The Pressure’s On AstraZeneca and Nexium

Boston, MAThe manufacturer of a popular acid reflux drug, Nexium, appears to be in a state of flux with various issues percolating inherent with the pharmaceutical company. AstraZeneca, with a new leader at the helm, has reportedly axed thousands of jobs and is facing diminished returns from Nexium sales when the patent on the prescription version of the drug expires in the US next year.

But there is other news percolating in the Nexium drug medication reflux promo file. This past August, AstraZeneca, facing declining revenues, 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, although the latter will become less lucrative once the US patent expiry occurs in 2014 and generic competition appears on the horizon.

That could happen even sooner, if a New Jersey-based pharmaceutical company wins approval from the US Food and Drug Administration (FDA) for a new, generic version of Nexium. According to the New York edition of Newsday (1/29/13), 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, thereby getting 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. It was also noted that AstraZeneca is embroiled in a lawsuit with Hanmi.

All this activity involving Nexium - increased competition and the various Nexium drug medication reflux promo/marketing initiatives pending - seem distant from a class-action lawsuit filed against AstraZeneca in late 2004, on behalf of third-party payers who claimed AstraZeneca aggressively promoted Nexium as superior when compared against a competitor, whose patent was about to expire.

The lawsuit asserted that AstraZeneca failed to disclose flaws in its studies. An attorney at the time referenced AstraZeneca’s misleading Nexium drug medication reflux promo and other marketing initiatives.

One wonders, then, what impact adverse events will have on Nexium’s future - and ultimately, the wellbeing of AstraZeneca, which derives about $6 billion in revenue from Nexium each year, according to the IMS Health news service.

For women who take Nexium or other proton pump inhibitors (PPI) to combat the symptoms of acid reflux, there exists a rise in risk of hip fracture as high as 50 percent - this, according to researchers at Harvard Medical School and Massachusetts General Hospital in Boston. Results were published online in the British Medical Journal last year.

The highest risk is tied to PPI patients who are current or former smokers. However, 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 percent higher risk of hip fracture. Smoking drove that statistic up to 50 percent. 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 the FDA was right to mandate a change to a stronger warning on the prescribing label. “Our data supports the recent decision by the US Food and Drug Administration to revise labeling of PPIs to incorporate concerns about a possible increase in risk of fractures with these drugs,” he said.