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.”

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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Sangamo CEO Sandy Macrae

Pa­tient #9 has been a con­cern, but Sang­amo and Pfiz­er are bull­ish about win­ning the marathon he­mo­phil­ia A gene ther­a­py race

Patient number 9 has given Sangamo and its partners at Pfizer some heart palpitations in their high profile hemophilia A gene therapy program.

After watching his Factor VIII level rise following treatment like the rest, the crucial efficacy gauge they track saw a sudden and significant plunge. At week 13, the FVIII level had dropped below normal. Then it began to rise again.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Vas Narasimhan, Getty Images

No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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Jeff Jonas, Sage

UP­DAT­ED: Sage's star ex­per­i­men­tal de­pres­sion drug fails the cru­cial MOUN­TAIN study — shares crash

Sage Therapeutics’ crucial MOUNTAIN study for Sage-217 has failed, setting the stage for a quick and ugly investor backlash.

Widely viewed by analysts as the critical clinical study $SAGE needed to win on major depression, researchers say the drug failed to beat out a placebo at day 15, falling well short of the mark for statistical significance on the primary endpoint. And investors reacted with alacrity, fleeing the stock and gutting the price with a 60% instantaneous drop — erasing about $4.6 billion in market cap in an instant.

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