Almirall has licensed European rights to aclidinium bromide, both as a monotherapy and in combination with formoterol to Italian pharmaceutical company Menarini. The agreement covers most of the EU except for the UK, the Netherlands and the Nordic countries, plus several additional countries, including Russia and Turkey.
Almirall CEO Eduardo Sanchiz explained, “Amongst a number of interested partner candidates, Menarini stood out as it combines a powerful commercial platform with an impressive track record in successfully commercializing distinctive medicines. This brings a strong commitment to maximizing the value of the aclidinium franchise. Our joint efforts will extend aclidinium and its combination as a new therapeutic option to a broad range of physicians and patients.”
“We are proud to have undertaken this agreement with Almirall, a company which represents an EU gold standard of leadership, scientific value, and efficiency,” commented Menarini Group board member Alberto Giovanni Aleotti. “We are pleased that the cooperation between our two companies on aclidinium will bring improvement to the quality of life of COPD sufferers in Europe.”
In the US, the FDA has notified Almirall and Forest Laboratories that it will need an extra three months to consider the NDA for aclidinium bromide for the treatment of COPD, extending its review period until July 2012. According to the companies, the agency did not request any additional data. In February 2012, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the application.
Forest licensed US rights to aclidinium bromide, an inhaled long-acting antimuscarinic agent, from Almirall. The companies submitted the New Drug Application to the FDA at the end of June 2011. Almirall submitted an MAA to the EMA a month later.
Read the Almirall and Menarini press release.
Read the Almirall and Forest press release.
