CORRECT: (11/25) Teva Files 2nd Citizen's Petition To Block
Generic Copaxone
("Teva Files 2nd Citizen's Petition To Block Generic Copaxone" published at 3:
44 p.m. EST Wednesday misstated the year when a generic Copaxone could enter the
market in the 10th paragraph. The correct version follows.)
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Teva Pharmaceutical Industries Ltd. (TEVA) has filed a
second citizen's petition asking the Food and Drug Administration to block
approval of a generic version of its Copaxone multiple sclerosis treatment, a
move that comes after an initial attempt failed earlier this year.
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 2011.
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.)
(END) Dow Jones Newswires
11-27-091205ET
Copyright (c) 2009 Dow Jones & Company, Inc.
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