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Almost one year ago, and what about the profit?
Wednesday, 21 November 2007 13:46 GMT
Leo launches antithrombin ATryn in UK - first drug from transgenic goat
http://www.apmhealtheurope.com/story.php?include_profilDepsPage=6&numero=9220&profil=92&ctx=a62e4ccb3d9cd116b77ff2fa20a35bde
Section II:
The five most promising drugs launched or receiving approval.
http://scientific.thomson.com/thomsonpharma/media/pdfs/tpqr/tp_qr_oct-dec_07.pdf
Thx Dew
Phase II Study of MM-093 to Treat Patients With Uveitis
This study is ongoing, but not recruiting participants.
http://clinicaltrials.gov/ct2/show/NCT00444743?term=MM-093&rank=1&flds=Xabco
Sponsored by: Merrimack Pharmaceuticals
Information provided by: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00444743
Last Updated:
July 24, 2008
http://clinicaltrials.gov/ct2/results?flds=Xo&flds=a&flds=b&flds=c&term=MM-093&show_flds=Y
#msg-27656417
GTC’s Largest Shareholders
Dew, those information about Genzyme is not up to date?
Correct me, if i'm wrong?
http://tiny.cc/nGNv8
Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
This study has been completed.
http://clinicaltrials.gov/ct2/show/NCT00105976?term=MM-093&rank=4&flds=Xabco
Last Updated: July 10, 2008
Yesterday partner.
Today $0.39
Is this normal, no it isn't!
0.36 dollar
Year Low!
Whats next?
Pharming Announces Positive Results From North American Randomized Trial With Rhucin®
Company to move forward with regulatory filings
Leiden, The Netherlands, June 16, 2008. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today positive safety and efficacy results from its North American trial with Rhucin® (recombinant human C1 inhibitor) for the acute treatment of Hereditary Angioedema (HAE). The positive results with both primary and secondary endpoints of study allow Pharming to move forward with regulatory filings for Rhucin®.
The randomized double-blind placebo-controlled study with Rhucin® was conducted at several sites in the US and Canada. On having an acute HAE attack, 39 patients were randomized to one of two doses of Rhucin® (100 U/kg, 50 U/kg) or placebo. For the primary endpoint, the intent-to-treat analysis demonstrates that patients who received the 100 U/k! g dose of Rhucin® reported median first symptom relief at approximately 68 minutes, those that received the 50 U/kg dose reported relief at approximately 100 minutes, and those that received placebo reported symptom relief at approximately 258 minutes. The time to minimal clinical symptoms, the secondary endpoint, was reported by patients in the 100 U/kg, 50 U/kg, placebo groups as approximately 245, 247, and 1098 minutes, respectively. The primary and secondary endpoint results with both doses of Rhucin® were clinically meaningful and statistically significant relative to placebo with p-values < 0.01. There was no statistically significant difference observed between patients treated with 100 U/kg or 50 U/kg dose of Rhucin®.
The North American randomized results with Rhucin® are in line with the positive results from the European randomized placebo-controlled Phase III clinical trial reported previously. The safety experience from the trial indicates that Rhuci! n® continues to be very well tolerated and no relevant, treatment-rel ated adverse events were reported in any of the three treatment groups. Preliminary data from the ongoing open-label phase of the study, including treatment of over 100 attacks, further demonstrates that Rhucin® is safe and effective when treating patients for HAE attacks on a repeated basis. Data on treating repeat attacks represents an important addition to the database and will strengthen upcoming filings. The full results of the open label studies in the US and EU will be reported separately.
“Rhucin® is the only recombinant human C1 inhibitor product in development for HAE patients and has now unequivocally demonstrated fast acting efficacy in two independent randomized controlled trials,” said Bruno Giannetti MD, PhD, Chief Operations Officer of Pharming. “The safety profile of the recombinant product is also excellent and has been confirmed in several clinical trials involving over 100 subjects with over 200 infusions. We wish to thank all the patient! s as well as investigators for their support in these trials and look forward to providing them a much needed treatment.”
