The future of Byetta in Australia is increasingly uncertain following the cessation of Amylin Pharmaceuticals' and Eli Lilly's decade-long alliance for diabetes treatment exenatide. Eli Lilly plans to hand back marketing rights for the drug by 2013, leaving Amylin to seek new partners outside the US. Unless a new partner is signed, the prospects of the drug are greatly diminished.
Exenatide products available in Australia include 5mg and 10mg preparations of Byetta, as well as long-acting pipeline candidate Bydureon. This latter developmental drug was denied a reimbursement decision by the Pharmaceutical Benefits Advisory Committee (PBAC) in July, because under the new parallel-processing system it is still awaiting Therapeutic Goods Administration (TGA) approval.
Amylin will assume responsibility for commercialization of the type 2 diabetes treatments worldwide. Amylin has no presence in Australia or elsewhere in Asia Pacific, and has stated that it will seek "one or more partners outside the US" to take over marketing of exenatide from Lilly by the end of 2013.
One potential partner in Asia Pacific could be Japan's Takeda, already strategically partnered with Amylin for obesity therapies. Takeda is well-versed in the diabetes market following the global success of Actos (pioglitazone), which has recently suffered safety setbacks and patent expiration in Australia. The company has no competing glucagon-like peptide-1 (GLP-1) agonists in its portfolio or pipeline, and has recently been expanding its reach with the establishment of new offices in South East Asia and the acquisition of multinational Nycomed. Datamonitor anticipates that other key candidates may include Sanofi and Roche (REF Christine's SCRIP article).
The cessation of Amylin's and Lilly's alliance follows months of litigation, initiated after Lilly entered into a similar strategic alliance for diabetes compounds with Boehringer Ingelheim in January 2011. The first of these compounds was recently registered in Australia, and is expected to be recommended by the PBAC for reimbursement in a matter of weeks. In July, the PBAC deferred a decision on Trajenta (linagliptin), awaiting TGA approval, but noted that the panel was "of a mind to recommend listing" the drug for treatment in combination with metformin or a sulfonylurea.
November is not even half over, and already it has been a dynamic month for the diabetes market, and particularly Eli Lilly. The outlook for the first-in-class and currently only reimbursed GLP-1 agonist in Australia is now uncertain, and will remain unclear until a new marketing partner for exenatide is signed.
Sunday, November 13, 2011
Lilly/Amylin: changing alliances shake up the Australian diabetes market