Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Van­da Phar­ma­ceu­ti­cals is mak­ing a name for it­self, at least in terms of su­ing the FDA.

The DC-head­quar­tered firm on Mon­day filed its lat­est suit against the agency, with the com­pa­ny rais­ing con­cerns over the FDA’s fail­ure to grant a fast track des­ig­na­tion for Van­da’s po­ten­tial chron­ic di­ges­tive dis­or­der drug tradip­i­tant, which is a neu­rokinin 1 re­cep­tor an­tag­o­nist.

Specif­i­cal­ly, Van­da said FDA’s “es­sen­tial point” in its one-page de­nial let­ter on the des­ig­na­tion point­ed to “the lack of nec­es­sary safe­ty da­ta,” which was “in­con­sis­tent with the cri­te­ria for … Fast Track des­ig­na­tion.”

But Van­da says that tradip­i­tant, which it’s hop­ing to treat short-term nau­sea in gas­tro­pare­sis pa­tients, “has been stud­ied ex­ten­sive­ly in an­i­mals and hu­mans for mul­ti­ple in­di­ca­tions, be­gin­ning in 2003. No rel­e­vant hu­man safe­ty sig­nals have emerged.”

In De­cem­ber 2018, how­ev­er, FDA im­posed a par­tial clin­i­cal hold on tradip­i­tant, pre­vent­ing Van­da from study­ing the drug in hu­mans for longer than 3 months un­til the com­pa­ny could con­duct a 9-month tox­i­c­i­ty study in non-ro­dent an­i­mals (dogs, mon­keys, or pigs).

“Van­da de­clined to con­duct such a study,” the com­pa­ny said in its law­suit. “Long-term tox­i­c­i­ty stud­ies al­ways con­clude in the killing of the test-sub­ject dogs, typ­i­cal­ly young bea­gles. And it would have di­vert­ed Van­da’s lim­it­ed re­sources from drug re­search and de­vel­op­ment ef­forts to un­help­ful an­i­mal tests.”

And while the FDA paved some­what of a path for Van­da to move for­ward, the agency said in its fast-track de­nial let­ter that based on the cur­rent tradip­i­tant de­vel­op­ment plan as FDA un­der­stood it, “Van­da might not be able to ob­tain safe­ty and ef­fi­ca­cy da­ta to achieve mar­ket­ing ap­proval.”

Van­da’s de­ci­sion to sue the FDA might seem like an odd move, but the com­pa­ny has sued the agency mul­ti­ple times and lost at least one case re­cent­ly con­cern­ing that clin­i­cal hold from FDA on tradip­i­tant.

The FDA is­sued the hold af­ter con­clud­ing that “ex­ist­ing tradip­i­tant stud­ies in non­ro­dents con­tain suf­fi­cient trou­bling in­di­ca­tions of tox­i­c­i­ty such that—while short­er-term hu­man stud­ies may be safe enough to pro­ceed—FDA needs to see if those tox­i­c­i­ty mark­ers in­crease dur­ing long-term non­ro­dent stud­ies be­fore al­low­ing long-term hu­man stud­ies.”

Van­da Phar­ma­ceu­ti­cals al­so the agency again in the same DC dis­trict court in April, al­leg­ing this time that the agency is wrong­ful­ly with­hold­ing parts of a re­jec­tion let­ter for a new in­di­ca­tion for its sleep drug Het­lioz (tasimelteon) for jet lag.

Sales of the com­pa­ny’s mela­tonin re­cep­tor ag­o­nist Het­lioz, ap­proved in 2020 for non-24-hour sleep-wake dis­or­der and night­time sleep dis­tur­bances in Smith-Ma­ge­nis syn­drome, in­creased by $12.9 mil­lion, or 8%, to $173.5 mil­lion for 2021, com­pared to $160.7 mil­lion for 2020.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.