UP­DAT­ED: Astel­las walks away from $450M+ Cy­to­ki­net­ics pact af­ter tak­ing a few ex­tra months to see progress

Months af­ter los­ing long­time part­ner Am­gen on its lead heart drug, Cy­to­ki­net­ics is wav­ing good­bye to an­oth­er al­ly — and with it, more than $450 mil­lion in po­ten­tial mile­stones.

Cy­to­ki­net­ics said in an SEC fil­ing last week that Astel­las is of­fi­cial­ly walk­ing away from a pact to re­search skele­tal sar­com­ere ac­ti­va­tors for dis­eases as­so­ci­at­ed with mus­cle weak­ness. The com­pa­nies had ex­tend­ed the re­search term of their part­ner­ship — which was ini­tial­ly set to ex­pire on Dec. 31 — through March of this year to fin­ish work they couldn’t get done dur­ing the pan­dem­ic, Cy­to­ki­net­ics CEO Robert Blum told End­points News. But on April 27, Astel­las gave writ­ten no­tice that it’s hit­ting the ex­it.

Ac­cord­ing to the fil­ing, Astel­las is giv­ing up “all li­cens­es and oth­er rights” grant­ed through the pact.

The re­search, de­vel­op­ment and com­mer­cial­iza­tion pact was ini­tial­ly struck back in 2013. But in April 2020, Astel­las re­turned the rights to relde­sem­tiv, Cy­to­ki­net­ics’ can­di­date to treat mus­cle wast­ing, and oth­er fast skele­tal reg­u­la­to­ry ac­ti­va­tor (FS­RA) com­pounds that were sub­ject to the orig­i­nal agree­ment. Astel­las agreed to pay one-third of the out-of-pock­et costs for Cy­to­ki­net­ics’ con­tin­ued Phase III tri­al for the drug in ALS, in re­turn for “low- to mid-sin­gle dig­it” roy­al­ties in the US, Cana­da, UK and EU for ei­ther 10 years af­ter the first sale, or un­til 2034, ac­cord­ing to an SEC fil­ing.

“The re­search pro­gram that was ex­tend­ed was done with joint agree­ment, just so we could wind down on a cou­ple of mat­ters that we agreed we want­ed to put to bed be­fore we stepped away,” Blum said“We joint­ly de­cid­ed that we were go­ing to fin­ish the re­search to­geth­er, and then go our sep­a­rate ways.”

End­points reached out to Astel­las, but did not re­ceive a re­sponse as of press time.

Cy­to­ki­net­ics is left with­out the op­por­tu­ni­ty to scoop up some ma­jor mile­stones laid out in the orig­i­nal deal. Ac­cord­ing to the deal, Astel­las could have nabbed ex­clu­sive rights to co-de­vel­op and sell the skele­tal sar­com­ere ac­ti­va­tors in all in­di­ca­tions, leav­ing Cy­to­ki­net­ics the right to co-pro­mote and do cer­tain sales work in the US, Cana­da and/or Eu­rope “un­der agreed sce­nar­ios.”

If Astel­las want­ed to take any of the can­di­dates for­ward on its own, it would have owed Cy­to­ki­net­ics $25 to $35 mil­lion per prod­uct, plus up to $250 mil­lion more for all prod­ucts and an­oth­er $200 mil­lion in com­mer­cial mile­stones. On top of all that, Cy­to­ki­net­ics would have been set to re­ceive roy­al­ties in the “mid-sin­gle-dig­it lev­el to low dou­ble-dig­its.”

The news comes about two years af­ter relde­sem­tiv flopped in a Phase II ALS tri­al. At the time, in­ves­ti­ga­tors said the study failed on change from base­line in slow vi­tal ca­pac­i­ty (SVC) af­ter 12 weeks of dos­ing (p=0.11). The analy­sis al­so showed poor p-val­ues for the ALS Func­tion­al Rat­ing Scale and slope of the Mus­cle Strength Mega-Score.

But de­spite fail­ing the pri­ma­ry end­point, the com­pa­ny ar­gued that the da­ta re­flect­ed “clin­i­cal­ly mean­ing­ful mag­ni­tudes of ef­fect” across all dose lev­els, and main­tained that the place­bo group de­clined at a slow­er rate than ex­pect­ed, which didn’t help.

“Re­sults from FOR­TI­TUDE-ALS are among the most im­pres­sive we have seen in a Phase II clin­i­cal tri­al in ALS,” lead in­ves­ti­ga­tor Je­re­my Shefn­er said back in 2019.

That wasn’t the first or last time Cy­to­ki­net­ics has tout­ed weak or failed da­ta. Back in No­vem­ber, the com­pa­ny cheered a Phase III read­out for its Am­gen-part­nered heart drug ome­cam­tiv mecar­bil. But while the can­di­date met the pri­ma­ry com­pos­ite end­point, it missed a sec­ondary end­point which an­a­lysts had been fol­low­ing as a key mark­er for suc­cess — re­duc­tion of car­dio­vas­cu­lar death.

Lat­er that month, Am­gen shrugged off its 14-year al­liance with Cy­to­ki­net­ics, leav­ing the com­pa­ny to sol­dier on alone.

“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. “… Un­for­tu­nate­ly, the re­sults of GALAC­TIC-HF did not meet the high bar we had set for the pro­gram.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Josep Bassaganya-Riera, Landos Biopharma CEO (Landos)

Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD

One of China’s biggest up-and-comers has a brand new partner, and it’s one whose backers are likely familiar with the other’s.

Perceptive’s LianBio has secured a collaboration with Landos Biopharma, the lead company in Chris Garabedian’s Xontogeny fund, to develop and market two programs in Greater China and other countries in the region, the biotechs announced Monday morning. In exchange, Landos is getting an upfront payment of $18 million, up to $200 million in milestones and royalties on sales in the licensed territories.