and with this story, perhaps there`s a good probability that MNTA will enjoy sole generic competitor status for a good period of time...
US rejects Teva version of MS drug, but shares up
* Proposed new Copaxone drug has less volume
* FDA says mechanism of action not fully understood -Teva
* FDA action signals hurdles for generic Copaxone-analysts
* Shares up 2.6 percent
(Rewrites first paragraph, adds further analyst comment)
By Lewis Krauskopf and Susan Heavey
NEW YORK/WASHINGTON, Dec 23 (Reuters) - U.S. regulators
rejected a lower-volume form of Teva Pharmaceutical Industries
Ltd's Copaxone multiple sclerosis treatment,
but the drugmaker's shares rose as the decision could mean a
delay for generic competition to its biggest product.
Analysts said the Food and Drug Administration's rejection
suggests that rivals seeking to make generic versions of
Copaxone, like Momenta Pharmaceuticals Inc and Mylan
Inc , may encounter obstacles in winning approval.
The potential for a generic Copaxone is a major issue
weighing on shares of the Israel-based drugmaker.
"The FDA's letter highlighted the high hurdle potential
generic manufacturers of Copaxone face in gaining approval," JP
Morgan analyst Chris Schott said in a research note on
Thursday.
"Today's news, in our view, increases the probability of
clinical data requirements for generic Copaxone manufacturers,"
said Schott.
Teva is the world's largest generic drugmaker, but it is
heavily reliant on its branded Copaxone, which had $2.8 billion
in sales last year and is administered by injection.
Although the new version contains the same amount of active
ingredient as the product on the market, the FDA said it was
not entirely clear how the drug worked or how changing it could
affect patients' treatment, according to Teva.
The FDA said in a letter to the company that "because the
mechanism of action of Copaxone is not fully understood, even a
formulation change could impact clinical outcomes," Teva said
in a statement.
Unless Teva can prove there is no effect on how well the
drug works, it would need to conduct "an adequate and well
controlled" study to prove its effectiveness, the FDA said,
according to the drugmaker.
The FDA's response supports the company's belief that even
slight changes to a drug like Copaxone "can significantly and
unpredictably influence the efficacy, toxicity and
immunogenicity profile of the compound," Teva said.
Teva has long maintained that Copaxone is a difficult
product to replicate and has said that any potential generic
version should be evaluated with full-scale clinical trials.
"Their perspective is: Look, we're the company that
manufactures this drug, and if we can't even get another
formulation approved by the FDA," what chance would rivals
have, said Morningstar analyst Michael Waterhouse.
Teva said it would continue to work with the FDA on
possible next steps for the lower-dose version.
Schott said the approval path for the low-volume version
was unclear, although he described Thursday's news as a "net
positive" for Teva shares.
Shares of Teva were up 2.6 percent at $52.54 in afternoon
trading on Nasdaq. |
