Rat­tled by set­backs, Cel­gene turns to ex-Mer­ck R&D star Alise Re­icin to re­pair its dam­aged de­vel­op­ment rep

At a time when the ex­ec­u­tive crew at Cel­gene has rat­tled in­vestors with a se­ries of set­backs on clin­i­cal de­vel­op­ment, the big biotech is re­or­ga­niz­ing its lead­er­ship on drug de­vel­op­ment and turn­ing to a for­mer Mer­ck R&D star to lead the way out of the wilder­ness.

Alise Re­icin

Alise Re­icin, who played a ma­jor role in the big de­vel­op­ment cam­paign for Mer­ck’s Keytru­da, is be­ing placed in charge of the crit­i­cal mid- to late-stage de­vel­op­ment work at Cel­gene, where it’s been ex­pe­ri­enc­ing its biggest prob­lems.

Re­icin spent the last 3 years as a se­nior VP at the Ger­man Mer­ck’s biotech arm, EMD Serono, where she helped lead the charge on Baven­cio (avelum­ab), their PD-L1 part­nered with Pfiz­er.

“Led by Alise, our clin­i­cal de­vel­op­ment or­ga­ni­za­tion will be struc­tured to more com­plete­ly align with our strat­e­gy and mis­sion to dis­cov­er, de­vel­op and com­mer­cial­ize in­no­v­a­tive ther­a­pies for pa­tients with un­met need,” says CEO Mark Alles in a state­ment. He not­ed that Re­icin would be in charge of project lead­er­ship and man­age­ment, leav­ing Ru­pert Vessey to head up ear­ly re­search and de­vel­op­ment.

Left un­said is the tac­it mess that’s been af­flict­ing Cel­gene’s late-stage de­vel­op­ment work. Their pro­gram for ozan­i­mod, picked up in a $7.8 bil­lion deal to buy Re­cep­tos, led straight to an em­bar­rass­ing refuse-to-file no­tice from the FDA, which want­ed to wait for some ad­di­tion­al stud­ies to be com­plete. Cel­gene has promised to get that done and back to the FDA in Q1 2019, but an­a­lysts have been buzzing about the po­ten­tial for fur­ther em­bar­rass­ing de­lays.

The prob­lems with ozan­i­mod, com­ing right af­ter the Phase III fail­ure of mon­gersen last fall — the sub­ject of a rich $710 mil­lion deal — ran­kled in­vestors and an­a­lysts, who were used to see­ing a crisp per­for­mance un­der the old team led by Bob Hug­in, in­clud­ing in­sid­ers like Tom Daniel and George Golumbes­ki, who even­tu­al­ly fol­lowed Hug­in — now run­ning for the US Sen­ate — out the ex­it.

Still play­ing out as well, Cel­gene has to in­te­grate Juno’s CAR-T op­er­a­tions in­to the com­pa­ny af­ter Alles’ $9 bil­lion buy­out. And ru­mors are start­ing to cir­cu­late in in­dus­try cir­cles that that process has al­so been less than ide­al.

Re­icin al­so played a role in the de­vel­op­ment of Vioxx at Mer­ck, yanked from the mar­ket in 2004 af­ter ev­i­dence mount­ed that the pain drug caused a spike in risk for heart at­tacks. She fea­tured in The New York Times cov­er­age, over­rid­ing a physi­cian’s con­clu­sion that one of their tri­al pa­tients had died of a heart at­tack.

”I think this should be called an un­known cause of death,” Re­icin replied, ac­cord­ing to the Times re­port. Soon af­ter, she added, “I would pre­fer un­known cause of death so we don’t raise con­cerns.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' 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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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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