GLP-1 Peptide
Glucagon Like Peptide (GLP-1) is widely viewed as an important emerging treatment for diabetes and obesity. There is also growing interest in GLP-1 as an anti apoptotic and neuro protective agent.
CellMed has discovered a novel family of GLP-1 analogues. Strong intellectual property rights protecting these new peptides is in place. CellMed is using a very potent GLP-1 peptide from this family, as the active ingredient in the CellBeads Neuro programme. CellMed's preclinical data in this field are promising, as well as early clinical results from a Phase I/II study. In December 2008 the Company announced the signing of an Agreement with AstraZeneca:
“Biocompatibles is pleased to announce the signing of Product Development and Option-to-Licence Agreements with AstraZeneca for a proprietary GLP-1 analogue invented and developed by Biocompatibles’ CellMed subsidiary. The initial target indications are Type 2 Diabetes and obesity.
The Product Development Agreement provides for a programme of pre-clinical, Phase I and Phase IIa activities that will be managed by CellMed. Payment by AstraZeneca of a schedule of option fees, totalling up to €8.8m, is designed to cover the cost of the product development work. The financial consequences of this agreement will be incorporated into the Company’s financial guidance for 2009 which will be issued in January.
The Option-to-License provides AstraZeneca with an exclusive option to license the relevant patents for exploitation in the field of diabetes and obesity, at any time during the course of the Product Development program. 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.
The GLP-1 analogue is part of a new family of GLP-1 analogues discovered by CellMed and relevant patents have been filed. The GLP-1 class is viewed as an important emerging treatment for diabetes and obesity. CellMed's preclinical data comparing the GLP-1 analogue to native GLP-1 are promising. The patents, which AstraZeneca has the option to license, also protect CellMed’s inventions in stroke, which Biocompatibles will remain free to develop and commercialise. The first product in this programme is already under clinical investigation as announced on 2 December 2008.
The World Health Organization (WHO) estimates that more than 180 million people worldwide have diabetes and that almost three million deaths per year are attributable to the disease. WHO projects that diabetes deaths will increase by more than 50% in the next ten years without urgent action; and by more than 80% in upper-middle income countries. It is estimated that about two thirds of the adult population in the US are overweight.
Crispin Simon Chief Executive Biocompatibles commented: “A product development agreement with AstraZeneca in the field of diabetes and obesity is a significant event for Biocompatibles and further evidence of the value being created by CellMed. This programme is now a high strategic and operational priority.
“We are delighted to adopt the licensing model with a company of AstraZeneca’s drug development and marketing capabilities.”
Gunnar Olsson, VP & Head of Cardiovascular and Gastrointestinal Therapy Area, Global Drug Development, Astra Zeneca, commented: “This innovative molecule with differentiated properties has the potential to become an important therapy in both diabetes and obesity. We believe that the Biocompatibles compound has potential advantages to other GLP-1 medicines, a clear patent position and some very interesting properties.”
The completion of the pre-clinical programme and initiation of the first clinical trials is expected in 2010.
