Regulatory Announcements
Biocompatibles Intl. Statement re Agreement to Initiate Clinical Trial Prog
07/12/2009
DJ Biocompatibles Intl. Statement re Agreement to Initiate Clinical Trial Prog.
TIDMBII
BIOCOMPATIBLES INTERNATIONAL PLC
("Biocompatibles" or the "Company")
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 EUR4.3m instalment of a schedule of payments of EUR8.8m, 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 EUR25m
and would assume financial and management responsibility for the programme.
Further milestones of EUR37.5m 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 EUR256m.
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.
END
(END) Dow Jones Newswires
07-12-09 0700GMT