Once a multi­bil­lion dol­lar com­pa­ny, Ova­Science ends a pen­ny­s­tock ve­hi­cle for Mil­len­do's re­verse merg­er

An am­bi­tious fer­til­i­ty com­pa­ny plagued by a se­ries of dis­ap­point­ments is play­ing out its fi­nal act — serv­ing as a ve­hi­cle for an­oth­er ven­ture’s suc­cess. Ova­Science, once val­ued at $1.8 bil­lion for its idea to help old­er women ex­tend their re­pro­duc­tive years, is merg­ing with Ann Ar­bor’s Mil­len­do Ther­a­peu­tics.

The re­verse merg­er is a way for Mil­len­do to back its way on­to the Nas­daq mar­ket, as Ova­Science is al­ready list­ed as $OVAS. Us­ing a near­ly-de­funct pub­lic com­pa­ny as a ve­hi­cle is a fair­ly com­mon way to gain ac­cess to the pub­lic mar­kets with­out go­ing on a lengthy road­show and putting to­geth­er your own IPO. Af­ter the merg­er is wrapped up, the com­bined com­pa­ny will be called Mil­len­do Ther­a­peu­tics, of course, and the new tick­er sym­bol will be $ML­ND.

Ju­lia Owens

A group of in­vestors has come to­geth­er to back Mil­len­do, com­mit­ting $30 mil­lion for af­ter the merg­er is com­plete. The mon­ey comes from New En­ter­prise As­so­ci­ates, Fra­zier Health­care Part­ners, and Roche Ven­ture Fund, among oth­ers. The new mon­ey will set up Mil­len­do to push for­ward two pro­grams: ATR-101, in Phase IIb tri­als for con­gen­i­tal adren­al hy­per­pla­sia, a rare en­docrine dis­ease; and a brand new drug to its pipeline called liv­o­le­tide. The lat­ter is a Phase II pro­gram ac­quired from French biotech Al­izé Phar­ma SAS last year. The med is meant to treat a rare ge­net­ic dis­ease called Prad­er-Willi Syn­drome (the most com­mon form of ge­net­ic obe­si­ty). That pro­gram is planned to en­ter Phase IIb/III tri­als in the first quar­ter of 2019.

“We are ex­cit­ed about the op­por­tu­ni­ties cre­at­ed by this merg­er, as it po­si­tions us to be­come a leader in rare en­docrine dis­eases with the fund­ing need­ed to pur­sue the po­ten­tial ap­proval and com­mer­cial­iza­tion of our first-in-class pro­grams,” said Ju­lia Owens, pres­i­dent and CEO of Mil­len­do, in a state­ment.

It’s good news for Mil­len­do, but a sad end for Ova­Science. Ova­Science was found­ed sev­en years ago around the dog­ma-chal­leng­ing claim by a sci­en­tist now at North­east­ern Uni­ver­si­ty that he had dis­cov­ered “egg pre­cur­sor” cells in hu­man ovaries that could gen­er­ate new, young eggs for old­er women, po­ten­tial­ly ex­tend­ing re­pro­duc­tive years. Ova­Science’s founders in­clud­ed Boston/Cam­bridge big shots like Rich Aldrich, Michelle Dipp, David Sin­clair and Christophe West­phal.

Ex­tend­ing fer­til­i­ty years was the long goal, but the com­pa­ny’s first lead prod­uct, called Aug­ment, was meant to boost a woman’s chance of preg­nan­cy dur­ing IVF treat­ment. The up­take for that ser­vice was painstak­ing­ly slow, and the com­pa­ny’s stock slow­ly de­clined over the years. One day a multi­bil­lion dol­lar com­pa­ny, the next it’s firm­ly a pen­ny­s­tock.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.