Buck­le up: Biotech board ac­tivist Alex Den­ner is out to shake things up at Iron­wood

The change mas­ter of biotech is knock­ing at Iron­wood Phar­ma­ceu­ti­cals’ front door. And he wants in with plans to stay for awhile.

Alex Den­ner, known for forc­ing out old CEOs and forc­ing through new buy­outs, has now set his sights on the long­time Boston/Cam­bridge play­er guid­ed by found­ing CEO Pe­ter Hecht, who launched the com­pa­ny 20 years ago with a plan for the long haul.

In an un­usu­al move, Iron­wood put out word of Den­ner’s move to join the board in a press re­lease Mon­day. And the com­pa­ny took the op­por­tu­ni­ty to point­ed­ly praise the board Hecht has al­ready as­sem­bled, which in­cludes 8 in­de­pen­dent di­rec­tors on the 9-mem­ber group.

Ac­cord­ing to the re­lease, Iron­wood now wants to get some feed­back on the move from in­vestors, not­ing that the Saris­sa Cap­i­tal chief has been by for one vis­it and that they hope con­struc­tive talks will con­tin­ue. Its stock $IR­WD shot up 10% as in­vestors ea­ger­ly an­tic­i­pat­ed a change­up.

“I hope that we’re go­ing to con­tin­ue to have a pleas­ant and con­struc­tive con­ver­sa­tion, as I be­lieve we were hav­ing,” Den­ner told CN­BC. “To the ex­tent that they state in their press re­lease that they’re con­cerned with what in­vestors want, I’ve been told that more val­ue has been cre­at­ed for Iron­wood share­hold­ers to­day than in any sin­gle day in his­to­ry.”

That sounds at least slight­ly skep­ti­cal.

Be­hind the barbed pleas­antries, though, it’s clear that Den­ner is out to shake things up at Iron­wood, a com­pa­ny best known for its fran­chise drug Linzess and a pipeline of ther­a­pies in the same space. Sev­er­al an­a­lysts think the com­pa­ny could do bet­ter on the stock price, and Den­ner is all about val­ue cre­ation — with a big ap­petite for prof­it­ing from tur­bu­lence.

Iron­wood gained an ap­proval for Duza­l­lo, a com­bo ther­a­py that match­es lesin­u­rad and al­lop­uri­nol in one pill, last sum­mer. But Ge­off Meacham at Bar­clays and oth­ers ques­tioned Hecht’s rev­enue pro­jec­tions at the time. The biotech has al­so dis­ap­point­ed an­a­lysts with da­ta on IW-3718 for un­con­trolled GERD, which were pos­i­tive but fell short of Hecht’s en­thu­si­as­tic pro­jec­tion.

Add it up, and Den­ner can count on some lin­ger­ing frus­tra­tions to help add to his clout at Iron­wood — if he’s suc­cess­ful at this new play.

He’s cer­tain­ly not re­luc­tant to use his in­flu­ence to max­i­mum ef­fect.

As Carl Ic­ahn’s right hand man, Den­ner steered Bio­gen in a new di­rec­tion, forc­ing out Jim Mullen and bring­ing in George Scan­gos more than 5 years ago. Now that com­pa­ny is ex­pect­ed to steer through a new stretch of reengi­neer­ing as a new CEO looks over the pipeline and its prospects. Den­ner — who now runs his own shop at Saris­sa — al­so forced the sale of Ari­ad to Take­da and more re­cent­ly played a di­rect role in see­ing Biover­a­tiv go to Sanofi. Den­ner was Sanofi’s first stop on that deal, and was al­ways the most like­ly to see the up­side in a takeover tied to a big pre­mi­um. And he re­cent­ly took con­trol of The Med­i­cines Co. $MD­CO amid con­sid­er­able buzz.

What’s next for Iron­wood?

We’ll see. But busi­ness as usu­al is over for now.


Im­age: Alex Den­ner. CN­BC via GET­TY

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Robert Hariri, Celularity CEO (Vivien Killilea/Getty Images for Brain Mapping Foundation)

Celu­lar­i­ty warns of loom­ing lay­offs, spot­lights ear­ly pro­grams as mon­ey runs dry

Celularity has warned “a substantial portion” of its employees that layoffs could be looming in the face of a reprioritization effort. In the same breath, it touted some of its very early next-gen candidates in degenerative diseases and oncology.

“While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees,” the news release reads, in part.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.