U.S. regulators rejected a lower-volume form of Teva Pharmaceutical Industries Ltd's (TEVA.TA)(TEVA.O) 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 (MNTA.O) and Mylan Inc (MYL.O), 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.
No comments:
Post a Comment