Iron­wood pleas with in­vestors: Don't give us Alex Den­ner

Iron­wood $IR­WD is ramp­ing its ef­forts to fend off a board ac­tivist known for auc­tion­ing biotechs to the high­est bid­der, send­ing out a plea to share­hold­ers Wednes­day to re­ject Alex Den­ner’s bid for a board seat.

Alex Den­ner

At first, Iron­wood ap­peared open to the idea, no­ti­fy­ing share­hold­ers last month that Saris­sa Cap­i­tal, Den­ner’s com­pa­ny, planned to nom­i­nate him. Saris­sa took a stake in Iron­wood late last year. Den­ner is prob­a­bly best known as Carl Ic­ahn’s pro­tégé, with a his­to­ry of spurring ac­qui­si­tions of the com­pa­nies in which he in­vests. He served as chair­man of Ari­ad be­fore Take­da ac­quired the can­cer com­pa­ny for $5.2 bil­lion last year. He was al­so a board mem­ber at Biover­a­tiv be­fore it was sold to Sanofi for $11.6 bil­lion ear­li­er this year. And he re­cent­ly took con­trol of The Med­i­cines Co $MD­CO amid con­sid­er­able buzz.

Now with his eye on Iron­wood, the com­pa­ny’s stock price has climbed at the thought of high­er share­hold­er val­ue. But af­ter three meet­ings with Den­ner to bet­ter un­der­stand his in­ten­tions for the com­pa­ny, Iron­wood’s ex­ec­u­tives de­cid­ed they weren’t thrilled with the prospect of him on their board.

“Iron­wood strong­ly be­lieves that Saris­sa has not made a com­pelling case for Iron­wood to add Alex Den­ner to the board, giv­en the skills, ex­pe­ri­ence and di­ver­si­ty of the ex­ist­ing di­rec­tors who have act­ed to un­lock val­ue for Iron­wood share­hold­ers,” Iron­wood stat­ed in new press re­lease Wednes­day.

In­stead, Iron­wood is urg­ing share­hold­ers to vote for three in­de­pen­dent di­rec­tors who are up for re-elec­tion. The move comes a week af­ter Iron­wood an­nounced it would split in­to two pub­lic-trad­ed com­pa­nies: one fo­cused on the com­pa­ny’s FDA-ap­proved gas­troin­testi­nal drugs, and the oth­er on de­vel­op­ing treat­ments for rare dis­or­ders and oth­er se­ri­ous con­di­tions. The idea might be an ef­fort to show in­vestors that Iron­wood can be prof­itable with­out Den­ner’s in­flu­ence.

Iron­wood’s next an­nu­al meet­ing of share­hold­ers, in which the vote will take place, is sched­uled for May 31.

 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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