Kiniksa inks li­cens­ing deal to take a Re­gen­eron castoff in­to Asian mar­kets

Af­ter dig­ging through Re­gen­eron’s trash bin, Kiniksa has man­aged to put to­geth­er a tiny run with the ag­ing drug Ar­c­a­lyst in re­cent years. Now, the com­pa­ny will look to break through in Asian mar­kets.

Huadong Med­i­cine will pay $22 mil­lion up­front and a po­ten­tial $640 mil­lion in down­stream mile­stones to ex­clu­sive­ly li­cense Kiniksa’s Ar­c­a­lyst, an IL-1α and IL-1β block­er, and Covid-19 an­ti­body can­di­date mavril­i­mum­ab in Asian mar­kets not in­clud­ing Japan, the part­ners said Wednes­day.

Ar­c­a­lyst, an ag­ing drug Kiniksa picked up from Re­gen­eron’s junk heap back in 2017, has con­tin­ued earn­ing div­i­dends for the com­pa­ny in the past few years, most re­cent­ly earn­ing an ap­proval in March 2021 to treat re­cur­rent peri­cardi­tis and re­duce the risk of re­cur­rence in pa­tients 12 years and old­er.

Ar­c­a­lyst was first ap­proved in 2008 for cry­opy­rin-as­so­ci­at­ed pe­ri­od­ic syn­dromes (CAPS), in­clud­ing fa­mil­ial cold au­toin­flam­ma­to­ry syn­drome and Muck­le-Wells syn­drome. It got an­oth­er OK in De­cem­ber 2020 for the main­te­nance of re­mis­sion of de­fi­cien­cy of IL-1 re­cep­tor an­tag­o­nist (DI­RA). Kiniksa con­trols full sales and dis­tri­b­u­tion of the drug for all three in­di­ca­tions in the US.

Now, the com­pa­ny is lean­ing on a lo­cal part­ner to help dis­trib­ute across the re­gion, which in­cludes mar­kets in Chi­na, Hong Kong, Tai­wan, South Ko­rea, Aus­tralia, and 18 oth­er coun­tries, Kiniksa said. That’s a com­mon strat­e­gy for West­ern drug­mak­ers look­ing to break in giv­en the unique mar­ket dy­nam­ics in Chi­na in par­tic­u­lar.

Mean­while, the pact al­so in­cludes the lit­tle-her­ald­ed mavril­i­mum­ab, one of many an­ti­body hope­fuls look­ing to make a dent in the late stage of the pan­dem­ic.

Back in De­cem­ber 2020, the com­pa­ny re­vealed mid­dling da­ta for that drug, once a can­di­date in rheuma­toid arthri­tis, in pre­vent­ing se­vere Covid-19 pa­tient deaths over place­bo. But Kiniksa has plowed ahead re­gard­less af­ter cast­ing a hope­ful light that the da­ta were mov­ing in the right di­rec­tion.

Ul­ti­mate­ly, how­ev­er, the wan­ing pan­dem­ic and a lack of pa­tient in­ter­est could smoth­er the drug’s chances even if an un­like­ly ap­proval comes down. That’s a tes­ta­ment to the suc­cess of the Covid-19 vac­cines and the emer­gency ap­provals of mul­ti­ple oral an­tivi­rals.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Cedric Ververken, Confo Therapeutics CEO

Dai­ichi Sankyo inks $183M dis­cov­ery deal with GPCR biotech for CNS tar­get

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.