Last year AstraZeneca sold the marketing rights to its over-the-counter (OTC) version of Nexium to Pfizer Inc. due to declining revenues, for $250 million. AstraZeneca will receive royalty payments from Pfizer for the OTC version, as well as retention of exclusive rights to manufacture and market the prescription version. However, once the U.S. patent expires in 2014 and generics are manufactured, the rights will become less lucrative.
This may occur even sooner if a New Jersey-based pharmaceutical company wins approval from the U.S. Food and Drug Administration (FDA) for a new, generic version of Nexium.
It was recently reported in the New York edition of Newsday that Amneal Pharmaceuticals LLC has partnered with Hammi Pharmaceutical Co. to produce a version of Nexium to be ready for market within the latter part of this year. This will give them a headstart from other generic competitors. Newsday did not identify whether or not the new drug would be geared for the OTC or the prescription market.
Nexium has been receiving a lot of attention. A class action lawsuit is pending against AstraZeneca. The suit was filed in 2004 on behalf of third-party payers. It was alleged in the lawsuit 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 may very well have an effect on Nexium’s future. Nexium brings in about $6 billion each year for AstraZeneca, according to the IMS Health news service.
There has been a lot of publicity following the results of a study published online in the British Medical Journal last year. Researchers at Harvard Medical School and Massachusetts General Hospital in Boston revealed serious risks to women who take Nexium or other proton pump inhibitors (PPI) to help symptoms of acid reflux. There is a rise in the risk of hip fracture as high as 50 percent. The highest risk is tied to PPI patients who are current or former smokers. According to researchers who studied more than 80,000 women as part of the Nurses’ Health Study, any woman having used a PPI drug regularly for two years or more, faced a 35 percent increased risk of hip fracture. The study stated that smoking raised that statistic to 50 percent.
PPI drugs such as Nexium are suspected of inhibiting the bodies’ calcium absorption, resulting in brittle bones, which can fracture easily. Researchers call the evidence “compelling.” Dr. Hamed Khalili, a clinical and research fellow in gastroenterology at Massachusetts General Hospital notes that the FDA was correct in mandating 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 the risk of fractures with those drugs.”
Although it is uncomfortable to suffer from acid reflux or severe heartburn, for some people on a daily basis, it is even more uncomfortable to suffer from fractured bones, as a result from your medication. Many patients were unaware that this risk was present, since the labels did not have warnings stating this risk.
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