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.”

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.