Replies to post #121534 on Biotech Values

[DewDiligence]

MRK/Hanwha Chemical ink collaboration for Enbrel biosimilar:

http://finance.yahoo.com/news/Merck-and-Hanwha-Chemical-bw-4078125348.html?x=0&.v=1

Hanwha Chemical Corporation, through its Bio Business Unit, and Merck, through a subsidiary, will work together to develop and commercialize HD203, a candidate biosimilar form of etanercept developed by Hanwha. Merck will conduct clinical development and be responsible for manufacturing. In addition, upon marketing approval, Merck will commercialize HD203 globally, except for in Korea and Turkey where Hanwha has retained marketing rights. In return, Hanwha receives an upfront payment from Merck and will be eligible for additional payments associated with milestones for technology transfer and regulatory progress as well as tiered royalties on sales. Specific financial terms of the agreement were not disclosed.

The PR does not say whether MRK intends to seek US approval via a conventional BLA or via the new 351(k) pathway for FoB’s. Enbrel had 2010 worldwide sales of $7.2B, of which about half was in the US (#msg-59851976).

[investorgold2002]

Have they in the past talked about or guided to any other ANDA(not new FOB pathway) in next 2-3 years (of course other than copaxone)? it could be a generic for a biologic approved using new drug pathway like lovenox