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

Mar­tin Shkre­li faces an­oth­er law­suit, this time from in­sur­er, al­leg­ing plans to cre­ate a mo­nop­oly for Dara­prim

The no­to­ri­ous “Phar­ma Bro” Mar­tin Shkre­li prompt­ed na­tion­al out­rage in 2015 when he and then-Tur­ing Phar­ma­ceu­ti­cals raised the price of Dara­prim, the “gold stan­dard” treat­ment of the par­a­sitic in­fec­tion tox­o­plas­mo­sis, from $17.50 to $750 per tablet. De­spite this, he was ul­ti­mate­ly jailed in 2017 for un­re­lat­ed se­cu­ri­ties fraud charges for mis­lead­ing in­vestors in one of his oth­er com­pa­nies, Retrophin.

Now, though, a promi­nent in­sur­ance com­pa­ny is tak­ing Shkre­li to court over the Dara­prim up­roar, al­leg­ing a scheme to cre­ate a mo­nop­oly for the drug and block gener­ic com­pe­ti­tion.

Blue Cross Blue Shield of Min­neso­ta is su­ing Shkre­li and Tur­ing-turned-Vy­era Phar­ma­ceu­ti­cals 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.

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.

All of this hap­pened, the law­suit says, while Shkre­li made re­peat­ed pub­lic com­ments about how Vy­era “wel­comed” gener­ic com­pe­ti­tion. Shkre­li and the oth­er de­fen­dants al­so hatched their scheme be­fore in­sti­tut­ing the price hike, ac­cord­ing to the suit.

“Ab­sent De­fen­dants’ an­ti­com­pet­i­tive and de­cep­tive con­duct, mul­ti­ple gener­ic com­peti­tors would have en­tered the Dara­prim mar­ket soon­er and at low­er prices, ren­der­ing De­fen­dants’ price hike un­sus­tain­able — such that they would not have pur­sued it in the first place,” the suit says.

Bloomberg was among the first to re­port on the law­suit, which was filed last Thurs­day.

This is not the first suit Shkre­li is fac­ing over al­leged an­ti-com­pet­i­tive tac­tics. In Jan­u­ary 2020, the FTC and the state of New York made sim­i­lar ac­cu­sa­tions in­to Shkre­li’s ac­tiv­i­ty, and are aim­ing to bar him and Mul­leady from the phar­ma­ceu­ti­cal in­dus­try per­ma­nent­ly.

Shkre­li al­so al­leged­ly ran parts of his busi­ness while serv­ing his prison sen­tence us­ing a con­tra­band cell phone and through emails sent via the prison sys­tem. The FTC is seek­ing to ren­der the lat­ter com­mu­ni­ca­tions as un­priv­i­leged, say­ing the emails took place on mon­i­tored prison servers and there­by void­ing at­tor­ney-client priv­i­lege, the reg­u­la­to­ry body said last Au­gust.

Then in De­cem­ber, Shkre­li came un­der scruti­ny again af­ter al­leged­ly try­ing to ma­nip­u­late Phoenixus’ board of di­rec­tors for his own per­son­al gain, hand­pick­ing board mem­bers he knew would op­er­ate in his in­ter­ests. Phoenixus is the par­ent com­pa­ny of Vy­era, which is al­so based in Switzer­land.

Tox­o­plas­mo­sis is caused by a par­a­site most of­ten found in cat stool, and rarely caus­es symp­toms in healthy in­di­vid­u­als. But the dis­ease can prove dead­ly for those with com­pro­mised im­mune sys­tems, such as peo­ple with HIV/AIDS and preg­nant women.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.