Tecfidera (dimethyl fumarate)
Launch Date: April 2013
First-Year Sales: N/A
First-Half 2013 Sales: $192.1 million
Analyst Estimate for 2018: $3.78 billion
Known until just recently by its experimental name, BG-12, Tecfidera is one of those drugs that inspires great expectations. Doctors, multiple sclerosis patients, analysts--and Biogen Idec ($BIIB), of course--couldn't wait for it to hit the market. The only group that wasn't happy when Tecfidera rolled out in April 2013? Novartis ($NVS) and Sanofi ($SNY), whose earlier-to-market MS pills now face more head-to-head competition.
And Tecfidera represents impressive competition. Late-stage trials delivered solid statistics, showing that Tecfidera could slash the annual relapse rate, stave off lesion growth and slow progression to disability. The numbers compare favorably with those of both its rivals. Safety-wise, Tecfidera so far stands clear of the sort of worries that afflict Aubagio, with known liver risks, and Gilenya, with heart-rate issues that recently prompted an FDA review. Plus, Biogen priced Tecfidera at $54,900 per year, less than Gilenya's $58,000 sticker.
So, when Biogen reported $192 million in first-quarter sales--more than twice the $70 million analysts had expected--bystanders were awed but not astonished. After all, analysts estimate $3.8 billion in sales by 2018, and that's just 5 years away. The launch was so successful, in fact, that it threw a wrench into Biogen's real estate plans. Rather than moving to the new HQ in Cambridge, commercial operations are expected to stay in Weston, MA, at least for now. The drug has come up against some reimbursement snags, but Biogen has countered those delays by offering Tecfidera for free to patients who have to wait longer than two weeks for reimbursement.
One key obstacle remains for the Biogen drug--marketing in the EU. Because of intellectual property concerns, the Cambridge, MA-based company decided to hold off on a European launch for now. Some believe European sales will eventually account for 40% of Tecfidera revenues, but securing the drug against generic competition is job one. Long-term, the company says, a delay will be worth the immediate cost.
Another development to watch: In July 2013, an MS patient who had been taking Tecfidera died while suffering from a form of pneumonia that tends to afflict MS patients. She had been using Tecfidera a little over 5 weeks. The company said it's investigating but that it's unlikely that its drug caused her death.
Biogen's Tecfidera races past estimates with $192M in Q2 sales
Biogen: Tecfidera link to MS patient's death 'unlikely'
Biogen Idec taps brakes on EU launch of oral MS drug Tecfidera
Biogen prices Tecfidera below oral MS rival Gilenya
Biogen Idec rolls up FDA OK for blockbuster multiple sclerosis drug Tecfidera
-- Tracy Staton (email | Twitter)