Martin Shkreli (AP Images)

Fed­er­al judge de­nies Mar­tin Shkre­li all but one mo­tion to dis­miss mo­nop­oly claims in the FTC's Dara­prim law­suit

“Phar­ma Bro” Mar­tin Shkre­li filed mo­tions in May to dis­miss the FTC’s claims that his com­pa­ny Vy­era Phar­ma­ceu­ti­cals boxed out com­pe­ti­tion and cre­at­ed a mo­nop­oly for the tox­o­plas­mo­sis drug Dara­prim af­ter rais­ing prices by 4,000% overnight. But on Tues­day, a fed­er­al judge said not so fast.

Judge Denise Cote de­nied all but one re­quest for dis­missal. The suit was filed in Jan­u­ary by the Fed­er­al Trade Com­mis­sion, New York and oth­er states, which claimed that Shkre­li and co-de­fen­dant Kevin Mul­leady par­tic­i­pat­ed in “an un­law­ful scheme” to hin­der gener­ic com­pe­ti­tion and “pre­serve a mo­nop­oly,” which they al­leged­ly kept go­ing even while Shkre­li was in prison, ac­cord­ing to court doc­u­ments.

Shkre­li and Mul­leady launched Vy­era in 2014 — then known as Tur­ing Phar­ma­ceu­ti­cals — and snagged US rights to Dara­prim for $55 mil­lion the fol­low­ing year. Overnight, the com­pa­ny raised Dara­prim’s price from $17.50 to $750 per tablet. The move was a fa­mil­iar one for Shkre­li, whose com­pa­ny Retrophin ac­quired the rights to Thi­o­la in 2014, then raised its price by 2,000%, ac­cord­ing to the FTC com­plaint.

The ex­ec was lat­er re­moved from the Retrophin board of di­rec­tors for mis­con­duct, and he’s cur­rent­ly serv­ing a 7-year sen­tence on fraud charges in re­la­tion to his hedge fund op­er­a­tions.

The FTC ac­cused Vy­era of set­ting up a re­strict­ed dis­tri­b­u­tion sys­tem to pre­vent gener­ic com­peti­tors from get­ting their hands on sam­ples for bioe­quiv­a­lence test­ing. And Shkre­li has been ac­cused of or­ches­trat­ing the scheme from prison.

In an Aug. 12 let­ter to Cote, the FTC said it found records of con­ver­sa­tions that Shkre­li had with Vy­era ex­ec­u­tives, in­clud­ing Mul­leady, on the prison’s TRU­FONE and TRULINCS sys­tems. Dur­ing these calls, the ex­ecs al­leged­ly dis­cussed mat­ters “to pre­vent gener­ic com­pe­ti­tion to Dara­prim.” Shkre­li was re­moved from a New Jer­sey fed­er­al prison and re­lo­cat­ed last year af­ter re­port­ed­ly run­ning the biotech with the use of a con­tra­band cell­phone.

The co-de­fen­dants ar­gued in court that Vy­era ne­go­ti­at­ed and ex­e­cut­ed the con­tracts be­fore the suit was filed. But in a writ­ten opin­ion, Cote called the ar­gu­ment “mer­it­less.”

“The FTC is not re­quired to bring suit at the ex­act mo­ment con­trac­tu­al ne­go­ti­a­tions ripen in­to ex­e­cut­ed con­tracts. It is the ex­tant scheme that pro­vides the ba­sis for the law­suit,” she wrote.

A month af­ter the FTC filed its law­suit, the FDA ap­proved the first gener­ic for Dara­prim, which was in de­vel­op­ment for 7 years. “This hard-won ap­proval does not im­mu­nize the de­fen­dants from an­titrust li­a­bil­i­ty,” Cote wrote.

“The Amend­ed Com­plaint ex­plains how mul­ti­ple man­u­fac­tur­ers of gener­ic phar­ma­ceu­ti­cals that wish to com­pete with Vy­era have been de­layed for years in ob­tain­ing FDA ap­proval be­cause of their in­abil­i­ty to ob­tain Dara­prim for bioe­quiv­a­lence test­ing and API from an FDA-ap­proved man­u­fac­tur­er. And of course, Vy­era con­tin­ues to sell Dara­prim at the in­flat­ed price of $750 per tablet,” her opin­ion states.

Cote did grant dis­missal for one claim un­der the Penn­syl­va­nia Un­fair Trade Prac­tices and Con­sumer Pro­tec­tion Law.

“The Amend­ed Com­plaint does not ad­e­quate­ly al­lege that the an­ti­com­pet­i­tive con­duct it de­scribes is ‘fraud­u­lent,’ ‘de­cep­tive,’ or like­ly to cre­ate ‘con­fu­sion’ or ‘mis­un­der­stand­ing,'” the opin­ion states. “… In fact it as­serts that Vy­era in­formed its dis­trib­u­tors and sup­pli­ers of the pur­pose be­hind its de­sired con­trac­tu­al terms, and Vy­era ex­ec­u­tives tes­ti­fied be­fore the Sen­ate about their in­ten­tion to pre­vent po­ten­tial com­peti­tors from ob­tain­ing enough Dara­prim to con­duct bioe­quiv­a­lence test­ing.”

Shkre­li has a lot on the line — the law­suit re­quests that the for­mer ex­ec be banned per­ma­nent­ly from the phar­ma in­dus­try.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.