Merck & Co yesterday said a shareholders’ suit alleging the US giant’s directors concealed the cardiovascular safety issues linked to its now withdrawn painkiller Vioxx (rofecoxib) has been dismissed in court by US District Judge Stanley Chesler. Importantly for the firm, the judge also denied the request for the suit to be amended, and Merck’s share price responded in the positive, rising 1.2% to close at $35.12 on the New York Stock Exchange.
Merck pulled the once $2.5-billion drug Vioxx off the global market in September 2004, devastating its financials and causing waves at other companies selling drugs from the same COX-2 class. It made the move after finding that patients given Vioxx over an 18-month or longer period were significantly more likely than those receiving placebo to suffer a heart attack or stroke. But the heat remains: it is still facing more than 11,500 lawsuits – which stay unaffected by this decision – having thus far lost three cases incurring multi-million dollar damages.
But with this suit off its shoulders at least, Merck’s attention will now be focused on tomorrow’s all-important US Food and Drug Administration advisory panel meeting, which will discuss whether to recommend its cervical cancer vaccine Gardasil for approval.
Gardasil is touted as the next potential star in Merck’s pipeline, with a potentially multi-billion dollar peak sales forecast, so all eyes will be on the forthcoming decision. It has a priority review user fee date of June 8, which could give it a clear lead over GlaxoSmithKline’s rival offering Cervarix, which is not expected to be filed until the second half of the year.
But age could prove to be the sticking point. Merck’s clinical programme included patients aged nine to 45 years and the company is seeking approval for the nine to 26 year-old range. A February meeting of the Centers for Disease Control and Prevention gave a nod to the routine immunisation of females with a vaccine against human papillomavirus, the virus responsible for cervical cancer, but only for females aged 11-12.
But Merck appears to be feeling pretty confident of a positive recommendation, and has already started a medical education campaign to women.