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

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

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.