Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lil­ly is fronting some new cash in a space they’re quite fa­mil­iar with.

The com­pa­ny is part­ner­ing with Japan’s Asahi Ka­sei Phar­ma on an ex­per­i­men­tal drug for chron­ic pain, ac­quir­ing the rights for the P2X7 re­cep­tor an­tag­o­nist pro­gram dubbed AK1780. Lil­ly will shell out a pret­ty pen­ny for the pro­gram, promis­ing up to $410 mil­lion to­tal should each mile­stone pay­ment come to pass.

Asahi Ka­sei will re­ceive an up­front sum of $20 mil­lion for the can­di­date. In ad­di­tion, Lil­ly is on the hook for up to $210 mil­lion in de­vel­op­ment and reg­u­la­to­ry mile­stones and an­oth­er po­ten­tial $180 mil­lion in sales mile­stones. Asahi Ka­sei can al­so ob­tain roy­al­ties rang­ing from the mid-sin­gle to low-dou­ble dig­its should an ap­proved prod­uct come out of the deal.

AK1780 re­cent­ly com­plet­ed Phase I sin­gle and mul­ti­ple as­cend­ing dos­es and clin­i­cal phar­ma­col­o­gy stud­ies, Asahi Ka­sei said Thurs­day. Lil­ly’s im­me­di­ate plans for the pro­gram are un­clear, and we’ve sent out a re­quest for com­ment.

The P2X7 re­cep­tor that’s the tar­get of this deal comes from a fam­i­ly of purinocep­tors that are ac­ti­vat­ed by ATP. P2X7 specif­i­cal­ly is ac­ti­vat­ed on­ly by high con­cen­tra­tions of ATP and is thought to play a role in cell death and in­flam­ma­tion, as well as in­flam­ma­to­ry bow­el dis­ease, neu­rode­gen­er­a­tive dis­eases, mood dis­or­ders and can­cers.

Some oth­er re­cep­tors in the group, such as P2X3, are ac­ti­vat­ed at low­er con­cen­tra­tions and can pop up in dis­eases caused by ab­nor­mal neur­al trans­mis­sions. P2X-re­lat­ed pro­grams saw sig­nif­i­cant in­vest­ment in the ear­ly 2000s, ac­cord­ing to Na­ture, but poor ef­fi­ca­cy re­sults in clin­i­cal tri­als, par­tic­u­lar­ly in rheuma­toid arthri­tis. One ma­jor play­er backed off around this time, with Roche axed a P2X3 can­di­date.

Pain pro­grams are noth­ing new for Lil­ly, which cur­rent­ly has tanezum­ab be­fore the FDA for os­teoarthrit­ic pain. Lil­ly col­lab­o­rat­ed with Pfiz­er on the can­di­date and its ex­pect­ed PDU­FA date had been last De­cem­ber, but no de­ci­sion has been reached just yet.

The tanezum­ab rul­ing could have im­pli­ca­tions on the an­ti-NGF class of pain drugs. Near­ly a decade ago, the field was crushed by safe­ty is­sues and be­gan a long, slow re­turn to late-stage test­ing. Lil­ly and Pfiz­er are hop­ing to turn the for­tunes around, but poor Phase III safe­ty da­ta re­vealed in ear­ly 2019 had an­a­lysts run­ning for the hills.

De­spite the grim out­look, the pair de­cid­ed to push for­ward any­way to see if they can squeeze past the FDA with the low-dose ver­sion of tanezum­ab. A ri­val ther­a­py from Re­gen­eron and Te­va was al­so giv­en long odds af­ter post­ing Phase III da­ta last Au­gust, and Re­gen­eron chief Len Schleifer told End­points News at the time that the com­pa­ny will be pay­ing close at­ten­tion to the FDA’s rul­ing on tanezum­ab.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.