Ab­b­Vie bails on So­sei Hep­tares pact for nov­el neu­rol­o­gy can­di­dates in blow to dis­cov­ery out­fit's A-list Rolodex

Japan’s So­sei Hep­tares has built a who’s who list of big-name part­ners look­ing to li­cense the com­pa­nies’ dis­cov­ery-stage G pro­tein-cou­pled re­cep­tors for nov­el neu­rol­o­gy path­ways and be­yond. But with So­sei’s goal of sign­ing two to three deals per year, there are bound to be set­backs — the most re­cent cour­tesy of phar­ma gi­ant Ab­b­Vie.

Ab­b­Vie will walk away from a lega­cy Al­ler­gan li­cens­ing pact with So­sei due to “pipeline de­ci­sions” that will leave So­sei’s mus­carinic ag­o­nist can­di­dates for schiz­o­phre­nia, Alzheimer’s and oth­er neu­ro­log­i­cal con­di­tions seek­ing a new home, the com­pa­nies said Tues­day.

So­sei will re­gain ex­clu­sive com­mer­cial rights to those mol­e­cules, in which Al­ler­gan had in­vest­ed around $55 mil­lion over their four-year part­ner­ship, So­sei es­ti­mat­ed.

Los­ing Ab­b­Vie on this deal is a blow to So­sei’s ever-grow­ing list of Big Phar­ma part­ners that have lever­aged the Japan­ese dis­cov­ery out­fit for nov­el path­ways tied to GPCRs. But So­sei, now po­ten­tial­ly look­ing at a mul­ti-year path back to a part­ner­ship for those mus­carinic ag­o­nists giv­en re­cent his­to­ry, is por­tray­ing the de­ci­sion as busi­ness as usu­al giv­en Ab­b­Vie’s oth­er cuts across its merged pipeline with Al­ler­gan.

Even still, Ab­b­Vie’s de­ci­sion to move away from a nov­el path­way in­to neu­rol­o­gy giv­en the suc­cess of an­tipsy­chot­ic Vray­lar — which us­es the dopamine ag­o­nist mech­a­nism of ac­tion So­sei’s drugs even­tu­al­ly plan to re­place — does come as a sur­prise with just one of So­sei’s mol­e­cules in this space hav­ing its day in the clin­ic.

So­sei was quick to point out that Ab­b­Vie’s de­ci­sion had noth­ing to do with its mol­e­cules’ safe­ty or ear­ly ef­fi­ca­cy re­sults, tamp­ing down sus­pi­cions Ab­b­Vie was lay­ing down a los­ing hand. More­over, the Japan­ese firm is still work­ing with Ab­b­Vie on a sep­a­rate dis­cov­er-li­cens­ing pact signed in June for small mol­e­cules tar­get­ing in­flam­ma­to­ry and au­toim­mune dis­eases.

Shinichi Tamu­ra So­sei Hep­tares

“We en­joyed a pro­duc­tive re­la­tion­ship with Al­ler­gan over the course of our mus­carinic ag­o­nist col­lab­o­ra­tion and con­tin­ue to work pos­i­tive­ly with Ab­b­Vie on a new pro­gram in in­flam­ma­to­ry dis­eases that we an­nounced in June last year,” So­sei CEO Shinichi Tamu­ra said in a state­ment. “The con­sid­er­able progress that we made to­geth­er with Al­ler­gan has re­in­forced our view in the po­ten­tial of this ap­proach to cre­ate im­por­tant new prod­ucts that treat se­vere and de­bil­i­tat­ing symp­toms of Alzheimer’s dis­ease, schiz­o­phre­nia and oth­er neu­ro­log­i­cal dis­eases.”

With Ab­b­Vie off the board for its mus­carinic ag­o­nists, high­ly se­lec­tive mol­e­cules that tar­get the M1 and M4 GPCRs in the brain with­out the side ef­fects of ac­ti­vat­ing the M2 and M3 re­cep­tors, So­sei is go­ing back to the draw­ing board to find a new part­ner — which isn’t un­heard of based on the com­pa­ny’s his­to­ry.

Back in 2015, As­traZeneca agreed to part­ner with So­sei on A2a mol­e­cules af­ter Shire dumped its li­cens­ing pact with the Japan­ese com­pa­ny in 2012. In an­oth­er case — the most re­cent —Bio­haven picked up a li­cense for a group of CGRP mol­e­cules in De­cem­ber af­ter Te­va walked away from its own pact in 2015. That lat­er deal came with a mi­nus­cule $10 mil­lion in up­front cash and up to $370 mil­lion in down­stream pay­ments plus tiered roy­al­ties.

Take ei­ther ex­am­ple and it could be be­tween three and five years be­fore So­sei scrounges up an­oth­er deal for its mus­carinic ag­o­nists. In the mean­time, the com­pa­ny is look­ing to high­light new “val­ue in­flec­tion points” for its can­di­dates as a pos­si­ble sales pitch and is work­ing to­ward its goal of ink­ing two to three new ma­jor li­cens­ing deals per year.

In De­cem­ber, Glax­o­SmithK­line tapped So­sei for dis­cov­ery work tar­get­ing IBD and oth­er gas­troin­testi­nal im­mune dis­or­ders with small-mol­e­cule ag­o­nists for GPR35, an or­phan G pro­tein-cou­pled re­cep­tor with a ge­net­ic link to those con­di­tions. As part of the deal, So­sei will lead pre­clin­i­cal R&D and hand clin­i­cal work, man­u­fac­tur­ing and com­mer­cial­iza­tion to GSK.

The British drug gi­ant agreed to hand out $44 mil­lion for near-term de­vel­op­ment mile­stones and re­search fund­ing. So­sei will al­so be due up to $437 mil­lion pend­ing a se­ries of de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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