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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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FDA push­es back As­cendis' PDU­FA for long-act­ing hor­mone ther­a­py; De­bio­pharm takes home a win in mid-stage test for ADC

Danish biotech Ascendis Biopharma has been working on a treatment for pediatric growth hormone deficiency, but the FDA says they’re going to have to wait a little bit longer before they can make their approval decision.

Regulators extended the review period by three months on Monday, Ascendis said, pushing back the PDUFA date to September 25. The extension was in response to additional information Ascendis submitted as part of its BLA.

Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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