For 15 years, Susan Cohn-Child has injected herself with a multiple sclerosis drug at least once a week to keep the disease in check. But Cohn-Child and thousands of other MS patients may soon be able to replace their needles with a pill being developed by Biogen Idec Inc.
Following promising clinical trial results that sent Biogen Idec shares soaring last spring, the Weston biotechnology company yesterday filed a new drug application with the Food and Drug Administration seeking approval to sell the oral treatment, now known as BG-12. Most existing treatments for the autoimmune disorder, which affects about 400,000 people in the United States, require regular injections or intravenous infusions. One other oral treatment exists, but there is hope that the new Biogen Idec drug will prove a more effective option.
Cohn-Child, 47, a financial manager who volunteers with the National Multiple Sclerosis Society to raise awareness about the disease, said the pill would “be a game changer,’’ especially for patients who have difficulty injecting themselves. The Acton mother currently uses Avonex, also made by Biogen Idec.
“This means you’re opening up the possibility for a whole other group of people to receive treatment who wouldn’t have considered it before,’’ Cohn-Child said.
Biogen Idec, a leader in MS medicines and the largest biotech based in Massachusetts, lost a race with Swiss company Novartis AG to market the first MS pill, but that has not lowered expectations for the new treatment.
“This has the potential to be a very important and a very big drug,’’ said Douglas E. Williams, executive vice president for research and development at Biogen Idec.
While there is no head-to-head data comparing Biogen Idec’s pill with the Novartis drug, called Gilenya, Biogen Idec’s version proved extremely safe and effective in testing and, if approved, is projected to generate strong sales as patients abandon current MS drugs, including Biogen Idec’s.
Susan Cohn-Child said the pill would ‘be a game changer,’ especially for patients who have difficulty injecting themselves.
“This is just one more drug we can make available to patients so that when they have conversations with their doctors, we have a variety of offerings,’’ Williams said.
The company asked the FDA to grant priority review for the pill, which would result in a decision in six months rather than the standard 10. In either case, Biogen Idec would probably be able to start marketing it by the end of the year. Later this week, the company is also planning to apply for approval from European regulators to sell the pill, a process that could take a year.
Biogen Idec also disclosed yesterday that the FDA approved two dosing innovations for patients taking Avonex, an MS treatment that has been on the market for 15 years. One is an intramuscular autoinjector using a smaller needle that is easier for patients to tolerate. The other is a dosing regimen that reduces the incidence and severity of flu-like symptoms that the treatment can sometimes cause.
In the case of both Avonex and BG-12, “we’re trying to improve the patient experience,’’ Williams said. “It’s clearly a theme that we’re trying to put in place.’’ Biogen Idec also sells Tysabri, a multiple sclerosis drug for patients with advanced forms of the disease.
Michael Yee, a managing director at investment bank RBC Capital Markets, said that if the drug lives up to its potential, it could grab at least 20 percent of the MS market, as much as $3 billion annually. The pill’s price will not be set until the treatment is approved by the FDA.
The pill “could certainly be the biggest drug for Biogen,’’ said Yee, who was in New York yesterday attending a neurology panel hosted by RBC at which doctors spoke about the drug’s promise. He estimated that the overall market for MS drugs will grow from $11 billion today to $15 billion by 2016.
During clinical trials, the experimental drug worked especially well on the most common form of multiple sclerosis, helping to protect cells from damage and inflammation caused when the disease attacks the central nervous system.
Symptoms of multiple sclerosis worsen over time and can range from numbness of limbs to paralysis. The disease is also marked by painful flare-ups.
Dr. Daniel Kantor, president of the Florida Society of Neurology, said one of his first reactions to BG-12 was “wow!’’ Kantor called the pill a potential “blockbuster in the MS market.’’
“BG-12 is going to fundamentally change how I approach [treating] multiple sclerosis,’’ he said.
At the MS Center at St. Elizabeth’s Medical Center in Boston, director Ellen Lathi said patients are just thrilled about the Biogen Idec pill.
“If we have something that’s even comparable to or better than the injectables available now and has excellent safety, wouldn’t most people want a pill?’’ Lathi said. “It’s a very exciting time.’’
Kingston resident Susan Howard said switching from Avonex to an oral treatment would help her regain some of the independence she has lost because of MS. Diagnosed six years ago, Howard said she injected herself with Avonex once a week for nearly a year before she hit a wall psychologically, and her hands started to shake too much for her to handle a needle. Since then, she has relied on nurses to administer her weekly shot.
“I can’t look at a needle any more,’’ Howard said. “I have to turn my head and say, ‘OK, just get it done quickly.’ But I persevere.’’
Even so, Howard said, Avonex often leaves her with flu-like symptoms, and the injections cause muscle aches - forcing her to cut back on gym workouts or forgo a night of dancing with friends. The new drug, she said, would lessen her reliance on others and increase her ability to move freely.
“To pop a pill,’’ Howard said, “it would be huge.’’Erin Ailworth can be reached at firstname.lastname@example.org. Follow her on Twitter @ailworth. Robert Weisman can be reached at email@example.com.