Malcolm Weir, Sosei vice chairman

Glax­o­SmithK­line joins So­sei's who's-who list of clients with glob­al li­cens­ing pact for IBD small mol­e­cules

Big drug­mak­ers are on the hunt for nov­el ther­a­peu­tics in a range of ul­tra-com­pet­i­tive ther­a­peu­tic ar­eas. Japan’s So­sei Hep­tares has emerged in re­cent years as a sought-af­ter part­ner for Big Phar­mas seek­ing nov­el neu­ro can­di­dates — but now Glax­o­SmithK­line wants to try the pre­clin­i­cal R&D ex­pert’s work in in­flam­ma­to­ry bow­el dis­ease.

GSK has tapped So­sei Hep­tares for dis­cov­ery work tar­get­ing IBD and oth­er gas­troin­testi­nal im­mune dis­or­ders with small-mol­e­cule ag­o­nists for GPR35, an or­phan G pro­tein-cou­pled re­cep­tor (GPCR) with a ge­net­ic link to those con­di­tions, the com­pa­nies said Sun­day.

As part of the deal, So­sei will lead pre­clin­i­cal R&D on ag­o­nists iden­ti­fied by its struc­ture-based drug de­sign plat­form and pro­pri­etary StaR tech­nol­o­gy, and will hand clin­i­cal work, man­u­fac­tur­ing and com­mer­cial­iza­tion to GSK. The British drug gi­ant will hold glob­al com­mer­cial li­cens­ing rights to any win­ning can­di­dates and will hand an ini­tial $44 mil­lion for near-term de­vel­op­ment mile­stones and re­search fund­ing. So­sei will al­so be due up to $437 mil­lion pend­ing a se­ries of de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones.

“Us­ing ge­net­ics to pri­ori­tise po­ten­tial treat­ments for a chal­leng­ing im­mune dis­or­der like IBD ex­em­pli­fies the ap­proach we are tak­ing at GSK to de­vel­op nov­el trans­for­ma­tive med­i­cines,” John Lep­ore, GSK’s se­nior VP of re­search, said in a re­lease. “So­sei Hep­tares is a world leader with an es­tab­lished track record in GPCR drug dis­cov­ery, so we are con­fi­dent in our po­ten­tial to joint­ly iden­ti­fy high qual­i­ty clin­i­cal can­di­dates to de­liv­er im­por­tant new med­i­cines for the mil­lions of pa­tients who are wait­ing.”

It’s a big-name pick­up for So­sei, which has made its name in li­cens­ing out ear­ly-stage GPR tar­get­ing can­di­dates to ma­jor drug­mak­ers, most no­tably Ab­b­Vie and Roche’s Genen­tech. Mal­colm Weir, So­sei’s vice chair­man, tout­ed GSK’s ex­ist­ing ex­per­tise in IBD and ex­ten­sive clin­i­cal ex­pe­ri­ence as a ma­jor draw for So­sei’s li­cens­ing strat­e­gy.

“In our minds, (this deal) was very dri­ven by a group that we can work with and col­lab­o­rate ef­fec­tive­ly,” Weir said. “But, it’s a project that still needs to work it­self out in the clin­ic.”

Weir pre­dict­ed a clutch of So­sei can­di­dates would see the clin­ic in the “near-term” fu­ture but de­clined to guess on ex­act­ly when that would be. The Japan­ese com­pa­ny has made its name iden­ti­fy­ing GPCR can­di­dates, most­ly spe­cial­iz­ing in neu­ro­science, Weir said. While IBD is a most­ly new en­deav­or, So­sei thinks there’s po­ten­tial in that ther­a­peu­tic area.

“What we did was looked at a fair num­ber of nov­el tar­gets and there was ev­i­dence of ge­net­ic as­so­ci­a­tions with dis­eases like ul­cer­a­tive col­i­tis and oth­er dis­or­ders,” Weir said. “We were very struck by that and struck by the promise of that.”

Back in June, Ab­b­Vie tapped So­sei in a very sim­i­lar deal, agree­ing to pay $32 mil­lion up­front for a range of in­flam­ma­to­ry and au­toim­mune dis­eases with po­ten­tial op­tion, de­vel­op­ment and com­mer­cial pay­ments of up to $377 mil­lion. That deal could ex­pand, how­ev­er, if Ab­b­Vie choos­es to ex­e­cute on all four tar­gets in the pact; in that case, the agree­ment could grow in­to the bil­lion-dol­lar range, a So­sei spokesper­son said at the time.

That was ac­tu­al­ly So­sei’s sec­ond deal with Ab­b­Vie af­ter the com­pa­ny signed a deal with Al­ler­gan — which Ab­b­Vie ac­quired in mid-2019 — back in 2016 for a slate of sub­type-se­lec­tive mus­carinic re­cep­tor ag­o­nists. In that deal, So­sei got $125 mil­lion up­front with a $50 mil­lion com­mit­ment to­ward Phase II stud­ies in ad­di­tion to over $3 bil­lion in promised mile­stones.

In Ju­ly 2019, Genen­tech al­so jumped on board with So­sei, agree­ing to front $26 mil­lion in up­front and near-term pay­ments, in ad­di­tion to fu­ture mile­stone pay­ments that may ex­ceed $1 bil­lion, as well as po­ten­tial roy­al­ties. The tar­get­ed ther­a­peu­tic ar­eas weren’t dis­closed in that deal. So­sei has al­so signed pre­vi­ous pacts with British drug­mak­ers As­traZeneca and No­var­tis, among a suite of oth­er Big Phar­mas.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.