AstraZeneca, facing declining revenues last year, sold the marketing rights to its over-the-counter (OTC) version of Nexium to Pfizer Inc. for $250 million. AstraZeneca will be in line for milestone and royalty payments from Pfizer for the OTC version, as well as retention of exclusive rights to manufacture and market the prescription version. But the latter will become less lucrative once the US patent expiry occurs in 2014 and generic competition appears on the horizon.

The problems could happen even sooner if a New Jersey-based pharmaceutical company wins approval from the U.S. Food and Drug Administration for a new, generic version of Nexium. It was reported recently in the New York edition of Newsday that Amneal Pharmaceuticals LLC has partnered with Hanmi Pharmaceutical Co. to produce a version of Nexium and have it ready for market within the second half of this year. That will give them a jump on other generic competitors. Newsday did not identify whether or not the new drug would be geared for the OTC or prescription market.

With all this activity involving Nexium, it should be noted that a class-action lawsuit is pending against AstraZeneca. It was filed in 2004 on behalf of third-party payers. It was contended in the suit that AstraZeneca aggressively promoted Nexium as superior when compared to a competitor, whose patent was about to expire. The lawsuit claimed that AstraZeneca failed to disclose flaws in its studies. This lawsuit could definitely have an effect on Nexium’s future. AstraZeneca derives about $6 billion in revenue from Nexium each year, according to the IMS Health news service.

There is another serious problem and that involves a risk known to the drug’s maker. For women who take Nexium or other proton pump inhibitors (PPI) to combat the symptoms of acid reflux, there exists a rise in the risk of hip fracture as high as 50%. This was revealed by researchers at Harvard Medical School and Massachusetts General Hospital in Boston. Results from the study were published online in the British Medical Journal last year. The highest risk is tied to PPI patients who are current or former smokers. But, according to researchers who studied more than 80,000 women as part of the exhaustive Nurses’ Health Study, any woman having used a PPI drug on a regular basis for two years or longer faced a 35% higher risk of hip fracture. It was stated by the study that smoking drove that statistic up to 50%.

PPI drugs such as Nexium are suspected of inhibiting calcium absorption, thereby lending itself to brittle bones. Researchers call the evidence “compelling.” Dr. Hamed Khalili, a clinical and research fellow in gastroenterology at Massachusetts General Hospital in Boston, notes that the FDA was right to mandate a change to a stronger warning on the prescribing label. He added:

Our data supports the recent decision by the U.S. Food and Drug Administration to revise labeling of PPIs to incorporate concerns about a possible increase in risk of fractures with these drugs.

We will continue to watch all of the above closely. If you need additional information on Nexium, contact Melissa Prickett, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at


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