Bain’s Adam Kop­pel com­mits $350M to launch­ing a new biotech that is carv­ing out Pfiz­er’s neu­ro pipeline

Adam Kop­pel and his team at Bain Cap­i­tal are carv­ing out the neu­ro­sciences pipeline that Pfiz­er shut­tered at the be­gin­ning of the year, set­ting aside $350 mil­lion to back a start­up called Cerev­el which will now take con­trol of the work.

All of the mon­ey for this deal — to be an­nounced lat­er Tues­day morn­ing — is com­ing from Bain Cap­i­tal Pri­vate Eq­ui­ty and Kop­pel’s Bain Cap­i­tal Life Sci­ences.

Doug Gior­dano

Pfiz­er star­tled the neu­ro­sciences world at the be­gin­ning of this year with its de­ci­sion to abrupt­ly bow out of the field — ax­ing about 300 staffers in the process. Now Kop­pel is work­ing on re­cruit­ing his own team, which will be charged with tak­ing their 10 pro­grams through a planned Phase III, a Phase II and a slate of pre­clin­i­cal and ear­ly-stage work.

“This is a very unique deal for Bain Cap­i­tal,” Kop­pel tells me. But it’s al­so not like­ly the last time the pri­vate eq­ui­ty group will stand up new com­pa­nies like this. He com­pares it to Spring­Works, a com­pa­ny fund­ed by Bain, Or­biMed and oth­ers that took a slate of 4 drug pro­grams off the shelves of Pfiz­er last fall and point­ed them back in­to de­vel­op­ment.

The start­up al­so pops up in the wake of a sim­i­lar deal at Al­lo­gene, which raced to pick up Pfiz­er’s off-the-shelf CAR-T work and bar­rel straight in­to a record-set­ting IPO to back the play by Arie Bellde­grun and David Chang. In Al­lo­gene’s case though, the part­ners were gift­ed with a team of 40 Pfiz­er re­searchers who were deeply en­gaged in the process.

In this case, Kop­pel says they are bring­ing over a few Pfiz­er staffers, but not many. “There are a cou­ple of key peo­ple com­ing over, but it’s not a lot, as we are large­ly fo­cused on build­ing out a team,” he notes.

Aside from Pfiz­er’s BACE drug, which is be­ing left aside in the wake of a de­fin­i­tive late-stage fail­ure for the lead BACE at Mer­ck, Cerev­el is get­ting every­thing Pfiz­er had, with plans to be ful­ly op­er­a­tional in Q1 2019.

Mor­ris Birn­baum

Pfiz­er, which gets 25% of the eq­ui­ty in Cerev­el in ex­change for the pipeline, al­so plans to stay di­rect­ly en­gaged at the com­pa­ny, with Doug Gior­dano, se­nior vice pres­i­dent of world­wide busi­ness de­vel­op­ment, and Mor­ris Birn­baum, se­nior vice pres­i­dent, CSO of in­ter­nal med­i­cine, join­ing the board along­side Kop­pel and Chris Gor­don, an­oth­er man­ag­ing di­rec­tor at Bain.

Kop­pel is still keep­ing many of his cards close to his vest. He’s not say­ing how many staffers he ex­pects to re­cruit for the ini­tial ef­fort. An IPO may even­tu­al­ly be one way to go, but it’s not on his agen­da for dis­cussing with writ­ers to­day. 

The com­pa­ny won’t lack for mon­ey; Bain is ready to put up more cash if nec­es­sary.

Says Kop­pel: “This com­pa­ny will be well fund­ed.”

Their mon­ey will go to a late-stage D1 par­tial ag­o­nist, which Kop­pel ex­pects to en­ter Phase III next year as they ex­plore the drug’s po­ten­tial for con­trol­ling symp­toms of Parkin­son’s. A Phase II-ready se­lec­tive GA­BA 2/3 ag­o­nist will start off in an epilep­sy pro­gram. The com­pa­ny al­so has ac­tive pro­grams in ear­ly de­vel­op­ment, dis­cov­ery and a re­search pro­gram in neu­roin­flam­ma­tion. 

I sug­gest­ed that neu­ro­sciences, which has seen a va­ri­ety of Big Phar­mas bow out in the wake of fear­some fail­ure rates, was a tough field to jump in­to. But Kop­pel didn’t agree, cit­ing cas­es where Sage, Neu­ro­crine and oth­ers have been mak­ing a rep­u­ta­tion for them­selves.

The key here, he says, is whether a lean­er, mean­er biotech ma­chine can more ef­fi­cient­ly de­vel­op this pipeline of drugs, which is an idea that Pfiz­er is wide open to. And if it works, they can be one of the lead­ing biotechs in the field as well.


Im­age: Adam Kop­pel. BAIN

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.