European drugmakers hit with poor test results

AP News
Posted: Dec 20, 2011 11:01 AM
European drugmakers hit with poor test results

Three top European pharmaceutical companies announced on Tuesday disappointing news from clinical tests on drugs they had hoped would turn out to be big sellers.

France's Sanofi said its multiple sclerosis drug candidate teriflunomide did not achieve one of its goals in a late-stage clinical trial, while Swiss rival Novartis announced it would terminate trials of its high blood pressure treatment Rasilez for patients with diabetes and renal impairment. Britain-based AstraZeneca abandoned plans to develop a new anti-ovarian cancer drug.

Shares in the three companies underperformed European stock markets _ AstraZeneca lost 2.3 percent and Novartis 1 percent, while Sanofi gained 0.8 percent _ as investors reined in their earnings expectations.

Sanofi said teriflunomide, also known by the trade name Aubagio, worked no better than an older drug, Rebif, in preventing relapses, as the study found "no statistical superiority" between Rebif and either 7 mg or 14 mg doses of teriflunomide. Rebif is marketed by Merck KGaA of Germany.

Sanofi's Genzyme unit enrolled 324 patients with relapsing forms of MS in a two-year study.

The study was the second of five planned efficacy studies of teriflunomide in MS. Genzyme expects to file an application for marketing approval in the European Union in the first quarter of 2012.

In Basel, Switzerland, Novartis said it was terminating a trial of its high blood pressure treatment Rasilez in high-risk patients with diabetes and renal impairment.

The drugmaker said in a statement that it terminated the study on the recommendation of the independent monitoring committee overseeing the trial. The committee found that patients were unlikely to benefit from treatment with Rasilez, and also identified higher incidences of non-fatal stroke, renal complications and other difficulties.

Rasilez, known as Tekturna in the U.S., had sales of $449 million in the first nine months of 2011 and Novartis expects sales will be negatively affected by the study results going forward. Novartis said that as a precautionary measure it will cease promotion of Rasilez/Tekturna-based products for use in combination with standard anti-hypertension treatments.

Also Tuesday, British drugmaker AstraZeneca PLC said it is abandoning plans to develop a new anti-ovarian cancer drug and that a planed antidepressant has underperformed in tests.

The British drug company said Tuesday that it would take a one-time pre-tax loss of $285 million for the failure of olaparib _ a drug that was meant to fight ovarian cancer.

It added that the underperformance of the antidepressant, known as TC-5214, in tests would cost it another $96.5 million, pre-tax.