Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Mar­tin Shkre­li didn’t just blog, read up on drug de­vel­op­ment news and run his biotech busi­ness with a con­tra­band cell phone in prison. Ac­cord­ing to the FTC, he was al­so co­or­di­nat­ing the an­ti­com­pet­i­tive scheme to shield Dara­prim — the drug at the cen­ter of a price-goug­ing con­tro­ver­sy that earned him the “Phar­ma Bro” nick­name — from gener­ic ri­vals.

Back in Jan­u­ary the FTC, to­geth­er with New York’s at­tor­ney gen­er­al, launched a fed­er­al law­suit against Shkre­li, who’s now serv­ing a 7-year sen­tence for de­fraud­ing in­vestors in his hedge fund, al­leg­ing that he ef­fec­tive­ly cre­at­ed a drug mo­nop­oly. While Shkre­li’s no­to­ri­ous move to raise the per tablet price of Dara­prim from $17.50 to $750 was per­fect­ly le­gal, the tac­tics he al­leged­ly de­ployed to box out com­peti­tors weren’t.

“Dur­ing our pre-com­plaint in­ves­ti­ga­tion, the FTC learned that Mr. Shkre­li was com­mu­ni­cat­ing from prison about rel­e­vant mat­ters,” reads a let­ter to Judge Denise Cote.

Specif­i­cal­ly, they found records of his con­ver­sa­tions with ex­ec­u­tives of Vy­era — for­mer­ly Tur­ing and now Phoenixus — in­clud­ing co-de­fen­dant Kevin Mul­leady, which con­tained “in­for­ma­tion rel­e­vant to this case, in­clud­ing about Mr. Shkre­li’s ef­forts from prison to sup­port Vy­era’s scheme to pre­vent gener­ic com­pe­ti­tion to Dara­prim.” There are al­so ma­te­ri­als on his com­mu­ni­ca­tion with at­tor­neys.

The agency wants the court to rule that the com­mu­ni­ca­tions it ob­tained from the Fed­er­al Bu­reau of Pris­ons are not priv­i­leged — and there­fore fair game for the en­su­ing le­gal bat­tle.

Un­like the records on his con­tra­band cell phone, the FTC ar­gues, these calls and emails hap­pened on the prison’s TRU­FONE and TRULINCS sys­tems, which Shkre­li knew could be mon­i­tored and record­ed. Nei­ther at­tor­ney-client priv­i­lege nor the work prod­uct doc­trine should ap­ply here, it writes.

It’s un­clear how much Dara­prim’s pric­ing will be af­fect­ed. A month af­ter the FTC and the New York AG filed their law­suit ask­ing, among oth­er things, to re­store com­pet­i­tive con­di­tions and halt any on­go­ing an­ti-com­pet­i­tive con­duct, the FDA ap­proved the first gener­ic for Dara­prim. Al­though the gener­ic mak­er hasn’t dis­closed how much it’s charg­ing for its copy­cat drug, it was enough to kick Dara­prim off the list of the top 20 most ex­pen­sive treat­ments in the US.

But for Shkre­li and Mul­leady, los­ing the law­suit could mean be­ing barred from the phar­ma in­dus­try in the fu­ture in ad­di­tion to mon­e­tary re­lief.

The prospect could be es­pe­cial­ly tough for Shkre­li, who sought — but was de­nied — a 3-month fur­lough to re­search Covid-19 cures af­ter post­ing a pa­per de­scrib­ing a drug screen and propos­ing RdRp in­hibitors as po­ten­tial treat­ments.

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.