Shares of Momenta took a hit after the company warned that its development of a generic version of Sanofi's blood thinner Lovenox is likely to take longer than expected. Shares slid 15 percent on the news that the regulatory review of its abbreviated new drug application would take longer than the 18 to 24 months originally expected. Momenta is developing M-Enoxaparin with Sandoz, the generic arm of Novartis. Momenta is considered one of the key players in the development of a new generation of follow-on biologics. Sanofi has argued that its blockbuster Lovenox is too complex to be copied. But a judge opened the door to a competing therapy last February with a ruling invalidating the patent on the injectable. Momenta is competing with Amphastar Pharmaceuticals and Teva to do just that.
- read the AP report on Momenta's worries
Analysis: A bipartisan group of Senators is forming to back a new bill that would grant four years of exclusive sales to a biologic before it faced generic competition. The bill also would allow follow-on drugs to be marketed as interchangeable and that generic developers would have to mount at least one clinical trial for approval--with a proviso that the FDA could waive that requirement. Report
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