Teva Files 2nd Citizen's Petition To Block Generic Copaxone
In a document posted last week, Teva claims generic drug makers can't show their drug is a precise copy of Copaxone--a fact that should preclude market approval. Furthermore, those companies can't eliminate the possibility that product differences are "clinically insignificant" for patients.
Momenta Pharmaceuticals Inc. (MNTA) and Mylan Inc. (MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world's best selling MS treatments and a key component of Teva's business, was approved in 1996. In 2008, it racked up sales of $2.26 billion.
Israel-based Teva had previously filed a similar petition with the FDA. In March, Teva disclosed the agency had declined to review it without commenting on the approvability of a generic Copaxone because "it would be premature and inappropriate to do so at this time."
The Copaxone battle is notable because it pits the world largest generics company, which has benefited from challenging the patents of other pharmaceutical companies, against generic competitors to protect the exclusivity of its own brand.
Drug makers can ask the FDA to use special criteria when considering approval of generic copies of branded drugs, citing health or safety reasons. The petitions can slow the approval process and prolong market exclusivity for branded drugs.
Officials from Teva weren't immediately available for comment.
Mylan spokesman Michael Laffin said the company maintains confidence in its application and the supporting data. He said the company believed Teva's petition is "without merit."
A spokeswoman for Momenta, which has a worldwide partnership with Novartis AG (NVS) unit Sandoz for generic Copaxone, declined to comment.
Separately, Teva has sued both companies. That triggered an automatic 30-month stay on FDA approval, which is required by a generics-related law, meaning no generic version of Copaxone can enter the U.S. market until early 2012.
In its petition, Teva asserts that generic companies can't show their versions are an adequate copy because current analytical methods aren't capable of characterizing its make-up and reverse engineering won't create an identical product.
It performed tests on a generic version sold in India and Ukraine produced by Natco Pharma Ltd. (524816.BY) and found it "differed greatly" from branded Copaxone and that batches of Natco's generic version actually differed from each other.
Mylan signed a worldwide marketing and distribution license with Natco for its generic version of Copaxone last year.
In late Wednesday trading, Teva shares were down 4 cents to $53.24, while Mylan was up 8 cents to $18.38 and Momenta was down 2.5%, or 26 cents, to $10.32.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
(Peter Loftus in Philadelphia contributed to this article.)
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Publié le 25 novembre 2009 Copyright © 2009 Dowjones
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