Tom Ross, Grand River Aseptic Manufacturing CEO

CEO of Michi­gan CD­MO ex­plains how he nabbed mon­key­pox vac­cine con­tract

As US cas­es of the mon­key­pox out­break have now risen above 14,000, the gov­ern­ment is mov­ing quick­ly to make more dos­es avail­able, with the Jyn­neos vac­cine look­ing to be de­ployed wider as Bavar­i­an Nordic’s sites in Eu­rope get the all-clear from the FDA.

Mean­while, a Grand Rapids, Michi­gan-based CD­MO land­ed a deal with Bavar­i­an Nordic, to fill and fin­ish the vac­cine. Grand Riv­er Asep­tic Man­u­fac­tur­ing, a rel­a­tive­ly new play­er in the CD­MO world, on­ly be­ing around since 2010, an­nounced it re­ceived the deal from Bavar­i­an Nordic as well as ap­proval from HHS and BAR­DA to in­crease the do­mes­tic sup­ply of Jyn­neos.

Tom Ross, CEO of Grand Riv­er, said in an in­ter­view with End­points News, that a ma­jor rea­son why the com­pa­ny man­aged to net such a high-pro­file con­tract was due to the com­pa­ny’s pre­vi­ous work with BAR­DA in Op­er­a­tion Warp Speed, pro­duc­ing the J&J vac­cine dur­ing the height of the Covid-19 pan­dem­ic.

“When Bavar­i­an Nordic was look­ing for a US-based CD­MO I think we were one of the few com­pa­nies that BAR­DA had rec­om­mend­ed and that led to some dis­cus­sions and we were very im­pressed by Bavar­i­an Nordic I think they liked what we had to of­fer here and they came out and saw our fa­cil­i­ties,” Ross said to End­points.

Ross al­so added that an­oth­er piece that at­tract­ed Bavar­i­an Nordic was that Grand Riv­er has in­vest­ed a large amount of cap­i­tal to im­prove its fa­cil­i­ties re­cent­ly. The com­pa­ny net­ted a $120 mil­lion grant from the US gov­ern­ment to ex­pand its fill-fin­ish sites, with the com­pa­ny in­vest­ing $40 mil­lion of its own mon­ey to ex­pand its 80,000-square-foot, large-scale fill­ing fa­cil­i­ty and 200,000-square-foot fin­ish­ing cen­ter in Grand Rapids. The com­pa­ny has al­so re­cent­ly fin­ished two new man­u­fac­tur­ing lines in a $50 mil­lion in­vest­ment as well.

For the deal with Bavar­i­an Nordic, Grand Riv­er will re­ceive the bulk drug sub­stance and Grand Riv­er do­ing the for­mu­la­tion and fill­ing vials and even­tu­al­ly dis­trib­ute through Bavar­i­an’s dis­tri­b­u­tion chan­nel. Ross said that Grand Riv­er will be pro­duc­ing mil­lions of vials, but the ex­act num­ber is yet to be de­ter­mined as it is un­cer­tain how many dos­es will be need­ed.

While the fi­nan­cial terms of the deal were not dis­closed to End­points, the com­pa­ny is plan­ning to make more hires over the next two to three months and has al­ready ramped up the hir­ing process, Ross said.

And while the over­all deal came to­geth­er in a very short pe­ri­od, ac­cord­ing to Ross, the tech trans­fer is now kick­ing in­to gear in an ac­cel­er­at­ed fash­ion, but it will take a few months to get ful­ly up and run­ning as it con­ducts en­gi­neer­ing runs and oth­er process­es. Ross told End­points that full-scale com­mer­cial pro­duc­tion is ex­pect­ed to start in 2023 Ross said.

While Ross did not com­ment on the record if Grand Riv­er will net an­oth­er BAR­DA con­tract for mon­key­pox vac­cine man­u­fac­tur­ing, he did note that the sit­u­a­tion is a bit dif­fer­ent from the Covid-19 sit­u­a­tion that it has faced but that some of the el­e­ments re­main.

“It’s not as big as a COVID re­sponse, of course, but in terms of the in­ten­si­ty the tim­ing, and the ur­gency it’s all the same,” he said. “It’s im­por­tant to re­spond and try to do what we can col­lec­tive­ly to re­spond, and the vac­cine is one of the tools.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.