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

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.