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.”

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.