“The results from the US study demonstrate Rhucin®’s excellent efficacy and safety profile in treating acute attacks of HAE,” said Bruce Zuraw, MD, Professor of Medicine at the University of California San Diego and Principal Investigator of the North American trial. “Having a recombinant human C1 inhibitor protein, such as Rhucin®, as a treatment option for HAE is a notable advance in the field that will be important to both patients and physicians.”
Based on these results, Pharming intends to file regulatory submissions for Rhucin® in several early launch markets in the second half of 2008 and will meet with EMEA and FDA to accelerate regulatory filings in Europe and the USA.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, aging diseases! , specialty products for surgical indications, intermediates for vario us applications and nutritional products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema and human lactoferrin for use in food products. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technologies in the field of tissue repair (via its collaboration with NovaThera) and DNA repair (via DNage BV). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
<<Pharming - GTC
so a merger w/ 1 share of Pharm.as for 1 share of GTC
would you as a shareholder approve?
if / once Rhucin gets thru regulatory,
Pharming will recover.>>
<< wont happen >>
Why not?
And again YL ?
End 2008, PPS 0.001 $
Going to hell with this.
Thank you Cox
In accordance with the existing collaboration agreement,
LFB will be providing additional FUNDING to support GTC’s work in the recombinant human alpha-1 antitrypsin program for 2008.
A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis
This study has been completed.
Last Updated: March 24, 2008
http://clinicaltrials.gov/ct2/show/NCT00458146?term=mm-093&rank=2&flds=Xabco
<< A buyout may be our last, best option.>>
Yes, and they give 100% bonus, that means 1 dollar.
Are you happy, i'm not.
ALL TIME LOW!
Who sells his shares now?
This is ridiculous, were going to zero, that's for sure!
Human Recombinant Butyrylcholinesterase Purified from the Milk of Transgenic Goats Interacts with Beta-Amyloid Fibrils and Suppresses Their Formation in vitro.
http://content.karger.com/produktedb/produkte.asp?doi=113711
Conclusion:
Our findings demonstrate that rBChE interacts with A fibrils and can attenuate their formation, extension and branching, suggesting further tests of rBChE, with unlimited supply and no associated health risks, as a therapeutic agent for delaying the formation of amyloid toxic oligomers in AD patients.
And again Year Low.
Tomorrow $0.50, what a piece of
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
This study has been completed.
http://clinicaltrials.gov/ct2/show/NCT00110513?term=ATryn&rank=2&flds=Xabco
Study ID Numbers: GTC AT HD 012-04
First Received: May 10, 2005
Last Updated: February 28, 2008
ClinicalTrials.gov Identifier: NCT00110513
Health Authority: United States: Food and Drug Administration
And again a nice PR today:
LAST PATIENT ENROLLED IN ATryn® PIVOTAL STUDY.
Always the same, good PR, but the stock is going nowhere?
Ok, one direction, always the South one, this is not normal.
