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.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.