Mer­ck KGaA gets a thumbs up for once-dead MS drug; Aveo shares soar as ti­vo makes a come­back

→  Cladrib­ine is back. Once giv­en up for dead by Mer­ck KGaA, the mul­ti­ple scle­ro­sis drug has been en­dorsed by the CHMP in Eu­rope, set­ting up a like­ly ap­proval. Long­time Mer­ck KGaA watch­ers will re­call that Mer­ck killed the pro­gram af­ter the FDA and the EMA quashed in­ad­e­quate ap­pli­ca­tions 6 years ago — an em­bar­rass­ing set­back that trig­gered a ma­jor over­haul of the com­pa­ny’s R&D group. “The pos­i­tive opin­ion from the CHMP is an ex­tra­or­di­nary de­vel­op­ment for Mer­ck, af­firm­ing our be­lief in Cladrib­ine Tablets as a po­ten­tial im­por­tant treat­ment op­tion for pa­tients liv­ing with mul­ti­ple scle­ro­sis,” said Belén Gar­i­jo, CEO Health­care and mem­ber of the ex­ec­u­tive board of Mer­ck. “We now ea­ger­ly await the Eu­ro­pean Com­mis­sion de­ci­sion, and the op­por­tu­ni­ty to make a dif­fer­ence in the MS treat­ment par­a­digm.”

 Cladrib­ine wasn’t the on­ly come­back sto­ry of the day. The CHMP al­so rec­om­mend­ed ap­proval of Aveo’s $AVEO drug tivozanib (Fo­tiv­da) for ad­vanced re­nal cell car­ci­no­ma, send­ing the mi­cro­cap’s shares up more than 70% Fri­day morn­ing.  The Eu­ro­pean Com­mis­sion is ex­pect­ed to make its fi­nal de­ci­sion with­in 67 days. Its ap­proval would trig­ger a $4 mil­lion re­search and de­vel­op­ment re­im­burse­ment pay­ment from EU­SA, and the pos­si­bil­i­ty of up to $12 mil­lion in ad­di­tion­al mile­stones.

→  Ex­ec­u­tives are un­der fire for sell­ing drugs that trig­gered se­ri­ous ad­verse events for three in­fants. Paul Elmer, pres­i­dent and own­er of Phar­makon, and Caprice Bear­den, di­rec­tor of com­pli­ance, are fac­ing fed­er­al charges of en­gag­ing in com­merce with adul­ter­at­ed drugs in an in­dict­ment un­sealed on Thurs­day. The in­dict­ment al­leges that the com­pa­ny was no­ti­fied 70 times that the po­ten­cy of their drugs did not match the la­bels, but that they con­tin­ued to send them out re­gard­less, with­out no­ti­fy­ing the FDA or care providers.

→  Bio­pro­cess­ing com­pa­ny Repli­gen is merg­ing with Spec­trum, which spe­cial­izes in fil­tra­tion and pu­rifi­ca­tion, for $359 mil­lion in cash and stock.

→  Gen­Sight Bi­o­log­ics (Eu­ronext: SIGHT) raised €22.5 mil­lion in a stock of­fer­ing. The gene ther­a­py com­pa­ny says it will use the cash to prep for a mar­ket launch of GS010 in Eu­rope and the US.

→  GSK is pre­sent­ing re­sults from its Phase III Zoster-048 study at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing. The re­sults are promis­ing, show­ing that its can­di­date vac­cine, Shin­grix, for the pre­ven­tion of her­pes zoster (shin­gles) in­duces a strong im­mune re­sponse in old­er adults who have pre­vi­ous­ly been vac­ci­nat­ed against shin­gles with the cur­rent­ly avail­able live-at­ten­u­at­ed zoster vac­cine.

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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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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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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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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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.