Martin Shkreli, AP

Mar­tin Shkre­li push­es back on life­time pub­lic com­pa­ny ban from prison cell in bid to get back to busi­ness

De­spite serv­ing his stint be­hind bars, the Mar­tin Shkre­li saga con­tin­ues to sprout legs with new law­suits pop­ping up. Now, in an­tic­i­pa­tion of be­ing a free man once again, Shkre­li is push­ing back on a fed­er­al ban that would seek to keep him out of a pub­lic com­pa­ny’s board­room for the rest of his life.

Shkre­li’s lawyers hope to re­scind the for­mer Retrophin CEO’s life­time ban from the SEC on serv­ing as a di­rec­tor or of­fi­cer of a pub­licly trad­ed com­pa­ny, ar­gu­ing that oth­er dis­graced ex­ec­u­tives have re­ceived much more le­nient 10-year bans, ac­cord­ing to a brief filed in a NY court­room.

The lawyers point­ed to Shkre­li’s sta­tus as a first-time of­fend­er to make the case he like­ly wouldn’t re­peat the white-col­lar mis­con­duct that placed him in prison  and ar­gued that his age — 38 — means a life­time ban “would have a far greater puni­tive im­pact on him than on a sim­i­lar­ly sit­u­at­ed, but old­er, de­fen­dant.”

In ar­gu­ing his case, Shkre­li’s team point­ed the ex­am­ple of for­mer Ther­a­nos head Eliz­a­beth Holmes, who earned a 10-year ban from the SEC de­spite fac­ing fraud charges in fed­er­al court. Holmes, lawyers ar­gued, en­gaged in crimes “a hun­dred times the size of the fraud” Shkre­li com­mit­ted and earned a more le­nient ban. An­oth­er case they point­ed to was Schultz Chan, a for­mer Ake­bia bio­sta­tis­tics di­rec­tor who com­mit­ted in­sid­er trad­ing and was on­ly shut out of serv­ing at a pub­lic com­pa­ny for five years.

Shkre­li’s team al­so ar­gued that he shouldn’t be on the hook for a $1.4 mil­lion fine from the SEC giv­en his on­go­ing sen­tence and the mil­lions he’s al­ready lost in civ­il fine and for­fei­tures.

The idea of Shkre­li, the “phar­ma bro” who de­fraud­ed Retrophin’s in­vestors, get­ting back to busi­ness should be enough to make the biotech in­dus­try’s blood run cold. But even in the mid­dle of his prison sen­tence, Shkre­li’s prob­lems are on­ly start­ing.

In March, Blue Cross Blue Shield of Min­neso­ta sued Shkre­li and Vy­era Phar­ma­ceu­ti­cals — for­mer­ly Tur­ing — over plans to uti­lize what are known as “re­sale re­stric­tions,” pre­vent­ing pro­duc­ers of po­ten­tial Dara­prim gener­ics from ob­tain­ing the nec­es­sary sam­ples of the drug need­ed for FDA eval­u­a­tion. Dara­prim, you’ll re­mem­ber, was the tox­o­plas­mo­sis drug for which Shkre­li jacked up the price and sparked na­tion­al out­rage.

Shkre­li, Vy­era and the oth­er de­fen­dants named — the Swiss biotech Phoenixus and its CEO Kevin Mul­leady — al­so al­leged­ly tried to buy up all the sup­ply of Dara­prim’s ac­tive in­gre­di­ent pyrimethamine, and re­fused ac­cess to the Dara­prim sales da­ta need­ed to de­ter­mine whether a gener­ic prod­uct would be com­mer­cial­ly vi­able.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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