UP­DAT­ED: Ab­b­Vie looks to shed Al­ler­gan's lega­cy wom­en's health unit as it hun­kers down for Hu­mi­ra biosim dooms­day — re­port

With the clock tick­ing on its block­buster Hu­mi­ra patent in the US, Ab­b­Vie is re­port­ed­ly in talks to sell the $5 bil­lion women’s health port­fo­lio it ac­quired from Al­ler­gan in or­der to pay off debt and fo­cus on new ar­eas.

Un­named sources told Reuters  that Ab­b­Vie is work­ing with Mor­gan Stan­ley to auc­tion off the port­fo­lio, which in­cludes the Lo Loestrin Fe birth con­trol pill. The po­ten­tial sale has re­port­ed­ly at­tract­ed the likes of CVC Cap­i­tal Part­ners, which the sources say is eye­ing the unit for its port­fo­lio com­pa­ny, Ther­amex.

End­points News reached out to Ab­b­Vie for con­fir­ma­tion, to which a com­pa­ny spokesper­son sim­ply replied: “We don’t com­ment on ru­mors.”

This won’t be the first time ex­ec­u­tives look to sell the unit. In 2018, then-Al­ler­gan CEO Brent Saun­ders laid out plans to of­fload the com­pa­ny’s women’s health and in­fec­tious dis­ease units. The fol­low­ing year, Saun­ders de­cid­ed to hold on to the women’s health unit — sev­er­al months be­fore Ab­b­Vie plunked down $63 bil­lion to buy out the com­pa­ny.

The deal gave Ab­b­Vie the Botox fran­chise and $16 bil­lion in an­nu­al rev­enue to work with ahead of los­ing US patent pro­tec­tion for Hu­mi­ra in 2023. The im­munol­o­gy megablock­buster pulled in $16.1 bil­lion in net sales last year alone. Since the buy­out, Ab­b­Vie has been steadi­ly shed­ding Al­ler­gan pipeline prod­ucts, with the main fo­cus on Botox.

Back in Au­gust, Ab­b­Vie bid adieu to the gene edit­ing work with Ed­i­tas it in­her­it­ed in the buy­out. And two months ear­li­er, it swept out a col­lab­o­ra­tion deal with As­sem­bly Bio­sciences.

Reuters re­port­ed that the women’s health port­fo­lio gen­er­ates a 12-month EBIT­DA of $500 mil­lion, and could be val­ued at 10 times that.

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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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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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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