May 1, 2004
The Boston Globe
Cambridge drug maker Biogen Idec Inc. yesterday warned of possible shortages of its Avonex drug for multiple sclerosis because of manufacturing problems with some prefilled syringes, which led to a $2.1 million inventory write-down in the first quarter and could lead to more charges.
In a filing to the Securities and Exchange Commission after the close of trading yesterday, Biogen Idec, the country's third-largest biotechnology company, also said it wrote off $1.5 million worth of its Amevive drug for psoriasis after the drugs passed their expiration date.
The company had previously mentioned its manufacturing problem with Avonex to analysts, and the problems didn't stop Biogen Idec from reporting $355 million in Avonex sales for the three months that ended March 31, 29 percent higher than a year earlier.
Biogen Idec said that it can continue to supply patients currently on Avonex with the drug but that it is asking doctors to prescribe a less-convenient powdered form to new patients until it resolves the issues.
Avonex has become Biogen's second-largest-selling product since it was approved in 1996, though MS patients had to mix the powdered form of it into a solution for injection. Last year Biogen Idec got approval to sell its own mixture in prefilled syringes, and since then it has converted about 75,000 of 80,000 patients on the drug to the prefilled version -- meant to help Biogen Idec compete with similar products from Serono SA and Schering-Plough.
Recently, quality problems cropped up at at least one vendor it uses to make the drug, a Biogen Idec spokeswoman said yesterday evening, leading the company to report the issues to the Food and Drug Administration. Specifically, a vendor had allowed more "aggregates" to form in the liquid placed in the syringe. Aggregates occur when proteins bind together, which theoretically could increase the body's production of antibodies to a harmful level.
Biogen Idec spokeswoman Amy Ryan said the company hasn't heard of health
problems but decided to notify doctors and the FDA after noticing the problem
in about 5,000 packages, with four prefilled syringes apiece, that had
already been sent to wholesalers and in some cases had reached consumers.
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