This comes as a blow to sanofi, especially as Lovenox is the leading hospital-based medication in the US and had 2009 sales for the company of US$2.7 billion.

The US District Court for Columbia refused to issue a preliminary injunction to block the generic, marketed by Novartis AG's Sandoz unit and Momenta, on the grounds that it would deny the public an important treatment.

Sanofi has expressed concerns with the FDA review process and with their ability to ensure that the generic, which was approved in July 2010, has the same active ingredient as Lovenox.

Momenta, on the other hand, continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection abbreviated new drug application. In a statement by President and CEO of Momenta, Mr Craig Wheeler, he added that they “are pleased that the court re-affirmed the validity of the FDA's decision”.

This is probably not the end of the story, as sanofi have stated that they will continue to move their case against the FDA forward, even without preliminary injunctive relief. Sanofi believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.

Sanofi added that they are committed to making healthcare professionals aware of the complexities related to the biologic composition and manufacturing of Lovenox – so the battle moves to the front lines!!

(see also FDA approves first biosimilar enoxaparin sodium)

References:

Sanofi-aventis press release. Sanofi-aventis Comments on Injunctive Relief Hearing Regarding Lovenox. 26 August 2010

Momenta Pharmaceuticals Press Release. Momenta Pharmaceuticals Provides Litigation Update: District Court Denies sanofi-aventis Request for Preliminary Injunction for Generic Lovenox. 26 August 2010