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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.