Richard Pops (Photographer: Patrick T. Fallon/Bloomberg via Getty Images)

Alk­er­mes wins FDA nod for com­bo med with an­tipsy­chot­ic olan­za­p­ine — this time with­out the weight gain red flags

Alk­er­mes has had a rough go in the past few years, mak­ing the de­ci­sion to slice away a healthy por­tion of its R&D work­force last year af­ter a ma­jor set­back in de­pres­sion. The drug­mak­er placed a lot of hope in an­tipsy­chot­ic drug ALKS 3831 to turn things around, and af­ter a win­ning ad­comm late last year that bet is fi­nal­ly pay­ing off.

The FDA on Tues­day ap­proved Alk­er­mes’ Ly­balvi (olan­za­p­ine and sami­dor­phan) to treat schiz­o­phre­nia and bipo­lar 1 dis­or­der, the com­pa­ny said in a re­lease.

The drug was ap­proved as a main­te­nance monother­a­py, or for the acute treat­ment of man­ic or mixed episodes as a monother­a­py or ad­junct to lithi­um or val­proate, Alk­er­mes said. Ly­balvi is a com­bi­na­tion of nov­el chem­i­cal sami­dor­phan and an­tipsy­chot­ic olan­za­p­ine, an ag­ing an­tipsy­chot­ic con­sid­ered one of the field’s most ef­fec­tive de­spite pre­vi­ous red flags over pa­tients’ weight gain.

But with the new for­mu­la­tion, Alk­er­mes thinks it has cracked the code on those pri­or olan­za­p­ine is­sues. The agency based its re­view on ex­pan­sive da­ta from Alk­er­mes’ EN­LIGHT­EN pro­gram, which in­clud­ed 27 clin­i­cal stud­ies, in­clud­ing 18 stud­ies test­ing Ly­balvi and nine study­ing sami­dor­phan alone, the com­pa­ny said. Among those, EN­LIGHT­EN-2 churned out da­ta show­ing schiz­o­phre­nia pa­tients on Ly­balvi post­ed sig­nif­i­cant­ly less weight gain than pa­tients tak­ing olan­za­p­ine alone.

Alk­er­mes $ALKS shares were trad­ing up about 6% be­fore the bell Tues­day.

Ly­balvi will come with a black box warn­ing for in­creased risk of mor­tal­i­ty in el­der­ly pa­tients with de­men­tia-re­lat­ed psy­chosis, ac­cord­ing to its la­bel. That warn­ing is tied to re­port­ed cas­es of cere­brovas­cu­lar side ef­fects in clin­i­cal tri­als, in­clud­ing stroke and tran­sient is­chemic at­tack. The drug will come with con­traindi­ca­tions for pa­tients tak­ing opi­oids or who are un­der­go­ing acute opi­oid with­draw­al.

The drug­mak­er ex­pects Ly­balvi to hit the mar­ket in the Oc­to­ber/No­vem­ber time­frame and plans to lean on its ex­ist­ing com­mer­cial in­fra­struc­ture from mar­ket­ed an­tipsy­chot­ic Aris­ta­da to grease the wheels for the new drug’s suc­cess­ful launch, ac­cord­ing to a re­lease. The team will add 50 sales reps to that Aris­ta­da “core,” CCO Todd Nichols said on a Tues­day morn­ing call with in­vestors, as it works to ramp up com­mer­cial man­u­fac­tur­ing and fi­nal­ize its pro­mo­tion­al claims pri­or to a full roll­out at launch.

Alk­er­mes didn’t re­lease the list price, say­ing it was wait­ing on pay­er ne­go­ti­a­tions pri­or to launch.

An­tipsy­chotics is an un­usu­al mar­ket, with most first-line scripts dom­i­nat­ed by gener­ics al­though a pro­por­tion of pa­tients even­tu­al­ly cy­cle through those ear­ly drugs. That means the po­ten­tial mar­ket for Ly­balvi will like­ly take a while to de­vel­op, with Alk­er­mes pre­dict­ing around $10 mil­lion in sales by the end of the year.

“We have es­tab­lished a pro­file that there will be a path­way to ac­cess at launch, but it will de­vel­op over time,” Nichols said. “They’re most like­ly go­ing to have to step through one or two gener­ics be­fore ac­cess, and we’re pre­pared for that.”

Ly­balvi, for­mer­ly dubbed ALKS 3831, faced an FDA ad­vi­so­ry com­mit­tee in Oc­to­ber dur­ing which the ques­tion of a po­ten­tial REMS was pro­posed for the drug. The com­mit­tee vot­ed 11-6 that po­ten­tial la­bel­ing was enough to mit­i­gate risk, a big draw for Alk­er­mes in the heav­i­ly reg­u­lat­ed an­tipsy­chot­ic space.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,500+ biopharma pros reading Endpoints daily — and it's free.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.