Eli Lil­ly part­ner Ab­Cellera ac­quires bis­pe­cif­ic plat­form; Te­va faces more law­suits, this time over opi­oid mar­ket­ing

An Eli Lil­ly part­ner help­ing de­vel­op a lead­ing Covid-19 project has just scored a new ac­qui­si­tion.

Tim Ja­cobs

Ab­Cellera, a small but well-con­nect­ed biotech out of Van­cou­ver, an­nounced it has pur­chased a plat­form from Du­a­log­ics called Or­thomab, which en­gi­neers pro­teins to cre­ate IgG-like bis­pe­cif­ic an­ti­bod­ies from any two an­ti­body se­quences. The trans­ac­tion fur­thers the deal­ings be­tween the two com­pa­nies, as Du­a­log­ics CTO Tim Ja­cobs joined Ab­Cellera in ear­ly Au­gust.

Thurs­day’s agree­ment gives Ab­Cellera full rights to the Or­thoMab plat­form while Du­a­log­ics re­tains the abil­i­ty to de­vel­op ex­ist­ing pro­grams and com­plete ex­ist­ing part­ner­ships.

The biotech emerged from rel­a­tive ob­scu­ri­ty dur­ing the Covid-19 pan­dem­ic thanks to its “lab-on-a-chip” tech­nol­o­gy that iso­lates an­ti­body-pro­duc­ing cells from blood sam­ples and us­es ma­chine learn­ing to pro­cure the best ones. Af­ter ob­tain­ing a sam­ple from a Covid-19 sur­vivor in Feb­ru­ary, Ab­Cellera part­nered with Eli Lil­ly the next month and then pulled in a hefty $105 mil­lion Se­ries B fundraise.

They’re not de­vel­op­ing a vac­cine, but Ab­Cellera has made waves with their po­ten­tial treat­ment, pick­ing up steam in Busi­ness­week and MIT Tech­nol­o­gy Re­view. Vir and Re­gen­eron are al­so work­ing on sim­i­lar clin­i­cal stud­ies.

New York sues Te­va and Al­ler­gan over roles in opi­oid epi­dem­ic

On the heels of fed­er­al pros­e­cu­tors ac­cus­ing Te­va of de­fraud­ing the Medicare sys­tem, the Is­raeli drug­mak­er is fac­ing more le­gal pro­ceed­ings.

New York State has launched its own in­quiry in­to Te­va’s deal­ings re­gard­ing the opi­oid cri­sis, gov­er­nor An­drew Cuo­mo’s of­fice an­nounced Tues­day, al­leg­ing that the com­pa­ny “know­ing­ly fur­thered false nar­ra­tives” in or­der to boost sales of its drugs. Cuo­mo al­so in­clud­ed Al­ler­gan, which was left out of the fed­er­al com­plaint, in the state’s law­suit. A hear­ing will take place on Oc­to­ber 26.

Among the most se­ri­ous al­le­ga­tions is that Te­va mis­rep­re­sent­ed the risks of fen­tanyl and mar­ket­ed such drugs for off-la­bel use. The law­suit cites the FDA ap­proval of Ac­tiq in can­cer pa­tients as proof this strat­e­gy suc­ceed­ed, boost­ing sales of the drug from $16 mil­lion in 2000 to $590 mil­lion by 2006.

The com­plaint al­so dinged the com­pa­nies for uti­liz­ing key opin­ion lead­ers to im­prop­er­ly dis­sem­i­nate mis­in­for­ma­tion about opi­oids in med­ical in­for­ma­tion cours­es and pam­phlets, tar­get­ing pa­tients and pre­scribers.

Tues­day’s fed­er­al suit dealt with price fix­ing, as the gov­ern­ment said Te­va paid hun­dreds of mil­lions of dol­lars to two foun­da­tions to boost sales for the mul­ti­ple scle­ro­sis drug Co­pax­one.

Evotec ex­pands deal with Cen­to­gene to in­clude Gauch­er re­search

Ger­man drug dis­cov­ery com­pa­ny Evotec is ex­pand­ing an ex­ist­ing part­ner­ship with a com­pa­ny fo­cused on min­ing da­ta from pa­tients with rare dis­eases.

The scope of the col­lab­o­ra­tion with Cen­to­gene, based in Cam­bridge, MA, will broad­en in­to pro­duc­ing treat­ments for Gauch­er dis­ease, a ge­net­ic dis­or­der caused by mu­ta­tions in the glu­co­cere­brosi­dase gene. Re­searchers will look to tar­get GBA by com­bin­ing Evotec’s stem cell plat­form with Cen­to­gene’s rare dis­ease plat­form.

The two com­pa­nies orig­i­nal­ly en­tered in­to the part­ner­ship in 2018 with the goal to de­vel­op ther­a­pies for rare hered­i­tary meta­bol­ic dis­eases.

Gauch­er dis­ease is an in­her­it­ed dis­or­der and can af­fect the cen­tral ner­vous sys­tem. Signs and symp­toms can vary wide­ly among af­fect­ed in­di­vid­u­als, rang­ing from the en­large­ment of the liv­er and spleen, ane­mia and lung dis­ease in Type 1 to seizures and brain dam­age in Types 2 and 3.

The most com­mon of the lyso­so­mal dis­eases, Gauch­er is of­ten treat­ed with imiglucerase, a re­com­bi­nant form of the de­fi­cient en­zyme, al­though sev­er­al new treat­ments have been ap­proved in re­cent years.

Proces­sa li­cens­es gas­troin­testi­nal can­di­date from South Ko­re­an phar­ma

A South Ko­re­an phar­ma is li­cens­ing out a lead­ing gas­troin­testi­nal treat­ment to a US part­ner.

Yuhan Corp will sell ex­clu­sive glob­al de­vel­op­ment and com­mer­cial­iza­tion rights, with the ex­cep­tion of Ko­rea, to Proces­sa Phar­ma­ceu­ti­cals for YH12852. The deal nets Yuhan up to $415 mil­lion and $2 mil­lion in Proces­sa shares as a down pay­ment.

Cur­rent­ly, the can­di­date is be­ing eval­u­at­ed for the treat­ment of dys­pep­sia and con­sti­pa­tion, but a Phase II study in Ko­rea was sus­pend­ed last Sep­tem­ber with Yuhan need­ing to re­con­fig­ure its dosage.

YH12852 works by stim­u­lat­ing the 5-HT4 re­cep­tor, which plays an es­sen­tial role in the reg­u­la­tion of in­testi­nal move­ment. The com­pa­ny hopes it can com­pete with cis­apride-based drugs in gas­troin­testi­nal in­di­ca­tions, aim­ing to show few­er car­dio­vas­cu­lar side ef­fects than cur­rent­ly li­censed drugs.

Proces­sa is plan­ning its own Phase II study for oth­er gas­troin­testi­nal motil­i­ty dis­eases, such as post­op­er­a­tive in­testi­nal ob­struc­tion or opi­oid-in­duced con­sti­pa­tion, be­gin­ning in 2021 pend­ing guid­ance from the FDA.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.