Nexium(AstraZeneca) to be OTC marketed by Pfizer
AstraZeneca has entered into an agreement with Pfizer Inc. for the over-the-counter (OTC) rights for Nexium (esomeprazole magnesium) currently approved to treat the symptoms of Gastroesophageal Reflux Disease (GERD). Under the terms of the agreement, 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.
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. 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.
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