ACL
Appointment of Dr Reddy's Laboratories Limited RDY as its marketing partner for synthetic heparin (fondaparinux sodium).
http://investor.biospace.com/biospace?GUID=1898426&Page=MEDIAVIEWER
Alchemia Announces Appointment of Non Executive Director
Fri Mar 7, 8:01 AM
http://ca.news.finance.yahoo.com/s/07032008/34/biz-finance-news-alchemia-announces-appointment-non-executive-director.html
Alchemia Approaching Several Key Milestones in 2008
Tuesday February 26, 8:00 am ET
BRISBANE, Australia--(BUSINESS WIRE)--Alchemia Limited (�the Company�) (ASX:ACL - News) today announced its half year results for the six months ended 31 December 2007.
Dr Peter Smith, Alchemia�s Chief Executive Officer and Managing Director, today set out the significant progress the Company had made over the reporting period to advance and de-risk the Company�s drug discovery and delivery platforms, through the completion of a number of highly important initiatives and milestones. The major highlights for the period include:
1.
Fondaparinux Program on Track to Deliver in 2009
Generic fondaparinux remains on track for approval around the end of calendar year ("CY") 2008, subject to review times at the US Food and Drug Administration (FDA).
-- Strong growth in Arixtra(R) sales up 87% to US$200 million, from US$107 million in CY 2006. Once the FDA issue their final letter of approval for the ACS indication (an approvable letter for ACS (acute coronary syndromes) was issued early in 2007) this is likely to have a positive impact on US sales of Arixtra.
-- Alchemia remains confident that its fondaparinux will be the sole generic version of Arixtra.
-- As the only synthetic molecule in the heparin market, generic fondaparinux will not meet the same regulatory hurdles that have delayed other generic heparins of animal origin at the FDA.
2.
HyACT Technology Closer to Market
In early 2008 the Company announced the results of its successful pre-IND meeting with the FDA for the design of the pivotal Phase III study for HA-irinotecan. This important milestone significantly de-risks the program and increases the potential opportunities for partnering and financing. The Company expects to file an IND (Investigational New Drug Application) to commence pivotal clinical trials of HA-irinotecan later this financial year.
3.
Other Highlights
In addition Dr Smith noted the following key achievements:
-- Development of the VAST(TM) 'Universal Library' (UL) remains on track for completion in 2009. The UL will comprise in excess of 10,000 drug-like VAST(TM) molecules and is designed to target the therapeutically rich area of G-protein coupled receptors, GPCRs.
-- The Company has undertaken successful screens against several targets for two international drug development companies using the Company's VAST(TM) compounds, with great success and is currently developing focussed libraries for those companies.
-- Receipt of a key HyACT(R) patent granted in Europe which underpins the HyACT(R) technology and the HA-irinotecan product.
Dr Smith was also delighted with the depth and calibre of the industry experts attracted to the Company's Clinical Advisory Board (CAB) and Scientific Advisory Board (SAB). The CAB comprises experts with research and clinical experience in the field of oncology, and advises on the clinical development of HyACT(R) products. The SAB advises on disease targets for Alchemia's drug discovery technology VAST(TM).
4.
Finances
For the six months to 31 December 2007 Alchemia incurred a net loss after tax of $5.1 million (2006: $6.9 million).
Total revenue for the period was $1.2 million, down from the previous period (2006: $2 million). This decrease is due to the receipt of lower grant revenue and other income. Grant revenue was down due to lower income received from a Federal Government Commercial Ready Grant for the ACL16907 anticancer program.
Operating expenditure of $6.5 million was lower than the corresponding period (2006: $9.1 million), principally because of the reduction in R&D expenditure for the period to $1.3 million compared with the previous period (2006: $3.9 million). This is mainly due to the assumption of fondaparinux manufacturing costs by Dr Reddys.
In July the Company successfully completed a private placement of 19 million shares which raised $14.7 million (net). US institutional interest in this raise was strong and resulted in over 12 million of the shares being placed into that market. The capital raising has significantly strengthened Alchemia's balance sheet, with cash at December 31 of $20.3 million. This should provide sufficient funding to see the company through to receipt of fondaparinux revenues in 2009.
5.
The 2008 Outlook
Commenting on the outlook for the remainder of the financial year Dr Smith noted that the company has a number of significant milestones ahead. "We will continue to report on our progress with our oncology platform, including preparations for Phase III clinical trials for HA-irinotecan, partnering and development of other HyACT(R) based products. For commercial reasons we are unable to give precise guidance on the ANDA filing date for generic fondaparinux but expect this event to substantially increase interest in the stock."
Alchemia Limited is a biotechnology company with particular expertise in chemistry, which it has applied to the discovery and development of human therapeutic products.
Fondaparinux - a late stage generic antithrombotic with high-barrier-to-entry characteristics, targeting the multi-billion dollar heparin-drug market from 2009. ANDA filing pending.
HA-irinotecan (HyCAMP) - a late stage anticancer formulation targeting the US$900+m irinotecan market. Recently successfully completing a Phase II trial in patients with metastatic colorectal cancer. Phase III trial pending.
HyACT - a drug delivery technology, which has produced mid and late stage reformulated products with improved safety and efficacy profiles.
VASTTM - a drug discovery technology, yielding early stage new chemical entities targeting the US$100b GPCR market.
Lovenox 2x daily versus Arixtra 1x daily injection
Low Molecular Weight Heparin (LMWH)
Brands: Lovenox, Fragmin, Fraxiparin
Introduced : 1993
Source : Animal derived
Composition : Complex mixture
Delivery : 2x daily injections
Reduction in DVT : 67%
Activity : Factor II<Xa, others
---------------------------------------------------------
Fondaparinux
Brands : Arixtra
Introduced : 2002
Source : Synthetic
Composition : Single molecule
Delivery : 1x daily injection
Reduction in DVT : 85%
Activity : Factor Xa
A unique generic opportunity
Alchemia has the only known generic fondaparinux sodium
GSK’s synthetic process is complex and low-yielding
Alchemia has a superior, patented process
Completely synthetic –not animal derived
Low-molecular weight heparins e.g. Lovenox, are complex biological mixtures
Route to market via Abbreviated New Drug Application (ANDA)
Regulatory path for other generic heparins is not clear
FDA has rejected Momenta/Sandoz ANDA for generic Lovenox
Alchemia’s fondaparinux may be the first generic in the $4.5Bn heparin market
Generic copy of GlaxoSmithKline’s Arixtra®
Arixtra is gaining market share in $4.5Bn heparin market
Superior safety profile versus market leader Lovenox®
47% reduction in bleeding compared with Lovenox in ACS
Superior efficacy profile versus Lovenox
56% improvement in deep vein thrombosis (DVT) prophylaxis
New indications for Arixtra will drive future growth
Approvable letter for ACS indication 5 Feb 2007
ACS approved in EU September 2007
Highest recommendations from ECS, AHA and ACC
from Hotcopper Board :
posted by fodz
I spoke to the MD yesterday, and I feel a hell of a lot better about the company now.
