Martin Shkreli (AP Images)

New York law­suit again ac­cus­es Mar­tin Shkre­li of ma­nip­u­la­tion from be­hind bars

As part of Mar­tin Shkre­li’s ef­forts to con­tin­ue run­ning his biotech busi­ness from be­hind bars, a sear­ing new law­suit in New York says the “Phar­ma Bro” ma­nip­u­lat­ed his com­pa­ny’s board of di­rec­tors for his own per­son­al gain.

Filed with the New York State Supreme Court just be­fore Thanks­giv­ing, two LLCs and three named share­hold­ers of Phoenixus AG — the par­ent com­pa­ny of Switzer­land-based Vy­era Phar­ma­ceu­ti­cals — say that Shkre­li in­ter­fered with the board and Phoenixus’ top man­age­ment struc­ture by hand­pick­ing peo­ple he knew would op­er­ate in his in­ter­ests.

This, the suit says, re­sult­ed in cor­po­rate waste and a breach of Phoenixus fidu­cia­ry du­ties. The four Shkre­li con­fi­dants named in the lit­i­ga­tion — Kevin Mul­leady, Akeel Mithani, Jor­dan Walk­er and Aver­ill Pow­ers — are ac­cused most no­tably of dis­sem­i­nat­ing false and mis­lead­ing fi­nan­cial re­port­ing that harmed Phoenixus and its share­hold­ers.

The law­suit is the lat­est in a string of on­go­ing in­quiries in­to Shkre­li, who be­gan serv­ing a sev­en-year prison sen­tence for se­cu­ri­ties fraud in 2017 yet has still been linked to ac­tive ef­forts to box out com­peti­tors from ef­forts to for­mu­late a gener­ic ver­sion of Dara­prim. The an­ti­malar­i­al drug is at the cen­ter of the price-goug­ing scan­dal that earned Shkre­li the “Phar­ma Bro” nick­name.

In Jan­u­ary the FTC and New York’s at­tor­ney gen­er­al launched a fed­er­al law­suit against Shkre­li, al­leg­ing that he ef­fec­tive­ly cre­at­ed a drug mo­nop­oly by rais­ing Dara­prim’s price by a fac­tor of 56 from $13.50 to $750 per pill.

In Au­gust, the FTC re­vealed that Shkre­li was ac­tive­ly co­or­di­nat­ing an an­ti­com­pet­i­tive scheme from prison re­gard­ing Dara­prim through com­mu­ni­ca­tions with Vy­era ex­ec­u­tives, in­clud­ing Mul­leady.

The New York state suit ap­pears to sep­a­rate­ly fol­low up on that dis­cov­ery and Shkre­li’s com­mu­ni­ca­tions via prison de­vices that can be mon­i­tored and record­ed. For Shkre­li and Mul­leady, los­ing ei­ther of the two suits could re­sult in their dis­bar­ment from the phar­ma­ceu­ti­cal in­dus­try.

The No­vem­ber law­suit in par­tic­u­lar seeks fed­er­al over­sight of Phoenixus, the ap­point­ment of new di­rec­tors from an in­de­pen­dent third par­ty, as well as re­cov­ery of dam­ages from the board mem­bers with con­nec­tions to Shkre­li.

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 dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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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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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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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.