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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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