SOT Annual Meeting
16 - 20 March 2008
The Use of Transgenic Animal Technology in Toxicological Research
http://www.toxicology.org/AI/MEET/AM2008/submitab.asp
AM05—BASIC
Sunday, March 16
8:15 AM–12:00 NOON
Chairperson(s): Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA and Roy Forster, CIT, Evreux, France
Endorsed by:
Comparative and Veterinary Specialty Section*
Drug Discovery Toxicology Specialty Section
Mechanisms Specialty Section
The ability to direct genetic changes at the molecular level in vivo has resulted in a revolution in biology. Nowhere has this been more apparent than in the production of transgenic animals. A host of techniques has been used to effect change in gene expression and develop new toxicological testing paradigms. Genetically modified animals are commonly produced and often yield important information relevant to safety/toxicological assessment. This session will help guide the toxicologist in the use and interpretation of data derived from transgenic models. The first speaker will introduce this topic and set the stage for subsequent speakers. The second speaker will review the history of genetic engineering technologies leading to the development of loss-of-function, gain-of-function modeling technologies across mammalian platforms. Transgenic animals have provided us with powerful tools to explore cellular and physiological processes in vivo. Current technologies allow us to modify cell-, tissue-or organ-specific gene expression in controlled temporal and spatial fashion. Accordingly, experimental considerations including strain-specific variability impacting experimental outcomes will be explored. The third speaker will cover current practice and previous experience gained in the regulatory use of transgenic animals in testing new products. In the area of safety evaluation, transgenic models have been used in the testing of biotechnology products (homologous models), in carcinogenicity testing, and in early toxicology screening. The presentation will cover the use of transgenics from the point of view of theory, the concrete practical aspects of putting such studies in place and new developments in this area. From gene-targeting, gene-trapping, and conditional expression modeling, gene knockout technology in mice is employed as an integrated platform to study physiological and behavioral functions and pharmaceutical utility of targeted genes. The fourth speaker will present recent data comparing pharmacological inhibition of selected targets, with a focus on differentiating between mechanism and nonmechanism-based toxicity and in determining on-target versus off-target toxicity for drug candidates. The final speaker will discuss how the lack of practical methods for the study of mutagenesis using endogenous genes stimulated the development of alternative mutation assays. These mutation analytical systems, developed first in rodents, and subsequently in fish share a similar general approach. Transgenic mutation models provide opportunities for comparative studies of complex processes of mutagenesis simply not possible otherwise. The introduction of a mutation model based on a transgenic fish, here the transgenic medaka, builds upon the knowledge and experience gained from the rodent models, and expands opportunities for increasing the understanding of fundamental mechanisms of mutagenesis.
Introduction,
Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA
Overview of Transgenic Animal Technology,
Carl A. Pinkert, Auburn University Auburn, AL
Current Use of Transgenics in Screening and Regulatory Toxicology,
Roy Forster, CIT, Evreux, France
Using Mouse Knockouts to Predict Mechanism-Based Toxicity,
Brian P. Zambrowicz, Lexicon Pharmaceuticals, The Woodlands, TX
From Transgenic Rodent to Fish Modeling: Enhancing Insights into Shared Mechanisms of Mutagenesis,
Richard N. Winn, University of Georgia, Athens, GA
Session III - Cancer Drug Development in Clinical Trials
Moderator: Ulrik Nielsen, Ph.D., Vice President, Research, Merrimack Pharmaceuticals
http://gtcbio.com/userAgenda.aspx?id=116
02.22.08 - 9:00
Model-Simulated Design of Cancer Therapies
Ulrik Nielsen, Ph.D., Vice President, Research, Merrimack Pharmaceuticals
Computational biology is improving our understanding of complex biological systems. Using very large biological datasets of cell signaling we have constructed detailed, mechanistic models. These may be used to predict network responses to targeted therapeutics such as monoclonal antibodies and small molecule inhibitors. Using growth factor signaling as an example, we will present how computational modeling can be used to simulate the best therapy with single agents or combinations of targeted inhibitors.
Look at this stock price, before the Approval?
http://finance.yahoo.com/q/hp?s=GTCB&a=00&b=1&c=2006&d=01&e=22&f=2008&g=d&z=66&y=462
Dew, can you see when snorkle his last post was here?
He was laughing here with us!
ATryn® (Antithrombin Alfa)
Pre-launch?
http://www.leo-pharma.com/41256A84002BE7FC/(AllDocsByDocId)/2691A92F74995CB1C1256BA00050866D?OpenDocument
Klereaandeel
zero.87
<< If the partnership news is very good, the PPS will start to move higher. >>
Again?
And again, a very nice share price.
When there is good news, we don't go up!
But when there is bad news, then we go ...
They don't want this stock, but why?
OV Grandes Pathologies - 5 AHU
Maladie thrombo-embolique veineuse.
