Draw­ing Shire par­al­lel, Flem­ming Ørn­skov mulls IPO for Gal­der­ma; Rei­s­tone shows re­sults from eczema study with JAK1 block­er

Two years ago, Flem­ming Ørn­skov took up a new chal­lenge as CEO of Gal­der­ma with the ex­pec­ta­tion he would work the mag­ic like he did with Shire — cul­mi­nat­ing in the rare dis­ease biotech’s $62 bil­lion sale to Take­da — with the pure-play der­ma­tol­ogy out­fit fresh­ly spun out of Nestlé.

Now that the ship is steady, he’s seem­ing­ly set­ting his sights on an IPO.

In an in­ter­view with Bloomberg, Ørn­skov said he’s ac­cel­er­at­ing re­search spend­ing while re­cruit­ing more der­ma­tol­o­gists and med­ical spe­cial­ists to the com­pa­ny. The strat­e­gy, he added, is sim­i­lar to Shire’s in the sense that he would dou­ble down on the sci­ence and shift to cut­ting-edge, high-risk prod­ucts that can com­mand high prices — even as Gal­der­ma con­tin­ues to bring in rev­enue through its con­sumer aes­thet­ic and skin care prod­ucts such as Cetaphil mois­tur­iz­ers.

The pipeline is high­light­ed by nemolizum­ab, an an­ti-IL-31 an­ti­body po­si­tioned for atopic der­mati­tis, pruri­go nodu­laris and rosacea. And Ørn­skov ap­pears un­fazed about steer­ing straight in­to a crowd­ed space.

“When I start­ed as CEO at Shire, rare dis­eases was a min­i­mal part of the busi­ness,” he said. “Even my board was prob­a­bly skep­ti­cal.”

Gal­der­ma’s cur­rent own­ers, led by the in­vest­ment firm EQT, are aim­ing for a val­u­a­tion of up to $22 bil­lion, Bloomberg re­port­ed cit­ing in­sid­ers. — Am­ber Tong

Rei­s­tone fin­ish­es an­oth­er JAK1 block­er study — this time in AD

Shang­hai biotech Rei­s­tone Bio­phar­ma re­vealed pos­i­tive re­sults to­day from a Phase II study in­volv­ing a top­i­cal oint­ment with JAK1 block­er SHR0302.

The study, which looked at the oint­ment in adults and ado­les­cents with mild-to-mod­er­ate atopic der­mati­tis, had all three dosages (0.5%, 1% and 2%) meet the study’s pri­ma­ry end­point of eczema im­prove­ment based on im­proved per­cent­age change of a pa­tient’s Eczema Area and Sever­i­ty In­dex (EASI) score from base­line ver­sus place­bo at week 8.

This is not the on­ly in­di­ca­tion in the works for Rei­s­tone’s JAK1 block­er — back in Au­gust, the Chi­nese firm fin­ished an­oth­er Phase II study test­ing the drug in pa­tients with patchy hair loss.

SHR0302 oint­ment was gen­er­al­ly well-tol­er­at­ed at all dos­es.

“We are pleased to see the pos­i­tive re­sults from this study of a new top­i­cal ther­a­py,” said Rei­s­tone co-founder and CEO Min Ir­win. “We be­lieve this top­i­cal for­mu­la­tion will be an in­valu­able ad­di­tion to the SHR0302 port­fo­lio.” — Paul Schloess­er

Chi­na’s Chance Phar­ma­ceu­ti­cals rais­es $30M for drug pipeline and man­u­fac­tur­ing fa­cil­i­ty

Chi­nese biotech Chance Phar­ma­ceu­ti­cals fin­ished a Se­ries C round for $30 mil­lion, the com­pa­ny said in a state­ment to­day.

With the Se­ries C led by new in­vestor La­pan Cap­i­tal along­side oth­er new and ex­ist­ing in­vestors, the $30 mil­lion is to ad­vance Chance’s pipeline of in­hala­tion ther­a­pies, start new busi­ness col­lab­o­ra­tions and as­sist in the build­ing of their man­u­fac­tur­ing fa­cil­i­ty.

The last fundrais­ing was a Se­ries B in June 2020, amount­ing to just over $707,000.

“We are op­ti­mistic about the mar­ket po­ten­tial of trans­for­ma­tive in­hala­tion ther­a­pies,” com­ment­ed La­pam Cap­i­tal chair­man Zhi­hua Yu. — Paul Schloess­er

ATAI an­nounces pre­ci­sion psy­chi­a­try biotech in part­ner­ship with Duke spin­out

Ger­man biotech ATAI an­nounced the launch of pre­ci­sion psy­chi­atric play­er PsyPro­tix to­day, formed in a part­ner­ship with Duke Uni­ver­si­ty biotech spin­out Chymia. The biotech will fo­cus on de­vel­op­ing ther­a­peu­tics for treat­ment-re­sis­tant de­pres­sion (TRD) and oth­er men­tal health in­di­ca­tions, ac­cord­ing to a state­ment.

PsyPro­tix’s goal is to fo­cus on metabolom­ic mech­a­nisms and un­der­ly­ing de­pres­sion symp­toms for cer­tain pa­tients, with the goal of de­riv­ing more tai­lored and po­ten­tial­ly cus­tomiz­able treat­ments for each in­di­vid­ual pa­tient.

“This emerg­ing tech­nol­o­gy adapts to the vari­abil­i­ty of con­di­tions, such as de­pres­sion, with the aim of al­low­ing pa­tients with psy­chi­atric dis­or­ders to po­ten­tial­ly be di­ag­nosed and treat­ed more ac­cu­rate­ly and ef­fi­cient­ly ac­cord­ing to their spe­cif­ic needs,” said ATAI CSO and co-founder Srini­vas Rao. — Paul Schloess­er

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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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.

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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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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