Alex Denner (Getty Images)

Two years af­ter a re­buffed ac­tivist at­tack, Alex Den­ner fi­nal­ly gets his seat on Iron­wood's board

Faced with an in­sur­gency from the ac­tivist in­vestor Alex Den­ner in 2018, Iron­wood Phar­ma­ceu­ti­cals mount­ed a vo­cal and ul­ti­mate­ly suc­cess­ful cam­paign to keep the for­mer Carl Ic­ahn pro­tégé off their board.

Now, two years lat­er and with the com­pa­ny fac­ing a re­struc­tur­ing and ma­jor ques­tions about its board, Iron­wood has is­sued a short and sur­pris­ing press re­lease: Alex Den­ner is join­ing the board.

“Iron­wood has de­vel­oped a strong re­la­tion­ship with Alex over these past few years, as Saris­sa has be­come one of our largest share­hold­ers,” Iron­wood said in an emailed state­ment.  “Alex knows Iron­wood well, and the Board be­lieves he brings to the com­pa­ny an im­por­tant share­hold­er per­spec­tive as well as broad health­care-in­dus­try knowl­edge and ex­pe­ri­ence as a board di­rec­tor in over­see­ing the op­er­a­tions of health­care com­pa­nies.”

Much has changed for Iron­wood since Den­ner first took aim at the com­pa­ny, in­clud­ing the ex­ec­u­tive team that pushed back the 2018 at­tack. Iron­wood has since ap­point­ed a new CEO, COO and pres­i­dent. Mean­while, af­ter two fail­ures wiped out their pipeline, the com­pa­ny faces ma­jor strate­gic ques­tions about how to turn its one ap­proved drug in­to a block­buster and whether to bring in new as­sets.

In the state­ment, Den­ner, who man­ages Saris­sa Cap­i­tal, added on­ly: “I look for­ward to work­ing with my fel­low board mem­bers to cre­ate val­ue at Iron­wood.”

Al­though Iron­wood suc­cess­ful­ly kept the Ic­ahn dis­ci­ple off their board, they fol­lowed one of the key changes Den­ner pro­posed, name­ly split­ting the com­pa­ny in­to two new en­ti­ties: Iron­wood and Cy­cle­ri­on. The for­mer would fo­cus on com­mer­cial and two big late-stage as­sets, the lat­ter on the ear­ly-stage pipeline.

Mark Mal­lon

As part of that move, Iron­wood CEO and co-founder Pe­ter Hecht went to lead Cy­cle­ri­on, while for­mer As­traZeneca ex­ec­u­tive Mark Mal­lon came in to run the old com­pa­ny.

Nei­ther biotech, though, has fared well since their di­vorce. This year, Iron­wood axed the on­ly two ex­per­i­men­tal drugs in its pipeline af­ter both failed late-stage tri­als, leav­ing them with the ap­proved GI drug Linzess and a de­cid­ed­ly com­mer­cial strat­e­gy. Cy­cle­ri­on, mean­while, axed two of its own pro­grams af­ter ear­ly stud­ies came up bust.

Af­ter the sec­ond missed tri­al, Mal­lon an­nounced they would lay off 100 em­ploy­ees and, faced with ques­tions from in­vestors, said their main fo­cus was turn­ing Linzess from a $150 mil­lion per year drug in­to a $1 bil­lion per year drug. He added they could scout for late or com­mer­cial-stage GI as­sets.

“We’re con­fi­dent that there are go­ing to be in­ter­est­ing op­por­tu­ni­ties,” he said. “But the first pri­or­i­ty re­mains Linzess and gen­er­at­ing prof­it. ”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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