AstraZeneca and Biocompatibles agree to initiate Clinical Trial Programme
Schedule of Phase I and Phase II Trials agreed for Type II Diabetes Drug
Farnham, UK, 4 December 2009: Biocompatibles International plc is pleased to announce that it will initiate clinical trials for CM3, a type II diabetes drug, under development with AstraZeneca, in January. 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. Phase I studies are scheduled to start early in 2010 and Phase II studies are expected to start later in 2010. The pre-clinical phase of the programme was completed ahead of schedule with positive results.
A further €4.3m instalment of a schedule of payments of €8.8m, first announced by Biocompatibles on 22 December 2008, will be paid by AstraZeneca in January.
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:
“The First Generation GLP-1s have established the drug class in treating Type II diabetes but have also shown some limitations. We see CM3 as a second generation GLP-1, which has the potential to overcome these limitations. The pre-clinical results confirm that this is a realistic vision. They show that we have options for dosing and alternative routes of delivery.”
Gunnar Olsson, VP & Head of Cardiovascular and Gastrointestinal Therapy Area, Global Drug Development, AstraZeneca, commented:
“AstraZeneca is committed to working toward solutions to the health problems that stem from diabetes and obesity. We are pleased that CM3 will soon be in the clinical phase. It increases the strength of our portfolio of compounds that can potentially lead to medicines that meet the needs of patients in the treatment of diabetes and obesity, two major risk factors for cardiovascular events.”
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Contact:
Biocompatibles +44 (0)1252 732706
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Anna Keeble +44 (0)7879 818876
Julian Walker +44 (0)20 7357 9477
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.
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.