Something of note that he mentioned regarding share price was that AMP are dumping the share due to them losing their biotech research guy, but that all the other top 20 shareholders haven't budged.
This will be a winner, I have absolutely no doubt. Especially with the expected market move towards synthetic heparin drugs vs animal stuff.
MARC SINATRAS BIOGUIDE: ALCHEMIA
Overview: When Alchemia arrived on the ASX it had two primary assets, its synthetic heparin program and its Vast drug design platform. In 2006, Alchemia acquired Meditech Research, adding the Hyact (from hyaluronic acid) drug delivery portfolio.
With its heparin product close to market, outstanding phase II results from Meditech�s former lead product and two quality platform technologies, Alchemia should be one of the most exciting companies around. Instead its share price, at 50 cents, is languishing near all time lows.
How does Alchemia prick investor interest? What do they need to do to be identified as company likely to generate exciting returns?
Directors: Non-executive chairman, Mel Bridges; chief executive officer, Dr Pete Smith; non-executive directors, Prof Peter Andrews, Dr Julian Clark, Dr Tracie Ramsdale, Nerolie Withnall.
The make-up of the board appears more dependent on Alchemia�s past than it does on its future and, consequently, desirable areas of expertise are missing (see below).
Product Development Programs:
1) Fondaparinux - A generic of Glaxosmithkline�s Arixtra, which is used for the prevention and treatment of deep vein thrombosis. Alchemia will receive a minimum 50 percent of the profit on sales by Dr Reddy�s Laboratories, their manufacturing and North American marketing partner. FDA approval for fondaparinux is expected in late 2008.
2) Hyact drug delivery technology - Works on the premise that many cancers express hyaluronic acid receptors and that existing chemotherapeutics entrapped in hyaluronic acid will target these cancers, leading to better safety and effectiveness.
(i) HA-Irinotecan (formerly, Hycamp) � Combines HA and Pfizer�s Camptosar (irinotecan). It has been shown to significantly increase progression free survival in metastatic colorectal cancer patients compared to irinotecan alone. Only one further trial is required before the FDA will accept a new drug application. This trial should begin before 2009 and be completed in three years.
(ii) Hydox and Hyfive are combinations of HA with doxorubicin and 5-fluorouracil, respectively. Both have successfully completed phase I/IIa studies. Development plans for these products are being reviewed.
3) Vast drug development platform - versatile assembly on a sugar template (Vast) new chemical entities are created though the addition of drug-like binding groups to a carbohydrate spine in a defined manner. The performance of initial entities can be used to develop superior ones. VAST is the subject of collaborations with Euroscreen, where leads for two g-protein-coupled receptors have been identified, and with Tetraq, where hits against various opioid receptors have been obtained.
4) Novel antibiotic program - Development of antibiotics that act via a unique mechanism. Results of further preclinical testing are due in the current quarter.
Significant Product Markets: The heparin market was $US4.2 billion dollars in 2006. Various drugs crowd this market, but it is dominated by the low molecular weight heparin, Lovenox (enoxaparin). It had sales of $US3.0 billion in 2006. Sales of Arixtra were $US190 million in 2007. Several new drugs in development have the advantage of being oral. These include the highly anticipated Xarelto (rivaroxaban) from Johnson & Johnson and Bayer, which has outperformed Lovenox in comparative trials. US filing for Xarelto is expected in 2008, while EU filing occurred in 2007.
The colorectal cancer drugs market was $US7.0 billion in 2006. Irinotecan is one of seven approved drugs for patients with metastatic colorectal cancer. Its sales were $US$910 million in 2005 and $US903 million in 2006. In terms of product development, there are numerous compounds in phase II studies, while both Astra Zeneca and Pfizer have compounds in phase III trials. Other companies are combining substances with irinotecan to try and improve safety and efficacy, but Alchemia is the furthest ahead.
Verdict: Alchemia�s fondaparinux should create reasonable cash flows. It is not an easy drug to make and given Alchemia�s manufacturing patents, further generic competition is unlikely. This should allow margins to be maintained. Xarelto is likely to take significant market share from the injectable heparins. However, major pre-operatiion and post-operation markets exist where injectable heparins will be preferred. Fondaparinux should do well in these markets, given its superiority to Lovenox in clinical trials.
HA-irinotecan looks especially promising given the extremely good phase II trial results obtained recently and that only one more trial will be required before registration. Considering the current sales of Camptosar and despite the current and expected future tightening in the market for metastatic colorectal cancer drugs, HA-irinotecan could yield some very significant, low-risk cash flows.
Alchemia already possesses the technology to become an exciting company, but I am not sure its directors have the skill set to make it one. Both Hyact and Vast present an enormous array of opportunities, but without the experience to quickly and accurately choose the best opportunities for each, time will be lost and mistakes made.
The Euroscreen and Tetraq collaborations are evidence that Alchemia is getting its strategy right, while their high quality advisory boards give them access to considerable experience. Nonetheless, the injection of a big dose of experience with international pharmaceutical platform-development strategy to the board should improve the speed and efficiency with which Alchemia�s technologies are commercialized and, consequently, impress upon investors how much value there is in them.
Despite these needed changes, I believe Alchemia is one of the most undervalued ASX listed life science companies, as reflected in my valuation of $1.61 a share.
CEO & Directors are buying Alchemia
13 Feb 2008
CEO Peter Smith bought 500.000 shares at 50 cent
13 March 2008
Director Carlo Montagner bought 15.000 shares at 37,5 cent
Heparin Trail: Pig Intestines From China Via Wisconsin
Posted by Jacob Goldstein February 15, 2008, 8:27 am
http://blogs.wsj.com/health/2008/02/15/heparin-trail-pigs-intestines-from-china-via-wisconsin/
This is what global drug outsourcing looks like.
Baxter International, of Deerfield, Ill., buys the active ingredient for the anti-clotting drug heparin (possibly tied to a few deaths and several hundred cases of nasty side effects) from Scientific Protein Laboratories of Waunakee, Wis., the WSJ reports.
chinadrugsScientific Protein gets most of the stuff — which comes from pig intestines — from a joint venture called Changzhou SPL in Changzhou, China. Scientific Protein, by the way, is owned mostly by a buyout and financing firm called American Capital Strategies based in Bethesda, Md.
Got all that?
The heparin story is adding to worries over FDA oversight of imported drugs and drug ingredients and heightening specific concerns about Chinese health products. China, though a minor supplier of finished drugs, already is a major source of active ingredients for drugs. FDA says it hasn’t inspected the Changzhou plant. The agency is required to inspect domestic drug manufacturers every two years, but that requirement doesn’t apply to the growing number of overseas plants.
Scientific Protein said it has been making the heparin active ingredient at the Chinese plant since 2004, and that the company “engages in the same testing and quality-control procedures as U.S. facilities that produce bulk heparin” and meet FDA standards.
David G. Strunce, president of Scientific Protein, told the WSJ that most of its active ingredient for heparin is made in China, but some comes from a Wisconsin factory. “There’s nothing that would explain these reactions, and we are very concerned about this,” he said. “We have no idea if these reactions have anything to do with our product.”
