Roche has boosted its pipeline of drugs for metabolic diseases with a 229 million euro ($289m) agreement with France’s Ipsen to secure rights to a new drug for diabetes.
The drug candidate, BIM 50177, is a glucagon-like peptide-1 analogue similar to Eli Lilly and Amylin’s already-marketed Byetta (exenatide) and Novo Nordisk’s liraglutide, which is in Phase III testing. All these agents are also known as incretin mimetics.
According to Roche, BIM 50177 has shown good safety and efficacy in Phase I and II testing, and could have more patient-friendly dosing than its rivals that in turn may boost compliance with therapy, a key factor in long-term avoidance of diabetes complications such as cardiovascular disease, eye damage and neuropathies. Both Byetta and liraglutide require twice-daily injections, although Lilly and Amylin are working on a once-weekly version and Novo’s most recent data suggests once-daily dosing may be feasible.
Byetta sales reached $67 million in the second half of last year, having been launched in the USA just over a year ago, although sales have been held back by manufacturing capacity problems.
BIM 50177 makes use of a proprietary delivery system developed by Ipsen which allows extended drug delivery up from a day up to two weeks from a single subcutaneous injection, said Roche. A Phase II study of a sustained-release formulation of the drug is due to start early next year.
For Ipsen, the deal includes an upfront payment of 56 million euros, a further 3 million euros payable after the end of 2006 and up to 170 million euros in clinical, manufacturing, regulatory and commercial milestones. In return Roche gets exclusive worldwide rights to BIM 50177, with the exception of France and Japan where Ipsen and development partner Teijin, respectively, have retained co-marketing rights.
BIM 50177 joins a growing stable diabetes candidates at Roche, including two small-molecule enzyme modulators, R1438 and R1440, in Phase II testing.
Tercica deal achieves another Ipsen objective
Meanwhile, Ipsen also announced the purchase of a quarter-stake in Tercica, an endocrinology specialist based in the USA.
Ipsen will pay Tercica $77 million in cash and a further $46 million in licensing milestones under the terms of the agreement, which will give Tercica the right to sell the French drugmaker’s Somatuline Autogel (lanreotide) product for acromegaly in the USA and Canada.
In return, Ipsen gains rights to sell Tercica’s Increlex (mecasermin) – a treatment for short stature in children which was approved in the USA last September – on a worldwide basis except for the USA, Canada, Japan, the Middle East and Taiwan.
The deals tick two of three boxes for transactions Ipsen was hoping to announce this year. The remaining one is to find a partner for its facial wrinkles treatment Reloxin (botulinum toxin type A) in Europe, after Medicis Pharmaceutical pulled out of an earlier alliance for the product.