Biogen Idec Inc., the maker of multiple sclerosis drugs Avonex, Tysabri and Tecfidera, said it anticipates bringing the hemophilia treatment Eloctate to market in mid-2014, later than previously projected.
The Food and Drug Administration asked for more information about the way the manufacturing data are collected and reported, Tony Kingsley, head of commercial operations for the Weston, Massachusetts-based drugmaker, said today at a Credit Suisse conference. The delay is equal to about 90 days.
Biogen had projected it would market Eloctate in the first half of next year, and said on an October conference call there might be a postponement. The drug, developed with partner Swedish Orphan Biovitrum AB, is aimed at treating hemophilia A, an inherited blood disorder. Eloctate may draw $700 million in revenue for Biogen in 2020, according to a Cowen & Co. estimate.
“The FDA requested additional information related to certain steps in the validation process in our manufacturing,” Kingsley said today. “We are working with them to provide that information.”
Biogen gained less than 1 percent to $235.62 at the close in New York. The shares have increased 61 percent this year, fueled by investor excitement over another drug, Tecfidera for multiple sclerosis.
Tecfidera was approved by the FDA in March, and Kingsley told investors today there are about 35,000 patients on the drug. That makes it the most-prescribed pill for relapsing-remitting MS, the most common form of the disease, he said.
“Tecfidera got off to a faster start in the U.S. than we had anticipated,” Kingsley said today in a telephone interview. “There was a lot of pent-up demand at the time the product launched.”
The drug drew $286.4 million in third-quarter revenue, the company reported Oct. 28, topping analysts’ average $217.2 million estimate. They predict Tecfidera will bring in $3.52 billion in annual revenue by 2016.
The medicine competes with treatments including Sanofi’s Aubagio and Novartis AG’s Gilenya, other oral therapies for MS. Avonex, Biogen’s top-seller with $2.91 billion in 2012 revenue, is given by injection.
Tecfidera is not yet approved in Europe. The company is in discussions with regulators there to resolve an issue of data protection for the drug, Kingsley said. Biogen said last month that the European Medicines Agency expects to make a decision at its November meeting.
Drugs for multiple sclerosis are typically priced in Europe at about half of their U.S. price, a disparity that exists among medicines for many diseases, Kingsley said in response to a question at his presentation.
“That may give you some guide about how to think about the pricing dynamic,” he said.