________________________________________________________________
All natural heparins are now sourced from pig intestines. That includes the full length heparin Baxter was selling and the low molecular weight heparins like enoxaparin. They used to be sourced from Cattle as well but since mad cow disease that supply source has stopped.
The issue with the Baxter material seems to one of quality control. That's a very difficult issue when the product is extracted from animal sources because the heparin comes out as a complex mixture (like crude oil). It is not yet certain whether that is at source or in the US (though I bet there will be a lot of finger pointing going on).
Fortunately for Alchemia, fondaparinux is a synthetic heparin and can't suffer from animal contamination issues. It will be interesting to see how much of the market moves to the safer fondaparinux option in light of the recent problems with pig heparin. Fondaparinux certainly seems to have a market advantage here.
Insider & Institutional Transactions
Insider Transactions
http://au.finance.yahoo.com/q/ait?s=ACL.AX
Institutional Transactions
http://au.finance.yahoo.com/q/ast?s=ACL.AX
Alchemia Approaching Several Key Milestones in 2008
Tue Feb 26, 8:22 AM
BRISBANE, Australia--(BUSINESS WIRE)--Alchemia Limited (“the Company”) (ASX: ACL.AX) today announced its half year results for the six months ended 31 December 2007.
Dr Peter Smith, Alchemia’s Chief Executive Officer and Managing Director, today set out the significant progress the Company had made over the reporting period to advance and de-risk the Company’s drug discovery and delivery platforms, through the completion of a number of highly important initiatives and milestones. The major highlights for the period include:
Fondaparinux Program on Track to Deliver in 2009
Generic fondaparinux remains on track for approval around the end of calendar year ("CY") 2008, subject to review times at the US Food and Drug Administration (FDA).
Strong growth in Arixtra(R) sales up 87% to US$200 million, from US$107 million in CY 2006. Once the FDA issue their final letter of approval for the ACS indication (an approvable letter for ACS (acute coronary syndromes) was issued early in 2007) this is likely to have a positive impact on US sales of Arixtra.
Alchemia remains confident that its fondaparinux will be the sole generic version of Arixtra.
As the only synthetic molecule in the heparin market, generic fondaparinux will not meet the same regulatory hurdles that have delayed other generic heparins of animal origin at the FDA.
HyACT Technology Closer to Market
In early 2008 the Company announced the results of its successful pre-IND meeting with the FDA for the design of the pivotal Phase III study for HA-irinotecan. This important milestone significantly de-risks the program and increases the potential opportunities for partnering and financing. The Company expects to file an IND (Investigational New Drug Application) to commence pivotal clinical trials of HA-irinotecan later this financial year.
Other Highlights
In addition Dr Smith noted the following key achievements:
Development of the VAST(TM) 'Universal Library' (UL) remains on track for completion in 2009. The UL will comprise in excess of 10,000 drug-like VAST(TM) molecules and is designed to target the therapeutically rich area of G-protein coupled receptors, GPCRs.
The Company has undertaken successful screens against several targets for two international drug development companies using the Company's VAST(TM) compounds, with great success and is currently developing focussed libraries for those companies.
Receipt of a key HyACT(R) patent granted in Europe which underpins the HyACT(R) technology and the HA-irinotecan product.
Dr Smith was also delighted with the depth and calibre of the industry experts attracted to the Company's Clinical Advisory Board (CAB) and Scientific Advisory Board (SAB). The CAB comprises experts with research and clinical experience in the field of oncology, and advises on the clinical development of HyACT(R) products. The SAB advises on disease targets for Alchemia's drug discovery technology VAST(TM).
Finances
For the six months to 31 December 2007 Alchemia incurred a net loss after tax of $5.1 million (2006: $6.9 million).
Total revenue for the period was $1.2 million, down from the previous period (2006: $2 million). This decrease is due to the receipt of lower grant revenue and other income. Grant revenue was down due to lower income received from a Federal Government Commercial Ready Grant for the ACL16907 anticancer program.
Operating expenditure of $6.5 million was lower than the corresponding period (2006: $9.1 million), principally because of the reduction in R&D expenditure for the period to $1.3 million compared with the previous period (2006: $3.9 million). This is mainly due to the assumption of fondaparinux manufacturing costs by Dr Reddys.
In July the Company successfully completed a private placement of 19 million shares which raised $14.7 million (net). US institutional interest in this raise was strong and resulted in over 12 million of the shares being placed into that market. The capital raising has significantly strengthened Alchemia's balance sheet, with cash at December 31 of $20.3 million. This should provide sufficient funding to see the company through to receipt of fondaparinux revenues in 2009.
The 2008 Outlook
Commenting on the outlook for the remainder of the financial year Dr Smith noted that the company has a number of significant milestones ahead. "We will continue to report on our progress with our oncology platform, including preparations for Phase III clinical trials for HA-irinotecan, partnering and development of other HyACT(R) based products. For commercial reasons we are unable to give precise guidance on the ANDA filing date for generic fondaparinux but expect this event to substantially increase interest in the stock."
re: The only fully synthetic Heparin near approval(end 2008)
good article in the "Biotech Daily News"
MARC SINATRAS BIOGUIDE: ALCHEMIA
Overview: When Alchemia arrived on the ASX it had two primary assets, its synthetic heparin program and its Vast drug design platform. In 2006, Alchemia acquired Meditech Research, adding the Hyact (from hyaluronic acid) drug delivery portfolio.
With its heparin product close to market, outstanding phase II results from Meditech�s former lead product and two quality platform technologies, Alchemia should be one of the most exciting companies around. Instead its share price, at 50 cents, is languishing near all time lows.
How does Alchemia prick investor interest? What do they need to do to be identified as company likely to generate exciting returns?
Financials: Market cap: A$80 million; cash: A$20.3 million; last quarter cash burn: $1.7 million.
Directors: Non-executive chairman, Mel Bridges; chief executive officer, Dr Pete Smith; non-executive directors, Prof Peter Andrews, Dr Julian Clark, Dr Tracie Ramsdale, Nerolie Withnall.
The make-up of the board appears more dependent on Alchemia�s past than it does on its future and, consequently, desirable areas of expertise are missing (see below).
Product Development Programs:
1) Fondaparinux - A generic of Glaxosmithkline�s Arixtra, which is used for the prevention and treatment of deep vein thrombosis. Alchemia will receive a minimum 50 percent of the profit on sales by Dr Reddy�s Laboratories, their manufacturing and North American marketing partner. FDA approval for fondaparinux is expected in late 2008.
2) Hyact drug delivery technology - Works on the premise that many cancers express hyaluronic acid receptors and that existing chemotherapeutics entrapped in hyaluronic acid will target these cancers, leading to better safety and effectiveness.
(i) HA-Irinotecan (formerly, Hycamp) � Combines HA and Pfizer�s Camptosar (irinotecan). It has been shown to significantly increase progression free survival in metastatic colorectal cancer patients compared to irinotecan alone. Only one further trial is required before the FDA will accept a new drug application. This trial should begin before 2009 and be completed in three years.
