With PD-1 OK loom­ing, Re­gen­eron antes $100M on blue­bird al­liance for next-gen TCR cell ther­a­py pact

Some­time in the next few months, we’re like­ly to see the FDA come through with an ap­proval for the world’s 6th PD-1/L1 check­point in­hibitor from Re­gen­eron $REGN and its long­time de­vel­op­ment part­ners at Sanofi. But now the fast-grow­ing Re­gen­eron is al­so al­ly­ing it­self with blue­bird bio $BLUE, putting up $100 mil­lion in eq­ui­ty cash on a 50/50 de­vel­op­ment deal aimed at cre­at­ing a new pipeline of cell ther­a­pies with an eye to ex­pand­ing the hori­zon in on­col­o­gy with a new set of T cell re­cep­tor tar­gets.

The top sci­en­tists at blue­bird and Re­gen­eron took time Sun­day to pre­view a deal that moves the small­er com­pa­ny well past the BC­MA pro­gram it has put in the spot­light, while the an­ti­body de­vel­op­ment ex­perts at Re­gen­eron work their tech plat­form for 6 undis­closed tar­gets used to kick off the 5-year al­liance.

The mar­ket loved the idea, send­ing blue­bird’s shares up 7% in pre-mar­ket trad­ing.

In a typ­i­cal al­liance in­volv­ing a big­ger com­pa­ny, says Re­gen­eron R&D chief George Yan­copou­los, mak­ing a stren­u­ous ef­fort to dis­tin­guish this deal from the pack, you see a dom­i­nant play­er look­ing to add a par­tic­u­lar kind of ex­per­i­men­tal drug to the pipeline.

This isn’t that kind of deal.

“When I say we’re in­ter­est­ed in blue­bird bio,” says the Re­gen­eron co-founder, “it wasn’t for any par­tic­u­lar can­di­date.”

Philip Gre­go­ry

In­stead, says blue­bird CSO Phil Gre­go­ry, this is about a CAR-T and gene ther­a­py ex­pert, blue­bird, al­ly­ing it­self with a com­pa­ny that makes “the best binders that ex­ist.”

“Both com­pa­nies are en­tire­ly all in,” from the CEO on down, adds Yan­copou­los with all the in­ten­si­ty the in­dus­try has come to ex­pect from one of the most pro­duc­tive — and best paid — R&D di­rec­tors in the in­dus­try. “This is a ma­jor fo­cus for us.”

Re­gen­eron orig­i­nat­ed the idea, he adds, and made it hap­pen with a $100 mil­lion up­front for an eq­ui­ty stake in blue­bird, with a hefty pre­mi­um built in to blue­bird’s al­ready con­sid­er­able stock price.  But it’s not splurg­ing. Re­gen­eron’s price bakes in a $37 mil­lion pre­mi­um, which will be used to pay for its first round of re­search costs in the part­ner­ship.

For Re­gen­eron and blue­bird, it’s a chance to con­sid­er­ably widen the hori­zon of cell ther­a­py tar­gets — adding a va­ri­ety of in­tra­cel­lu­lar TCR tar­gets. And blue­bird fat­tens a cash re­serve that was re­cent­ly built up with a whop­ping $632 mil­lion raise, as it looks to tran­si­tion to a com­mer­cial stage with an up­com­ing fil­ing on β-tha­lassemia and more da­ta for bb2121.

The part­ners built the terms for a marathon pact, run­ning ini­tial­ly for 5 years but with terms that would al­low them to con­tin­ue to move on in cre­at­ing a pipeline to­geth­er. I asked the usu­al ques­tions. What are the first tar­gets? When will they make it to the clin­ic and in­to hu­man pa­tients?

Not sur­pris­ing­ly, those cards will re­main close to the vest for now. But both com­pa­nies are well known for a fo­cus on prod­ucts and per­for­mance. So it’s not an in­def­i­nite si­lence.

As both com­pa­nies close in on the on­col­o­gy mar­ket, where a myr­i­ad of con­tenders are look­ing to make their mark, they’re sat­is­fied to­day that they are stronger to­geth­er, than apart.

Im­age: George Yan­copou­los. GET­TY IM­AGES

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.

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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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.

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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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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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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European Commissioner for Health Stella Kyriakides (AP Photo/Francisco Seco, Pool)

One fi­nal push: EU phar­ma in­dus­try group de­mands com­pe­ti­tion check on in­com­ing leg­isla­tive over­haul

The Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) this morning called on the European Commission to ensure that it adequately assesses how its re-writing of the 20+-year-old pharma legislation, which is due to be released before the end of the month, damages the competitiveness of the pharma industry.

EFPIA’s opposition to the changes has lingered since the beginning, and its latest estimate is that the rewritten legislation could cost the industry €640 million ($688 million).

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.