No­vo bets on swift FDA re­view for oral di­a­betes drug semaglu­tide

The world’s top di­a­betes drug mak­er No­vo Nordisk is in a hur­ry. As part of its fourth-quar­ter re­sults on Fri­day, the com­pa­ny $NVO said it was plan­ning to use a pri­or­i­ty vouch­er to has­ten the FDA re­view process for its po­ten­tial block­buster oral GLP-1, semaglu­tide, a crit­i­cal com­po­nent of the Dan­ish drug­mak­er’s long-term growth strat­e­gy.

The com­pa­ny has spent near­ly a cen­tu­ry lean­ing on its ros­ter of in­jectable di­a­betes treat­ments, but as com­pe­ti­tion heats up and pric­ing pres­sure in the Unit­ed States in­ten­si­fies, No­vo is bet­ting on a pill to en­tice pa­tients who are averse to in­jec­tions or those who haven’t so far re­quired in­jec­tions to man­age their in­sulin lev­els. An es­ti­mat­ed 425 mil­lion peo­ple glob­al­ly suf­fer from di­a­betes, ac­cord­ing to the In­ter­na­tion­al Di­a­betes Fed­er­a­tion.

The drug, like oth­ers in its class, is a GLP-1 treat­ment that stim­u­lates in­sulin pro­duc­tion. Last year, late-stage da­ta showed No­vo’s pill out­per­formed a place­bo and in a head-to-head tri­al beat Boehringer In­gel­heim and Eli Lil­ly’s Jar­diance, an oral SGLT2-in­hibitor ap­proved back in late 2016. No­vo’s once-a-week in­jectable ver­sion of semaglu­tide — called Ozem­pic — was launched in the Unit­ed States last Feb­ru­ary and has now cap­tured 26% of the week­ly new-to-brand pre­scrip­tion mar­ket share, No­vo said on Thurs­day. Arch-ri­val Lil­ly’s once-week­ly block­buster in­jectable GLP-1 Trulic­i­ty is cur­rent­ly the mar­ket leader.

The GLP-1 pill will be sub­mit­ted for US re­view at the end of the first quar­ter of 2019, and No­vo will sub­mit a pri­or­i­ty re­view vouch­er in tan­dem, which should speed up the FDA process to six months, ver­sus the stan­dard 10 months.

If ap­proved, fo­cus will turn to the price of No­vo’s med­i­cine, as the soar­ing cost of drugs in the Unit­ed States trig­gers the ire of pa­tients and politi­cians alike. Anec­do­tal re­ports of di­a­bet­ics ra­tioning or fore­go­ing in­sulin have elicit­ed wide­spread crit­i­cism, and in re­cent years law­mak­ers across the aisle have pro­posed a raft of poli­cies to tack­le the larg­er is­sue of drug pric­ing, which is al­so con­sid­ered a top pri­or­i­ty by US vot­ers.

“We see risk ap­pre­hen­sion grows on GLP-1 pric­ing, no­tably around 2023E Vic­toza gener­ics, but al­so from US pay­ers as the class bal­loons and when oral semaglu­tide is launched at a low­er price point,” Jef­feries an­a­lysts wrote in a note on Fri­day.

A No­vo spokesper­son de­clined to com­ment on the com­pa­ny’s pric­ing plans for oral semaglu­tide. The drug is ex­pect­ed to gen­er­ate about $2.2 bil­lion in sales in 2024, ac­cord­ing to Eval­u­ate Phar­ma es­ti­mates.

Mean­while, No­vo is al­so nav­i­gat­ing a soup of Brex­it un­cer­tain­ty. The com­pa­ny is the biggest sup­pli­er of in­sulin to the UK, but with no clar­i­ty on Britain’s de­par­ture, the drug­mak­er has put to­geth­er a con­tin­gency plan. The prepa­ra­tions in­cludes stock­pil­ing ahead of March 29 — the ex­pect­ed date of Britain’s de­par­ture from the EU — and sched­uled month­ly air­freight slots be­tween April and Ju­ly 2019 to en­sure sup­ply isn’t dis­rupt­ed. In a state­ment mid-Jan­u­ary, No­vo said it would have dou­bled its UK stock to 16 weeks by the end of the month.

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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