AT
http://grandespathos.free.fr/wp-content/uploads/partie1/09_deficit-en-at-joly-devaux.ppt
http://www.pjonline.com/pdf/_donotindex/pj_20071222_nb.pdf
Drugs for which Discount is not Deducted January 2008 Changes.
http://www.psnc.org.uk/index.php?type=more_news&id=2731&k=3
The list of ‘drugs for which discount is not deducted’
is a dynamic list with additions and deletions each month.
From January 2008 the following products will be added to the list of Drugs for which discount is not deducted:
ATryn 1,750iu powder for solution for infusion vials
Fostair 100 micrograms/dose/6micrograms/dose inhaler
There are no deletions this month.
If you are unable to obtain discount on a product that you believe should be considered for inclusion in the list of ‘drugs for which discount is not deducted’, please report this to PSNC via the Zero Discount Online Reporting Form (www.psnc.org.uk/zd) or by contacting the PSNC Information Team (01296 432823/zd@psnc.org.uk). The PSNC information Team will investigate whether this product meets the new criteria and make an application to the Department of Health for the product to be listed as appropriate.
Thank you management, with 11 directors, thank you very much. Nize, very nize, 0.88 dollar?
This is not normal, with a day low of 0.84 dollar.
ATryn 1750 IU powder for solution for infusion.
(Antithrombin alfa) - New SPC
http://www.nelm.nhs.uk/Record%20Viewing/viewRecord.aspx?id=587796
Phase II Study of MM-093 to Treat Patients With Uveitis.
This study is currently recruiting participants.
Verified by Merrimack Pharmaceuticals,
December 2007
Last Updated: December 5, 2007
http://clinicaltrials.gov/ct2/show/NCT00444743?term=MM-093&rank=1&flds=Xabco
The fact is,
0.94 dollar!
A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis
This study is currently recruiting participants.
Verified by Merrimack Pharmaceuticals, November 2007
http://clinicaltrials.gov/ct2/show/NCT00458146?term=mm-093&rank=2
Last Updated: November 19, 2007
Phase 2 Study of MM-093 to Treat Patients With Uveitis
This study is currently recruiting participants.
Verified by Merrimack Pharmaceuticals, November 2007
http://clinicaltrials.gov/ct2/show/NCT00444743?term=mm-093&rank=1
Last Updated: November 19, 2007
It's already cheap for 18 months?
When is the time at last to go up?
FDA approval, partnership US, partnership Japan, similar deal like Merrimack, PharmeAthene, LFB, LEO ...
Look today, it' opens at 1.08 dollar with a close 0.99 dollar, high volume?
Wake up, management.
Unbelievable,
GTCB 0.99 dollar or 0.68 Euro.
Pharming Group, 4.95 dollar or 3.39 Euro?
And have Pharming any approval, no way.
Can you hear the silence?
US-partner ATryn®?
I hope it, for you and for me.
But why, is this shareprice so low?
Belarusian, Russian scientists raise transgenic goatlings with implanted human DNA.
11-08-2007
http://law.by/work/EnglPortal.nsf/0/1C23650B7B2E9866C225738D00495D1B?OpenDocument
Belarusian and Russian scientists have successfully implanted a human gene into goat’s DNA and received transgenic goatlings for the first time in the CIS. The information was released by Alexander Budevich, scientific supervisor of the Belarusian part of the Belarusian-Russian programme BelRosTransgen, head of the Lab for Reproduction and Genetic Engineering of Farm Animals of the Animal Breeding Research Centre of the National Academy of Sciences of Belarus.
The production of transgenic animals has been officially confirmed by the Gene Biology Institute of the Russian Academy of Sciences. The Institute has examined tissue samples of the animals. Materials displaying the implanted human genes into the goat’s DNA are attached to the conclusion of the Russian experts.
The presence of transplanted genes could have been verified only by the Gene Biology Institute — the place where the genetic structures had been created.
