Watch out Pfiz­er, No­var­tis’ LEE011 bags quick OK for front­line use against breast can­cer

Bruno St­rig­i­ni, CEO No­var­tis On­col­o­gy

No­var­tis picked up a key reg­u­la­to­ry win to­day, gain­ing the FDA’s quick OK for LEE011, its CDK 4/6 drug now ap­proved as a front­line ther­a­py for post­menopausal women with hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive ad­vanced or metasta­t­ic breast can­cer in com­bi­na­tion with any aro­matase in­hibitor.

The drug, al­so known as ri­bo­ci­clib, hits the mar­ket as Kisqali with peak sales es­ti­mates of around $2.5 bil­lion a year, giv­ing the phar­ma gi­ant a clear shot at a new block­buster fran­chise.

The phar­ma gi­ant has kept to the in­side track at the FDA right through the re­view. The OK now puts No­var­tis in di­rect com­pe­ti­tion with Pfiz­er’s Ibrance (pal­bo­ci­clib), the pi­o­neer in this field, with Eli Lil­ly com­ing up from be­hind with abe­maci­clib.

The head­line fig­ure from ES­MO, based on a study that was wrapped ear­ly due to its suc­cess, was that ri­bo­ci­clib com­bined with letro­zole re­duced the risk of death or pro­gres­sion by 44% among first-line pa­tients com­pared to letro­zole alone.

Re­searchers al­so pegged me­di­an PFS of 25.3 months for Kisqali plus letro­zole com­pared to 16 months for letro­zole alone.

Bill Hin­shaw, head of No­var­tis US On­col­o­gy, told re­porters this af­ter­noon that they’ve priced this drug whole­sale at $10,950 for the 600 mg dose, $8,760 for their 400 mg dose and $4,380 at 200 mg for a 28-day pack­age with 21 pills, to al­low for flex­i­ble dos­ing and pric­ing. Pa­tients can al­so get the drug at no up­front cost as they’re work­ing out de­tails with their in­sur­er.

Sea­mus Fer­nan­dez at Leerink is go­ing with Pfiz­er in this show­down, not­ing that No­var­tis’ price is an 18% to 20% dis­count over Ibrance, which should help it bore its way on­to pay­ers’ for­mu­la­ries. Be he al­so as­serts that safe­ty is­sues with Kisqali will lim­it its mar­ket pen­e­tra­tion, fa­vor­ing Ibrance.

The close­ly-watched da­ta have kept this drug square­ly in the sights of an­a­lysts cov­er­ing this mar­ket. It’s a top-10 con­tender this year, in the front ranks of late-stage block­busters, with an EMA de­ci­sion ex­pect­ed in the sec­ond half of this year. There was no im­me­di­ate word on how much No­var­tis plans to charge for the drug.

Dr. Gabriel N. Hor­to­bagyi, MD An­der­son

“Kisqali is em­blem­at­ic of the in­no­va­tion that No­var­tis con­tin­ues to bring for­ward for peo­ple with HR+/HER2- metasta­t­ic breast can­cer,” said Bruno St­rig­i­ni, CEO, No­var­tis On­col­o­gy. “We at No­var­tis are proud of the com­pre­hen­sive clin­i­cal pro­gram for Kisqali that has led to to­day’s ap­proval and the new hope this med­i­cine rep­re­sents for pa­tients and their fam­i­lies.”

The UK’s As­tex is al­so chuffed. As­tex and No­var­tis be­gan col­lab­o­rat­ing on dis­cov­ery back in 2005, start­ing them down a path that led to this new drug.

Gabriel N. Hor­to­bagyi, MD, Pro­fes­sor of Med­i­cine, De­part­ment of Breast Med­ical On­col­o­gy, The Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter and MONALEESA-2 Prin­ci­pal In­ves­ti­ga­tor, not­ed:

These re­sults af­firm that com­bi­na­tion ther­a­py with a CDK4/6 in­hibitor like ri­bo­ci­clib and an aro­matase in­hibitor should be a new stan­dard of care for ini­tial treat­ment of HR+ ad­vanced breast can­cer.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.

UP­DAT­ED: Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

AbbVie is donating more than $1 million worth of an HIV drug to help combat the fast-spreading coronavirus outbreak in China, the company announced on Friday.

China’s National Health Commission has suggested Aluvia, a pill containing lopinavir and ritonavir, as one of two possible treatments for the symptoms of the virus currently known as 2019-nCoV in the absence of effective antiviral medications. The other part is nebulized alpha-interferon.

UP­DAT­ED: Ab­b­Vie and Al­ler­gan di­vesti­tures are in, and an old As­traZeneca drug comes home

When AbbVie announced their $63-billion Allergan acquisition last year, executives acknowledged the two companies would have to divest some drugs to satisfy regulators. The two main assets in discussion have now been sold off – and one of them is coming home.

AstraZeneca will acquire brazikumab, Allergan’s late-stage IL-23 candidate for Crohn’s disease and ulcerative colitis. The drug was originally developed by AstraZeneca’s defunct subsidiary MedImmune, in collaboration with Amgen. Allergan licensed it for $250 million upfront and $1.27 billion in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.