No­var­tis’ star can­cer drug lands on an in­side FDA track, rac­ing Lil­ly to a show­down with Pfiz­er

No­var­tis just got a help­ing hand from the FDA as it races against Eli Lil­ly to jump in­to a three-way tug of war with Pfiz­er over a block­buster can­cer drug mar­ket. The agency has giv­en its CDK 4/6 can­cer drug LEE011 (ri­bo­ci­clib) its break­through sta­tus, like­ly cut­ting months off the reg­u­la­to­ry re­view process.

No­var­tis gained a BTD — its 11th — for the drug in com­bi­na­tion with letro­zole for the treat­ment of hor­mone re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HR+/HER2-) ad­vanced or metasta­t­ic breast can­cer.

No­var­tis will want every edge it can get in this race. Pfiz­er led the way on this new can­cer drug cat­e­go­ry with its ac­cel­er­at­ed ap­proval of Ibrance (pal­bo­ci­clib) ear­ly last year. But both Lil­ly and No­var­tis still see plen­ty of block­buster op­por­tu­ni­ties as they look to notch their first ap­provals in the field.

No­var­tis was able to tout pos­i­tive pro­gres­sion-free sur­vival re­sults from its MONALEESA-2 tri­al, which formed the ba­sis for its break­through ap­pli­ca­tion. Da­ta from that study has yet to be post­ed.

Lil­ly’s abe­maci­clib may be be­hind in the race, not un­usu­al for the me­thod­i­cal drug de­vel­op­ers at the com­pa­ny. But as Dana Far­ber’s Ge­of­frey Shapiro told me in May, re­search has shown that the drug ap­pears suit­able for con­tin­u­al dos­ing rather than the three weeks on/one week off reg­i­men used for No­var­tis’ and Pfiz­er’s drugs. That, along with some bet­ter ear­ly re­sults for use as a monother­a­py rather than in a com­bi­na­tion, may help Lil­ly seize a big­ger share of the mar­ket.

And it’s a big mar­ket. Ibrance sales shot up to $514 mil­lion in the sec­ond quar­ter of this year, about half of the to­tal for its on­col­o­gy di­vi­sion. It’s at $942 mil­lion for the half. And an­a­lysts typ­i­cal­ly dole out peak sales fore­casts in the bil­lions for these three drugs.

No­var­tis On­col­o­gy chief Alessan­dro Ri­va

The FDA’s break­through drug pro­gram has had a par­tic­u­lar­ly marked ef­fect in the can­cer field, where reg­u­la­tors like Richard Paz­dur have open­ly em­braced the 4-year-old process to speed along new reme­dies. One re­cent analy­sis con­clud­ed that BTD ap­provals snipped an av­er­age of about three months off of the re­view stage.

“This des­ig­na­tion shows the po­ten­tial of LEE011, and we look for­ward to close col­lab­o­ra­tion with the FDA and the ad­vanced breast can­cer com­mu­ni­ty to pro­vide a new treat­ment op­tion for women liv­ing with HR+/HER2- ad­vanced breast can­cer as quick­ly as pos­si­ble,” said No­var­tis On­col­o­gy chief Alessan­dro Ri­va in a state­ment.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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