Un­want­ed by Ab­b­Vie and In­fin­i­ty, bat­tered Ve­rastem gets an OK for du­velis­ib and a sec­ond shot at suc­cess

Ve­rastem $VSTM is get­ting its prover­bial sec­ond chance.

Once bat­tered, bruised and left on the ropes af­ter the com­plete fail­ure of the ini­tial strat­e­gy mapped by Christoph West­phal, the ex­ec­u­tive team at Ve­rastem snapped up a tar­nished star as In­fin­i­ty hap­pi­ly hand­ed off its per­fect­ly ap­prov­able — but com­mer­cial­ly un­ex­cit­ing — PI3K drug du­velis­ib for ex­act­ly noth­ing up front.

To­day, the FDA did its part, hand­ing over an ac­cel­er­at­ed ap­proval for the drug, which will now be sold as Copik­tra, the on­ly gam­ma/delta in­hibitor on the mar­ket for third-line cas­es of chron­ic lym­pho­cyt­ic leukemia/small lym­pho­cyt­ic lym­phoma. And the agency al­so of­fered up a tan­dem OK as a 3rd-line ther­a­py for fol­lic­u­lar lym­phoma.

Fur­ther ham­per­ing its mar­ket po­ten­tial, the FDA is stamp­ing the la­bel with a black box warn­ing of 4 po­ten­tial­ly lethal tox­i­c­i­ties: in­fec­tions, di­ar­rhea or col­i­tis, cu­ta­neous re­ac­tions, and pneu­moni­tis. 

Robert For­rester, Ve­rastem CEO

On­col­o­gists of­ten call for new ther­a­pies that they can con­sid­er for dy­ing, drug re­sis­tant pa­tients. And now they have an­oth­er one.

At one stage, Ab­b­Vie hand­ed over $275 mil­lion up­front to part­ner on this drug, on­ly to walk away when it proved to be an­oth­er PI3K with se­vere­ly lim­it­ed com­mer­cial po­ten­tial. Ab­b­Vie’s dis­card, though, still looked plen­ty good to Ve­rastem, which re­tains high hopes for mak­ing some­thing re­al out of this.

Ve­rastem has a mar­ket cap of $657 mil­lion.

“Pa­tients liv­ing with CLL/SLL or FL are in need of ad­di­tion­al treat­ment op­tions, and new ther­a­pies such as Copik­tra are cru­cial be­cause each pa­tient’s treat­ment jour­ney is unique,” said Meghan Gutier­rez, the CEO of the Lym­phoma Re­search Foun­da­tion.

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.