Mo­men­ta whacks top ex­ecs, 110 jobs in re­struc­tur­ing; Genen­tech gains $62M in R&D back­ing from BAR­DA

Mo­men­ta Phar­ma­ceu­ti­cals $MN­TA is re­struc­tur­ing, boot­ing 110 jobs and a slate of ex­ecs in search of some deep bud­get cuts. As part of the re­struc­tur­ing, Mo­men­ta says it will nar­row its biosim­i­lars work to two late-stage pro­grams while it shifts fo­cus to nov­el ther­a­peu­tics.

Mo­men­ta says it will shed 5 pro­grams in­volved in its part­ner­ship with My­lan, stick­ing with a knock­off of Oren­cia. 

Out: Ganesh Kaun­dinya, chief op­er­at­ing of­fi­cer and chief sci­en­tif­ic of­fi­cer; Bruce Le­ich­er, SVP, gen­er­al coun­sel and sec­re­tary; James An­der­son, SVP phar­ma­ceu­ti­cal sci­ence; Robert Ciap­penel­li, SVP and head of com­mer­cial; and Scott Stor­er, SVP, chief fi­nan­cial of­fi­cer and trea­sur­er.

“Our goal when we en­tered this strate­gic re­view was to find an ef­fec­tive way to re­duce our lev­el of in­volve­ment in biosim­i­lar de­vel­op­ment so that we could re­fo­cus our re­sources on our promis­ing nov­el drug can­di­dates for im­mune-me­di­at­ed dis­eases. We ex­plored a num­ber of op­tions, in­clud­ing the sale of all of our biosim­i­lar as­sets in a sin­gle trans­ac­tion,” said Mo­men­ta CEO Craig Wheel­er. “Af­ter mul­ti­ple rounds of com­plex ne­go­ti­a­tions, it was de­ter­mined that the re­struc­tur­ing of our Com­pa­ny to fo­cus on the ad­vance­ment of our nov­el drug pipeline and the con­tin­ued de­vel­op­ment of our two late-stage biosim­i­lar pro­grams, M923 and M710, pro­vides us with what we be­lieve to be the best path for­ward be­cause of the po­ten­tial for these two biosim­i­lar pro­grams to gen­er­ate rev­enues that could help fund our fu­ture Phase 3 nov­el drug clin­i­cal tri­als.”

Genen­tech has won some sig­nif­i­cant sup­port for its new flu drug from a new part­ner — and this one is hap­py to con­tribute to the cause with­out tak­ing any­thing in re­turn. BAR­DA is con­tribut­ing $43 mil­lion over five years to sup­port a study of balox­avir mar­box­il. Roche of­fi­cials have been bull­ish about this drug, es­pe­cial­ly as they’d like to re­place the rev­enue be­ing lost to cheap knock­offs of Tam­i­flu with a new brand­ed drug rev­enue stream. They’ve talked up its abil­i­ty to re­solve the flu in 24 hours, ver­sus 72 hours for Tam­i­flu, but the pres­ence of a cheap gener­ic has dragged back sales ex­pec­ta­tions. BAR­DA will al­so pro­vide $19 mil­lion over 18 months to ad­vance al­teplase (tPA) for a new in­di­ca­tion to treat acute lung in­juries called cast for­ma­tion caused by in­hal­ing sul­fur mus­tard gas. 

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

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.