Wednesday, July 10, 2013

Amgen inlicenses US rights for CHF drug from Servier

AMGN announced a deal with Servier (a privately held French pharma) to gain US rights to  Procoralan. Procoralan is an oral drug indicated for treatment of chronic heart failure and stable angina (chest pain). Amgen will pay $50mn upfront payment and future undisclosed milestones and royalties. 

Procoralan is already approved in EU for treatment of stable angina in 2005 and for chronic heart failure in 2012 and is currently marketed in over 100 countries and generated $280mn in LTM sales.

Procoralan is not approved in the US and Amgen would take the responsibility for getting Procoralan through US regulatory hurdles. It  plans to meet with the FDA shortly to discuss a filing and believes the current data set will be enough to secure an approval.

The composition of matter patent for Procoralan expires this year, though AMGN noted that it expects to rely on five years of NCE data exclusivity upon FDA approval as well as other patents through 2025.

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