Replies to post #86834 on Biotech Values

[DewDiligence]

Merck KGaA resubmits Cladribine NDA in RRMS:

http://www.reuters.com/article/idCNLDE62O0CG20100608

The FDA issued a Refusal to File letter in Nov 2009 in response to the original NDA submission (#msg-44040202). Merck KGaA refused to divulge what the problem was, leading to speculation that the FDA had insisted on another phase-3 trial (#msg-46949655, #msg-46954975).

Merck KGaA expects a ruling on Cladribine from the EMEA in 3Q10.

[DewDiligence]

Cladribine, Merck KGaA’s oral drug for MS, was approved for marketing in Russia under the brand name, Movectro; Merck plans to launch in Russia after obtaining reimbursement:

http://www.reuters.com/article/idCNLDE66B0GB20100712

Cladribine applications are pending at the FDA (#msg-51012919) and EMA (#msg-39836037); in the former case, the application was resubmitted following a Refusal to File letter.