GSK sub­mits its first ap­pli­ca­tion for dapro­du­s­tat in Japan; Two drug­mak­ers part with $15M to avoid opi­oid tri­al

→ Just as Hal Bar­ron planned, GSK $GSK has sub­mit­ted its first reg­u­la­to­ry ap­pli­ca­tion for its oral hy­pox­ia-in­ducible fac­tor pro­lyl hy­drox­y­lase in­hibitor (HIF-PHI), dapro­du­s­tat, in Japan for pa­tients with re­nal ane­mia due to chron­ic kid­ney dis­ease (CKD). The ap­pli­ca­tion is based on pos­i­tive Phase III da­ta con­duct­ed in Japan on ane­mic pa­tients across the spec­trum of CKD from stages 3-5 — which in­clud­ed pa­tients on and not on dial­y­sis, re­gard­less of pri­or ane­mia treat­ment with ery­thro­poiesis-stim­u­lat­ing agents (ESAs). If ap­proved, dapro­du­s­tat will be ex­clu­sive­ly dis­trib­uted in Japan by Ky­owa Kirin Co.

→ Two drug­mak­ers — En­do $ENDP and Al­ler­gan $AGN — have agreed to part with $15 mil­lion al­to­geth­er to avoid go­ing to tri­al in Oc­to­ber in a land­mark case by two Ohio coun­ties, who have ac­cused a raft of drug man­u­fac­tur­ers and dis­trib­u­tors of stok­ing the opi­oid cri­sis, Reuters re­port­ed on Tues­day. Oth­er drug firms em­broiled in the mul­ti­dis­trict lit­i­ga­tion in­clude Pur­due, Te­va and J&J as well as drug dis­trib­u­tors such as McKesson $MCK, Car­di­nal Health $CAH and Amerisource­Ber­gen $ABC.

“(T)he En­do set­tle­ment in two OH coun­ties would ex­trap­o­late to a po­ten­tial na­tion­al set­tle­ment of $1.8B for En­do, <50% of our pub­lished es­ti­mate,” SVB Leerink an­a­lysts wrote in a note. “The En­do set­tle­ment pro­vides a pos­i­tive readthrough for My­lan and Am­neal in­di­cat­ing that the set­tle­ment num­bers for them could end up be­ing <50% of our pub­lished es­ti­mates of $0.8B and $1.2B, re­spec­tive­ly. For Te­va and Mallinck­rodt, the readthrough is less clear and varies de­pend­ing on whether we use sales mix or vol­ume mix as our ba­sis…a key piece of the puz­zle in ad­di­tion to the city/coun­ty law­suits is the state AG law­suits which re­main a wild card, and we un­der­stand that tri­als for these cas­es will not be held un­til 2020.”

Cere­cor‘s $CERC oral for­mu­la­tion of D-man­nose — a nat­u­ral­ly oc­cur­ring mono­sac­cha­ride — called CERC-802 has been grant­ed fast track sta­tus by the FDA to treat Man­nose-Phos­phate Iso­merase De­fi­cien­cy (MPI-CDG). CDG’s are rare, in­her­it­ed, meta­bol­ic dis­or­ders with high in­fant mor­bid­i­ty and mor­tal­i­ty and no FDA-ap­proved treat­ments. The over­all es­ti­mat­ed oc­cur­rence of MPI-CDG glob­al­ly is less than 50 cas­es, al­though re­searchers sus­pect it is un­der-di­ag­nosed.

Tetra Bio-Phar­ma — a com­pa­ny fo­cused on de­vel­op­ing cannabi­noid-based ther­a­peu­tics — is join­ing forces with Thorne Re­search and Onegevi­ty to form a joint ven­ture, CB2 Ther­a­peu­tics. CB2 will fo­cus on de­vel­op­ing com­pounds for chron­ic in­flam­ma­to­ry con­di­tions with high un­met needs that aren’t ad­e­quate­ly served with cur­rent ther­a­pies. The joint ven­ture is tar­get­ing an ini­tial raise of $10,000,000 to start its Phase II clin­i­cal tri­als for ir­ri­ta­ble bow­el syn­drome (IBS) and the com­mer­cial­iza­tion of its di­etary sup­ple­ments for in­ter­sti­tial cys­ti­tis.

Ca­dent Ther­a­peu­tics — cur­rent­ly in col­lab­o­ra­tion with No­var­tis $NVS to de­vel­op a neg­a­tive al­losteric mod­u­la­tor, now in Phase II for the treat­ment of treat­ment-re­sis­tant de­pres­sion — wel­comed John McBride on board as CFO. McBride jumps over from the same role at Syn­tim­mune, where he helped with the com­pa­ny’s ac­qui­si­tion to Alex­ion $ALXN. Pri­or to his time at Syn­tim­mune, McBride served as the COO and CFO at Tokai Phar­ma­ceu­ti­cals and had stints at Glouces­ter Phar­ma­ceu­ti­cals, Phar­ma­cia, Cy­toTher­a­peu­tics and Phytera. In ad­di­tion, the com­pa­ny an­nounced the ap­point­ment of sev­er­al oth­er hires, in­clud­ing Min­nie Mild­woff, Vice Pres­i­dent, Reg­u­la­to­ry Af­fairs and Qual­i­ty As­sur­ance; Robert Gaffey, Vice Pres­i­dent, Fi­nance and Ad­min­is­tra­tion; Nicole Lu­osey, Vice Pres­i­dent, Strate­gic and Pro­gram Op­er­a­tions and Noah Good­man, Ex­ec­u­tive Di­rec­tor, Busi­ness De­vel­op­ment.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.