Mer­ck KGaA sells off its biosim­i­lars port­fo­lio in €670M deal; uniQure boost­ed by PRIME; Strug­gling Oph­thotech gets new CEO

→ With its new ap­proval for the check­point drug avelum­ab in the bank, so to speak, Mer­ck KGaA has com­plet­ed a deal to sell off its port­fo­lio of biosim­i­lars. The Ger­man Mer­ck says Fre­se­nius is bag­ging the lot for €170 mil­lion up­front and €500 mil­lion more in mile­stones. Biosim­i­lars are start­ing to stack up as the first wave of knock­offs ar­rive in the US. And that might ex­plain a rel­a­tive­ly mod­est up­front for these drugs. “We have in­creas­ing con­fi­dence in our Bio­phar­ma pipeline and this trans­ac­tion will help pri­or­i­tize in­no­v­a­tive drug de­vel­op­ment of high qual­i­ty and first-to-mar­ket best-in-dis­ease as­sets,” com­ment­ed Belén Gar­i­jo, mem­ber of the Ex­ec­u­tive Board of Mer­ck KGaA and CEO of their Health­care unit: “The part­ner­ship with Fre­se­nius will al­low us to ex­ploit our Biosim­i­lars port­fo­lio to full po­ten­tial while grant­i­ng us a sub­stan­tial re­turn on pri­or in­vest­ments.”

→ The Dutch biotech uniQure $QURE got a big boost from the news that its he­mo­phil­ia B gene ther­a­py AMT-060 has re­ceived a PRIME des­ig­na­tion from the EMA. Its shares jumped 9% on the news, which close­ly fol­lowed a de­ci­sion to scrap its $1.2 mil­lion treat­ment Gly­bera, which was large­ly un­used. Stat­ed Matthew Ka­pus­ta, chief ex­ec­u­tive of­fi­cer of uniQure: “Sim­i­lar to the Break­through Ther­a­py des­ig­na­tion that AMT-060 re­ceived from the U.S. Food and Drug Ad­min­is­tra­tion ear­li­er this year, we look for­ward to this en­hanced col­lab­o­ra­tion with the EMA to ad­vance the clin­i­cal de­vel­op­ment of  this po­ten­tial­ly trans­for­ma­tive ther­a­py for he­mo­phil­ia B pa­tients.”

→ Playa Vista, CA-based Sci­ence 37 has raised $29 mil­lion for its Se­ries C, de­signed to fur­ther its work on us­ing a telemed­i­cine ap­proach to cre­at­ing site-less clin­i­cal tri­als. The biotech has now raised $67 mil­lion. Glynn Cap­i­tal Man­age­ment led the round with a con­tri­bu­tion from GV, for­mer­ly Google Ven­tures. The round in­clud­ed a new in­vest­ment from Am­gen Ven­tures, as well as par­tic­i­pa­tion from all ex­ist­ing in­vestors: Lux Cap­i­tal, Red­mile Group, dRx Cap­i­tal (a Qual­comm and No­var­tis joint in­vest­ment com­pa­ny), and Sanofi Ven­tures.

Arch Ven­ture Part­ners and Ven­vest have led a $40 mil­lion round for West­lake Vil­lage, CA-based Si­en­na Bio­phar­ma­ceu­ti­cals. The biotech is in­vest­ing in a pipeline of top­i­cal ther­a­pies for con­di­tions like pso­ri­a­sis, atopic der­mati­tis and ac­ne. “We are very pleased with the sup­port of in­vestors who share our com­mit­ment to de­vel­op­ing in­no­v­a­tive and dis­rup­tive new prod­ucts in med­ical der­ma­tol­ogy and aes­thet­ics,” said Fred­er­ick C. Bed­ding­field III, Si­en­na’s Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer. “We have built out an ac­com­plished team and a di­ver­si­fied mul­ti-as­set pipeline. We be­lieve this fi­nanc­ing will en­able us to ad­vance our de­vel­op­ment pro­grams, which span piv­otal clin­i­cal tri­als to pre­clin­i­cal pro­grams.”

→ The share price of Oph­thotech $OPHT fell off a cliff last fall af­ter two Phase III stud­ies of a wet-AMD drug — part­nered with No­var­tis in a $1 bil­lion deal — failed bad­ly. And now, with its busi­ness de­vel­op­ment team on the hunt for new deals to re­or­ga­nize the pipeline, the biotech is mov­ing CEO David Guy­er to the ex­ec­u­tive chair­man’s role while pro­mot­ing CFO Glenn P. Sblendo­rio to the CEO spot. “As the Com­pa­ny con­tin­ues to re­view strate­gic al­ter­na­tives and ac­tive­ly ex­plores po­ten­tial­ly ob­tain­ing rights to ad­di­tion­al prod­ucts, prod­uct can­di­dates and tech­nolo­gies to treat oph­thalmic dis­eases, par­tic­u­lar­ly those of the back of the eye, David Guy­er’s ex­ten­sive ex­per­tise and ex­pe­ri­ence brings a wealth of oph­thal­mol­o­gy knowl­edge that is crit­i­cal as we ex­e­cute a strat­e­gy to max­i­mize share­hold­er val­ue,” stat­ed Mr. Sblendo­rio.

→ Trans­gene has struck a deal with Bris­tol-My­ers Squibb to put a com­bi­na­tion of its can­cer vac­cine TG4010 in­to a Phase II tri­al for front­line non-squa­mous non-small cell lung can­cer com­bined with Op­di­vo.

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.