(ii) Hydox and Hyfive are combinations of HA with doxorubicin and 5-fluorouracil, respectively. Both have successfully completed phase I/IIa studies. Development plans for these products are being reviewed.
3) Vast drug development platform - versatile assembly on a sugar template (Vast) new chemical entities are created though the addition of drug-like binding groups to a carbohydrate spine in a defined manner. The performance of initial entities can be used to develop superior ones. VAST is the subject of collaborations with Euroscreen, where leads for two g-protein-coupled receptors have been identified, and with Tetraq, where hits against various opioid receptors have been obtained.
4) Novel antibiotic program - Development of antibiotics that act via a unique mechanism. Results of further preclinical testing are due in the current quarter.
Significant Product Markets: The heparin market was $US4.2 billion dollars in 2006. Various drugs crowd this market, but it is dominated by the low molecular weight heparin, Lovenox (enoxaparin). It had sales of $US3.0 billion in 2006. Sales of Arixtra were $US190 million in 2007. Several new drugs in development have the advantage of being oral. These include the highly anticipated Xarelto (rivaroxaban) from Johnson & Johnson and Bayer, which has outperformed Lovenox in comparative trials. US filing for Xarelto is expected in 2008, while EU filing occurred in 2007.
The colorectal cancer drugs market was $US7.0 billion in 2006. Irinotecan is one of seven approved drugs for patients with metastatic colorectal cancer. Its sales were $US$910 million in 2005 and $US903 million in 2006. In terms of product development, there are numerous compounds in phase II studies, while both Astra Zeneca and Pfizer have compounds in phase III trials. Other companies are combining substances with irinotecan to try and improve safety and efficacy, but Alchemia is the furthest ahead.
Verdict: Alchemia�s fondaparinux should create reasonable cash flows. It is not an easy drug to make and given Alchemia�s manufacturing patents, further generic competition is unlikely. This should allow margins to be maintained. Xarelto is likely to take significant market share from the injectable heparins. However, major pre-operatiion and post-operation markets exist where injectable heparins will be preferred. Fondaparinux should do well in these markets, given its superiority to Lovenox in clinical trials.
HA-irinotecan looks especially promising given the extremely good phase II trial results obtained recently and that only one more trial will be required before registration. Considering the current sales of Camptosar and despite the current and expected future tightening in the market for metastatic colorectal cancer drugs, HA-irinotecan could yield some very significant, low-risk cash flows.
Alchemia already possesses the technology to become an exciting company, but I am not sure its directors have the skill set to make it one. Both Hyact and Vast present an enormous array of opportunities, but without the experience to quickly and accurately choose the best opportunities for each, time will be lost and mistakes made.
The Euroscreen and Tetraq collaborations are evidence that Alchemia is getting its strategy right, while their high quality advisory boards give them access to considerable experience. Nonetheless, the injection of a big dose of experience with international pharmaceutical platform-development strategy to the board should improve the speed and efficiency with which Alchemia�s technologies are commercialized and, consequently, impress upon investors how much value there is in them.
Despite these needed changes, I believe Alchemia is one of the most undervalued ASX listed life science companies, as reflected in my valuation of $1.61 a share.
Alchemia closed at 39 cents.
re :MNTA is working on a generic version of Lovenox.
Please Dew do some research before you post !
Synthetic heparin programme on track to deliver in 2008
Also GlaxoSmithKline (GSK) has released solid 4Q07 Arixtra sales results, with the
historical upward trend intact. Given that ACL is developing the only generic version
of GSK’s Arixtra (fondaparinux); we are focused on the level of sales recorded for
Arixtra. ACL also remains on track for approval of its generic fondaparinux around the
end CY08, depending on FDA review times. Further detail is contained overleaf.
Quarterly Arixtra results continue to trend upwards
GlaxoSmithKline (GSK) released its 4Q07 results on 8 February. Given that ACL is
developing the only generic version of GSK’s Arixtra (fondaparinux sodium), we are
focused on the level of sales recorded for Arixtra. The solid sales data reported
supports our positive outlook for ACL and we believe that the approvals for further
indications in the US and EU will further drive sales. The table below lists the recent
quarterly sale figures.
■ Following a flat 3Q07, it was pleasing to see Arixtra sales continue to grow in line
with historical trends to US$59m for the quarter and US$200m for CY07. We note
that in GSK’s quarterly presentation, the company identified Arixtra as a new
product opportunity, particularly with the ACS indication pending approval.
■ GSK received an approvable letter from the FDA in February 2007 for the use of
Arixtra in acute coronary syndrome (ACS) and submitted additional information to
the agency during the first quarter to support this. We are still awaiting approval
for this indication. We are not aware of any issues which are slowing this process
and take comfort from GSK’s mention of the ACS indication in its presentation
that this may well be around the corner. We think this approval will have a
positive impact on US sales of Arixtra.
■ In September 2007 GSK received the formal approval from the European
Medicines Agency (EMEA) for the once daily use of Arixtra for the treatment of
patients with ACS. We think this is a key driver of EU qoq growth.
■ ACL’s generic copy of Arixtra will be able to enter the EU market in 2012, when EU
market exclusivity expires. We also expect to see first sales in the US in 1HCY09,
following approval around the end of CY08, an important milestone for the
company.
re :Alchemia vs Momenta Pharma = Alchemia is the Winner
They are not in competition with one another.
not ?
http://www.nelm.nhs.uk/Record%20Viewing/vR.aspx?id=587147
Fondaparinux more effective than enoxaparin at slowing bleeding during PCI?
Date Published 12/11/2007
Reporter initials Nicola
Reporter surname Pocock
Reporter affiliation Hospital Pharmacist
Source J Am Coll Cardiol 2007;50:1742-1751.
Resource Links
PubMed abstract
NeLM ‘In-Focus’ of OASIS-5
According to the findings of a prospectively planned analysis of the OASIS-5 trial, fondaparinux is associated with a lower risk of major bleeding than enoxaparin in patients with acute coronary syndrome (ACS) who undergo early percutaneous coronary intervention (PCI).
The OASIS-5 (Fifth Organisation to Assess Strategies in Acute Ischaemic Syndromes) trial compared the efficacy and safety of fondaparinux with enoxaparin in patients with ACS without ST-segment elevation. The full results of this study were published in NEJM in 2006, and were the subject of an ‘In Focus’ article on NeLM (see link above to view). In summary, the study found that fondaparinux had a similar efficacy to enoxaparin in the short-term, but was associated with a reduced incidence of major bleeding at day 9 (2.2% vs. 4.1%; HR 0.52; [0.44 to 0.61]; p<0.001) and a lower mortality at day 30 (2.9% vs. 3.5%; HR 0.83; [0.71 to 0.97]; p=0.02).
