Replies to post #62353 on Biotech Values

[BioSpecialist]

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."

[BioSpecialist]

Aberforth Partners increases stake in Ark Therapeutics....

to more than 10% and now holds 20,822,415 shares.

22 May 2008
http://moneyextra.uk-wire.com/cgi-bin/articles/200805221327020879V.html


Ark therapeutics (AKT.L)

Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p

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.

[BioSpecialist]

Cerepro(R) Phase III results meet primary endpoint

Ark Therapeutics Group PLC 30 July 2008

# Secondary endpoints yet to be established with 45% of patients still alive -

London, UK 30 July 2008 - Ark Therapeutics Group plc (AKT:LSE) today announces that the preliminary analysis of Study 904, a Phase III study of Cerepro(R), its novel gene-based therapy being developed as an Orphan Drug for the treatment of operable primary malignant glioma, demonstrates that the trial has met its primary endpoint. Cerepro(R) treatment resulted in significant improvements in median survival on the primary endpoint compared with various control groups. In the secondary endpoints, with 45% of patients still alive, benefits have yet to be established.

Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients designed, following advice from the EMEA, to confirm the safety and efficacy of Cerepro(R) in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Patients were randomised to either standard care plus Cerepro(R) or standard care alone. Standard care was surgery and radiotherapy or surgery and radiotherapy followed by temozolomide, depending on the investigating centres' standard practice and patient suitability, giving four treatment groups. This allowed comparison of the efficacy of Cerepro(R) and temozolomide in the same trial without denying patients what physicians considered the appropriate established standard care. The primary endpoint was survival, defined as time to death or re-intervention(1). At randomisation, the treatment groups were well matched in terms of demographics and the standard prognostic features (age, Karnofsky Score etc).

The overall combined controls primary endpoint analysis in the Intention to Treat (ITT) population (n=236) compared Cerepro(R) with and without temozolomide against controls with and without temozolomide. It showed a 42 day improvement in median survival (310 days vs 268 days) and the improvement over standard care reached significance (p<0.032). The analysis was performed approximately 14 months after completion of recruitment.

On the primary endpoint, the group given Cerepro(R) and temozolomide showed an improvement of 68% in median survival time compared with standard care surgery and radiotherapy controls (350 days vs 208 days). Against the same controls, treatment with Cerepro(R) alone showed an improved median survival trend approaching 50%, similar to those given treatment with temozolomide alone after surgery and radiotherapy (300 days and 307 days respectively vs 208 days with standard care). Improvements in the combined Cerepro(R) and temozolomide treatment group (n=58) and temozolomide alone group (n=76) were significant (p<0.05). In the smaller Cerepro(R) alone treatment group (n=61), the effect is approaching significance (p<0.065) with 16% still to report an event. Of the total 53 patients still to report an event, only 7 are in the surgery and radiotherapy control group and thus confidence intervals and statistical significance levels in all treatment groups might be expected to improve with time.

On the secondary endpoints, which include MRI based progression, all-cause mortality, safety and quality of life, the effects of Cerepro(R) treatment have yet to be established with around 45% of patients still alive. Data from a further time point analysis are needed to fully elucidate this.

Whilst increases were observed in hemiparesis, aphasia and pyrexia following therapy, the serious adverse event reports for Cerepro(R) were in line with those in previous studies, indicating that the product has an acceptable safety profile.

An updated analysis will be conducted in January 2009 according to the plan and all patients with be tracked until death in accordance with the gene therapy regulations.

The results of the study are expected to be presented at the European Association of Neuro-Oncology in Barcelona on 11-14 September 2008.

Commenting on the results Dr David Eckland, R&D Director at Ark, said: "We are very gratified that Cerepro has demonstrated efficacy in this multi-centre Phase III gene therapy study. This is in keeping with our experience and expectation of the product and we now have further evidence to show Cerepro(R) has an anti-cancer effect. Our next steps are to complete the full analysis and meet with our EMEA rapporteur to determine the way forward."

Dr Nigel Parker, CEO at Ark, added: "This is the first gene therapy product to successfully reach its primary endpoint in a major Phase III trial. With a number of patients in the trial still to report an event, there is a substantial amount of further information to come and we will update the analysis after the turn of the year in parallel with our regulatory activities. Malignant glioma is one of the most aggressive of all human diseases and to have seen a positive effect for Cerepro(R) in this disease area is very encouraging. Ark's adenoviral delivery technology has the potential to deliver a new era of gene-based therapies for acute and chronic human disease."

(1) Re-intervention is defined as any kind of treatment (surgery, chemotherapy or radiotherapy) given to prolong survival after tumour recurrence.

A conference call for analysts will be held at 9.00am today, 30 July 2008. Please call Claire Rowell on 0207 269 7285 for details.