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[User5]

Hallo,

kopie von der Homepage.

3rd January 2002


This announcement issued jointly by British Biotech and Biocompatibles International plc ("Biocompatibles")


Update on clinical trial programme for the Batimastat BiodivYsio® stent


Biocompatibles (LSE:BII) and British Biotech (LSE: BBG, Nasdaq: BBIOY) announced today two significant events in their collaborative programme for the Batimastat BiodivYsio® stent, a drug-coated device designed to reduce restenosis in patients who have undergone coronary angioplasty:

· Filing of an Investigational Device Exemption (IDE) requesting the approval of the US Food and Drug Administration (FDA) to start a pivotal clinical trial (BATMAN II) designed to secure a marketing authorisation in the United States.

· The start of a pivotal clinical trial (BRILLIANT II) in Europe designed to secure CE Mark approval.

Batimastat BiodivYsio Stent: Clinical Trials

The BRILLIANT (EU) and BATMAN (Americas) programmes are a series of clinical studies designed to evaluate the safety and efficacy of the Batimastat BiodivYsio® stent, which comprises Biocompatibles` proprietary drug-eluting stent technology and British Biotech`s proprietary MMP inhibitor, batimastat. Data from the trials will be used to support applications to register the product in Europe and the US.

The BATMAN Trials

The BATMAN trials are designed to secure a marketing approval in the United States. BATMAN I is a pilot safety trial underway in Latin America. BATMAN II is a pivotal trial to be run at 40 centres in the United States and Canada. The IDE was filed on December 20th and the protocol for BATMAN II will be announced upon approval of the IDE.

The principal investigators for BATMAN II are James P. Zidar, MD of Duke University, North Carolina, and Dr Christopher Buller at Vancouver General Hospital, Vancouver, Canada. Dr Zidar commented: "The investigator group is excited about this unique therapy and look forward to starting the trial when the IDE is approved."

The BRILLIANT Trials

BRILLIANT I was designed to demonstrate safety of the Batimastat BiodivYsio stent. Recruitment in this 150 patient multi-centre registry was completed ahead of schedule on 9th November 2001. All patients in this trial are scheduled to undergo six-month angiography.

BRILLIANT II is a 400 patient multi-centre, double-blind, pivotal randomised trial to be conducted at centres in the UK, France, Belgium and Holland. French national ethical approval has been obtained and the first patient was treated on December 24th by Dr Fajadet at the Clinique Pasteur in Toulouse. The trial will determine clinical performance of the batimastat-loaded stent relative to a PC Technology™ stent without the drug.

Data from BRILLIANT I and II will be submitted together to form the basis of an application for European approval for the device.

Batimastat BiodivYsio Stent: Pre-Clinical Trials

Batimastat`s anti-migratory mode of action may enable it to reduce restenosis without interfering with the cell cycle or causing cell death. Indeed, pre-clinical trials have shown that the batimastat stent reduces neo-intimal hyperplasia without delaying the healing process of the vessel; re-endothelialisation of the batimastat-loaded stent is essentially complete at five days. No local toxic effects have been detected at doses up to five times those planned for the US studies.

Biocompatibles` PC Technology coating has been specifically engineered to deliver the batimastat dose directly to the vessel wall, resulting in minimal systemic loss of batimastat from the stent to the circulation. Pharmacokinetic studies undertaken at Massachusetts Institute of Technology (MIT) have demonstrated that there is an even distribution of batimastat within the stented artery; that essentially no batimastat is detected outside the coronary arteries; and that the release kinetics indicate that the batimastat is delivered with timing appropriate to the mode of action - combating migration of smooth muscle cells.

Market Overview

If the Batimastat BiodivYsio stent receives IDE approval, it is believed that batimastat will be only the third pharmaceutical compound to be investigated in clinical trials in the United States in the field of stent drug delivery. No stent drug delivery product designed to prevent restenosis has yet received approval for sale, in a market which independent investment analysts estimate will be worth $5 billion worldwide by 2005.

Crispin Simon, Chief Executive of Biocompatibles, commented: "This is another important milestone and it demonstrates that a leadership position in the stent drug delivery market, when it becomes a reality, is within our reach."

Dr Elliot Goldstein, Chief Executive Officer of British Biotech, said: "In less than a year since forming this collaboration we have already reached the point where pivotal trials are starting. We are delighted with the progress of this innovative programme and look forward to evaluating the critical clinical data as they emerge during the coming year."

Batimastat is licensed to Biocompatibles by British Biotech, and BiodivYsio stents are distributed in the United States by Abbott Laboratories.

---ends---


For further information, please contact:

Biocompatibles International plc
Crispin Simon, Chief Executive Officer
Peter Stratford, Managing Director, Drug Delivery Division
Tel: [phone]

British Biotech plc
Dr Elliot Goldstein, Chief Executive Officer
Tony Weir, Finance Director
Tel: [phone]

Financial Dynamics
David Yates/ Melanie Toyne Sewell
Tel: [phone]

This news release contains forward-looking statements that reflect the Companies` current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company`s research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.

