Cy­to­ki­net­ics may walk a lone­ly road to mar­ket with tar­nished heart med ome­cam­tiv af­ter last part­ner bows out

Once flush with part­ners for heart fail­ure drug ome­cam­tiv mecar­bil, Cy­to­ki­net­ics watched its long­time al­ly Am­gen flee last month over weak da­ta from a Phase III tri­al. Now, Cy­to­ki­net­ics’ last run­ning mate is hit­ting the ex­it — leav­ing ome­cam­tiv on an un­cer­tain path to mar­ket.

Les Lab­o­ra­toires Servi­er and In­sti­tut de Recherch­es In­ter­na­tionales Servi­er is pulling out of a sub­li­cense agree­ment for ome­cam­tiv that it struck with Am­gen back in 2016. The news comes ex­act­ly one month af­ter Am­gen un­veiled its own plans to walk away in May 2021 from a 14-year al­liance for ome­cam­tiv and the tens of mil­lions it spent de­vel­op­ing the con­tro­ver­sial drug, which it said “did not meet the high bar we had set for the pro­gram.”

Ome­cam­tiv’s trou­bles trace back to the Phase III GALAC­TIC-HF study, in which it met the pri­ma­ry com­pos­ite end­point but al­so dis­ap­point­ed an­a­lysts on a key sec­ondary end­point. Af­ter the drug failed to sig­nif­i­cant­ly re­duce the risk of car­dio­vas­cu­lar (CV) death, Evan Seiger­man at Cred­it Su­isse pre­dict­ed its clin­i­cal ben­e­fit wouldn’t be enough to com­pete in the evolv­ing heart fail­ure mar­ket. Cy­to­ki­net­ics’ stock tanked 43% on the news, and oth­er an­a­lysts warned of a shaky path ahead.

Cy­to­ki­net­ics’ stock $CYTK was up 0.2% on Wednes­day morn­ing at $20.40 per share.

CEO Robert Blum in­sists on look­ing at the set­backs in a pos­i­tive light, an­nounc­ing that he’s “pleased to pro­ceed in­to 2021 with clar­i­ty,” and plans on ap­proach­ing reg­u­la­tors next year to “as­sess po­ten­tial reg­u­la­to­ry paths while al­so con­tin­u­ing our com­mer­cial plan­ning ac­tiv­i­ties.” He told End­points News that the com­pa­ny in­tends to file for ap­proval in the next year or so, and they hope the GALAC­TIC-HF study alone will be enough for an OK.

“Am­gen and Servi­er made their de­ci­sions based on their cor­po­rate pri­or­i­ties, their port­fo­lio in­ter­ests and oth­er ac­tiv­i­ties that read on their in­ter­est and re­turn on in­vest­ment,” he said. “But that should not be mis­in­ter­pret­ed to mean that there’s not a sig­nif­i­cant op­por­tu­ni­ty for ome­cam­tiv mecar­bil.”

Robert Blum

In terms of find­ing new part­ners, Blum said the com­pa­ny is look­ing at whether they should go it alone or line up a co-pro­mo­tion for ome­cam­tiv in the US. Out­side the US, it’s “more like­ly” that they’ll seek a part­ner, Blum said.

Ome­cam­tiv mecar­bil works by tar­get­ing myosin, a pro­tein that con­verts chem­i­cal en­er­gy in­to me­chan­i­cal force in the heart. 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. Over­all change in con­di­tion — mea­sured us­ing the Kansas City Car­diomy­opa­thy Ques­tion­naire — al­so failed to achieve sta­tis­ti­cal sig­nif­i­cance, ac­cord­ing to Teer­link.

Blum has shift­ed the fo­cus away from those key sec­on­daries to the re­sults from cer­tain sub­groups of pa­tients, in­clud­ing those with low­er left ven­tri­cle blood ejec­tion frac­tion, which he said the drug had a “dou­bling ef­fect on.”

Even so, some in­vestors are strug­gling to see a path for­ward.

“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 last month.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

UP­DAT­ED: Eli Lil­ly toss­es a mar­quee pain drug and hits the gas on Alzheimer’s — as Bio­gen’s suf­fer­ing opens mar­ket to ri­vals

The furious chorus of critics that brought sales of Biogen’s ultra controversial Alzheimer’s drug aducanumab (sold as Aduhelm) to a near halt is opening up some big opportunities for a major league rival that has long sought the lead role in this largely untapped megamarket.

In its Q3 update today, Eli Lilly — noted for its dogged persistence in attempting for years to get solanezumab across the FDA finish line — said that it has begun a rolling submission of its rival Alzheimer’s drug donanemab in search of an accelerated approval. Anne White, senior VP of Lilly’s neuroscience unit, acknowledged during the investor call the challenges Biogen has faced with uptake and noted Lilly may face similar hurdles.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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