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

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

 

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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With KRAS break­through on the hori­zon, Am­gen's David Reese re­flects on so­tora­si­b's loom­ing re­view date and murky fu­ture

After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline.

Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.