- New Biogen CEO Michel Vounatsos told investors during the company’s fourth quarter call that its newly approved spinal muscular atrophy (SMA) drug Spinraza (nusinersen) has been on the market for two weeks and gave updates about the launch.
- The drug, partnered with Ionis Pharmaceuticals and the first approved for SMA, brought in $5 million in sales already, which the company clarified was “channel building.”
- Vounatsos told investors on the call that the company expects Spinraza to be approved in the EU by mid-year.
While Biogen hasn’t been in the best place over the last several months, the big biotech has been celebrating its win with the approval of the rare disease drug Spinraza, which got the Food and Drug Administration greenlight just before the end of 2016.
Yet, it hasn’t been smooth sailing during the first few weeks of the launch – U.S. insurer Anthem announced earlier this week that it would restrict coverage of the drug to only the sickest patients, limiting the patient population and Biogen’s revenues.
Vounatsos confessed on the call that the company has a long slog ahead to educate patients and physicians and that reimbursement, as well as teaching clinicians, will limit uptake in 2017.
“We believe that over time, logic will prevail in having the patient access to a medicine that will save lives. So far we are satisfied with the progress that we are making,” said Vounatsos on the call.
The company expects revenues to trickle in for Spinraza over 2017 as reimbursement and education get worked out.
“It’s early days. As we’ve pointed out, it’s 40 or 50 sites and that’s a big percentage of the biz in the U.S.,” said another Biogen executive on the call. “We are doing meaningful education across the U.S. and reaching out to families. But it’s early days in getting through these capacity constraints and reaching out to payers.”
The big biotech reported full-year revenues of $11.4 billion, up 6% from the year-prior on a constant currency basis. Revenues grew on the strength of multiple sclerosis drugs Tecfidera (dimethyl fumarate), which gained 9% to reach sales of $3.97 billion, and Tysabri (natalizumab), which gained 4% to reach $1.96 billion.
The company is working on life cycle management for Tysabri, testing it in ischemic stroke, and told investors that it is looking to bolster its pipeline with further compounds in its key areas like MS and Alzheimer’s disease.