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By Nuala Moran
BioWorld International Correspondent
LONDON - Biocompatibles International plc sealed a deal with AstraZeneca plc worth a potential €302.3 million (US$422.6 million) for a glucagon-like peptide (GLP-1) analogue for treating diabetes and obesity.
As yet, the compound is in discovery. Signing the agreement triggers payment of €8.8 million to complete preclinical development and take the product through to Phase IIa. "At that point AstraZeneca will decide whether or not to take up the option to license [the product], in which case [it] will assume all further development costs," CEO Crispin Simon told BioWorld International.
"Obviously, if you out-license in preclinical you don't expect to get much. So we're very pleased. The program is paid for to Phase IIa, a cost we would otherwise have had to bear ourselves," Simon said. On exercise of the option AstraZeneca will pay a fee of e25 million, with further milestones of e37.5 million payable up to commercialization and sales-related milestones of e256 million. Royalties on sales will vary from single figures to mid-teens depending on volume
The compound is on the edges of Biocompatibles' mainstream interest of drug delivery. GLP-1 analogues are emerging as an important class of drugs for treating Type II diabetes, but since the natural form of the molecule has an extremely short half life, the challenge is to come up with long-acting formulations.
Simon said much of the preclinical work will focus on how to deliver the drug. "What the product looks like will depend on this work. It will be delivered in a different way from existing GLP-1 therapies and not necessarily with Biocompatibles' technology."
The aim is to offer a superior dosing schedule to Novo Nordisk's liraglutide, which is taken once daily, and to reduce the incidence of nausea, a serious side effect of GLP-1 analogues. "We think if we extend the time with dosing, and/or reduce nausea, it could be a class-leading product," Simon said. "Diabetes is massive and growing, and not terribly well-controlled. Most treatments start to become ineffective after a while. GLP-1 products sit right in the heart of the main area of market development."
The 80-page licensing agreement sets out all future terms should AstraZeneca decide to take up its option. "As soon as [AstraZeneca] believes it will be a clinical and commercial success, the option is ready to go. We're not a biopharmaceutical company, so for our brilliant scientists to come up with something we could license like this is great," Simon said.
The GLP-1 analogue was discovered by Farnham, UK-based Biocompatibles' German subsidiary CellMed AG, acquired in March 2005. The deal with AstraZeneca excludes neurological applications of GLP-1 products.
Earlier in December Biocompatibles announced the first patient was treated in a trial of a GLP-1 product in treating hemorrhagic stroke.
The treatment involves the use of the company's drug delivery technology CellBeads, which were implanted in the injury site during the surgery. These are programmed to deliver CM1, a proprietary version of naturally occurring GLP-1, which has been shown to have powerful anti-apoptotic effects.
The delivery mechanism is a cluster of human adult mesenchymal stem cells obtained from a healthy donor and encapsulated in alginate beads. The cells are genetically engineered to produce the protein, which is delivered continuously, directly to the injury site. The alginate beads protect the stem cells from the body's immune system. CellBeads are transplanted within a retrievable mesh device that is removed completely after 14 days, preventing possible long-term side effects.
The International Neuroscience Institute in Hannover, Germany, which is running the trial claims this is the first ever clinical trial for the treatment of stroke with a stem cell product.
The first patient was admitted to hospital on Oct. 15 and diagnosed with a hemorrhagic stroke. He made a good recovery from the surgery, there were no safety issues and there are clear signs of improvement from his condition prior to surgery. That patient has been discharged from the hospital.
In all, 20 patients will be treated in the Phase I/II trial. The primary endpoint is safety, and data will be gathered on a number of indicators of efficacy. | 
