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NEW YORK — Pfizer Inc. is slated to market over-the-counter Nexium (esomeprazole magnesium) under an agreement with AstraZeneca.
The pharmaceutical companies said late Monday that through the deal, Pfizer will acquire the exclusive global rights to market Nexium for the approved OTC indications in the United States, Europe and the rest of the globe.
In addition, Pfizer will make an upfront payment of $250 million to AstraZeneca, and AstraZeneca can receive milestone and royalty payments based on product launches and sales.
A proton pump inhibitor launched by AstraZeneca in Europe in 2000 and the United States in 2001, Nexium is a leading prescription drug for the treatment of the symptoms of gastroesophageal reflux disease (GERD).
Plans call for AstraZeneca to continue to manufacture and market the prescription product, as well as to supply Pfizer with the OTC product upon the receipt of regulatory approval.
The companies said a Marketing Authorisation Application for OTC Nexium in a 20-mg tablet form was filed with the European Medicines Agency in June and that, in the United States, a New Drug Application for OTC Nexium in 20-mg delayed release capsules is slated for the first half of 2013.
If approved, Pfizer expects to commercialize the product in the United States starting in 2014, with launches in other markets to follow.
U.S. sales of Nexium totaled $6.2 billion last year, making it one of the biggest-selling prescription medications, according to data from IMS Health.
"Nexium is one of the most recognized and respected products in its class, with tremendous brand equity and loyalty. We are proud to be AstraZeneca’s partner of choice for OTC Nexium," commented Pfizer Consumer Healthcare president Paul Sturman. "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 health care products."
Pfizer and AstraZeneca added that they are exploring a strategic partnership that could include similar agreements for other AstraZeneca prescription brands for which OTC versions might be appropriate. The companies said they 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.
"AstraZeneca has long been a leader in the gastrointestinal sector, and 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" stated Tony Zook, executive vice president of AstraZeneca’s Global Commercial Organization. "We’re pleased to work with Pfizer Consumer Healthcare and believe their sales and marketing of consumer health products makes them the optimal partner to commercialize OTC Nexium globally. This agreement will help AstraZeneca realize the substantial, long-term value of this brand and potentially other brands in our portfolio."
