In a blow to Eli Lil­ly, No­vo Nordisk lands FDA OK for their next big en­try in the di­a­betes mar­ket: Ozem­pic

An en­er­gized FDA has come through with an ap­proval of No­vo Nordisk’s once-week­ly GLP-1 di­a­betes drug semaglu­tide, open­ing the door to a mar­ket many an­a­lysts are con­vinced is worth more than $2 bil­lion a year in peak sales. And it could spell big trou­ble for ri­val Eli Lil­ly.

Mads Krogs­gaard Thom­sen

Type 2 di­a­betes is a mas­sive and fast-grow­ing dis­ease, with a glob­al mar­ket that has re­ward­ed a hand­ful of key play­ers like No­vo Nordisk a multi­bil­lion-dol­lar mar­ket. And No­vo ran a typ­i­cal­ly thor­ough Phase III pro­gram.

In do­ing so, No­vo al­so came up with su­pe­ri­or da­ta to Eli Lil­ly’s Trulic­i­ty, set­ting up a head-to-head show­down that could cost Lil­ly dear­ly.

Re­searchers al­so came up with some trou­bling in­stances of di­a­bet­ic retinopa­thy, which can lead to blind­ness. But a near unan­i­mous vote by a group of out­side ex­perts at the FDA felt that was an is­sue that could be mon­i­tored, in light of the ben­e­fits in glycemic con­trol the drug of­fered.

No­vo al­so isn’t done with the de­vel­op­ment of this drug, now Ozem­pic, for the big US mar­ket. Re­searchers are busi­ly putting it through an­oth­er big test as an obe­si­ty ther­a­py af­ter trig­ger­ing some im­pres­sive weight loss among obese pa­tients. And they would be squar­ing off against some unim­pres­sive ri­vals now on the mar­ket.

In an R&D up­date dur­ing its Cap­i­tal Mar­kets Day at its HQ near Copen­hagen just days ago, in­ves­ti­ga­tors for the com­pa­ny said they will re­cruit 4,500 pa­tients for a Phase II­Ia obe­si­ty tri­al for semaglu­tide. And they plan to launch the 68-week study next year, along­side a “land­mark” car­dio­vas­cu­lar out­comes study with 12,500 peo­ple en­rolled.

“We are very ex­cit­ed about the first ap­proval of Ozem­pic and look for­ward to mak­ing this im­por­tant in­no­va­tion avail­able to peo­ple in the US with type 2 di­a­betes in the be­gin­ning of 2018,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer, in a state­ment. “Type 2 di­a­betes is a com­plex dis­ease, but with the unique clin­i­cal pro­file of Ozem­pic, we be­lieve it has the po­ten­tial to set a new stan­dard for the treat­ment of the dis­ease.”

The FDA is now just a few ap­provals from break­ing the 45 NDAs of­fered in 2015.

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.

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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

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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.

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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.

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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

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