Notes to Editors
1. Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting and Stent Drug Delivery

PTCA is a minimally invasive procedure for the treatment of coronary heart disease, which involves the insertion of a small balloon into the narrowed area of a coronary artery. The inflation of the balloon causes the artery to open and thereby re-establishes normal blood flow when the balloon is deflated and removed. In a large proportion of angioplasty procedures, a stent (a small metal scaffold) is permanently placed in the artery to prevent it from closing again.

Stent Drug Delivery technology is targeted at reducing restenosis following PTCA. Restenosis is the re-blockage of an artery and occurs in 20% of patients who receive a stent and in excess of 50% of patients in some high-risk groups (e.g. diabetics). The fundamental biochemical and cellular processes that lead to restenosis have not been definitively established. It is, however, generally accepted that in addition to the vascular disease already present, the stretching of the vessel caused by ballooning results in an injury response in the local tissue. It is thought that the consequent inflammation, cell migration, smooth muscle cell replication and new endothelial cell growth, which are required for the normal healing process, may also lead to restenosis if the response is too strong. Stent Drug Delivery enables a drug to be delivered directly from a stent and thus be directed to the target tissue more precisely than is possible with parenteral delivery. This allows not only the administration of a smaller dose, thereby reducing the risk of undesirable side effects, but also the prospect of a greater concentration of drug in the target tissue, thereby increasing the prospect of efficacy.

In 2000, the worldwide coronary stent market was estimated to be $2.25 billion.

2. Stents coated with batimastat
During the repair of damaged vessels, remodelling of the extracellular matrix occurs which involves matrix metalloproteinases (MMP). Broad spectrum inhibitors of MMPs, such as batimastat, can inhibit the process of matrix degradation and subsequent cell migration that is implicated in restenosis. Batimastat may also inhibit the collagen deposition and vessel remodelling that may play a role in restenosis. From preclinical evidence, the batimastat-coated stent may ameliorate the restenotic process and allow the natural healing of the vessel to occur in a controlled manner.

3. The BiodivYsio® Stent
The BiodivYsio® stent (without batimastat), utilising Biocompatibles` PC TechnologyTM polymer coating, is commercially available in Europe; and in the US where it is marketed by Biocompatibles` marketing partner, Abbott Laboratories.

4. Biocompatibles International plc
Biocompatibles is an international medical device company with three divisions, Cardiovascular, Drug Delivery and Eye Care, using a unique technology based on Phosphorylcholine ("PC"). PC Technology reduces the body`s response to medical devices. PC is a chemical copy of part of the outer layer of a human cell membrane and is a synthetic polymer that can be coated onto medical devices or formed into products like contact lenses.

Biocompatibles employs approximately 1,200 people around the world. The Company`s cardiovascular distribution partner in the US is Abbott Laboratories and its distribution partner in Japan is Japan Lifeline. Biocompatibles` leading Drug Delivery programmes are strategic partnerships with Abbott Laboratories and British Biotech, and a programme with the generic anti-inflammatory compound, Dexamethasone.

Further information, news releases and glossary are available on the Company`s website at www.biocompatibles.co.uk.

5. British Biotech plc
British Biotech is a biopharmaceuticals company specialising in the development of new drugs to fight diseases with limited treatment options, principally cancer. Its strategy is to use its strengths in product development and registration to form collaborations with other companies in order to build a Product Portfolio of drugs in which it has a share of commercialisation rights.

Four products are currently in clinical development:
· BB-10901, in phase I development for small cell lung cancer in a collaboration with ImmunoGen Inc.
· E21R, in phase II development for acute myeloid leukaemia in a collaboration with BresaGen Ltd
· the Batimastat BiodivYsio stent, in patients trials in collaboration with Biocompatibles International plc
· BB-10153, a novel thrombolytic planned to go into a phase II study by the end of Q1 2002

The lead compounds in British Biotech`s Antibiotic Programme are peptide deformylase inhibitors in development for respiratory tract and other gram positive infections. Clinical studies with these compounds are on track for 2002 and a collaborative partner is being sought for this programme.

British Biotech also has collaborative research and product development agreements with Schering-Plough Corporation, Serono SA, OSI Pharmaceuticals, Inc., DevCo Pharmaceuticals Ltd and Tanabe Seiyaku.

6. Abbott Laboratories (NYSE: ABT)
Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. In 2000, the company`s sales and net earnings were $13.7b billion and $2.8 billion, respectively, with diluted earnings per share of $1.78.

[Ichweissauchnicht]

also, wenn Du hier schon mal die Aktie diskutieren willst,
mach es Dir bitte nicht ganz so einfach... die Highlights
aus dem Bericht könntest Du ja mal mindestens rausstellen,
oder ?
ichweissauchnicht....

[User5]

Hallo,

lesen kannst du doch oder?
will auch nur eure Meinung zu dem Bericht hören und keinen unnötigen Kommentar ;-)

Gruss User5