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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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