Re­gen­eron, Sanofi post good PhI­II asth­ma da­ta for Dupix­ent — but it’s los­ing its ha­lo

Just days af­ter As­traZeneca and Am­gen man­aged to catch an­a­lysts sleep­ing with a promis­ing new asth­ma drug called teze­pelum­ab, Re­gen­eron and Sanofi are com­ing in with new da­ta for Dupix­ent (dupilum­ab) which they are bet­ting will pave the way to a new ap­proval next year.

But sev­er­al an­a­lysts are say­ing Mon­day morn­ing that the new da­ta are a step down from the ex­cit­ing mid-stage re­sults these two ma­jor league part­ners put up. And they’re won­der­ing whether Dupix­ent — a one-time dar­ling — can live up to some old ex­pec­ta­tions.

George Yan­copou­los at­tends old Spring Har­bor Lab­o­ra­to­ry’s Dou­ble He­lix Medals at Amer­i­can Mu­se­um of Nat­ur­al His­to­ry on De­cem­ber 1, 2016 in New York City. get­ty im­ages

The da­ta for un­con­trolled asth­ma looked eas­i­ly good enough for an OK as Re­gen­eron and Sanofi lined up for their next BLA with Dupix­ent.

At 52 weeks, in the 300 mg dose group, dupilum­ab re­duced se­vere asth­ma at­tacks by 46 per­cent in the over­all pop­u­la­tion, 60 per­cent in pa­tients with 150 eosinophilic cells/mi­cro­liter or greater, and 67 per­cent in pa­tients with 300 eosinophilic cells/mi­cro­liter or greater (p less than 0.001 for all groups). At 12 weeks, in the 300 mg dupilum­ab dose group, mean im­prove­ment in lung func­tion over place­bo as as­sessed by forced ex­pi­ra­to­ry vol­ume over one sec­ond (FEV1) with dupilum­ab was 130 mL (9 per­cent) in the over­all pop­u­la­tion, 210 mL (11 per­cent) in pa­tients with 150 eosinophilic cells/mi­cro­liter or greater, and 240 mL (18 per­cent) in pa­tients with 300 eosinophilic cells/mi­cro­liter or greater (p less than 0.001 for all groups).

Biren Amin at Jef­feries looked it over and sum­ma­rized it this way:

This da­ta is com­pa­ra­ble to the IL-5 Nu­cala on ex­ac­er­ba­tions re­duc­tion but su­pe­ri­or on FEV1 im­prove­ment. Based on to­day’s da­ta, we be­lieve dupi will be com­pet­i­tive but not the clear choice in asth­ma.

Said Re­gen­eron chief sci­en­tist George Yan­capolous:

Dupilum­ab has now demon­strat­ed pos­i­tive late-stage re­sults in two se­ri­ous al­ler­gic dis­eases — asth­ma and atopic der­mati­tis — with ro­bust ef­fi­ca­cy and an ex­ten­sive safe­ty data­base. These re­sults con­tin­ue to sup­port our hy­poth­e­sis that the IL4/IL13 path­way is a crit­i­cal dri­ver of al­ler­gic dis­ease, and we re­main com­mit­ted to fur­ther in­ves­ti­gat­ing the IL-4/IL-13 path­way in oth­er al­ler­gic dis­eases.

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.

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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.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.