Rheumatoid arthritis was a bad indication for Merck this week. The pharma giant agreed to pay $950 million to offset allegations of off label promotion of VIOXX® for RA . The huge settlement, one of the largest for a pharmaceutical company, will be used to settle civil lawsuits and pay a criminal fine (violation of the FDC Act). If you have been following along, VIOXX Sales reps were more or less caught red-handed as their notes revealed plans to discuss RA treatment with physicians.
More bad news related to RA came to Merck this week as AMGEN’s pending etanercept patent (licensed from ROCHE) was approved. This put a damper on Merck’s deal to license Hanwha Chemical’s etanercept with the hopes of scoring big in the biosimilar market. This obviously doesn’t bode well for Merck but may also be an unfortunate precedent for any company interested in developing biosimilars. It sounds like more legal battles ahead but perhaps they will be worth it. ENBREL© (AMGEN’s etanercept ) has consistently been a multibillion dollar drug and one of the best selling biotherapeutics on the market.
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