Vi­sion or voodoo? Biotech IPO mas­ter Vivek Ra­maswamy is still set­ting up new biotechs and hatch­ing more deals

Vivek Ra­maswamy

In the 18 months since Vivek Ra­maswamy blind­sided the biotech in­dus­try with a record-set­ting IPO for the mys­tery biotech Ax­o­vant, the one-time hedge fund mae­stro turned drug en­tre­pre­neur has set up three more com­pa­nies and tak­en one of them pub­lic at near su­per­son­ic speed, all while busi­ly in-li­cens­ing drugs from a grow­ing list of sup­pli­ers.

And he isn’t slow­ing down. In a sit­down with me at JP Mor­gan this week, Ra­maswamy says he may well un­cork an­oth­er start­up and strike up an­oth­er three or four deals in 2017.

“I wouldn’t be sur­prised to see an­oth­er ma­jor ‘vant’ in 2017,” Ra­maswamy says, as he fo­cus­es on a va­ri­ety of new fields like a “post im­muno-on­col­o­gy world,” in­fec­tious dis­eases and pul­monolo­gy.

Ra­maswamy is per­haps the most ac­com­plished fi­nan­cial en­gi­neer in the in­dus­try, and that’s ex­act­ly the rep­u­ta­tion he hates the most.

“I don’t per­son­al­ly take pride in our IPOs as an ac­com­plish­ment,” says the young chief of Roivant Sci­ences, the um­brel­la com­pa­ny that hosts Ax­o­vant ($AX­ON, a $360 mil­lion IPO), My­ovant ($MY­OV, a $218 mil­lion IPO), En­zy­vant and Der­ma­vant. A pained frown clouds a typ­i­cal­ly smil­ing face as I list his Wall Street coups, which have added enor­mous­ly to his wealth.

In­stead of Wall Street sta­tus, Ra­maswamy is go­ing for bio­phar­ma vi­sion­ary, look­ing to take an al­ready well de­fined ap­proach in-li­cens­ing Big Phar­ma’s castoffs and ramp­ing it up while find­ing an ef­fi­cient, sus­tain­able R&D strat­e­gy that in­cludes re­al­ly in­cen­tiviz­ing the peo­ple do­ing the work to suc­ceed — rather than grim­ly hang­ing on to what­ev­er project they have in hand. And with that re­cruit­ment strat­e­gy Ra­maswamy fig­ures he can hire the best, in­clud­ing peo­ple like My­ovant CEO Lynn Seely, a Medi­va­tion vet­er­an.

He’s been able to do much of this af­ter rais­ing a phe­nom­e­nal amount of cash from in­vestors while of­ten pay­ing ex­tra­or­di­nar­i­ly lit­tle for his as­sets. (And not just from his share­hold­ers. Bil­lion­aire An­dreas Halvors­en’s Viking Glob­al In­vestors is al­so par­tic­i­pat­ing.) GSK let go of Ax­o­vant’s Alzheimer’s drug for a mere $5 mil­lion in cash — af­ter it had burned through much more in a failed ef­fort to gain pos­i­tive da­ta. My­ovant was whipped up through a pact with Take­da, which was glad to grab eq­ui­ty in pay­ment. Ra­maswamy al­so says that it was Take­da that pushed for an IPO.

Be­ing su­per suc­cess­ful at cre­at­ing pa­per bil­lions — at least tem­porar­i­ly — out of deals done with bar­gain base­ment prices at a time as­set val­u­a­tions have been go­ing through the roof has land­ed Ra­maswamy on the cov­er of Forbes, in TechCrunch and plen­ty of oth­er pubs and places as well.

And lat­er this year he can start to ei­ther live up to his self-im­age as the de­vel­op­er of im­por­tant new med­i­cines with a rad­i­cal new R&D strat­e­gy or start to feel the pain of re­search risk as his Alzheimer’s drug is set to read out late-stage da­ta.

In the mean­time, look out for for more deals ahead. Ra­maswamy is nev­er far from his smart phone.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Credit: Shutterstock

Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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