Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Am­gen is shrug­ging off a 14-year de­vel­op­ment al­liance and the tens of mil­lions of dol­lars spent to de­vel­op a new heart drug at Cy­to­ki­net­ics af­ter a Phase III tri­al turned up weak da­ta — leav­ing Cy­to­ki­net­ics to sol­dier on alone.

Ome­cam­tiv mecar­bil tech­ni­cal­ly worked, meet­ing the pri­ma­ry com­pos­ite end­point in the Phase III GALAC­TIC-HF study. But it missed a key sec­ondary end­point, which an­a­lysts had been fol­low­ing as a key mark­er for suc­cess — re­duc­tion of car­dio­vas­cu­lar (CV) death. While Cy­to­ki­net­ics cel­e­brat­ed the re­sults, its stock tanked 43% up­on the news, and an­a­lysts warned of an un­cer­tain path ahead. Now, Am­gen wants out.

“Car­dio­vas­cu­lar dis­ease is one of the most sig­nif­i­cant pub­lic health is­sues in the world which means pa­tients need more in­no­va­tion, not less,” Am­gen said in a state­ment on Mon­day. “…Un­for­tu­nate­ly, the re­sults of GALAC­TIC-HF did not meet the high bar we had set for the pro­gram.”

Robert Blum

In an in­ter­view with End­points News ear­li­er this month, Cy­to­ki­net­ics CEO Robert Blum said whether they’ll ap­proach reg­u­la­tors was still up for dis­cus­sion. But de­spite the loss of their long­time part­ner, Blum said in an in­vestor call on Mon­day that he doesn’t “fore­see a sce­nario in which we do not en­gage reg­u­la­to­ry au­thor­i­ties, and seek feed­back around a po­ten­tial reg­is­tra­tion path for­ward.”

In ad­di­tion to ome­cam­tiv, Am­gen is re­turn­ing the rights to AMG 594, a Phase I can­di­date in de­vel­op­ment for HFrEF and oth­er types of heart fail­ure. On the in­vestor call, Blum spun the set­back as an op­por­tu­ni­ty to “re­claim” the can­di­dates and go the path alone.

SVB Leerink an­a­lysts saw this com­ing. “We agree with Am­gen that ome­cam­tiv is un­like­ly to be a com­pet­i­tive drug in heart fail­ure with re­duced ejec­tion frac­tion (HFrEF), as the large Phase 3 study failed to achieve the high bar that in­vestors/com­pa­ny had ex­pect­ed (ex­pect­ing >20% CV risk re­duc­tion and mor­tal­i­ty ben­e­fit),” Ge­of­frey Porges, Ke Yuan and Charles Song wrote in a note to in­vestors on Mon­day.

“We don’t ex­pect Am­gen’s stock to move sig­nif­i­cant­ly on this news as most in­vestors had al­ready dis­count­ed the po­ten­tial of this pro­gram af­ter the topline re­sult was an­nounced in ear­ly Oc­to­ber,” they added.

John Teer­link

Cy­to­ki­net­ics’ stock was up 0.53% on Mon­day, hov­er­ing around $16 a share.

Ome­cam­tiv mecar­bil works by tar­get­ing myosin, a pro­tein that con­verts chem­i­cal en­er­gy in­to me­chan­i­cal force in the heart. Since 2005, it’s been through 11 Phase I stud­ies with over 300 pa­tients and 7 Phase II stud­ies with over 1,400 pa­tients.

In the 8,250-per­son GALAC­TIC-HF study, it re­duced the odds of hos­pi­tal­iza­tion or oth­er ur­gent care for heart fail­ure by 8%. The risk of first heart fail­ure event was re­duced by 7% in the treat­ment arm, but it “did not in­di­vid­u­al­ly reach sta­tis­ti­cal sig­nif­i­cance with a nom­i­nal p val­ue of 0.06,” Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co pro­fes­sor and GALAC­TIC-HF ex­ec­u­tive com­mit­tee chair John Teer­link said in a call with in­vestors a cou­ple of weeks ago. Over­all change in con­di­tion — mea­sured us­ing the Kansas City Car­diomy­opa­thy Ques­tion­naire — al­so failed to achieve sta­tis­ti­cal sig­nif­i­cance, Teer­link said.

At AHA, Blum tout­ed the re­sults from cer­tain sub­groups of pa­tients, in­clud­ing those with low­er ejec­tion frac­tion, which he said the drug had a “dou­bling ef­fect on.” Ex­ec­u­tive VP of R&D Fady Ma­lik said this month that there were some groups of more se­vere” pa­tients in which the drug had a greater ef­fect.

Fady Ma­lik

But oth­ers aren’t see­ing much of a sil­ver lin­ing. “While the CV ben­e­fits seem to be re­al and bet­ter, it re­mains un­clear if the ex­ist­ing dataset is suf­fi­cient to sup­port a reg­u­la­to­ry fil­ing based on this pre-spec­i­fied sub­group analy­sis,” the SVB Leerink an­a­lysts wrote af­ter the AHA pre­sen­ta­tion. Mizuho’s Sal­im Syed wrote that Cy­to­ki­net­ics will need to “ex­e­cute a bit more on ome­cam­tiv and show in­vestors there is a path.”

Am­gen paid Cy­to­ki­net­ics $42 mil­lion in up­front and tech­nol­o­gy ac­cess fees to de­vel­op and com­mer­cial­ize the drug back in 2007. It al­so pur­chased 3.4 mil­lion shares of the biotech’s com­mon stock at $9.47 apiece, to­tal­ing about $33 mil­lion.

Am­gen grant­ed a sub­li­cense to Les Lab­o­ra­toires Servi­er and In­sti­tut de Recherch­es In­ter­na­tionales Servi­er to com­mer­cial­ize ome­cam­tiv in Eu­rope and the Com­mon­wealth of In­de­pen­dent States, in­clud­ing Rus­sia, back in 2016. The sub­li­censed rights are still in ef­fect, now un­der Cy­to­ki­net­ics.

The re­cent news adds to a tu­mul­tuous cou­ple of years for Cy­to­ki­net­ics, which has strug­gled to meet key end­points in its ALS tri­als. Its lead mus­cle drug crashed and burned in a Phase III ALS tri­al, and its relde­sem­tiv flopped in a Phase II study last year.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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