Revolutionary diabetes R&D drives Biovitrum deal
license and collaboration agreement, which aims to develop DPP-IV
inhibitors for the treatment of type 2 diabetes and other metabolic
diseases.
The deal sees the two companies entering hostile territory as a clutch of R&D programs involving this class of drug have gained momentum. In particular, big pharma has expressed special interest in DPP-IV inhibitors as they represent a revolutionary treatment.
DPP-IV inhibitors act through enhancing glucose sensitive insulin secretion and insulin sensitivity and, compared to existing treatments, are expected to offer a superior side effect profile in terms of greatly reduced risk of hypoglycaemia, weight gain, fluid retention and nausea. DPP-IV inhibitors also offer the convenience of oral dosing.
According to the European Association for the Study of Diabetes, (EASD), the DPP IV inhibitors are among the more promising new therapies in the pipeline for the treatment of type 2 diabetes, which currently affects 37 million people in the top seven markets and is expected to grow to 50 million people by 2012.
Under the terms of the agreement, Swiss-based Santhera will receive an upfront payment of €4 million. Biovitrum and Santhera will share revenues according to a fixed percentage split of future revenues, which could include milestones and royalties from sub-licensees.
This means Santhera could receive milestone payments, which exceed €50 million per marketed product before royalties. It is anticipated that the first candidate drug from the DPP-IV program will be selected in Autumn 2005 with Phase I studies starting in 2006.
"We are very pleased to collaborate with Santhera on the development of this important new class of oral anti-diabetic drugs, which is generally considered to be among the most promising future treatments for diabetes," says Mats Pettersson, chief executive officer at Biovitrum, which is based in Sweden.
DPP-IV inhibitors represent one of the most promising new diabetes treatments. Physicians have been disappointed by the lack of successful new therapies for type 2 diabetes in the last 20 years, but if Phase III results, which are expected in Q3 2005, on Novartis' DPP-IV inhibitor LAF-237, the future is paved with drugs with a similar mechanism.
Meanwhile, Merck & Co has also been working on DPP IV inhibitors and was scheduled to start Phase III trials of a lead candidate - MK-0431. Bristol-Myers Squibb has an unnamed candidate in Phase II, while Novo Nordisk is very active in this area.
Researchers from the latter company published an article detailing the structure of DPP IV bound to a substrate in the January 2003 issue of Nature Structural & Molecular Biology.
Other companies working on DPP IV inhibitors includes GlaxoSmithKline, with three compounds in Phase I, and Germany's Probiodrug (which sold its DPP IV platform to UK firm Prosidion in June 2004).
Dia-B Tech has been experimenting with ISF402 - its DPP IV inhibitor candidate. However, in the face of such competition, Dia-B Tech's ISF402 has two primary disadvantages, namely a lack of support from major companies and the drug's early developmental stage (human trials are scheduled to begin at the end of 2006).
Di-B Tech is unlikely to find the means to take the compound through clinical trials without the intervention of a bigger partner. Furthermore, if the compound gets through clinical trials, its early developmental stage will mean a late entry to a market already crowded with many anti-diabetes agents.
