AstraZeneca, a global biopharmaceutical company, has entered into an agreement with Pfizer, a global research-based pharmaceutical company, for the over-the-counter (OTC) rights for Nexium (esomeprazole magnesium), a prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).
Pfizer will acquire the exclusive global rights to market Nexium for the approved over-the-counter indications in the U.S., Europe and the rest of the world. Pfizer will make an upfront payment of $250 million to AstraZeneca. AstraZeneca will also be eligible to receive milestone and royalty payments based on product launches and sales.
Nexium, a Proton Pump Inhibitor, was launched by AstraZeneca in Europe in 2000 and the U.S. in 2001. AstraZeneca will continue to manufacture and market the prescription product, as well as supply Pfizer with the OTC product. A Marketing Authorization 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 U.S. in 20mg capsules is targeted for the first half of 2013 and if approved Pfizer anticipates commercializing this product in the U.S. beginning in 2014 with launches in other markets to follow.
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).
"We believe that an OTC version of Nexium will complement this globally successful prescription medicine and help bring relief to more patients around the world," said Tony Zook, executive vice president of global commercial organization, AstraZeneca. “This agreement will help AstraZeneca realize the substantial, long-term value of this brand and potentially other brands in our portfolio."