Top sto­ries of the week: Thumbs up/Thumbs down

End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

Cel­gene taps its new biotech co-star


This was the per­fect week to an­swer a ques­tion I’ve been think­ing about re­gard­ing Cel­gene. The Big Biotech, which has spe­cial­ized in lin­ing up rich deals for star col­lab­o­ra­tors, has set­tled on Jounce as its lat­est pick for up-and-com­ing biotech with the most po­ten­tial. Cel­gene has been stitch­ing to­geth­er a whole pipeline of im­muno-on­col­o­gy drugs through its BD team, head­ed by George Golumbes­ki. Our chart on all its pacts, and the $3.2 bil­lion it spent on deals over the past two years, proved to be the most pop­u­lar part of the week. Those deals al­so il­lus­trate how in­dus­try part­ner­ships dri­ve new pro­grams. Im­por­tant point: It’s not over at Cel­gene.

What were they think­ing at Zaf­gen?


There aren’t many biotechs which han­dle set­backs well. Zaf­gen, though, has be­come a case study in clue­less­ness. Af­ter in­sist­ing for months that they had com­pelling piv­otal da­ta and an ef­fec­tive plan to get its obe­si­ty drug back on track af­ter the death of two pa­tients, Zaf­gen had to ac­knowl­edge this week that the drug is dead. But on­ly af­ter tout­ing pre­clin­i­cal da­ta for their new, un­known lead drug. By the end of this week, the com­pa­ny’s shares are trad­ing at half cash, not what you would call a ring­ing en­dorse­ment for the new plan or the way they han­dled them­selves in the cri­sis. There’s no ques­tion about the com­pa­ny’s sin­cer­i­ty—these are smart, ex­pe­ri­enced and com­mit­ted play­ers who lost their way–but as an­a­lysts turn their backs on Zaf­gen, that may not mat­ter much any­way. This is a teach­able mo­ment in cri­sis PR. Don’t waste it.

  The Scan­gos lega­cy is­sue


George Scan­gos ar­rived on the scene at Bio­gen six years ago as its sav­ior. He leaves as the com­pa­ny looks for a new mes­si­ah. But what a ride. He and his new team pushed Tec­fidera through, and made it a block­buster in the MS mar­ket. In the mid­dle of a biotech boom, Bio­gen could boast ma­jor league sta­tus along­side Gilead and Cel­gene. Then the sales weak­ened, pipeline set­backs tar­nished their im­age, an over­haul was in or­der and the com­pa­ny is now in line for a new makeover, it might even be ac­quired. Maybe Scan­gos stayed a year too long and trust­ed in home run swings too much. But no one can take away the win­ning years.

The bio­phar­ma mi­gra­tion to the hubs con­tin­ues


We’ve been gath­er­ing some fresh ev­i­dence this week on just how pop­u­lar the two big biotech hubs are in the U.S. Mer­ck has been prep­ping a big move in­to a new cam­pus in the Bay Area as more re­searchers are be­ing pulled in­to Boston/Cam­bridge. And Ger­many’s Mer­ck KGaA un­veiled its blue­print for a new cam­pus in Burling­ton, MA. Big bio­phar­ma R&D loves the hubs, as com­pa­nies look to put them­selves in the main­stream of all the best sci­ence. It doesn’t hurt that these two big hubs al­ready host most of the start­up com­pa­nies in biotech.

More un­cer­tain­ty in a new round of re­or­ga­ni­za­tions


But of course there’s a down side to every big trend. The lat­est re­or­ga­ni­za­tions com­ing hand in hand with down­siz­ing some op­er­a­tions, as Mer­ck made clear. As­traZeneca has al­so been culling its U.S. ranks in Mary­land and Mass­a­chu­setts. The biggest re­search groups be­gan to over­haul R&D about 7 or 8 years ago now. Mer­ck, Pfiz­er, As­traZeneca, Sanofi, Roche and oth­ers all took a big swing at their or­ga­ni­za­tions, look­ing to find some re­al ef­fi­cien­cies from the multi­bil­lion dol­lar op­er­a­tions com­mit­ted to drug de­vel­op­ment. These lat­est re­or­ga­ni­za­tions un­der­score the fact that any­one look­ing for job se­cu­ri­ty might want to find an­oth­er line of work, or a dif­fer­ent place to do it. If it’s not about down­siz­ing, there’s al­ways a re­jig in core fo­cus ar­eas. Still, few in­dus­tries of­fer the kind of short-term op­por­tu­ni­ties as bio­phar­ma R&D; ask any se­r­i­al en­tre­pre­neur in the field.

Brex­it blues


Per­haps it was an un­in­tend­ed con­se­quence, but the gov­ern­ment reshuf­fle fol­low­ing the Brex­it vote in the UK cost the in­dus­try its ded­i­cat­ed min­is­ter for the life sci­ences. George Free­man heads to big­ger and bet­ter things at a time the in­dus­try faces a cri­sis of con­fi­dence it can ill af­ford. Leav­ing the EU means wav­ing off EU re­search cash and tal­ent from the con­ti­nent, some­thing the Gold­en Tri­an­gle can miss bad­ly as it looks to es­tab­lish their life sci rep­u­ta­tion. On the oth­er hand, the UK con­tin­gent of biotech has a scrap­py un­der­dog side to it that will see it through to bet­ter days. Stay calm and car­ry on. It’s worked be­fore.

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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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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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.

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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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:”.

David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

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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