Scott Gottlieb testifies on Capitol Hill in 2017 (Photo: AP Images / Graphics: Endpoints News)

Why Scott Got­tlieb, ven­ture cap­i­tal­ist, sees op­por­tu­ni­ty in an­tibi­otics

A drug de­vel­op­er in­vestor say­ing she’s very ex­cit­ed about an­tibi­otics right now is about the equiv­a­lent of a trad­er telling you in 2008 the hous­ing mar­ket looks at­trac­tive. It’s not just that al­most no new an­tibac­te­ri­als have been de­vel­oped in decades; the ones that make the mar­ket don’t stand to make a lot of mon­ey.

But when a Reuters re­porter asked ex-FDA chief Scott Got­tlieb what he was ex­cit­ed about now that he’s back in ven­ture cap­i­tal, Got­tlieb named the long-ne­glect­ed class.

“I’m very in­ter­est­ed in find­ing op­por­tu­ni­ties in the an­ti-in­fec­tive space, par­tic­u­lar­ly around mul­ti-drug re­sis­tant or­gan­isms,” Got­tlieb, now at New En­ter­prise As­so­ci­ates, told Reuters. “An­ti-in­fec­tives have been unloved for a very long time. There’s a huge clin­i­cal need.”

Of course, every­one agrees on the clin­i­cal need. Re­port af­ter re­port con­tin­ues to high­light the risk from the rise of drug-re­sis­tant bac­te­ria and the grow­ing dan­ger they rep­re­sent to pub­lic health. It’s how you meet it that’s been the ques­tion.

Got­tlieb has had ideas in the past, but as a reg­u­la­tor, not a ven­ture cap­i­tal­ist. Be­fore his April de­par­ture, he used his perch at the FDA to push for new plans that would change the fun­da­men­tal eco­nom­ics that has dis­in­cen­tivized “su­per­bug” re­search: Drug com­pa­nies are paid per drug, and an­tibi­otics are more ef­fec­tive the less you use them. There’s just not much de­mand for new an­tibi­otics right now, leav­ing the bulk of the mar­ket to cheap gener­ics.

Fac­ing that log­ic, No­var­tis, As­traZeneca and Sanofi all re­cent­ly jet­ti­soned their an­tibi­otics pro­gram. Bris­tol-My­ers Squibb — one of the three com­pa­nies, along with Mer­ck and Pfiz­er, that orig­i­nal­ly made peni­cillin pos­si­ble in the 1940s – shut­tered their arm in 2006. And small biotechs hop­ing to gain trac­tion have found a fund­ing desert.

Got­tlieb, though, said the van­ish­ing dol­lars have cre­at­ed an op­por­tu­ni­ty. He sin­gled out Achao­gen, the once-promis­ing biotech that spi­raled dra­mat­i­cal­ly af­ter the its new an­tibi­ot­ic Zem­dri won an ap­proval in a high­ly lim­it­ed pa­tient pool and failed to se­cure a la­bel ex­pan­sion. The com­pa­ny went bank­rupt and auc­tioned Zem­dri off in June.

“Af­ter the Achao­gen episode, a lot of val­u­a­tions have been dri­ven down quite dra­mat­i­cal­ly,” he said. “I think there’s an op­por­tu­ni­ty to try to find some ex­ist­ing as­sets and maybe build a com­pa­ny around those as­sets.”

There are still some big play­ers left, in­clud­ing Pfiz­er, which ac­quired As­traZeneca’s an­tibi­otics branch in 2016, and Mer­ck. GSK just be­gan Phase III tri­als on a new an­tibi­ot­ic for uri­nary tract in­fec­tion and gon­or­rhea.

Part of what they’re hop­ing for is the rise of new re­im­burse­ment mod­els like the ones Got­tlieb had pushed for. In Britain, the gov­ern­ment is test­ing a pro­gram would pay com­pa­nies ac­cord­ing to the val­ue of the drug to the NHS and not the amount doled out. GSK has en­dorsed that mod­el.

As FDA chief, Got­tlieb pushed oth­er mod­els de­signed for the US health­care sys­tem, in­clud­ing an ex­tend­ed patent win­dow grant­ed by Con­gress and a li­cens­ing sys­tem where acute care in­sti­tu­tions paid a flat fee to give out a spec­i­fied num­ber of dos­es of the drug.

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.