Je­re­my Levin joins the biotech IPO rush, gain­ing $75M for Ovid’s R&D game plan

Je­re­my Levin, Ovid

Je­re­my Levin is once again run­ning a pub­lic com­pa­ny. His start­up Ovid Ther­a­peu­tics $OVID has suc­cess­ful­ly launched an IPO, rais­ing $75 mil­lion af­ter sell­ing 5 mil­lion shares at $15 each — the low end of the range.

The move came as Uro­gen saw its shares $URGN climb north af­ter rais­ing $58 mil­lion in an up­sized IPO. But the fi­nan­cial prize of the day went to Bio­haven $BHVN, which snagged $168 mil­lion af­ter sell­ing 9.9 mil­lion shares. Add it all up and you’re look­ing at the first sol­id ev­i­dence that the IPO win­dow is widen­ing, with more such plays in the off­ing as some pa­tient com­pa­nies that have been bid­ing their time start to jump in on the ac­tion.

The burst of biotech IPOs comes af­ter the big boom of 2014 and 2015 fiz­zled in­to more of a steady trick­le. Some an­a­lysts had pegged 2017 as a like­ly re­peat of 2016, ex­pect­ing a cou­ple of dozen IPOs for the year. Now we’ll get to see if the win­dow stays open, or turns stub­born again, mak­ing it dif­fi­cult for these plays come to fruition.

Levin, the for­mer busi­ness de­vel­op­ment chief at Bris­tol-My­ers dur­ing its hey­day, com­plet­ed a brief stint as Te­va CEO be­fore the board pushed him out of the com­pa­ny and in­to the biotech start­up busi­ness.

Ovid’s two chief as­sets are OV101, now in ear­ly-stage test­ing for An­gel­man Syn­drome and Frag­ile X, and OV935, in Phase I for epilep­tic en­cephalopathies. Two oth­er pre­clin­i­cal pro­grams are still large­ly un­der wraps. OV101 came from Lund­beck in the spring of 2015 and the two com­pa­nies are now 50/50 part­ners on the de­vel­op­ment pro­gram. And Levin has made it clear that he’d like to do more cre­ative deals on oth­er ex­per­i­men­tal bio­phar­ma as­sets look­ing for a home — an in­creas­ing­ly com­mon fea­ture of the start­up world, of­fer­ing a short­cut in­to late-stage ef­forts.

Levin greet­ed the IPO with a cheer.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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