As gener­ic en­try looms for its cash cow, Jazz wins FDA nod for fol­low-up sleep dis­or­der drug

Af­ter a 3-month de­lay at­trib­uted to la­belling dis­cus­sions, Jazz Phar­ma­ceu­ti­cals $JAZZ has notched an ap­proval for its wake-pro­mot­ing drug sol­ri­amfe­tol, now chris­tened Sunosi.

Like Xyrem — the block­buster nar­colep­sy drug that ac­counts for the bulk of Jazz’s sales — Sunosi is de­signed to treat ex­ces­sive day­time sleepi­ness for pa­tients with ob­struc­tive sleep ap­nea (OSA) as well as nar­colep­sy. In 2018, Xyrem sales reg­is­tered at $1.4 bil­lion, trans­lat­ing to over 70% of to­tal rev­enue. But with Sunosi in tow, to­tal prod­uct sales are ex­pect­ed to jump sub­stan­tial­ly.

Jazz bought Sunosi from Aer­i­al Phar­ma in 2014 af­ter the drug had passed muster in 2 Phase II tri­als for $125 mil­lion up­front. It’s the first dual-act­ing dopamine and nor­ep­i­neph­rine re­up­take in­hibitor to be ap­proved by the FDA, and al­though the com­pa­ny is un­clear as to how it works, the drug has im­proved pa­tients’ over­all clin­i­cal con­di­tion com­pared to a place­bo across four Phase III stud­ies.

Bruce Cozadd

“With this ap­proval, a new, day­time med­i­cine that can pro­vide sus­tained wake­ful­ness through­out the day will be avail­able for pa­tients,” CEO Bruce Cozadd said in a state­ment. “The FDA ap­proval of Sunosi al­so rep­re­sents an im­por­tant mile­stone for Jazz as we con­tin­ue to of­fer new treat­ment op­tions that ad­dress un­met needs for peo­ple liv­ing with chron­ic, and of­ten de­bil­i­tat­ing, sleep dis­or­ders.”

Sunosi is ap­proved with once-dai­ly dos­es of 75 mg and 150 mg for pa­tients with nar­colep­sy and dos­es of 37.5 mg, 75 mg, and 150 mg for pa­tients with OSA — but no­tably not 300 mg, Umer Raf­fat of Ever­core ISI wrote in a note.

[In] our opin­ion, not get­ting 300 mg ap­proved might be the sin­gle most im­por­tant thing that makes this la­bel as clean as it is. As you scroll to page 8 of (the) la­bel, there is a ta­ble on BP and HR da­ta on dos­es in­clud­ing 300 mg dose — and you can clear­ly see why FDA did NOT ap­prove that dose de­spite bet­ter ef­fi­ca­cy. In fact, la­bel men­tions “dosages above 150 mg do not con­fer in­creased ef­fec­tive­ness suf­fi­cient to out­weigh AE”.

By not hav­ing 300 mg, the BP and HR events mere­ly be­came a warn­ing, and NOT a black­box. And…al­though la­bel rec­om­mends as­sess­ing BP and HR be­fore ini­ti­at­ing and dur­ing treat­ment, (the) re­al­i­ty is that many nar­colep­sy and OSA pa­tients have mul­ti­ple CV risk fac­tors

Jazz is wait­ing for a DEA sched­ul­ing be­fore it can launch the drug, a process that’s es­ti­mat­ed to take 90 days. Mean­while, the com­pa­ny will be hir­ing 50 more sales reps for their 95-mem­ber sleep team, ac­cord­ing to Cowen an­a­lysts.

By mak­ing some cross-tri­al com­par­isons be­tween Sunosi and cur­rent stan­dard of care Provig­il/Nu­vig­il (which re­cent­ly went gener­ic), they gave the Jazz drug a ring­ing en­dorse­ment as a best-in-class agent.

“Im­por­tant­ly, our con­sul­tant checks and sur­vey re­sults in­di­cate that Sunosi ap­pears to be a need­ed treat­ment op­tion and a like­ly $500 mil­lion+ long du­ra­tion prod­uct,” they wrote. “The bot­tom line is that sol­ri­amfe­tol ap­pears to be the most ef­fec­tive wake-pro­mot­ing agent ever de­vel­oped for EDS.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.