Replies to post #106122 on Biotech Values

[DewDiligence]

FDA review of Cladribine extended to Feb 2011:

http://finance.yahoo.com/news/EMD-Serono-Announces-prnews-1755440006.html?x=0&.v=1

All told, things are not looking good for this MS drug from Merck KGaA. It was rejected outright by the EU in Sep 2010 (#msg-54812455). In the US, Cladribine received an RTF letter in 2009; Merck KGaA resubmitted the NDA in Jun 2010 (#msg-51012919) and surprisingly received a priority-review designation from the FDA. However, the FDA’s new 3-month extension for completing the review effectively nullifies the priory-review status.

[DewDiligence]

FDA issues CRL for Cladribine in MS:

http://finance.yahoo.com/news/EMD-Serono-Receives-Complete-prnews-1074707575.html?x=0&.v=1

In the complete response letter, the FDA concluded that substantial evidence of Cladribine Tablets' effectiveness was provided by the CLARITY study. However, the FDA has requested the Company provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.

All told, things are not looking good for this MS drug from Merck KGaA. It was rejected outright by the EU in Sep 2010 (#msg-54812455). In the US, Cladribine received an FDA RTF letter in 2009; Merck KGaA resubmitted the NDA in Jun 2010 (#msg-51012919).

[DewDiligence]

Merck KGaA terminates worldwide program for Cladribine in MS:

http://www.reuters.com/article/2011/06/22/merckkgaa-cladribine-idUSLDE75L05O20110622

German drugmaker Merck KGaA (MRCG.DE) has given up seeking approval for its multiple sclerosis pill cladribine after U.S. drug regulators said more costly testing may be needed to allay side effect concerns. In Australia and Russia, where cladribine is already approved and available under the trade name Movectro, Merck said it plans to withdraw the product from the market.

Cladribine has been an unmitigated disaster. It was rejected by the EU in Sep 2010 (#msg-54812455). In the US, the writing was on the wall when the FDA issued a CRL in Mar 2011 after failing to evaluate the NDA during the allotted time despite its having a priority review designation (#msg-57103405).

One fewer competitor for Teva, MNTA, NVS, and BIIB to worry about.