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.

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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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.

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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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.