Products in Trouble

Pharmaceutical Executive

Pharmaceutical Executive, Pharmaceutical Executive-05-01-2002,

Products in Trouble

Arcoxia: In March, Merck withdrew its application to sell Arcoxia (etoricoxib), a treatment for arthritis, chronic and acute pain, and dysmenorrhea, stating it was to "better position the product to compete successfully." Although Merck remains in the arthritis market with Vioxx (rofecoxib), the removal of Arcoxia is likely to benefit Pharmacia and Pfizer, who co-market hot-selling Celebrex (celecoxib), which had $3.11 billion in sales last year.

Commenting on Merck's refusal to explain the Arcoxia withdrawal in more detail, Richard Evans, an analyst with Bernstein Research, suggested there might be a safety issue that could prevent Arcoxia's approval. One concern affecting arthritis medication sales stems from a Journal of the American Medical Society study last year that showed Vioxx and Celebrex may increase the risk of heart attacks.

Vanlev: Two large-scale clinical trials have cast a shadow on Bristol-Myers Squibb's heart drug Vanlev (omapatrilat), a vasopeptidase inhibitor in development for the treatment of hypertension and heart failure. In a study of more than 5,700 heart patients, Vanlev failed to beat Merck's Vasotec (enalapril maleate) in reducing death or hospital admissions in patients with worsening heart conditions. In a second BMS-sponsored study of 25,000 hypertensive patients, Vanlev was more successful at reducing blood pressure but caused the rare side effect angioedema-a swelling of the head and neck-three times as often as Vasotec.

The results mean that, although Vanlev is effective, BMS will have trouble showing a clear benefit over Vasotec. The company's hopes to charge a premium price may also be dashed, because Vasotec is available as a pennies-per-pill generic. Undeterred, BMS plans additional studies of the product.

Meridia: Abbott faces a class action lawsuit filed on behalf of everyone who was prescribed the company's anti-obesity medicine Meridia (sibutramine). The plaintiffs seek to inform the public that Meridia consumers are at increased risk of harm and/or death, to establish a Meridia medical monitoring fund, and to compensate all victims for personal injuries and death.

Globally, at least 33 deaths and almost 400 serious adverse reactions have been attributed to Meridia. Italy has withdrawn all sibutramine products and FDA has been petitioned to remove Meridia from the market.

During the drug's initial development as an anti-depressant, trial scientists noticed that Meridia caused weight loss. Although FDA declined in 1996 to recommend approval of Meridia because of an "unsatisfactory risk-benefit ratio," it approved it in 1997 as a weight-loss medication. Known as Reductil in Europe, Meridia is marketed in 70 countries. An estimated two million people in the United States alone currently take it.