Amgen Sues Sanofi, Regeneron to Block Future Alirocumab BLA

Amgen is looking to head off future competition to a high cholesterol therapy, evolocumab, that hasn’t even been approved yet, with a patent infringement lawsuit against fellow biologics makers Sanofi and Regeneron.

The lawsuit filed in Delaware federal court claims that Sanofi and Regeneron’s joint PCSK9 inhibitor product alirocumab, currently in development, infringes on three patents protecting evolocumab, Amgen said last Friday. The suit seeks to block the marketing and sale of alirocumab, Amgen added.

Evolocumab has not yet been approved, although it is further along than Sanofi and Regeneron’s proposed therapy. Amgen said that the FDA had accepted its BLA Aug. 28. Meanwhile, alirocumab just completed Phase III clinical trials, and Sanofi and Regeneron have revealed their intention to submit their BLA to the FDA and an application to the EMA by the end of the year.

In its complaint, Amgen notes that Sanofi and Regeneron spent $67.5 million in July to purchase a priority review voucher from BioMarin Pharmaceuticals for their upcoming BLA, a move that would speed the FDA’s required response time to six months after receipt of the application, up from the standard 10 months. That in turn could put alirocumab on the market as soon as the second half of 2015 under the brand name Praluent, Amgen said.

The complaint offers little detail about the science behind the alleged patent infringement beyond the pursuit of a PCSK9 inhibitor that Amgen says its patents cover. Instead, the lawsuit focuses primarily on Sanofi and Regeneron’s commercial and legal preparations as they move toward a product launch.

The legal challenge represents the latest jockeying as pharmaceutical firms work to develop PCSK9 inhibitors, a new class of biologic heart drug. Roche, Pfizer, Bristol-Myers Squibb, Merck and Alnylam Pharmaceuticals all have their own products in various phases of development.

Regeneron said that it and Sanofi do not comment on ongoing litigation. However, Regeneron noted that it has not yet been served with papers and argued that the companies do not infringe on any valid claim in the patents in question. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.