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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.