Ar­ray walks back its FDA pitch on binime­tinib, de­rail­ing plans for com­mer­cial launch

Ron Squar­er, CEO

Ar­ray Bio­Phar­ma has some ex­plain­ing to do. Fif­teen months af­ter the Boul­der, CO-based biotech said that it had the da­ta need­ed for its first ap­proval of binime­tinib for NRAS-pos­i­tive melanoma, ex­ecs are walk­ing back the ap­pli­ca­tion and its plans for a launch.

In a state­ment out Sun­day evening, Ar­ray $AR­RY said that af­ter get­ting feed­back from the FDA, ex­ecs  “con­clud­ed that the clin­i­cal ben­e­fit demon­strat­ed in the Phase 3 NEMO clin­i­cal tri­al would not be found suf­fi­cient to sup­port ap­proval of the NRAS-mu­tant melanoma NDA.”

Shares of Ar­ray dropped 26% in pre-mar­ket trad­ing Mon­day.

Michael Schmidt at Leerink was not pleased. He not­ed:

While NRAS+ melanoma was on­ly a small val­ue dri­ver for the com­pa­ny, we think this comes as a sur­prise to in­vestors and is a clear set­back for the com­pa­ny and mgmt.’s reg­u­la­to­ry and com­mer­cial strat­e­gy. Re­call, man­age­ment planned to build a com­mer­cial in­fra­struc­ture and vis­i­bil­i­ty with cus­tomers this year around the launch in NRAS+ melanoma, which would al­so be in prepa­ra­tion for the planned launch in 2018 of binime­tinib/en­co­rafenib in more com­pet­i­tive BRAF+ melanoma, which is AR­RY’s main val­ue dri­ver.

It was a much dif­fer­ent sto­ry back in late 2015 when CEO Ron Squar­er said that their MEK block­er hit the pri­ma­ry end­point on pro­gres­sion-free sur­vival, with the drug arm reg­is­ter­ing 2.8 months com­pared to 1.5 months for a group on dacar­bazine. It didn’t look like much, but Ar­ray said it was plen­ty to take to the FDA.

In the sum­mer of 2016, though, the biotech al­so con­ced­ed that the drug had not sig­nif­i­cant­ly im­proved over­all sur­vival.

Ar­ray has had plen­ty of ups and downs with the drug. No­var­tis had part­nered with the com­pa­ny, but punt­ed the pro­gram when they ex­e­cut­ed a big as­set swap with Glax­o­SmithK­line. Pierre Fab­ry then took their spot, but Ar­ray held on to US com­mer­cial rights.

Ar­ray is plan­ning to file binime­tinib for BRAF-mu­tant melanoma in a few months.

Last fall the biotech re­port­ed that a com­bo of en­co­rafenib (LGX818) plus binime­tinib beat out a so­lo BRAF in­hibitor, Zelb­o­raf (ve­mu­rafenib), with a me­di­an pro­gres­sion-free sur­vival rate of 14.9 months vs. 7.3 months in the con­trol arm for BRAF-mu­tant melanoma pa­tients. There was a hitch, though, as the pair-up showed a me­di­an PFS of 14.9 months ver­sus 9.6 months for en­co­rafenib alone, which was not sta­tis­ti­cal­ly sig­nif­i­cant.

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.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

Endpoints Premium

Premium subscription required

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

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.

Endpoints Premium

Premium subscription required

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.