Last week, Teva Pharmaceutical (TEVA 0.91%) failed in another effort to block generic versions of its multiple sclerosis drug Copaxone from being approved by the Food and Drug Administration. The company, which also makes generic drugs, requested that a judge force the FDA to require additional tests to prove equivalency before the agency approved the copycats. The judge refused.
Copaxone is a complicated molecule made up of four different amino acids. It is hypothesized that the random chain of amino acids acts as a decoy to the immune system, decreasing the multiple sclerosis attacks.
Mylan (MYL +0.00%) is developing a generic version of the drug, as is a joint effort by Momenta Pharmaceuticals (NASDAQ: MNTA) and Novartis (NYSE: NVS). The companies claim they've characterized the brand-name drug well enough to show their products are equivalent. By ignoring Teva Pharmaceutical's request for additional tests, the agency seems to be siding with the generic-drug makers, though it hasn't approved generic versions yet.
The potential windfall for Mylan, Momenta Pharmaceuticals, and Novartis is huge; Teva books about $4 billion in Copaxone sales annually, with most coming from the U.S.
In the video below, senior biotech specialist Brian Orelli and health-care analyst David Williamson discuss the impact on Teva, including an appeal to the Supreme Court and the potential to switch patients to a three-days-per-week version of Copaxone to fight the coming generics.