The production of transgenic goatlings is a major genetic engineering breakthrough for Belarus, Russia and the entire international community. It is the result of five years of joint scientific experiments. Scientists around the globe produce and use lactoferrin out of cow milk. However, many believe the product’s medicinal qualities are inferior to those of human milk. Goat milk modified by the human gene will boast better qualities and will enjoy more demand.
Alexander Budevich said, the first transgenic goatling was born on October 8, 2007, the second one — October 21. They are both feeling well. Restricted access procedures are now in place at the farm of the Biotechnologies Centre in order to keep these unique goatlings safe and avoid any infections.
The transgenic goatlings were produced using various genetic structures involving human lactoferrin. Three years were spent to carry out over 100 embryo transplantation surgeries, with 30 transplant animals produced. The scientists are interested in getting a large number of male goats for the future production of transgenic animals. The experiment has proved that the available biotechnology allows producing healthy, viable transgenic offsprings.
According to the Belarusian laws the gengineered organism should be registered with the National Coordinating Centre for Biological Security and should be kept in an enclosed environment. The new Biotechnological Research Centre for Animal Breeding of the National Academy of Sciences of Belarus is enclosed cordoned-off space, which meets all the legal norms.
During the second stage of the Belarusian-Russian programme medications based on milk from transgenic animals will be produced. With the human gene, the gengineered goat milk will contain human lactoferrin — a natural antibiotic. The gengineered goat milk can be used to make medications irreplaceable for treating oncological diseases as well as illnesses of immune and digestive systems, as lactoferrin boasts a wide range of various qualities, including antitumor ones.
With the new genetic engineering technologies, such domestic medications will cost 25-30 times less than imported analogues. The gengineered goat milk will also help with artificial feeding of newborns as the content of lactoferrin-containing goat milk is close to that of human milk.
Taking into account the importance of the achievement, the Belarusian and Russian scientists insist on continuing the joint programme BelRosTransgen up to 2012. At least RUB500 million will be required to finance the programme.
GTC Biotherapeutics Reports Third Quarter 2007
Financial Results
Thursday November 1, 8:00 am ET
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the third quarter ended September 30, 2007. The total net loss for the current quarter was $8.4 million, or $0.11 per share, compared with $10.3 million, or $0.14 per share, in the third quarter of 2006. The total net loss for the first nine months of 2007 was $26.5 million, or $0.34 per share, compared to $27.9 million, or $0.43 per share, for the first nine months of 2006.
“We have made strong progress in our strategy for defining our product portfolios in recombinant plasma proteins and monoclonal antibodies, including follow-on biologics. These well-defined product groups provide a number of partnering opportunities that include our initial focus on the further development and commercialization of ATryn® in the United States,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “We look forward to completing our clinical study and initiating the filing of our rolling Biologics License Application, or BLA, for approval of ATryn® in the treatment of hereditary antithrombin deficient patients undergoing surgery or childbirth.”
ATryn® Commercial and Clinical Progress
ATryn® is being developed in Europe, Canada and the Middle East by LEO Pharma A/S. LEO continues commercialization activities in Europe for the approved indication in the treatment of hereditary antithrombin deficient patients undergoing surgical procedures. The first commercial sales are anticipated to be in the United Kingdom in the fourth quarter of 2007 and will occur in additional European countries as pricing is established. LEO is also preparing to submit ATryn® for regulatory approval in Canada in 2008 for the hereditary deficiency indication.
In the third quarter of 2007, LEO began patient enrollment for the approximately 200 patient Phase II dose ranging study of disseminated intravascular coagulation, or DIC, associated with severe sepsis. Initial patient recruitment rates have been slower than originally planned. LEO is evaluating actions to increase the rate of enrollment, including increasing the number of clinical sites, to meet the objective of obtaining top line results by the end of 2008. DIC is the widespread formation of clots within blood vessels, which often leads to organ failure, and is frequently associated with severe sepsis. In this indication, activation of coagulation results in increased consumption of the patient’s own antithrombin. This antithrombin deficiency then results in DIC. DIC occurs in an estimated 500,000 severe sepsis cases in the US and European Union each year, of which up to 50% are fatal, representing a major unmet medical need of significant interest in critical care. GTC estimates the market size of the DIC indication in the US is $2 to $3 billion with additional similarly sized markets in Europe and Japan.
