The mas­ter deal­mak­er is back: David Hung takes the helm at Vivek Ra­maswamy's Ax­o­vant

David Hung earned his spurs as a mas­ter deal­mak­er in biotech, blaz­ing through a string of ma­jor part­ner­ships for good (and bad) drugs be­fore sell­ing Medi­va­tion at auc­tion for a whop­ping $14 bil­lion. Now he’s back, join­ing hands with one of the bright­est fi­nan­cial en­gi­neers in the busi­ness, as CEO of Vivek Ra­maswamy’s Ax­o­vant.

Ra­maswamy turned heads and raised more than a few eye­brows when he snagged a failed Alzheimer’s drug from Glax­o­SmithK­line for $5 mil­lion up­front and then made it the cen­tral fea­ture in a record-set­ting biotech IPO for Ax­o­vant $AX­ON. Since then, Ra­maswamy has been wheel­ing and deal­ing him­self, set­ting up more com­pa­nies as well as an­oth­er IPO for My­ovant.

Vivek Ra­maswamy

Through­out, he has spe­cial­ized in re­cruit­ing some very high-pro­file ex­ecs to run his com­pa­nies. And you don’t get much high­er pro­file than Hung.

Said Ra­maswamy:

We were not search­ing for a new CEO at Ax­o­vant, but fol­low­ing the ac­qui­si­tion of Medi­va­tion I ap­proached David about tak­ing a role with us af­ter the MIND­SET study. David de­cid­ed that he want­ed to join us now. I have en­joyed a close pro­fes­sion­al and per­son­al re­la­tion­ship with David over the last ten years, and I am tru­ly thrilled that Ax­o­vant is in ca­pa­ble hands as I tran­si­tion full-time to my role as CEO of Roivant.

In­vestors loved it. The news drove up Ax­o­vant’s shares by 29%, adding sev­er­al hun­dred mil­lion dol­lars to its mar­ket cap.

Mar­i­on Mc­Court

Iron­i­cal­ly, the for­mer Medi­va­tion CEO is head­ed back to a field where he ex­pe­ri­enced his biggest, most em­bar­rass­ing set­back. Pfiz­er paid $225 mil­lion up­front to part­ner with Hung on Dime­bon, an an­ti­his­t­a­mine that turned out to be an aw­ful fail­ure in try­ing to blunt the progress of the mem­o­ry-steal­ing dis­ease.

Hung isn’t ar­riv­ing at Ax­o­vant alone; he’s bring­ing a small crew along. Mar­i­on Mc­Court, the for­mer COO at Medi­va­tion, is tak­ing the same job at Ax­o­vant. And two close as­so­ciates of Hung, Kathryn “Kate” E. Fal­berg and William An­tho­ny “Tony” Ver­non, are join­ing an ex­pand­ed board. They al­so were board mem­bers at Medi­va­tion.

Ax­o­vant is look­ing to a set of pos­i­tive da­ta that GSK had gath­ered for its 5HT6 drug for symp­toms of Alzheimer’s. While oth­ers like Pfiz­er and Lund­beck have failed, Ax­o­vant be­lieves that by tak­ing the suc­cess­ful dose back in­to the clin­ic, it can suc­ceed where every oth­er late-stage study over the past 14 years has failed.

That’s a tall or­der, but a num­ber of very se­ri­ous play­ers in the in­dus­try tell me that the com­pa­ny has a de­cent shot at suc­ceed­ing — though its drug will like­ly do lit­tle but de­lay the crush­ing dis­ease by some months. Right now, that looks like ma­jor progress.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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