Af­ter get­ting beat up on its de­pres­sion drug pitch, a bat­tered Alk­er­mes piv­ots to schiz­o­phre­nia with a pos­i­tive PhI­II read­out — but skep­tics are ready to pounce

Bad­ly need­ing a new fo­cus af­ter reg­u­la­tors and ex­perts slapped around their pitch for the de­pres­sion drug ALKS-5461, Alk­er­mes $ALKS is chang­ing the top­ic to­day to schiz­o­phre­nia.

Craig Hop­kin­son

Thurs­day morn­ing the biotech out­fit laid claim to promis­ing da­ta from ALKS-3831, their new and im­proved com­bo of olan­za­p­ine/sami­dor­phan, flag­ging a hit on both co-pri­ma­ry end­points re­lat­ed to weight gain and a key sec­ondary they’re hop­ing will help sell the drug — with a mar­ket­ing ap­pli­ca­tion now on sched­ule for the FDA. But the skep­tics who have been siz­ing up Alk­er­mes’ am­bi­tions won­der if this drug can do well com­mer­cial­ly, which may ex­plain why their stock slipped slight­ly in the red in pre­mar­ket trad­ing.

The ef­fi­ca­cy end­points in this sec­ond Phase III study fo­cused on a low­er mean per­cent weight gain for schiz­o­phre­nia pa­tients tak­ing ‘3831 as well as a com­par­i­son with olan­za­p­ine on the num­ber of pa­tients who added 10% or more of their body weight go­ing in­to the study.

In the olan­za­p­ine group 29.8% of pa­tients gained 10% or more of body weight in 6 months com­pared to 17.8% for ALKS 3831; for the 7%-plus weight gain cat­e­go­ry it was 42.7% for olan­za­p­ine vs. 27.5% for ALKS 3831.

Richard Pops, Alk­er­mes

The p val­ues Alk­er­mes pre­sent­ed were all up­beat and sig­nif­i­cant, though the com­pa­ny plans to hold back many of the de­tails for a con­fer­ence. And it’s clear from a re­view of an­a­lysts’ com­ments in re­cent weeks that the de­tails will be im­por­tant in as­sess­ing whether or not Alk­er­mes has a drug that can fetch a brand­ed price in a field dom­i­nat­ed by cheap gener­ics.

They’re not hold­ing back a new drug ap­pli­ca­tion, though. That is slat­ed for a de­liv­ery date some­time at the mid-point of next year.

“Im­por­tant­ly, ALKS 3831 fa­vor­ably shift­ed the weight gain dis­tri­b­u­tion curve com­pared to olan­za­p­ine, both in terms of mean weight gain and pa­tients ex­pe­ri­enc­ing ex­treme weight gain,” said Craig Hop­kin­son, Alk­er­mes’ CMO. 

The tout­ing of this study will like­ly be in­tense as Alk­er­mes ex­ecs led by CEO Richard Pops look to turn in­vestors’ at­ten­tion away from the train wreck that ALKS-5461 has be­come. But it won’t be easy.

Leerink’s Marc Good­man ini­ti­at­ed cov­er­age a few days ago, con­clud­ing that ‘5461 was dead in the wa­ter af­ter a large ma­jor­i­ty of FDA ex­perts turned thumbs down on it in a re­cent re­view, which fol­lowed a scathing as­sess­ment of the da­ta and tri­al plan by FDA in­sid­ers. ‘3831 may get ap­proved, he added, but sell­ing a drug like this will be no easy mat­ter.

(W)e be­lieve that ex­pec­ta­tions are too high for ALKS-3831. MEDA­Corp physi­cians (and we) like this prod­uct, but we be­lieve re­im­burse­ment will be dif­fi­cult for a new brand with­out a nov­el mech­a­nism in a high­ly gener­ic mar­ket; (3) we don’t agree with the bull­ish stance by some in­vestors that the base busi­ness can jus­ti­fy the cur­rent val­u­a­tion for the whole com­pa­ny and thus the pipeline is viewed as a free wild­card.

Stifel’s Paul Mat­teis had this to say re­cent­ly:

We think the Street is mod­el­ing around a 40-50% prob­a­bil­i­ty-of-suc­cess for 4Q18 da­ta (we’re at 50%); “suc­cess” in it­self is sub­jec­tive though, as there’s a con­tin­u­um of out­comes here with re­spect to a sta­tis­ti­cal win vs. a com­mer­cial­ly-rel­e­vant sig­nal.

This Phase III is the mon­ey shot for Alk­er­mes. The re­search group al­ready pro­duced pos­i­tive Phase III da­ta un­der­scor­ing that their an­tipsy­chot­ic drug per­formed bet­ter than a place­bo while prov­ing sta­tis­ti­cal­ly about the same as gener­ic olan­za­p­ine alone. Weight gain is a rou­tine side ef­fect for their drug, but they’re look­ing to re­place a stan­dard ther­a­py with one that can guard a greater per­cent­age of pa­tients from putting on pounds dur­ing treat­ment.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.