Merck said it would seek FDA approval to market five new drugs in 2010, including its Nomac/E2 contraceptive, boceprevir for hepatitis C, ridaforolimus for sarcoma, an extended-release version of its diabetes treatment Januvia and a Zocor-Januvia combo. Next year, Merck hopes to file for US approval of oral antiplatelet vorapaxar.
Merck said it reached a settlement with Glenmark, heading off a lawsuit and enabling the generics firm to begin selling copies of cardiovascular drug Zetia (ezetimibe) at least four months prior to the drug’s scheduled patent expiry. Settlement terms allow Glenmark to begin selling generic ezetimibe December 12, 2016, while Zetia’s patent doesn’t officially conclude until April 25, 2017. Glenmark believes it is the first to file an ANDA for Zetia, which would potentially provide another 180 days of marketing exclusivity on Zetia. Merck said Glenmark had challenged the basic compound patent covering Zetia on numerous grounds and that the settlement effectively ends a lawsuit that had been scheduled to begin tomorrow. Meanwhile, Glenmark will share US revenues from Zetia sales with Par Pharmaceutical, thanks to a licensing deal the firms announced this month giving Par exclusive US marketing rights to the product. Zetia posted 2009 US sales of about $1.4 billion, according to IMS Health data cited by Par.
inVentiv Health announced it was being acquired by a private equity firm, Thomas Lee Partners, for $1.1 billion, pending shareholder approval. The buyout follows a tough year for the firm, which nonetheless reported first quarter profit up 28% to $10.2 million and revenue up 5% to $269 million over the same period a year ago. The network’s sales business slumped 10% for the quarter to $96.6 million, but communications revenue was up 24% to $88.1 million, clinical revenue up 5% to $54 million and patient outcomes revenue up 7% to $30.7 million.
