Pfizer will shepherd OTC Nexium through switch process

NEW YORK — Pfizer will be the next consumer healthcare company to reach the market with a switched proton-pump inhibitor. Pfizer on Monday afternoon announced that it has entered into an agreement with AstraZeneca for the over-the-counter rights to Nexium.

“Nexium is one of the most recognized and respected products in its class with tremendous brand equity and loyalty,” Pfizer Consumer Healthcare president Paul Sturman said. “By working with AstraZeneca to offer upon regulatory approval an over-the-counter version of Nexium – a brand people know and trust – we are taking another crucial step to empower consumers by providing convenient access to important healthcare products.”

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 was launched by AstraZeneca in Europe in 2000 and the U.S. in 2001, as its predecessor Prilosec OTC was being presented as a possible switch candidate.

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 authorization application for OTC Nexium in a 20-mg 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 20-mg 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 noninfectious rhinitis (such as hay fever and house dust mite allergy).


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