Pfiz­er vet Ger­mano makes quick ex­it from In­trex­on as hands-on bil­lion­aire Kirk re­or­ga­nizes biotech


When Geno Ger­mano left a se­nior post at Pfiz­er and lat­er signed on as pres­i­dent of In­trex­on 10 months ago, he start­ed down a path that he was told led straight to the CEO’s job. In­stead, he wound up at the ex­it door on Fri­day, leav­ing bil­lion­aire Ran­dal “RJ” Kirk at the helm of the com­pa­ny he found­ed, re­or­ga­niz­ing the com­plex biotech side of the busi­ness.

Ger­mano had been head of the glob­al phar­ma busi­ness at Pfiz­er when he was sud­den­ly odd man out in a planned merg­er with Al­ler­gan, which al­so ul­ti­mate­ly nev­er hap­pened. Kirk wel­comed him with open arms, telling the world that Ger­mano would be the next chief for day-to-day op­er­a­tions $XON as he stepped up to the ex­ec­u­tive chair­man’s role.

That put the ex-Pfiz­er ex­ec right near the top of the pyra­mid of a wide net­work of sub­sidiaries all claim­ing to be work­ing on game-chang­ing syn­thet­ic bi­ol­o­gy tech in 5 big sec­tors: health, food, en­er­gy, en­vi­ron­ment and con­sumer mar­kets.

Now Ger­mano is go­ing back to the bio­phar­ma world, and “RJ” is stay­ing at the helm of In­trex­on, which en­joys a $2.8 bil­lion mar­ket cap. From Ger­mano’s state­ment:

RJ’s vi­sion can be seen in the goals he sets and the tremen­dous re­sources – fis­cal, tech­no­log­i­cal and hu­man – as­sem­bled to achieve them.  It is with the fore­go­ing in mind that it has be­come clear to me that RJ is in­te­gral to the day to day op­er­a­tion of this com­pa­ny and that it is there­fore ap­pro­pri­ate for him to re­main in the CEO role for the fore­see­able fu­ture.  At the same time, I have come to re­al­ize that my pref­er­ence is to work with­in the in­dus­try where I spent most of my life, and there­fore am leav­ing the com­pa­ny to con­tin­ue my ca­reer in the phar­ma/bio­phar­ma in­dus­try.

Kirk an­nounced Ger­man’s de­par­ture at the same time he set up yet an­oth­er sub­sidiary, this one dubbed Pre­ci­gen, that he said would make it eas­i­er to pur­sue “po­ten­tial strate­gic op­tions to en­hance share­hold­er val­ue.”

Kirk didn’t ex­act­ly ex­plain what those strate­gic op­tions are, but he made it clear that he want­ed all the part­nered pipeline col­lab­o­ra­tions — which are con­sid­er­able — un­der one arm of the com­pa­ny.

Their pipeline in­cludes ther­a­pies for a wide va­ri­ety of dis­eases, such as ad­vanced lym­phoid ma­lig­nan­cies, acute myeloid leukemia, pe­di­atric brain tu­mors, sol­id tu­mors, oral mu­cosi­tis, type 1 di­a­betes, wet age-re­lat­ed mac­u­lar de­gen­er­a­tion, Clostrid­i­um dif­fi­cile in­fec­tion, lin­ear scle­ro­der­ma, and car­diac dis­ease. Pre­ci­gen will al­so man­age a 75% stake in Xo­genex, which is pur­su­ing ge­net­ic strate­gies on car­diac dis­ease. It’s all pre­clin­i­cal right now, with an IND com­ing be­fore the end of the year.

Said Kirk:

While we have been re­view­ing po­ten­tial op­tions for over a year, as our col­lab­o­ra­tors in­creas­ing­ly be­gin to move in­to the clin­ic, it is ap­par­ent that our col­lec­tion of health as­sets may be over­shad­owed by the breadth and com­plex­i­ty of the op­por­tu­ni­ties the en­gi­neer­ing of bi­ol­o­gy has af­ford­ed us.  We are there­fore tak­ing this struc­tur­al ac­tion now to bet­ter po­si­tion us for strate­gic de­ci­sions re­gard­ing our health busi­ness mov­ing for­ward.

The com­pa­ny has inked a bliz­zard of deals over the years, but it’s al­so been bleed­ing cash. Ac­cord­ing to its 10K filed at the be­gin­ning of this month, In­trex­on was $187 mil­lion in the red in 2016 af­ter more than dou­bling down on its loss­es from 2015.

In­trex­on has man­aged to main­tain a large val­u­a­tion with­out demon­strat­ing much in the way of clin­i­cal im­pact, so far. That can’t last for­ev­er, but it’s held up bet­ter than most over the last few years.

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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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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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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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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.