Chi­na Bi­o­log­ic re­jects $3.9B buy­out bid from ex-CEO; Leo Phar­ma bags atopic der­mati­tis drug for $17M up­front

→ Chi­na Bi­o­log­ic $CBPO has re­ject­ed a buy­out bid ini­ti­at­ed from a con­sor­tium led by oust­ed chair­man and CEO David Gao. The $3.9 bil­lion of­fer, the com­pa­ny says, “is not in the best in­ter­ests of the com­pa­ny and its share­hold­ers as it did not re­flect the in­trin­sic val­ue” of the com­pa­ny. That’s de­spite the fact that at $118 a share, the of­fer from Gao’s group — which in­cludes GL Cap­i­tal Group, Bank of Chi­na Group In­vest­ment Lim­it­ed and CDH In­vest­ments — was al­ready well ahead of the $3.65 bil­lion on the ta­ble from CITIC Cap­i­tal. In­ci­den­tal­ly, the com­pa­ny an­nounced that CITIC has with­drawn its pro­pos­al.

CITIC will, how­ev­er, par­tic­i­pate in a di­rect sale of some new­ly-is­sued shares, in which Bei­jing-based Chi­na Bi­o­log­ic ex­pects to raise $590 mil­lion to “sup­port its busi­ness ex­pan­sion plan and strate­gic ac­qui­si­tions.” Oth­er in­vestors in the deal in­clude Cen­turi­um Cap­i­tal Man­age­ment and Hill­house Cap­i­tal Man­age­ment.

The in­vestors agreed to buy the shares at $100.90; as of press time, the stock price has fall­en more than 14% in pre-mar­ket trad­ing to $86.24.

→ The der­ma­tol­ogy spe­cial­ists at Leo Phar­ma have added an ear­ly-stage atopic der­mati­tis drug to their pipeline through a li­cens­ing deal with JW Phar­ma. For $17 mil­lion up­front, Leo is get­ting ex­clu­sive rights to de­vel­op and com­mer­cial­ize JW1601 any­where in the world ex­cept for Ko­rea, where JW is based. De­vel­op­ment and sales mile­stones to­tal an ad­di­tion­al $385 mil­lion, with two-dig­it roy­al­ties to fol­low should the drug go to mar­ket. JW1601 is an H4 re­cep­tor in­verse ag­o­nist that tar­gets both the itch and in­flam­ma­tion that comes with atopic der­mati­tis, and JW is plan­ning to sub­mit an IND this year.

As­traZeneca and Mer­ck are the lat­est phar­ma gi­ants to cel­e­brate a speedy nod for a po­ten­tial block­buster drug in Chi­na. Chi­nese reg­u­la­tors have giv­en the green light for the PARP in­hibitor Lyn­parza in ovar­i­an can­cer — one of 48 drugs list­ed as “ur­gent­ly need­ed” meds el­i­gi­ble for pri­or­i­ty re­view — nine months af­ter they be­gan pro­cess­ing the NDA. No­tably, Lyn­parza is the first im­port­ed drug to in­clude in­ter­na­tion­al mul­ti­cen­ter da­ta in its ap­pli­ca­tion.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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