In­sys pro­motes CFO to the helm as Saeed Mo­ta­hari hits the ex­it; Gele­sis gets OK to mar­ket weight loss treat­ment

An­drew Long

Saeed Mo­ta­hari is leav­ing In­sys Ther­a­peu­tics on the sec­ond an­niver­sary of his ap­point­ment as CEO. The Pur­due Phar­ma vet is suc­ceed­ed by his CFO, An­drew Long, who is step­ping up as the com­pa­ny strug­gles to stay afloat. A month ago, In­sys re­vealed that the strate­gic coun­sel it hired raised “sub­stan­tial doubt” about its abil­i­ty to con­tin­ue as a go­ing con­cern due to loss­es and un­cer­tain­ty as to whether it can gen­er­ate enough cash for its le­gal fees and set­tle­ments. Its for­mer ex­ec­u­tives are em­broiled in court for al­leged­ly brib­ing doc­tors to pre­scribe its po­tent, ad­dic­tive fen­tanyl spray Sub­sys off-la­bel. Mean­while, the drug­mak­er’s bil­lion­aire founder and for­mer chief John Kapoor is on tri­al for rack­e­teer­ing and con­spir­a­cy as­so­ci­at­ed with Sub­sys sales. In con­junc­tion with Long’s as­cent to the top, An­drece Hous­ley, the cur­rent cor­po­rate con­troller, will move up to fill its pre­vi­ous role. And In­sys has pro­mot­ed Venkat Goskon­da to CSO, over­see­ing what re­mains of the com­pa­ny’s R&D and man­u­fac­tur­ing ac­tiv­i­ties.

Gen­Script — the less­er known par­ent com­pa­ny of CAR-T dark horse Leg­end Biotech — has be­gun con­struc­tion of a com­mer­cial man­u­fac­tur­ing cen­ter spe­cial­iz­ing in plas­mids and virus­es man­u­fac­tur­ing. The Hong Kong-list­ed CRO ex­pects to build Chi­na’s first and largest hub for R&D of cell and gene ther­a­pies as well as an­ti­bod­ies, with ca­pac­i­ty for late-stage de­vel­op­ment and com­mer­cial pro­duc­tion. Lo­cat­ed in Zhen­jiang, the new 133,000-square-me­ter fa­cil­i­ty com­ple­ments a US site set to be­come op­er­a­tional soon.

→ The FDA has cleared a hy­dro­gel cap­sule de­vel­oped by PureTech af­fil­i­ate Gele­sis for mar­ket­ing as a pre­scrip­tion aid in weight man­age­ment. Made by cross-link­ing cel­lu­lose and cit­ric acid, Plen­i­ty is de­signed to swell up in the stom­ach so that peo­ple feel fuller be­fore meals and eat less. While it hit a goal of help­ing over­weight sub­jects lose at least 5% of their body weight, the piv­otal study failed on a co-pri­ma­ry on mean dif­fer­ence be­tween treat­ment and place­bo, but the low risk of tak­ing the prod­uct like­ly con­vinced reg­u­la­tors to give their green light.

Months af­ter re­port­ing pos­i­tive mid-stage de­pres­sion da­ta for its lead ex­per­i­men­tal pill, AXS-05, Ax­some $AXSM on Mon­day post­ed Phase II re­sults that showed the drug — a com­bi­na­tion of  dex­tromethor­phan (DM) and bupro­pi­on (BUP) — met the main goal as a smok­ing ces­sa­tion treat­ment. The da­ta “could add in­cre­men­tal up­side to the stock be­cause we don’t think that the Street has fac­tored smok­ing ces­sa­tion in­to its mod­els…the BUP com­para­tor arm in this Phase II falls with­in the ef­fi­ca­cy range of what has been used in reg­is­tra­tional tri­als for (GSK‘s) Zy­ban, the BUP monother­a­py that is cur­rent­ly ap­proved for smok­ing ces­sa­tion,” SVB Leerink’s Marc Good­man wrote in a note.

CNS-fo­cused EIP Phar­ma is bet­ting big on its lead ex­per­i­men­tal drug ne­flamapi­mod. The drug — which in­hibits the en­zyme p38 al­pha — is be­ing eval­u­at­ed in an on­go­ing proof-of-con­cept tri­al in pa­tients with ear­ly Alzheimer’s dis­ease, which is ex­pect­ed to read­out this fall. In the mean­time, the com­pa­ny has raised $11.2 mil­lion to ex­plore the use of the drug in de­men­tia with Lewy bod­ies and for the cog­ni­tive deficits in Hunt­ing­ton’s dis­ease — Phase II stud­ies for these new in­di­ca­tions are ex­pect­ed to com­mence in the sec­ond quar­ter. 

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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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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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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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”