A new company enters the Tecfidera fight, offering to kill two birds
The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.
Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experience. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.
Joseph Habboushe watched his father struggle with the same issue for high-dose niacin, a cholesterol treatment that also caused a flush that could be prevented if you only took aspirin 30 minutes to an hour before.
“Most patients, they just won’t do that,” Habboushe told Endpoints News. “It’s really hard.”
So Habboushe, an ER doc, entrepreneur and academic began working on a way to integrate the two and come up with something that would give aspirin’s anti-flush effect at the same time a patient took the main medicine. He filed his first patent in 2012, and today he’s officially announcing the company: Vitalis Pharmaceuticals.
Information is scant on Vitalis. The company has not disclosed its investors or how much money they have, and aside from an 18-person pilot study that found a 63% flush reduction, there’s little data to back them up. Despite that, they’re aiming to hit the market in 2021.
They have several candidates — including ones for non-opioid pain and dyslipidemia — but their main pitch is around Tecfidera, the pill that earned Biogen over $4 billion last year. Habboushe said that while he began by trying to find a way of warding off flush, he emerged with a pill he claims can not only reduce flush but also has better pharmacokinetic properties and can get around Biogen’s patents.
The future of Tecfidera — which fast beaome the number-one selling MS pill in the US after its approval in 2013 — is clouded by competitors and a heated patent dispute.
Biogen’s patents are slated to fully expire in 2028, but several companies have already challenged that, hoping to void it earlier. Most notably, Mylan is in the midst of a court case to void the patent on the basis of obviousness, and in 2017, Biogen paid $28 million and promised more in milestones to Alkermes to buyout their challenge.
Any change in the patent outlook would be consequential — both for Biogen and for any developer able to then enter the market. After Biogen disclosed the Mylan threat in February, Leerink analyst Geoffrey Porges wrote that a 2020 patent expiration would be worth 10-15% Biogen’s value.
Social image: Joseph Habboushe, NYU Langone Health