Replies to post #126747 on Biotech Values

[mouton29]

This a cut and paste from what is reported on my Thinkorswim trading software. Note the words "therapeutically equivalent."

WASHINGTON (Dow Jones)--A California biotechnology company won Food and Drug Administration approval Monday to sell a generic version of the blockbuster blood thinner Lovenox, following an eight-year battle.

Amphastar Pharmaceuticals Inc. said it received notification Monday morning that its version of enoxaparin, the generic name of Sanofi SA's (SAN.FR) Lovenox was approved for market, pending review of labeling matters. FDA officials "have concluded that adequate information has been presented to demonstrate that the drug is safe and effective for use as recommended" and "is therapeutically equivalent" to the original Lovenox, the FDA's letter to Amphastar said.

(This story and related background material will be available on The Wall Street Journal website, WSJ.com.)

Amphastar was the first company to apply to make generic Lovenox, filing for approval in 2003. Two years later, Momenta Pharmaceuticals Inc. (MNTA), a small company outside Boston, also applied for FDA approval. Momenta allied with Sandoz, part of the European pharmaceutical giant Novartis AG (NVS, NOVN.VX), to develop and market its version of enoxaparin.

Momenta's application was approved by the FDA in July 2010, over the objections of Amphastar, which has sued the FDA over the agency's handling of the issue. Momenta's approval quickly cut into Sanofi's sales of Lovenox.

In late-morning trading on Nasdaq, Momenta's shares were down some 23%. Momenta stood at $13.58, down $4.17.

-By Alicia Mundy, The Wall Street Journal; [e-mail]

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(END) Dow Jones Newswires 09-19-11 1202ET Copyright (c) 2011 Dow Jones & Company, Inc.