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. 

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.