Con­fi­dent he’ll be ex­on­er­at­ed on fraud charges, Mar­tin Shkre­li is work­ing on an­oth­er at­tempt to “shock and awe”

Mar­tin Shkre­li speaks dur­ing an in­ter­view with Bloomberg on Fri­day, Dec. 23, 2016. Shkre­li said the na­tion­al out­rage over drug pric­ing was blown out of pro­por­tion and height­ened by the U.S. pres­i­den­tial elec­tion, al­though he con­ced­ed he could have pre­dict­ed the blow­back bet­ter. Vic­tor J. Blue/Bloomberg via Get­ty Im­ages

Mar­tin Shkre­li has a date with pro­s­ec­tors at the fed­er­al cour­t­house in two months, but the no­to­ri­ous biotech en­tre­pre­neur still has time to talk with re­porters. And it turns out he’s work­ing on yet an­oth­er biotech start­up as his lawyers pre­pare to de­fend him on crim­i­nal fraud charges.

The re­porter in this case was Shee­lah Kol­hatkar from The New York­er. They met in a Man­hat­tan bar, where Shkre­li con­fi­dent­ly pre­dict­ed his loom­ing ex­on­er­a­tion on fraud charges.

“I think they’ll re­turn a not-guilty ver­dict in two hours,” he told Kol­hatkar. “There are go­ing to be ju­rors who will be fans of mine. I walk down the streets of New York and peo­ple shake my hand. They say, ‘I want to be just like you.’”

Shkre­li nev­er has faced more than a scold­ing from law­mak­ers for the 5000% hike in the price of Dara­prim, an old drug he ac­quired af­ter found­ing Tur­ing. Caught in the bright glare of a scan­dal, on­line mobs shriek­ing dig­i­tal abuse, Shkre­li turned ob­scene­ly de­fi­ant on Twit­ter — which lat­er banned him — and nev­er did back down from the price. He was forced to give up the CEO’s job af­ter the fraud charges hit.

Shkre­li, though, is clear­ly com­mit­ted to his fu­ture as a se­r­i­al en­tre­pre­neur.

In the in­ter­view he men­tioned a new biotech soft­ware com­pa­ny he is hatch­ing. This new ven­ture is called Gödel Sys­tems, but he’s stingy on de­tails.

Ac­cord­ing to a re­cent SEC fil­ing, Shkre­li and his con­fed­er­ates have raised $50,000 of a $1 mil­lion raise, lunch mon­ey com­pared to the larg­er sums raised for Tur­ing and his first start­up, Retrophin, which sued him.

He is, though, hap­py to pre­dict the stun­ning im­pact it will have.

“I haven’t told any­body what it is,” he said. “When I do, it will shock and awe the world.”

You’ve been warned.

Af­ter we pub­lished on Wednes­day, Shkre­li sent me a re­ply. See­ing as he’s been banned from Twit­ter, it seems on­ly fair to add it here:

Lol you love dis­in­for­ma­tion – it must be a loss-of-func­tion mu­ta­tion – do not re­pro­duce

He is very con­sis­tent.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

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 has vowed not to let politics overrule 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 the FDA and other health agencies under his purview of their rule making 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.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Frank Zhang (AP Images)

UP­DAT­ED: Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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