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

 

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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