Biotech Values

[InTheTrenches]

Still, this article does convey some apparent new information as to why Amphastar believes they are not being treated fairly:

Several days before the Feb. 4 call, Tribune Newspapers received a copy of an anonymous letter addressed to Sharfstein, in his capacity as chair of an internal FDA task force seeking to make the agency more transparent, alleging that the Momenta/Sandoz was being favored over Amphastar in the application process.

The letter, dated Jan. 22 and signed "Concerned CDER Scientists", claimed that Amphastar was being held to a stricter purity standard for its version of enoxaparin than Momenta/Sandoz.

But, this article later suggests that this whistle-blowing letter has some inconsistencies:

Included with that letter was a copy of a letter from an FDA drug reviewer to Amphastar describing the purity standard required of the company, and a separate set of documents purporting to memorialize a series of November 2009 telephone conversations between FDA and Sandoz officials concerning the purity standard for the Momenta/Sandoz version of enoxaparin.

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(One curious aspect of the purported communication between FDA and the Momenta/Sandoz team is that it mentions only Sandoz, and lists only Sandoz employees as contacts. In press accounts, Sandoz, a division of Swiss pharma giant Novartis, has been portrayed as a silent partner, responsible for financing and the eventual marketing of enoxaparin. Nearly all of the comment on the drug development effort has come from Momenta, which has presented itself as the technology end of the tandem.)