In this analysis, the authors focus on the outcomes of treatment in the 6,238 patients who underwent PCI. In those randomised to fondaparinux, intravenous fondaparinux was given for PCI. In the enoxaparin group, no additional anticoagulant was given if PCI was less than 6 h from last subcutaneous dose, and additional intravenous unfractionated heparin (UFH) was given if PCI was greater than 6 hours after the last dose. The main findings in this subgroup were:
• At day 9, the incidence of major bleeding was 2.4% in the fondaparinux group versus 5.1% in the enoxaparin group (hazard ratio [HR] 0.46, p < 0.00001)
• In the fondaparinux group, 6.3% of patients experienced a death, MI, or stroke by day 9, compared with 6.2% of patients in the enoxaparin group (HR 1.03, 95% CI 0.84 to 1.25, p = 0.79)
• The net clinical composite of death, MI, stroke, or major bleeding was statistically significantly lower with fondaparinux compared with enoxaparin at day 9 (8.2% vs. 10.4%, HR 0.78, p = 0.004).
• Catheter thrombus was more common in patients receiving fondaparinux (0.9%) than enoxaparin alone (0.4%), but was largely prevented by using UFH at the time of PCI, without any increase in bleeding
The authors conclude that these results were similar to those for trial participants who had not undergone PCI. They conclude that "a tailored approach of using fondaparinux in a broad range of patients with ACS as initial upstream therapy, followed by targeted therapy with UFH in those who require a PCI procedure, is an attractive strategy for the management of ACS."
Correction
Marketcap : 54 million US$ (not 100 million US$)
http://www.alchemia.com.au/irm/content/investor_investorfactsheet.html
The only fully synthetic Heparin near approval (end 2008)
Alchemia vs Momenta Pharma = Alchemia is the Winner
Alchemia Limited (acl.ax)
Marketcap: 100 million US$
Cash: 19 million US$
Generic fondaparinux (arixtra) - a unique drug opportunity
http://www.alchemia.com.au/irm/content/products.html
Analyst Reports --- ABN AMRO
http://www.alchemia.com.au/irm/content/investor_analystreports.html
Alchemia Approaching Several Key Milestones in 2008
Tue Feb 26, 8:22 AM
BRISBANE, Australia--(BUSINESS WIRE)--Alchemia Limited (“the Company”) (ASX: ACL.AX) today announced its half year results for the six months ended 31 December 2007.
Dr Peter Smith, Alchemia’s Chief Executive Officer and Managing Director, today set out the significant progress the Company had made over the reporting period to advance and de-risk the Company’s drug discovery and delivery platforms, through the completion of a number of highly important initiatives and milestones. The major highlights for the period include:
Fondaparinux Program on Track to Deliver in 2009
Generic fondaparinux remains on track for approval around the end of calendar year ("CY") 2008, subject to review times at the US Food and Drug Administration (FDA).
-- Strong growth in Arixtra(R) sales up 87% to US$200 million, from US$107 million in CY 2006. Once the FDA issue their final letter of approval for the ACS indication (an approvable letter for ACS (acute coronary syndromes) was issued early in 2007) this is likely to have a positive impact on US sales of Arixtra.
-- Alchemia remains confident that its fondaparinux will be the sole generic version of Arixtra.
-- As the only synthetic molecule in the heparin market, generic fondaparinux will not meet the same regulatory hurdles that have delayed other generic heparins of animal origin at the FDA.
HyACT Technology Closer to Market
In early 2008 the Company announced the results of its successful pre-IND meeting with the FDA for the design of the pivotal Phase III study for HA-irinotecan. This important milestone significantly de-risks the program and increases the potential opportunities for partnering and financing. The Company expects to file an IND (Investigational New Drug Application) to commence pivotal clinical trials of HA-irinotecan later this financial year.
Other Highlights
In addition Dr Smith noted the following key achievements:
-- Development of the VAST(TM) 'Universal Library' (UL) remains on track for completion in 2009. The UL will comprise in excess of 10,000 drug-like VAST(TM) molecules and is designed to target the therapeutically rich area of G-protein coupled receptors, GPCRs.
-- The Company has undertaken successful screens against several targets for two international drug development companies using the Company's VAST(TM) compounds, with great success and is currently developing focussed libraries for those companies.
-- Receipt of a key HyACT(R) patent granted in Europe which underpins the HyACT(R) technology and the HA-irinotecan product.
Dr Smith was also delighted with the depth and calibre of the industry experts attracted to the Company's Clinical Advisory Board (CAB) and Scientific Advisory Board (SAB). The CAB comprises experts with research and clinical experience in the field of oncology, and advises on the clinical development of HyACT(R) products. The SAB advises on disease targets for Alchemia's drug discovery technology VAST(TM).
Finances
For the six months to 31 December 2007 Alchemia incurred a net loss after tax of $5.1 million (2006: $6.9 million).
Total revenue for the period was $1.2 million, down from the previous period (2006: $2 million). This decrease is due to the receipt of lower grant revenue and other income. Grant revenue was down due to lower income received from a Federal Government Commercial Ready Grant for the ACL16907 anticancer program.
Operating expenditure of $6.5 million was lower than the corresponding period (2006: $9.1 million), principally because of the reduction in R&D expenditure for the period to $1.3 million compared with the previous period (2006: $3.9 million). This is mainly due to the assumption of fondaparinux manufacturing costs by Dr Reddys.
In July the Company successfully completed a private placement of 19 million shares which raised $14.7 million (net). US institutional interest in this raise was strong and resulted in over 12 million of the shares being placed into that market. The capital raising has significantly strengthened Alchemia's balance sheet, with cash at December 31 of $20.3 million. This should provide sufficient funding to see the company through to receipt of fondaparinux revenues in 2009.
The 2008 Outlook
Commenting on the outlook for the remainder of the financial year Dr Smith noted that the company has a number of significant milestones ahead. "We will continue to report on our progress with our oncology platform, including preparations for Phase III clinical trials for HA-irinotecan, partnering and development of other HyACT(R) based products. For commercial reasons we are unable to give precise guidance on the ANDA filing date for generic fondaparinux but expect this event to substantially increase interest in the stock."
About Alchemia Limited – www.alchemia.com.au
Symbollon Pharmaceuticals Signs Term Sheet to Acquire Chinese Pharmaceutical Company
Monday March 10, 10:25 am ET
Acquisition Will Expand Symbollon's Drug Development Efforts
FRAMINGHAM, MA--(MARKET WIRE)--Mar 10, 2008 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) today announced that it has signed a term sheet with all shareholders of Xi'an Maidefa Pharmaceutical Co., Ltd. ("Medpharm") to acquire Medpharm. Medpharm is a fully integrated pharmaceutical company currently marketing 23 products to the dairy and aquaculture markets in China. Medpharm was founded by Dr. Yongjun Duan, the former director of research and development of Symbollon.
Symbollon hopes to achieve the following from the acquisition:
-- Positive cash flow from anticipated 2008 Medpharm revenues;
-- Development of product formulations using Medpharm's experienced
development team;
-- Access to the Chinese clinical development market for its molecular
iodine technology;
-- Eventual commercialization of Symbollon's products in high-growth
Chinese market;
-- Broadening of Medpharm sales by in-licensing of third party products;
-- Increased licensing of our product opportunities based on clinical
data produced in China;
-- Access to low-cost manufacturing capacity for new products; and
-- Significant increase in human resources to facilitate growth.
