Debra Yu (LianBio)

Pfiz­er hands Lian­Bio $70M to tag along Per­cep­tive's Chi­na play, with an eye to beef­ing up re­gion­al port­fo­lio

When Per­cep­tive un­veiled its care­ful­ly cu­rat­ed syn­di­cate for Lian­Bio’s $310 mil­lion Se­ries A, Pfiz­er stood out as the on­ly phar­ma amid a mar­quee group of VCs. It turns out that the drug­mak­er wasn’t on­ly look­ing to share the fruits of Lian­Bio’s la­bor, it al­so wants to get down in­to the trench­es.

Pfiz­er has put an ad­di­tion­al $70 mil­lion on the ta­ble for Lian­Bio — which Per­cep­tive set out to shape in­to a “best-in-class sourc­ing and de­vel­op­ment en­gine” in Chi­na — to in-li­cense pro­grams that they can then co-de­vel­op. If a drug reach­es the mar­ket, Pfiz­er will be first in line to ne­go­ti­ate for stand­alone com­mer­cial deals.

Kon­stan­tin Poukalov

Hav­ing just re­cent­ly signed off on a $480 mil­lion col­lab­o­ra­tion to de­vel­op and com­mer­cial­ize CStone’s PD-1 in Chi­na, Doug Gior­dano, SVP of Pfiz­er world­wide busi­ness de­vel­op­ment, said the new deal ex­pands its “abil­i­ty to part­ner across the biotech ecosys­tem” and de­liv­er med­ical break­throughs to Chi­nese pa­tients.

“We’ve heard this re­peat­ed­ly from Big Phar­mas over the years that they get pro­grams com­ing down from glob­al but there’s of­ten not as much em­pha­sis and lit­tle ac­tiv­i­ty at the re­gion­al lev­el for busi­ness de­vel­op­ment,” De­bra Yu, Lian­Bio’s pres­i­dent/CBO and a Pfiz­er alum, told End­points News.

For Lian­Bio, the al­liance doesn’t just of­fer heavy­weight en­dorse­ment of its mod­el but al­so a way to tap in­to com­mer­cial in­fra­struc­ture that Pfiz­er has built over a decade.

Kon­stan­tin Poukalov, man­ag­ing di­rec­tor at Per­cep­tive and ex­ec­u­tive chair­man at Lian­Bio, not­ed that the in-kind help that Pfiz­er has com­mit­ted might just be as im­por­tant as the cash. From clin­i­cal tri­al ex­per­tise — Pfiz­er has 60-plus stud­ies un­der­way in the coun­try — and KOL net­work to cre­at­ing mar­ket ac­cess and deal­ing with the re­im­burse­ment process, the phar­ma gi­ant brings sig­nif­i­cant knowl­edge and ca­pac­i­ty to the pact.

Bing Li

In par­tic­u­lar, he adds, Lian­Bio will be pre­sent­ing to Pfiz­er as­sets that re­quire a large, spread-out sales force to cov­er vast ge­o­graph­i­cal re­gions. As­sets that are more tar­get­ed around spe­cif­ic cen­ters of care are more like­ly to be han­dled by the 30-plus Lian­Bio staffers (they’re still re­cruit­ing) CEO Bing Li is lead­ing in Shang­hai and Bei­jing.

As Yu scouts new deals with her New Jer­sey-based team, she be­lieves hav­ing Pfiz­er on board would con­vince biotech part­ners that by li­cens­ing Chi­na rights to Lian­Bio they will get the “best of both worlds.”

“It’s a very spe­cial kind of be­spoke cre­ative part­ner­ship that ben­e­fits all the three par­ties that are in­volved,” she said.

Pre­vi­ous­ly, Lian’s pitch­es main­ly re­volved around de­tailed mar­ket analy­ses and tai­lor-made de­vel­op­ment pro­pos­als that Bridge­Bio CEO Neil Ku­mar has praised as cre­ative. For $26.5 mil­lion in near-term pay­ments, he hand­ed over two tar­get­ed can­cer drug can­di­dates and gave away pref­er­en­tial fu­ture ac­cess to pro­grams across his sub­sidiaries’ port­fo­lio.

MyoKar­dia, mean­while, pro­vid­ed Lian with its first car­dio drug be­fore Bris­tol My­ers Squibb bought it for $13 bil­lion. Lian paid $40 mil­lion up­front for mava­camten and is on the hook for an­oth­er $147.5 mil­lion.

While Lian doesn’t en­vi­sion do­ing an­oth­er deal like the Pfiz­er one — elect­ing in­stead to pri­or­i­tize find­ing new drugs for its pipeline — Poukalov be­lieves oth­er phar­ma gi­ants are sim­i­lar­ly look­ing for ways to get their hands on drugs they may not oth­er­wise have ac­cess to.

“Just like you’ve seen in As­traZeneca’s case where they were able to do re­gion­al spe­cif­ic deals to dri­ve re­gion­al rev­enue, I think that’s top of mind for a lot of oth­er MNCs that are try­ing to evolve and re­al­ly kind of con­tin­ue to an­chor their po­si­tion in the mar­ket­place,” Poukalov said.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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