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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.