ADVERTISEMENT
"This acquisition is a significant step forward in our plans to commercialize our proprietary molecular iodine technology," said Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals. "The major drivers for this acquisition are the synergies it will create. Symbollon owns a technology platform with over 12 product opportunities. We plan to utilize Medpharm's research and development team to initiate clinical development of some of these opportunities in China. The production of clinical data in the cost-effective Chinese market should, if successful, support attempted commercialization of these products in China and possible licensing of these products in the United States, Europe and other parts of the world. We also plan to in-license compounds for Medpharm to add to its current product portfolio. We believe that the anticipated synergy from combining Symbollon's proprietary technology with a fully integrated pharmaceutical company operating in one of the fastest growing markets in the world should produce incremental value for our stockholders."
Medpharm was founded in February 2003 by Dr. Yongjun Duan. Dr. Duan was employed from 1994 through 2001 by Symbollon, most recently as its director of research and development. While at Symbollon, Dr. Duan helped develop the IoGen(TM) compound, Symbollon's proprietary drug currently in clinical trials for the treatment of breast pain and tenderness associated with fibrocystic breast disease. After leaving Symbollon, Dr. Duan was incentivized by the Chinese government to return to Chinese to establish Medpharm. Since initiating sales in 2005, Medpharm has more than doubled its annual sales year-over-year to their current levels of over $400,000 in 2007. Based on current activities, Medpharm is anticipating further sales growth in 2008. Currently, Medpharm employs over 30 employees, with over 70% holding college degrees. Upon closing of the acquisition, Dr. Duan will be joining Symbollon as its Vice President of Asian Operations, overseeing, in part, the Medpharm activities.
Under the term sheet, Medpharm will be acquired for $1.5 million. Symbollon will acquire approximately 64% of the company in a stock swap for Symbollon shares and acquire an option to purchase the remainder of the company for cash. The option is exercisable at any time after the initial closing over the remainder of 2008. The initial closing for 64% of Medpharm is expected to occur during April 2008. Symbollon's stock shall be valued at the 20 business day weighted average of the closing price as quoted on the OTC Bulletin Board preceding the closing, not to exceed $1.42 per share. Symbollon will need additional resources in order to exercise the option and acquire the remaining 36% of Medpharm shares.
The securities to be offered to the Medpharm shareholders will not be or have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
The acquisition contemplated by the term sheet is subject, among other things, to entering into a definitive agreement among the parties, completion of due diligence, and receipt of Chinese governmental agency approval.
I fell over laughing reading about iodine for fibrocystic breast disease
I only have a small position in Symbollon
Symba.ob stock is a 100% high risk gamble but an interesting gamble
http://www.jbc.org/cgi/content/full/281/28/19762
Molecular Iodine Induces Caspase-independent Apoptosis in Human Breast Carcinoma Cells Involving the Mitochondria-mediated Pathway......
HIV & HCV first-in-class drug Undiscovered Stock
Biotron Limited (Bit.ax)
Marketcap: 14 million US$
HIV trial start Phase 1b/2a in 2Q 2008 results in 3Q 2008
HCV trial start Phase 1b/2a in 2Q 2008 results in 3Q 2008
www.biotron.com.au
BIOTRON LIMITED
DIRECTORS' REPORT
The data from this Phase I clinical trial indicated BIT225 was well tolerated, with no dose limiting toxicities. Preliminary
analysis indicated that potentially therapeutic blood levels of BIT225 were achieved, based on calculations extrapolated
from preclinical in vitro antiviral efficacy studies. The data from this Phase I trial is the first human clinical analysis of
BIT225, and are important as they set the stage for further studies of the drug in patient populations. The data
demonstrate that the absorption, distribution, half-life, and tolerability of BIT225 are acceptable, and that safety and
pharmacokinetic (PK) profiles of BIT225 support ongoing clinical development.
BIT225 represents a novel, first in class approach to the treatment of HIV. BIT225 specifically targets HIV in reservoir
cells and represents an opportunity to attack HIV at its source in the body. Current HIV therapies have little or no effect
on HIV in the underlying reservoir of infected cells where the virus hides from the immune system.
In addition, BIT225 represents a first-in-class drug for treatment of HCV, targeting the p7 protein of HCV. It is estimated
that in the USA alone, some 4 million people have been infected with Hepatitis C with 2.7 million suffering from chronic
infection. Worldwide, 170 million people are infected. HCV causes inflammation of the liver, which may lead to fibrosis
and cirrhosis, liver cancer and, ultimately, liver failure. Existing drugs for HCV have limited effectiveness and toxicity
issues, leaving a significant need for new therapies. The worldwide market is currently almost US$3.0 billion, but it is
estimated that this market will expand to over US$10.0 billion as safe, effective therapies enter the market.
During this half year period, independent research in the USA demonstrated that Biotron's lead antiviral drug, BIT225,
significantly enhances the activity of existing HCV therapies in an in vitro model system. The results of this research,
performed by Southern Research Institute, Maryland, USA, are significant as they indicate that BIT225 has the potential
to be used in combination therapy to achieve a higher level of antiviral activity against HCV than is currently possible,
while improving the potency of each of the drugs in the combination.
The results demonstrated that BIT225 was highly synergistic in a triple combination with two of the most commonly used
HCV therapies - ribavirin and interferon-α. The addition of BIT225 to ribavirin and interferon-α increased the level of
inhibition of viral replication from 70% with the two other drugs to 100% when BIT225 was added to the mix. The
potency of BIT225 was increased tenfold in this triple combination, compared to its activity on its own.
The studies were conducted in vitro against the widely accepted surrogate model of the HCV, bovine viral diarrhea virus
(BVDV). BVDV is closely related to HCV and is an in vitro predictor of the efficacy of anti-HCV drugs in humans.
Previously, Biotron reported that BIT225 is a potent inhibitor of activity in this HCV surrogate model system.
Biotron has filed a new patent to extend the current protection over its lead antiviral drug BIT225 and analogues. This
latest patent filing further strengthens Biotron's extensive intellectual property portfolio in the antiviral drug development
field.
Biotron is now focused on progressing BIT225 into Phase Ib/IIa clinical trials in both HIV and HCV infected subjects. The
completed Phase I clinical trial in healthy volunteers will support the trials in these two patient populations, which
significantly reduces the costs and timelines of Biotron's clinical development program. Trial designs and regulatory and
ethics submissions are in final review for two trials, one in HIV and one in HCV populations and, subject to regulatory and
ethics approvals, with likely commencement of these trials in the second quarter of 2008 and concluding during third
quarter of 2008.
These proposed trials in HIV and HCV patients are critical steps in the Company's development. Demonstration that
BIT225 can attack these viruses in patients will be a truly major advance in terms of Company and technology valuations.
The Company is focused on achieving a successful outcome, and has been progressing discussions with potential
pharmaceutical companies in anticipation of finalising a deal once these trials have been completed. The proposed trials
are designed to benefit shareholders through significantly increasing the value of Biotron in the market and to its future
pharmaceutical company partners.
