Cy­to­ki­net­ics nabs Chi­nese part­ner, up to $450M as CV be­comes com­pa­ny fo­cus

Cy­to­ki­net­ics’ ALS pro­grams may have seen bet­ter days, but its car­dio­vas­cu­lar di­vi­sion has at­tract­ed well-backed part­ners, in­clud­ing Am­gen and Roy­al­ty Phar­ma, who, in 2017 paid $90 mil­lion in ex­change for a 4.5% roy­al­ty on their lead heart drug.

Now a Chi­nese drug­mak­er and a ma­jor in­vestor are sign­ing on­to their sec­ond car­dio­vas­cu­lar can­di­date, an ex­per­i­men­tal drug known as CK-274 and de­signed to treat hy­per­trophic car­diomy­opathies — ge­net­ic con­di­tions that cause heart mus­cles to be­come ab­nor­mal­ly and po­ten­tial­ly dan­ger­ous­ly thick. Ji Xing Phar­ma­ceu­ti­cals will pay Cy­to­ki­net­ics $25 mil­lion up­front for the rights to com­mer­cial­ize the drug in Chi­na and cer­tain neigh­bor­ing re­gions, along with $200 mil­lion in po­ten­tial mile­stones.

Along­side the sale of Chi­nese rights, Cy­to­ki­net­ics has en­tered a mul­ti-faceted arrange­ment with RTW In­vest­ments to raise up to $225 mil­lion to sup­port the drug’s de­vel­op­ment.

Robert Blum

“These deals af­ford us the op­por­tu­ni­ty to di­al up de­vel­op­ment of CK-274 in mul­ti­ple in­di­ca­tions and across a wider span of ge­o­gra­phies,” CEO Robert Blum said in a state­ment.

First, RTW will make $45 mil­lion avail­able to Cy­to­ki­net­ics if they reach cer­tain mile­stones for ob­struc­tive hy­per­trophic car­diomy­opathies (oHCM) in ex­change for 2% of fu­ture roy­al­ties. An­oth­er $45 mil­lion is avail­able for mile­stones in non-ob­struc­tive hy­per­trophic car­diomy­opathies (nHCM) in ex­change for an­oth­er 2% of roy­al­ties.

Sec­ond, RTW will pay $85 mil­lion up­front, due by Oc­to­ber, in ex­change for an undis­closed per­cent­age of roy­al­ties.

Third, RTW will pay around $50 mil­lion for 2 mil­lion shares of Cy­to­ki­net­ics, at $25 per share.

The new tranche of cash con­tin­ues Cy­to­ki­net­ics piv­ot to fo­cus on car­dio­vas­cu­lar dis­ease, and re­flects a con­tin­ued strat­e­gy to raise mon­ey by sell­ing rights and roy­al­ties, as op­posed to pub­lic of­fer­ings.

Al­though the South San Fran­cis­co biotech has had a heart dis­ease pro­gram since its ear­ly days, its ALS pro­gram cap­tured much of the at­ten­tion for years. In 2013, Astel­las signed on to it for up to $490 mil­lion. But in 2017, they scrapped their lead ALS drug af­ter it failed to beat place­bo in a 700-per­son tri­al, and last year, an­oth­er ALS drug failed an­oth­er mid-stage tri­al.

The lead car­dio­vas­cu­lar drug is ome­cam­tiv mecar­bil, which Cy­to­ki­net­ics has co-de­vel­oped with Am­gen since 2006 and which is now in a Phase III tri­al. CK-274 is now in a Phase II tri­al that’s due to read­out next year.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Robert Davis, Merck CEO

Mer­ck shares slide as re­sponse to its oral Covid an­tivi­ral plunges on lat­est up­date

After a second look, Merck says that its big breakthrough on the Covid front doesn’t look so good.

The pharma giant updated its data on its oral antiviral molnupiravir on Friday, and said that its drug reduced the rate of hospitalization and death by 30% — a sharp plunge from the 50% rate reported at the beginning of October during their interim readout.

And the news sparked a sharp retreat on Merck’s shares, which fell 4% ahead of the bell on Friday.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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BD an­nounces an­oth­er ex­pan­sion, this time in San Diego

Amidst a push to ease pressure on the supply chain domestically, BD Biosciences will expand at the San Diego Reagent Innovation Center, as the property developer announced the company’s plans Monday.

The San Diego site will be at Torrey View, a 10-acre life sciences R&D campus that Breakthrough Properties is creating alongside Mitsui Fudosan America. It’s within the life sciences cluster of Del Mar Heights, which offers nearby housing for employees in biopharma.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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