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Pfizer (PFE) Gains OTC Rights for NEXIUM; Will Pay Astra (AZN) $250M Upfront

August 13, 2012 4:46 PM EDT Send to a Friend
Pfizer Inc. (NYSE: PFE) today announced that it has entered into an agreement with AstraZeneca (NYSE: AZN) for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug 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. 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.

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 upon the receipt of regulatory approval. 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 U.S. in 20mg delayed release capsules is targeted for the first half of 2013. 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 could include similar agreements for other AstraZeneca prescription brands for which OTC versions might be appropriate. The companies have signed an agreement giving Pfizer 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).




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