Biotron continues to leverage shareholder funds by accessing non-equity funding to support its development programs.
During the half year period under review, the Company received a grant of $441,944 from the Commonwealth
Government's Commercial Ready Grant Program. The grant is a partial reimbursement of expenditures incurred in the
Phase I clinical development and testing of BIT225.
This latest grant is in addition to the previous grants, including a Biotechnology Innovation Fund (BIF) grant which
assisted with early-stage development of new drugs for various targeted viruses, and a Start Grant which facilitated the
selection and preclinical testing of BIT225.
In December 2007 Biotron initiated a $2.5 million underwritten Share Purchase Plan (SPP) to raise additional capital for
clinical development of its antiviral programs. The funds raised by the SPP will be used to support the Company's
ongoing operational costs, including funding the clinical development of the Company's drug BIT225 into Phase Ib/IIa
clinical trials in infected patients.
Other Viral Programs
In addition to excellent progress with the Company’s anti-HIV and HCV development programs, Biotron further advanced
its antiviral platform with the finding that several of its proprietary compounds have shown potent activity against the
Hepatitis B virus (HBV).
According to the World Health Organisation (WHO), 350 to 400 million people are chronically infected with HBV. Chronic
Hepatitis B (CHB) is a serious global health problem, with infection progressing to liver cirrhosis and hepatocellular
carcinoma, resulting in up to 1.2 million deaths worldwide each year. Up to 80% of the world's primary liver cancer,
which is currently the fifth most frequent cancer worldwide, is attributable to chronic CHB.
This latest activity data against HBV demonstrates the depth of Biotron's antiviral portfolio. The Company has an
impressive portfolio of clinical and preclinical antiviral programs developing drugs targeting HIV, HCV, Dengue virus and
Influenza virus. At present, focus is on development of the HIV and HCV programs into trials in infected patient
populations, and additional resources will be committed to these additional programs once these more advanced
programs have been successfully commercialised.
Discussions continue to be held with potential partners regarding the Virion technology. Whilst keen to secure a partner
to take the Company’s compounds through into clinical development, Biotron can significantly increase the value of the
technology by undertaking the proposed Phase Ib/IIa clinical trials before forming an alliance. This will translate into
much higher returns to the Company in the form of upfront payments as well as increased milestone and royalty
payments in the future.
The level of interest by the international community in Biotron’s antiviral programs is reflected by the selection of Biotron
to participate in several prestigious international scientific conferences. In July 2007, Biotron was selected to give two
presentations at the International AIDS Society conference in Sydney, NSW, and in December Biotron scientists were
selected to present data at an HCV conference and at an HIV conference in the USA. Presentation at these meetings
provided an excellent opportunity to further discussions of the Company’s technologies with potential pharmaceutical
mention in Hotchicksstockpicks.com
http://www.hotchicksstockpicks.com/index.php?option=com_content&task=view&id=26&Itemid=28
re re symbollon
Iodine treatment of fibrocystic breast disease
Townsend Letter for Doctors and Patients, Nov, 2004 by Alan R. Gaby
http://findarticles.com/p/articles/mi_m0ISW/is_256/ai_n6258834
One hundred-eight women with fibrocystic breast disease were treated with a preparation containing molecular (diatomic elemental) iodine at a dose of 0.08 mg per kg of body weight per day orally for nine months. Ninety-eight percent of the women were pain-free by the end of the study and objective improvement was seen in 71.8% of cases. Sixty-five percent of the women had a reduction in breast size coincident with clinical improvement. In a larger series of women (n = 1,365) treated with molecular iodine, side effects (usually minor) occurred in 10.9% of cases; these included acne, nausea, diarrhea, hair thinning, hyperthyroidism (0.1% incidence), hypothyroidism (0.3% incidence), skin rash, headache, or transient increase in breast pain (5.7% incidence).
Two other groups of women were treated with Lugol's solution (a preparation containing 95% sodium iodide and 5% free iodine) and iodized casein, respectively. The response rate with Lugol's solution was 70%, and with iodized casein was 40%. Molecular iodine was associated with a lower incidence of thyroid dysfunction than the other preparations.
Comment: Fibrocystic breast disease is one of the most common health problems in women. Although the symptoms are frequently minor, some women experience debilitating pain and discomfort. Treatments that are often effective include complete avoidance of dietary caffeine and other methylxanthines and supplementation with 400 to 800 IU per day of vitamin E. There are anecdotal reports that thiamine supplementation (100 mg per day) is also beneficial.
For women who do not respond to these treatments, oral iodine preparations are an important option. The molecular iodine used in the current study is not commercially available, but a compounding pharmacist should be able to make a similar preparation. Lugol's solution is readily available, but it has a lower success rate and causes a higher incidence thyroid dysfunction than does molecular iodine. Thyroid function should be monitored periodically in people taking pharmacological doses of iodine or iodides. Side effects may include metallic taste, excessive salivation, runny nose, and skin rash.
No Comments ?????
looks very interesting
http://www.symbollon.com/SYMBA%20TEAR%20SHEET%20REVISION%2012_31_2007.pdf
bought some shares
Exciting Range of Companies to Present at EQUITIES Magazine's Emerging Growth Stock Day Conference XV
Wednesday February 20, 12:01 am ET
NEW YORK, Feb. 20, 2008 (PRIME NEWSWIRE) -- EQUITIES Magazine proudly announces its 15th annual Emerging Growth Stock Day, to be held at the Princeton Club of New York on Friday, February 22, 2008. At this exciting event, emerging companies from a range of sectors will present to an audience of brokers, hedge fund managers, portfolio managers and sophisticated private investors.
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Opening the event will be Daniel Frishberg, founder and chairman of the BizRadio Network. Mr. Frishberg hosts the ``MoneyMan Report,'' created the MoneyGame, and runs Frishberg Jordan Steward & Kaleta Advisors, a financial services company that has $200 million under management and has returned 57% since its inception in April 2001.
The keynote speaker will be Mr. Jordan Kimmel, managing member of Magnet Management, manager of the Magnet Fund, and senior editor of the newsletter Jordan Kimmel's Magnet Investing Report. You may be familiar with his regular appearances on ABC, CNBC, Fox Business News, and on the VoiceAmerica Business Network where he hosts his weekly radio show, Profitable Investing with Jordan Kimmel.
Our list of worldwide sponsors includes NASDAQ, The Bank of New York Mellon, Standard & Poor's, the Investor Relations Group, Online Trading Academy, Argyle Executive Forum, InvestorVillage, Cambridge House, FSX, Investors Exchange, QuoteMedia, Onstream Media, National Investment Banking Association, Biz Radio Network, Richardson & Patel, and Ferrara Cafe of New York.
Seven promising companies will be presenting at EQUITIES' Emerging Growth Stock Day Conference XV in February. The list includes:
Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News), a specialty pharmaceuticals company focused on the development of women's healthcare and antimicrobial applications based on its molecular iodine technology platform.
