Genzime reports MS drug effective, but with small chance of deadly side effect
BOSTON Genzyme Corp. said yesterday that results from its experimental multiple sclerosis drug alemtuzumab proved it to be very effective, but patients must be monitored to avoid a potentially deadly side effect.
Three-year data from a mid-stage trial, which tested the drug on 334 patients with multiple sclerosis, showed the drug significantly reduced the risk of relapse compared to Merck’s MS drug called Rebif. Patients had at least a 70 percent reduced risk of progression of disability after three years, compared to those taking Rebif, Cambridge-based Genzyme said.
The data, presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis, showed patients who had not been treated and took Genzyme’s drug alemtuzumab had a 73 percent reduction in the risk of relapse.
“These results demonstrate the durability of the previously reported effect of alemtuzumab for the treatment of multiple sclerosis that, by our analysis, exceeds any marketed products and anything that we can see in development,” said Richard Moscicki, chief medical officer for Genzyme.
Still, there is concern among investors over its safety.
Six patients in the trial were diagnosed with idiopathic thrombocytopenic purpura, characterized by a decline in platelet counts that can lead to potentially catastrophic internal bleeding. One patient died, four were successfully treated, and one recovered without treatment.
To protect against this possible side effect, Genzyme’s monitoring program requires patients to have their blood drawn once a month.
Wyeth hit with $134.5 million in Nevada lawsuit
RENO, Nev. Wyeth has been ordered by a Washoe county court to pay more than $43 million each to three northern Nevada women who claimed that the company’s hormone replacement drugs, Prempro and Premarin caused their breast cancer, according to the Reno Gazette-Journal.
The jury said the drugs were defective and found the company negligent for producing, manufacturing and selling them. The jurors awarded $7.5 million to each woman in past damages and $36 million-$40 million in future damages.
The jurors still have to decide whether the company is liable for punitive damages. Wyeth is also fighting about 5,300 similar lawsuits involving 7,800 women in state and federal courts across the country.
Teva sues Apotex over Coreg infringement
TRENTON, N.J. Teva has sued Apotex to prevent it from selling a generic version of the heart medication Coreg, according to Bloomberg.
The two companies, as well as other generic drug makers, received approval from the Food and Drug Administration to sell a generic version on Sept. 5. Teva says it owns four patents that cover various forms and processes to make the generic, carvedilol. The company also said that Apotex might have to buy the compound made using the patented process in order to sell the generic.
The lawsuit was filed yesterday in a federal court in New Jersey. Coreg had sales of $853.8 million in the first six months of 2007.