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.

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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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

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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