Martin Shkreli (Dennis Van Tine/Sipa USA, Sipa via AP Images)

Mar­tin Shkre­li to go toe-to-toe with new FTC chair over Dara­prim price spikes

Much ink has been spilled over “Phar­ma Bro” Mar­tin Shkre­li, the en­tre­pre­neur who raised the price of a life­sav­ing an­tipar­a­sitic more than 55-fold overnight and is cur­rent­ly serv­ing a sev­en-year prison sen­tence for se­cu­ri­ties fraud.

But he’s al­so fac­ing an­titrust charges from the FTC and the agency’s new chair Lina Khan, and a court date has fi­nal­ly been set for the case.

Shkre­li has been or­dered to ap­pear in per­son for the an­titrust tri­al on Dec. 14, as Khan looks to bring the ham­mer down on what the FTC al­leges were mo­nop­o­lis­tic prac­tices by Tur­ing Phar­ma­ceu­ti­cals, now Vy­era. Reg­u­la­tors have as­sert­ed that Vy­era at­tempt­ed to buy up most — if not all — sup­ply of the drug that cat­a­pult­ed Shkre­li in­to in­famy, Dara­prim, in or­der to pre­vent gener­ic com­pe­ti­tion.

Ar­gu­ments will be heard in the South­ern Dis­trict Court of New York. Shkre­li’s hold­ing com­pa­ny Phoenixus, as well as for­mer di­rec­tor Kevin Mul­leady, were al­so im­pli­cat­ed in Wednes­day’s or­der.

The saga be­gan in Jan­u­ary 2020, when the FTC first sued Shkre­li and Vy­era for try­ing to keep Dara­prim gener­ics from en­ter­ing the mar­ket. Reg­u­la­tors said Shkre­li knew that as soon as he raised the price from $13.50 to $750 per pill, Vy­era would be vul­ner­a­ble to cheap­er, gener­ic meds.

So he pre­vent­ed gener­ic drug­mak­ers from ob­tain­ing the sam­ples they’d need to de­vel­op the gener­ics and blocked ac­cess to sales num­bers to make sure no one could ac­cu­rate­ly size up the mar­ket. The first gener­ic ver­sion of Dara­prim was ap­proved by the FDA in Feb­ru­ary 2020, about a month af­ter the suit land­ed.

As the en­su­ing months un­fold­ed, the FTC fur­ther al­leged in Au­gust 2020 that Shkre­li was en­gag­ing in mar­ket ma­nip­u­la­tion while be­hind bars. The agency said at the time it had phone and email records from the prison sys­tem in which Shkre­li dis­cussed with Mul­leady how to keep gener­ic Dara­prim off the mar­ket.

Shkre­li has ar­gued the com­mu­ni­ca­tions are priv­i­leged, but the FTC said be­cause the emails took place on mon­i­tored prison servers, he had es­sen­tial­ly waived that right.

Then, in De­cem­ber 2020, Shkre­li made news again when he sup­pos­ed­ly at­tempt­ed to ma­nip­u­late the se­lec­tion of the Phoenixus board for his own per­son­al gain, hand­pick­ing board mem­bers he knew would op­er­ate in his in­ter­ests. An ac­tivist group at­tempt­ing to take over the com­pa­ny failed in Ju­ly, when Shkre­li vot­ed from prison to help keep four of the five cur­rent di­rec­tors.

Shkre­li isn’t on­ly fac­ing an­titrust suits from the FTC, how­ev­er. Back March 2021, Blue Cross Blue Shield of Min­neso­ta got in­to the ac­tion, su­ing Shkre­li and Vy­era over plans to uti­lize the same “re­sale re­stric­tions” reg­u­la­tors al­leged they used to stop Dara­prim sam­ple dis­tri­b­u­tion. The moves came in the back­drop of what the in­sur­er said were com­ments by Shkre­li claim­ing he and then-Tur­ing “wel­comed” gener­ic com­pe­ti­tion.

For Khan, a con­vic­tion would mark an ear­ly splash in the chief’s tenure that has seen lit­tle in the way of the Big Phar­ma trust-bust­ing that had been promised. Though Khan en­tered her new po­si­tion as a cham­pi­on of an­titrust re­form, the FTC waved through As­traZeneca’s $39 bil­lion ac­qui­si­tion of Alex­ion with­out a hitch, viewed by an­a­lysts as a bell­wether for in­dus­try M&A.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.