FDA nom­i­na­tion in hand, Got­tlieb pre­pares to dis­en­tan­gle him­self from a long list of bio­phar­ma jobs and in­vest­ments

Steve Burd (R), pres­i­dent and CEO, Safe­way, Inc. and Scott Got­tlieb (L), res­i­dent fel­low at Amer­i­can En­ter­prise In­sti­tute par­tic­i­pate in a Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee hear­ing on Capi­tol Hill, June 11, 2009 in Wash­ing­ton, DC. (Cred­it: Mark Wil­son/Get­ty Im­ages)


Scott Got­tlieb wasn’t idle dur­ing the eight years of the Oba­ma ad­min­is­tra­tion. With De­moc­rats in the White House and Re­pub­li­cans out, the for­mer agency of­fi­cial turned to a busy ca­reer work­ing with quite a range of bio­phar­ma in­vestors and com­pa­nies.

Now that Got­tlieb has se­cured Trump’s nom­i­na­tion as the next FDA com­mis­sion­er and lined up an April 5th hear­ing at the Sen­ate, he’s be­gun the process of un­wind­ing those in­vest­ments and busi­ness re­la­tion­ships in bio­phar­ma. Got­tlieb filed a dis­clo­sure form yes­ter­day with the Of­fice of Gov­ern­ment Ethics that will sure­ly pro­vide fod­der for a De­mo­c­ra­t­ic at­tack dur­ing his con­fir­ma­tion hear­ings.

And there’s a lot to see.

Got­tlieb’s con­sult­ing work with Glax­o­SmithK­line is well known, and he’s put the phar­ma gi­ant on a long list of com­pa­nies he will steer clear of dur­ing his first year as com­mis­sion­er, re­cus­ing him­self from any FDA ac­tion re­gard­ing GSK. He’s al­so been a board mem­ber of Me­dA­vante, a med­ical de­vice com­pa­ny. Me­dA­vante owes him some com­pen­sa­tion, he says in the ethics form, but he’ll for­feit that if it doesn’t ar­rive ahead of his con­fir­ma­tion. And if it does, he’ll re­cuse him­self for two years.

There were board po­si­tions with Tolero and the clin­i­cal di­ag­nos­tic lab Com­bi­Ma­trix, which he re­signed from last De­cem­ber. And he set up a com­pa­ny to com­plete a sin­gle con­sult­ing con­tract with Bris­tol-My­ers Squibb. More con­sult­ing was done for Ver­tex and he wrote a se­ries of ar­ti­cles for Forbes.

He al­so has a po­si­tion with Amer­i­can Pathol­o­gy Part­ners and Col­lec­tive Health, but he plans to re­sign from those po­si­tions once he is con­firmed, then re­cuse him­self from ac­tions re­lat­ed to those com­pa­nies.

There are stock op­tions in Gradalis, Glytec and Strike Bio. He’s re­signed re­cent­ly from po­si­tions at Gradalis and Strike, and plans to re­cuse him­self from all three, di­vest­ing his in­vest­ments in 90 days af­ter he is con­firmed as com­mis­sion­er.

Got­tlieb was a part­ner at T.R. Win­ston, a bou­tique in­vest­ment bank, where he picked up in­vest­ments in Cell Bio­ther­a­py, An­gion Phar­ma­ceu­ti­cals, Chan­ti­cleer Hold­ings and:

  • Em­maus Life Sci­ences
  • In­spyr Ther­a­peu­tics
  • Kure
  • Lil­lis En­er­gy
  • Neu­ral­stem
  • Phar­ma-Bio Serv
  • Pros­et­ta Bio­sciences
  • So­cial Re­al­i­ty
  • Syn­the­sis En­er­gy Sys­tems
  • Tivor­san Phar­ma­ceu­ti­cals

All of that will go when he gets the nod from law­mak­ers.

He will still need to re­sign from po­si­tions at Amer­i­can En­ter­prise In­sti­tute, the New York Uni­ver­si­ty School of Med­i­cine, the So­ci­ety of Hos­pi­tal Med­i­cine, the BDO Cen­ter for Health­care Ex­cel­lence and In­no­va­tion, and Daichii Sankyo US.

(Whew.)

And he’ll re­cuse him­self from any ac­tions in­volv­ing all of them.

Chances are that the De­moc­rats will do what it can to paint these ties as an ex­am­ple of Got­tlieb’s too cozy re­la­tion­ship with an in­dus­try he plans to reg­u­late. But with the Re­pub­li­cans in charge of Con­gress and the White House, and bio­phar­ma of­fer­ing sol­id sup­port for the nom­i­na­tion, it’s un­like­ly he’ll be blocked.

The in­dus­try learned to yearn for Got­tlieb at the helm of the FDA pre­cise­ly be­cause his ex­pe­ri­ence had to make him aware of the re­al­i­ties in­volved in de­vel­op­ing ther­a­pies — a per­spec­tive that of­ten seems lack­ing in the White House. There’s no ques­tion his port­fo­lio took him on a glob­al jour­ney in bio­phar­ma that makes him a safe bet to run the agency.

But ex­pect to hear a lot more about this in the weeks to come.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.