In the Phase III study to support a BLA in the hereditary deficiency indication in the US, GTC continues to plan for obtaining top line results by the end of 2007 on the incidence of deep vein thrombosis, or DVT. ATryn® has been designated for fast track review with a rolling BLA submission for this indication. GTC plans to submit the initial section of the BLA, describing manufacturing, during the fourth quarter of 2007 and the final section, including all the clinical data, is planned for submission in the first half of 2008. This rolling submission process enables the US Food and Drug Administration, or FDA, to begin its review as the information is available rather than waiting until all sections are complete and filed together. In addition, GTC plans to request priority review which would assure a six month time limit for FDA review. If priority review is granted by the FDA and approval is obtained, GTC anticipates ATryn® would be commercially available in the US in the first half of 2009.
Antithrombin is used in patients with hereditary deficiency to reduce the risk of the formation of DVTs during high risk procedures. The U.S. study is a non-inferiority trial based on the observation of clinical symptoms of a DVT in this patient population in comparison to historical data in which patients have been treated with plasma derived products. The results from the 14 patients treated in the hereditary deficiency study for Europe will be combined with data from the current study to give a minimum of 31 evaluable patients.
The data on childbirth patients gathered in this phase III study for the U.S. is planned to be used in a subsequent filing with the EMEA in 2008 to request expansion of the approved label in the European Union to include childbirth procedures.
GTC has also defined the larger scale manufacturing process to more efficiently supply ATryn® for the larger acquired deficiency indications such as DIC. Contract purification as well as fill and finish facilities are being established for this larger volume capability.
Product Portfolios and Partnering
ATryn® is the lead program in the recombinant plasma protein portfolio that includes recombinant alpha 1 antitrypsin, or rhAAT, and recombinant factor VIIa, or rhFVIIa. ATryn® is the subject of partnering discussions for commercialization and further development in the US. The rhAAT and rhFVIIa programs are in preclinical development and are planned to have Investigational New Drug submissions in 2009.
LFB Biotechnologies and GTC are collaborating on the development of rhFVIIa and a CD20 antibody that is intended to be developed commercially as a follow-on biologic for the same target as Rituximab. GTC is developing a portfolio of follow-on biologic programs in addition to CD20 that may form the basis of future partnering opportunities.
Financial Results
Revenues were approximately $2.6 million for the current quarter, a $1.9 million increase from the approximately $0.7 million in the third quarter 2006. The revenues in the third quarter were primarily from the programs with PharmAthene for the services provided to their Protexia product and from Merrimack Pharmaceuticals for their MM-093 product. Third quarter revenues in 2006 were primarily from the services provided to Merrimack. Revenues for the first nine months of 2007 totaled $10.8 million, a $7.5 million increase compared to the $3.3 million in the first nine months of 2006. The revenues for the nine-month results were primarily due to the sale of ATryn® to LEO for use in the Phase II clinical study in DIC as well as revenue derived from the Merrimack and PharmAthene programs.
Costs of revenue and operating expenses totaled $10.9 million in the current quarter, a 2% decrease from the $11.1 million total in the third quarter 2006. Costs of revenue and operating expenses totaled $37.6 million in the first nine months of 2007, a 20% increase from the $31.4 million in the first nine months of 2006. The increase in the nine month costs included the cost of inventory sold to LEO to support the increased revenues and the inventory write-off of $2.9 million previously reported in the second quarter of 2007.
The per share results were affected by an increase in the weighted average number of shares outstanding from 71.7 million shares in the third quarter 2006 to 78 million shares in the third quarter 2007. The weighted average nu