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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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