Am­gen hands off rights to lep­rosy, tu­ber­cu­lo­sis med picked up as part of $13.4B Ote­zla deal

Am­gen scored a big pick­up with its ac­qui­si­tion of im­munol­o­gy block­buster Ote­zla from Bris­tol My­ers Squibb late last year. But that deal al­so came with a mol­e­cule for tu­ber­cu­lo­sis and lep­rosy with sig­nif­i­cant­ly less com­mer­cial val­ue, and Am­gen is ready to wipe its hands clean.

As part of the $13.4 bil­lion deal, Am­gen took over what be­came AMG 634 — a phos­pho­di­esterase type 4 in­hibitor cur­rent­ly in Phase II tri­als that is be­ing in­ves­ti­gat­ed for the treat­ment of both tu­ber­cu­lo­sis and ery­the­ma no­dosum lep­ro­sum, a com­pli­ca­tion from lep­rosy.

Now, Am­gen will li­cense that drug to Med­i­cines De­vel­op­ment for Glob­al Health, a non­prof­it bio­phar­ma com­pa­ny, and will keep its hands off of any fu­ture de­vel­op­ment or com­mer­cial rights to the ther­a­py.

David Reese Am­gen

As part of the agree­ment, Am­gen will con­tin­ue to sup­port the two Phase II tri­als — one study­ing tu­ber­cu­lo­sis and the oth­er study­ing ENL — and will fund the ENL study, the com­pa­nies said in a press re­lease. MDGH will as­sume full re­spon­si­bil­i­ty mov­ing for­ward for any fur­ther de­vel­op­ment and com­mer­cial­iza­tion of AMG 634.

“Am­gen sought an or­ga­ni­za­tion that could sup­port the de­vel­op­ment of AMG 634 to ad­dress the glob­al health un­met need,” David Reese, Am­gen’s R&D ex­ec­u­tive vice pres­i­dent, said in a state­ment. “MDGH’s track record and ex­pe­ri­ence in prod­uct de­vel­op­ment, glob­al health, and ne­glect­ed in­fec­tious dis­eases makes them an ide­al com­pa­ny to fur­ther de­vel­op AMG 634 for the ben­e­fit of pa­tients.”

The deal was an­nounced on the same day Am­gen re­vealed the fail­ure of a new asth­ma drug in a Phase III tri­al.

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

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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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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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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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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.

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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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

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.