Smart Move, Inc. (AMEX:MVE - News), an innovative logistics company that provides services through the deployment of a fleet of company-owned, GPS-equipped SmartVault moving containers to executive the movement of household and commercial goods securely and quickly.
Redpoint Bio Corp (OTC BB:RPBC.OB - News), using recent discoveries in the molecular biology of taste to discover and develop novel taste modulators for the food, beverage, and pharmaceutical industries.
Chemokine Therapeutics (OTC BB:CHKT.OB - News) (Toronto:CTI.TO - News), a leader in the design and development of peptide-based drugs targeting chemokine receptors addressing prominent diseases such as cancer, autoimmune, and cardiovascular diseases.
Meridian Medical, Inc. (OTC BB:MRDAF.OB - News), with 18 worldwide patents and over 2,000 clients, making it an established leader in the research, development, manufacturing, and sales of advanced medical devices in the worldwide healthcare industry.
SLM Holdings, Inc. (OTC BB:SMHI.OB - News), providing total turnkey customized solutions to the financial services industry. It offers CRM applications, sales tools, and data solutions that include tracking clients and prospective clients, employment, wealth, and events.
XsunX, Inc. (OTC BB:XSNX.OB - News), a thin-film photovoltaic (TFPV) company that's begun to executive a phased plan to build and install 100 mega-watts (MW) of amporphous silicon (a-Si) thin-film solar manufacturing capability. The company expects to complete base production systems in 2008 and bring production to 25MW early in 2009.
1000% and more ???? comments ?
found this on Onty board looks interesting..
Symbollon Pharma (Symba.ob)
Marketcap: 8,6 million $
Shares Outstanding : 15 million
Price: 0,57$
Massive Insider activity
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&kind=&timeframe=&intraday=&charttype=&splits=&earnings=&movingaverage=&lowerstudy=&comparison=&index=&symbol=SYMBA&symbol=PP&symbol=DNDN&symbol=PRAN&symbol=ALSE&symbol=EPCT&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&FormType=&mkttype=&pathname=&page=filings&selected=SYMBA
http://finance.yahoo.com/q/it?s=SYMBA.OB
Results of Pivotal Study to Be Published in March 2008
Symbollon Pharmaceuticals Completes Phase III Pivotal Trial for IoGen
Thursday February 7, 12:28 pm ET
FRAMINGHAM, MA--(MARKET WIRE)--Feb 7, 2008 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) today announced the completion of its IoGen(TM) Phase III pivotal trial. The study, conducted by physicians throughout the U.S., is designed to evaluate the effectiveness of IoGen, a treatment which may be the first FDA-approved, non-hormonal therapy for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD).
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With the last of the 140 patients randomized in the trial having completed the dosing stage of the study, Symbollon is focused on closing the database. The Company anticipates that the database will be locked in March 2008 and plans to release the trial results at that time.
"We believe that the release of the Phase III data will be the most significant milestone in Symbollon's history," said Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals. "Prior to this study, we had collected clinical data on approximately 3,000 women with FBD. The current Phase III study will help determine whether IoGen can be commercialized as the first non-hormonal drug approved to treat women suffering from FBD."
Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB - News) is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon is conducting a Phase III clinical trial evaluating IoGen as a potential treatment for moderate to severe periodic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD). FBD is a condition that affects approximately 20 to 33 million women in the U.S., and there are approximately 7 to 13 million women suffering from clinical periodic mastalgia. The Company believes IoGen also may be useful in treating and/or preventing endometriosis, ovarian cysts, and premenopausal breast cancer. Symbollon is also in preclinical development of antimicrobial products based on the same molecular iodine technology, and intends to investigate the potential effectiveness of its technology in applications such as dermatology, oral care, upper respiratory tract conditions, urinary tract infection and wound care. For more information about Symbollon, please visit the company's website at http://www.symbollon.com.
Symbollon Pharmaceuticals, Inc. (OTC BB: SYMBA) is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon is conducting a Phase III clinical trial evaluating IoGen (I2) for pain/tenderness associated with fibrocystic breast disease (FBD) and/or with potential to treat cancer. Enrollment for the study closes at the end of June 2007 and results are expected to be published in Q1 2008.
The Company believes IoGen has the ability to eliminate excess cell growth in female reproductive tissue, including the breast, ovaries and uterus. Other indications for IoGen include the treatment and/or preventing endometriosis, ovarian cysts, and pre-menopausal breast cancer. The company has 25 patents in the US, with foreign counterparts, covering the technology.
While there are several breast cancer drugs on the m arket, all available hormonal therapies have significant adverse effects. In contrast, IoGen is a non-hormonal treatment that allows for safe long-term use with little or no sides effects. In fact, in the last Phase II study of IoGen there were no drug-related adverse events reported.
“We believe that the current research provides substantive support for the initiation of human clinical studies on the use of molecular iodine as a treatment for breast cancer,” stated Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals, Inc. “The possibility that IoGen may be used as a treatment for breast cancer makes it all the more important that Symbollon expedite the commercialization time line for IoGen.”
Recent Developments
Symbollon announced that it would seek regulatory guidance in commercialization of IoGen in Europe. The company targeted The United Kingdom, Germany and Sweden. Symbollon has met with representatives of these regulatory bodies and has received guidance and comments, which should accelerate the commercialization of IoGen in Europe. The Company has also met with Canadian regulators and has received consistent comments that will allow for a regulatory filing after completion of the planned clinical trials.
In addition, Symbollon Pharmaceuticals announced that it is closing the enrollment of its IoGen Phase III pivotal pain study in June 2007 and anticipates announcing the study results in first quarter of 2008. The ongoing IoGen study has over 25 active sites across the United States. The study has been registered with FDA under the Protocol Registration System at ClinicalTrials.gov.
About IoGen
Symbollon has initiated a pivotal Phase III clinical trial evaluating IoGen as a potential treatment for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD).
FBD is characterized by benign excess cell growth (fibrosis) and mastalgia. Benign fibrosis is a chronic condition that affects approximately 20 million to 33 million women in the U.S. In addition, there are approximately 7 million to 13 million women suffering from clinical cyclic mastalgia.
Product Focus
Symbollon’s free molecular iodine technology has potential uses in a number of application areas, which can be broadly grouped into two areas: women’s healthcare (as mentioned above) and antimicrobial applications.
Symbollon is in preclinical development of antimicrobial and intends to investigate the potential effectiveness of its technology in applications such as dermatology, oral care, upper respiratory tract conditions, urinary tract infection and wound care.
Symbollon has commercialized one animal drug, a bovine teat sanitizer, for use on the dairy farms to disinfect cow’s udders. The product is a powdered concentrate that delivers high levels of molecular iodine for fast and effective elimination of all pathogens.
listen to the presentation and review the slides
15 Feb 2008
http://www.financialhearings.com/hearing/financia1.nsf/(recordednew)/36A4ADC8FEA67F01C12573D2002C386A?OpenDocument
listen to the presentation and review the slides
15 Feb 2008
http://media.fronto.com/streaming/fh/default.aspx?id=%7B06ff2d14-8518-4f65-9cdf-53525033dd5e%7D