NEW RESEARCH STUDIES ADD TO CONCERNS OVER ISRAEL'S TEVA

Local studies have prompted concerns over the safety of Israeli generic major Teva's Copaxone (glatiramer acetate injection) product, indicated for muscular degenerative disorder multiple sclerosis (MS). The research, conducted at Ben-Gurion University in Israel, appears to show that the company's product carries an increased risk of breast cancer. Some 892 women were surveyed in the study, which also studied three rival drugs. Reports suggest that Copaxone could have negated the stimulus of immune system responses against cancer supposedly induced by MS.

Teva has refuted the research, claiming that only four of 15 patients with breast cancer had not reported the disease prior to the start of the study. Furthermore, the company's own studies of the estimated 60,000 women to have taken the drug since its launch in 1996 indicate no higher incidence of breast cancer than among the general population.

Nevertheless, the company faces a number of other challenges in the medium term. Swiss drugmaker Serono recently announced that it would begin a two-year clinical comparison of the effectiveness of its Rebif MS treatment against Copaxone. Further, Teva continues to contest a US lawsuit brought by German pharmaceuticals producer Schwarz. The claim alleges that Teva violated patents on its Univasc (Moexipril) heart therapy, launched in mid-2003 but since suspended following Schwarz's successful appeal against an earlier ruling allowing Teva to file a patent for the drug. Liabilities of roughly US$20mn are expected.

Despite the adverse news, Teva is eager to point out that its ethical Azilect (Rasagiline) treatment for the initial stages of Parkinson's disease has already received Israeli approval, and clearance from European authorities is expected in the next few months. The global market for Parkinson's treatments is valued at some US$2.2bn per year.