Biotech companies spend years in the lab hoping new therapies can beat the odds and make it onto the market. Biogen Idec’s introduction of its first pill for multiple sclerosis patients achieved that and much more last year, becoming one of the most successful drug launches in US history.
For years, patients with the neurodegenerative disease could only be treated with injectable drugs. Novartis AG introduced the first MS pill in 2010, a milestone in the battle against the disease.
But Biogen took oral therapy for MS patients to a new level last year with its introduction of Tecfidera, a drug many considered safer than other pills on the market. Demand for the Cambridge company’s pills exploded, and Tecfidera rang up $876 million in first-year sales.
“Patients were really desirous of a drug that was easy to take, worked well, and seemed to be safe,” said chief executive George A. Scangos. “And that’s the niche Tecfidera filled. We brought patients a drug they really like. It’s had a big impact on the morale of the company. The realization that we’ve done something good for patients is important to our employees.”
Tecfidera helps reduce pain for MS patients by relieving stress that damages nerve cell coverings. Taken twice a day, it has proven to be more effective than injectable interferons.
Biogen is the leading seller of MS treatments globally, and industry watchers had anticipated the oral medicine would round out its drug portfolio. But the rapid takeoff of Tecfidera took most analysts by surprise. Sales of $506 million over the first three months of 2014 blew by Wall Street forecasts as the drug entered overseas markets.
Tecfidera drove Biogen Idec’s overall revenue gain — and its stock surge — in the past year even as sales of its other MS drugs, Avonex and Tysabri, declined, said Marko Kozul, senior biotech analyst for Leerink Swann, a Boston health care investment bank.
“This was key to the franchise,” Kozul said. “It was fundamental for Tecfidera to meet and beat [sales forecasts] every quarter in the past year and it did.”
Biogen Idec’s quest for an MS pill dates back to 2006, when it bought privately held Swiss drug maker Fumapharm. In the process, the Cambridge company acquired an experimental compound called BG-12 being studied as an oral treatment for both MS and psoriasis.
“We’ll go wherever we need to get the best drugs for the patient,” said Al Sandrock, Biogen Idec’s senior vice president and chief medical officer. Some are developed in the company’s labs, but others — like BG-12, which became Tecfidera — are purchased.
Biogen Idec, the largest Massachusetts-based biotechnology company, took the compound into clinical trials to test its effectiveness against MS at different dosage levels compared to placebos. The results from late-stage trials in 2011 turned out to be better than expected.
“It was a complete surprise and a very exciting day when we looked at the data,” recalled Kate Dawson, vice president for global medical neurology at Biogen Idec. After that, she said, “We knew we had a drug that was going to make a lot of difference for patients.”
In the ongoing fight against MS, which affects about 2.5 million people worldwide, Biogen Idec will next work to expand Tecfidera’s use to patients with secondary progressive MS, a stage that follows relapsing remitting MS, the indication for which the drug is approved.
Beyond that, the company’s most pressing research focus is a drug candidate known as anti-Lingo, which would not only treat the symptoms of MS but, for the first time, strengthen the ability of cells to repair nerve damage — a potential breakthrough in the field of neurology.
‘We’ll go wherever we need to get the best drugs for the patient.’
“That’s the need we’re going after now,” Scangos said.