EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU mem­ber states on alert over the short­age of two drugs that counter heart at­tacks due to an uptick in de­mand.

On Fri­day, the EMA sent out a warn­ing that two Boehringer In­gel­heim drugs are ex­pe­ri­enc­ing a short­age: Ac­til­yse and Metal­yse. The drugs are used as emer­gency treat­ments for adults ex­pe­ri­enc­ing acute my­ocar­dial in­farc­tion, or a heart at­tack, by dis­solv­ing blood clots that have formed in the blood ves­sels.

The EMA warn­ings said that a rise in de­mand for the drugs is lead­ing to an over­all short­age that is ex­pect­ed to last un­til 2024. Both drugs are man­u­fac­tured at Boehringer’s fa­cil­i­ty in Bib­er­ach, Ger­many.

A Boehringer In­gel­heim spokesper­son told End­points News in an email that the spe­cif­ic caus­es of the short­age in­clude an ag­ing pop­u­la­tion be­ing more sus­cep­ti­ble to heart at­tacks and strokes, as well as rec­om­men­da­tions for the drugs be­ing ex­pand­ed.

In 2022, health­care pro­fes­sion­als are treat­ing ever-in­creas­ing num­bers of pa­tients re­quir­ing throm­bolyt­ic treat­ments such as Ac­til­yse and Metal­yse. In an­tic­i­pa­tion of ris­ing de­mand, Boehringer In­gel­heim has more than dou­bled its pro­duc­tion ca­pac­i­ty at its fa­cil­i­ty in Bib­er­ach, Ger­many, over the last 10 years.

“With ris­ing glob­al de­mand for throm­bolyt­ic treat­ments de­spite all ef­forts we have reached a point where the pro­duc­tion of these med­i­cines is no longer keep­ing up with de­mand,” the spokesper­son said.

With Boehringer In­gel­heim at max­i­mum pro­duc­tion ca­pac­i­ty in Bib­er­ach, the EMA said in its warn­ing that, with­in the next three years, a new man­u­fac­tur­ing site will be es­tab­lished to in­crease ca­pac­i­ty. The com­pa­ny spokesper­son told End­points that it is plan­ning to trans­fer all Ac­til­yse drug man­u­fac­tur­ing to a new site in Vi­en­na, al­low­ing space to free up in Bib­er­ach for Metal­yse pro­duc­tion.

In the mean­time, Boehringer In­gel­heim is tak­ing sev­er­al mea­sures to ex­tend the sup­ply. It is plan­ning to sub­mit a vari­a­tion ap­pli­ca­tion glob­al­ly to ex­tend the shelf life of Metal­yse from 24 to 36 months to avoid the re­turn of un­used vials af­ter the ex­pi­ra­tion date and in­crease the vol­ume of Ac­til­yse’s 20mg dos­es to dis­cour­age the use of the 50mg ver­sion and re­duce prod­uct wastage.

Boehringer In­gel­heim is al­so de­vel­op­ing a man­u­fac­tur­ing process for Ac­til­yse that will give it a high­er yield, which was ap­proved by EU health au­thor­i­ties last month.

For now, the EMA is ad­vis­ing health providers to ex­tend sup­plies for as long as pos­si­ble, and any in­for­ma­tion on al­ter­na­tives should be re­ferred to na­tion­al agen­cies. Ad­di­tion­al­ly, pa­tients should reach out to health providers for more in­for­ma­tion or to re­ceive any al­ter­na­tives.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.