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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.