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. 

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection: