Further to the agreement signed in October 2003, Roche announced its decision to exercise its option to exclusively licence, develop and market Ipsen's patented anti-diabetic drug BIM 51077. This GLP-1 medicine has shown a good efficacy signal and latest data from phase I and II clinical studies showed potential to be more conveniently administered than existing members of the class, which would facilitate patient compliance.
Roche has been granted worldwide rights, except in Japan where these rights are shared with Teijin (Ipsen's Japanese partner), and in France where Ipsen may elect to retain co-marketing rights.
"Our decision to in-license this anti-diabetic medicine adds a very promising compound to our metabolic disease portfolio and also complements our diagnostics activities in diabetes" said Peter Hug, Global Head of Pharma Partnering for Roche. "Our continued collaboration with Ipsen, based on our respective complementary strengths, has the potential to deliver treatments that will make a difference in patients' lives."
Jean-Luc Bélingard, chairman and CEO of the Ipsen Group said "We are delighted that Roche, a world-class group with a strong commitment to the diagnosis and treatment of diabetes, decided to exercise its option to develop and market BIM 51077. It shows once again that Ipsen is a reference partner in the industry, able to deliver first-in-class products through its differentiated and unique R&D. We are very excited about BIM 51077's prospects and believe that Roche is uniquely placed to successfully market this product".
Roche's decision is supported by the phase I and II results obtained with BIM 51077, a glucagon-like peptide-1 (GLP-1) analogue, and partly presented at the American Diabetes Association (ADA) scientific meeting in Washington D.C. this year. These data showed that that this anti-diabetic compound exhibited an efficacy and safety profile in line with the GLP-1 class of incretins and was compatible with Ipsen's proprietary controlled delivery systems which upon subcutaneous administration could deliver over a period of one day, one week or two weeks. Phase II study, to confirm the efficacy and safety of this compound in a sustained release formulation, will start early 2007.
Under the terms of the agreement, the exercise of this option by Roche has triggered a payment to Ipsen of €56 million. Roche will also make a payment of ca.€3 million after the closing of Ipsen's 2006 financial statements.
Ipsen could receive total further payments of up to €170 million, contingent upon achievement of clinical, manufacturing, regulatory, and commercial milestones. Additionally, Ipsen will receive progressive royalties on any worldwide sales.
As of the date of exercise of the option, Roche is fully responsible for further developing and manufacturing of the product and will consequently hold the marketing authorisations. Roche will fund 100 per cent of the remaining development of BIM 51077, except with respect to Japan where expenses will be shared 50 per cent between Roche and Teijin.
BIM 51077, an analogue of peptide hormone GLP-1 (Glucagon Like Peptide-1), controls insulin secretion in response to elevated blood glucose levels.
BIM 51077 was selected among a series of GLP-1 analogues based on the human sequence, to be compatible with Ipsen's proprietary technology for controlled release, with the ultimate goal of providing a ready-to-use, user-friendly self-administration solution for diabetic patients. The current formulation is an aqueous solution devoid of excipients and can be conveniently injected with an insulin size needle, thus facilitating patients' compliance. The results obtained in the preclinical and clinical studies confirm the potential of the BIM 51077 slow release formulations over a period ranging from one day to two weeks. These results are very encouraging for the treatment of type 2 diabetes.
Ipsen's unique expertise lies in its ability to combine the engineering of therapeutic peptides with parenteral sustained-release delivery technologies and is currently marketing sustained release formulations of triptorelin (Decapeptyl) and lanreotide (Somatuline and Somatuline Autogel). The Group is also pursuing the application of its sustained-release technology to Decapeptyl with a 4 month microimplant entering phase III clinical studies. In addition, Ipsen signed a R&D agreement with Genentech in November 2004, which covers the development of sustained-release formulations of recombinant human growth hormone.