Markets stunned as Merck withdraws blockbuster Vioxx
pharmafile | September 30, 2004 | News story | |Â Â Merck, VioxxÂ
Merck has taken the pharmaceutical world by surprise by announcing the immediate withdrawal of its blockbuster arthritis pain drug Vioxx from worldwide markets.
The drug is one of the biggest selling drugs in the world, earning Merck $2.5 billion last year, its second biggest earning brand behind cholesterol treatment Zocor.
The company announced the voluntary withdrawal after new three-year trial data confirmed that the drug showed increased relative cardiovascular risk in patients – a side-effect that the company has until now denied as significant, despite growing evidence from previous trials.
“We are taking this action because we believe it best serves the interests of patients,” said Raymond Gilmartin, chairman and chief executive officer of Merck.
“Although we believe it would have been possible to continue to market Vioxx with labelling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”
Launched in the US in 1999 and marketed in more than 80 countries, Vioxx and its competitor in the Cox-II inhibitor market, Pfizer’s Celebrex, represented a new generation of painkiller drugs promising pain relief as effective as traditional NSAIDs without the gastrointestinal side-effects seen in the older drugs.
The trial named APPROVe was designed to evaluate the efficacy of Vioxx 25 mg in preventing a recurrence of colorectal polyps in patients with a history of colorectal adenomas but showed that patients who took the drug for longer than 18 months were at increased risk of a heart attack or stroke.
“Merck has always believed that prospective, randomised, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study and it has provided us with new data on the cardiovascular profile of Vioxx,” said Peter S Kim, president of Merck Research Laboratories.
“While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognize that Vioxx benefited many patients, we believe this action is appropriate.”
Merck said it remained comfortable with its 2004 earnings per share guidance of $3.11 to $3.17 and said it expects earnings per share to fall by $0.50 to $0.60 as a result of the announcement.
The news will undoubtedly have a long-term negative impact on the company’s share price, as investors were already doubtful about its ability to generate new drugs to replace its more mature products.
In the UK, the MHRA immediately issued guidance to healthcare professionals and patients, of which there are an estimated 400,000 taking the medicine.
Professor Sir Alasdair Breckenridge said: “Patients taking Vioxx should contact their doctor by phone or at the next convenient appointment to arrange an alternative prescription. The Committee on Safety of Medicines has looked at this issue this morning and agreed that this message should be communicated widely to health professionals and patients without delay.”
The withdrawal is the most significant since Bayer took Lipobay off the market in 2001, but there is no suggestion that Vioxx is linked to fatal side-effects, as was the case with the cholesterol-lowering drug.
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