Updated on 14 August 2012
AstraZeneca will continue to manufacture and market the prescription product and supply Pfizer with the OTC product upon regulatory approval
Singapore: Pfizer has entered into an agreement with AstraZeneca 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 US, 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 US 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 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 US in 20mg delayed release capsules is targeted for the first half of 2013. If approved, Pfizer anticipates commercializing 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 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).
Paul Sturman, consumer healthcare president, Pfizer, said, "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. 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."
Mr Tony Zook, executive vice president of AstraZeneca's Global Commercial Organization, said, "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."