Cel­gene's dis­clo­sures about ozan­i­mod this week spur an­a­lyst­s' fears of a lengthy de­lay for a key drug

Re­searchers for Cel­gene $CELG turned up at the Amer­i­can Acad­e­my of Neu­rol­o­gy meet­ing this week with some news about the mul­ti­ple scle­ro­sis drug ozan­i­mod that quick­ly cap­tured an­a­lysts’ at­ten­tion.

In a pre­sen­ta­tion on ozan­i­mod Phase III da­ta, an in­ves­ti­ga­tor spot­light­ed an ac­tive metabo­lite pro­duced by the drug, spurring an ah-ha mo­ment for an­a­lysts who have been puz­zling out why the FDA re­cent­ly is­sued a stun­ning refuse-to-file no­tice on the drug.

Jef­feries’ Michael Yee not­ed this morn­ing:

We and many ob­servers be­lieve the is­sue re­lates to this metabo­lite that hasn’t been suf­fi­cient­ly char­ac­ter­ized by CELG and may not have suf­fi­cient in­for­ma­tion and safe­ty da­ta to per­mit FDA to ful­ly re­view the drug for ap­proval which is a prob­lem.

There’s two ways to look at this, he adds, de­pend­ing on whether you’re a bull or a bear on the suf­fer­ing stock. The bull ar­gu­ment would pose that a pre­sen­ta­tion at a con­fer­ence like this would mean that Cel­gene couldn’t be all that con­cerned by the metabo­lite is­sue, while the bear view would be: 

(I)nsuf­fi­cient tox cov­er­age for this metabo­lite which is the ac­tu­al ac­tive moi­ety, FDA guid­ance sug­gests needs 1-2 years more pre­clin­i­cal stud­ies, brings big un­cer­tain­ty even if NDA fil­ing – whether Ozan­i­mod would ac­tu­al­ly get ap­proved and/or now has hair on it.

In­vestors now want to know if the com­pa­ny plans to re-file soon or will look to go back to the draw­ing board with new, and po­ten­tial­ly dam­ag­ing, de­lays to dis­close. But there’s no sign of an ear­ly re­ac­tion on the stock price, which is slight­ly in the green in pre-mar­ket trad­ing. The stock is down 18%, though, from the be­gin­ning of the year.

Mark Alles

The biotech re­port­ed at the end of Feb­ru­ary that the RTF came through be­cause the FDA de­ter­mined “that the non­clin­i­cal and clin­i­cal phar­ma­col­o­gy sec­tions in the NDA were in­suf­fi­cient to per­mit a com­plete re­view” for mul­ti­ple scle­ro­sis, leav­ing plen­ty of unan­swered ques­tions about a drug that Cel­gene ex­ecs had con­fi­dent­ly pre­dict­ed would bring in $4 bil­lion to $6 bil­lion a year. Com­ing on the heels of the im­plo­sion of its $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301), in­vestors start­ed won­der­ing why the com­pa­ny was sud­den­ly lurch­ing from dis­as­ter to dis­as­ter.

CEO Mark Alles fol­lowed up with a man­age­ment shake­up that left him with wider di­rect con­trol over op­er­a­tions at the com­pa­ny.

I’ve sent out a mes­sage to Cel­gene, but the com­pa­ny isn’t not­ed for quick trans­paren­cy.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

Click on the image to see the full-sized version

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
Bristol/Medarex
Gilead/Pharmasset
Sanofi/Genzyme
AstraZeneca/Acerta
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:
J&J/Actelion
Merck/Cubist
Alexion/Synageva
AbbVie/Stemcentrx
Gilead/Kite

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.