Monday, August 13, 2012

Pfizer buys global rights from AstraZeneca to launch Nexium OTC in 2014

Pfizer will acquire the exclusive global rights to market NEXIUM for the approved over-the-counter indications in the United States, Europe and the rest of the world.  Under the agreement, Pfizer will make an upfront payment of $250 million to AstraZeneca and AstraZeneca is eligible to receive milestone and royalty payments based on product launches and sales.  

In addition, both companies are exploring the potential for a strategic partnership that would include similar agreements for other AstraZeneca prescription brands for which an OTC version might be appropriate.  The companies have signed a right of first refusal regarding OTC rights for Rhinocort Aqua, a pump spray containing the glucocorticosteroid budesonide, with a local anti-inflammatory effect for the treatment of non-infectious rhinitis (such as hay fever and house dust mite allergy).

A Marketing Authorisation Application for OTC NEXIUM in a 20mg tablet form was filed with the European Medicines Agency in June 2012. A New Drug Application filing for OTC NEXIUM in the US in 20 mg capsules is targeted for the first half of 2013 and if approved Pfizer anticipates commercialising this product in the US beginning in 2014 with launches in other markets to follow