First Volunteer treated in Clinical Trial for Type II Diabetes Drug
Farnham, UK, 17 February 2010: Biocompatibles International plc (LSE:BII), the medical technology company, is pleased to announce that the first volunteer has been treated in a Phase I clinical trial for CM3, a type II diabetes drug, under development with AstraZeneca.
The Phase I study is a single-centre, randomised, double-blind, placebo-controlled clinical study to investigate safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers. 56 volunteers will be recruited by a Clinical Research Organisation in Germany.
Biocompatibles entered into an agreement with AstraZeneca in December 2008 to develop CM3. The agreement included pre-clinical, Phase I and Phase IIa activities managed by Biocompatibles’ subsidiary, CellMed. The first Phase I study is now under way and a second Phase I and a Phase II study are expected to start later in 2010.
The €4.3m instalment of a schedule of payments of €8.8m, first announced by Biocompatibles on 22 December 2008, was paid by AstraZeneca in January 2010.
CM3 is a glucagon-like peptide-1 (GLP-1) analogue invented and developed by CellMed and is part of a new family of GLP-1 analogues. The first of the relevant patents has recently been granted. This GLP-1 compound has the potential to be an important treatment for diabetes and obesity and may offer patient benefits not currently available from other GLP-1 drugs on the market.
The agreement also provides AstraZeneca with an exclusive option to license relevant patents for further exploitation, at any time during the course of the development programme, which is expected to be completed in 2012. On the exercise of the Option-to-License, AstraZeneca would pay a licence fee of €25m and would assume financial and management responsibility for the programme. Further milestones of €37.5m would be payable prior to first sale of product.
After launch, royalties in the single to mid-teens digit range would apply, the rate depending on the level of sales achieved. In addition there is provision for sales-related milestones up to a maximum value of €256m.
Crispin Simon, Chief Executive Biocompatibles, commented:
“I am delighted that the CM-3 programme has passed this important milestone and I congratulate the team at our CellMed subsidiary on their significant achievement. I look forward to announcing its progress into Phase II later in the year.”
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Contact:
Biocompatibles +44 (0)1252 732706
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Anna Keeble +44 (0)7879 818876
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead Products which are used in more than 35 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
This news release contains forward-looking statements that reflect Biocompatibles’ 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 Biocompatibles’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.
Notes to Editors:
Diabetes is a chronic, progressive disease and an ever-growing health care problem worldwide. Diabetes alone can lead to premature death but is particularly life threatening in patients with co-existing cardiovascular disease. More than six percent of the world's adult population suffer from diabetes and the incidence of newly diagnosed diabetes in the US has nearly doubled in the last 10 years. In 2010, 280 million people worldwide will have diabetes and it is predicted that, by 2030, more than 430 million people worldwide will suffer from this disease.
Diabetes is a disorder characterised by either lack of insulin (Type 1 Diabetes) or lack of proper response to, or poor production of, insulin (Type 2 Diabetes). Both diseases are associated with elevated concentrations of blood sugar, which affect the vascular system and the nerves, thereby increasing the risk of coronary artery disease, stroke and peripheral artery disease. Complications in organs that depend on the patency of small vessels such as the eye and kidney can lead to disabling conditions and costly and traumatic medical interventions.
CM3 is an investigational drug in the GLP-1 class. CM3 is unique because it contains the complete human amino acid sequence of GLP-1 in its primary structure. GLP-1 is a peptide naturally released in the gut after food intake to help maintain normal blood-sugar levels and to control appetite. This, the natural, GLP-1 has a very short duration of action due to rapid degradation. The recently completed preclinical programme indicates that CM3 has an extended duration of action in relation to the natural GLP-1 as well as excellent tolerability compared to other GLP-1 mimetics. The clinical study programme is expected to start in the first quarter of 2010.