Bris­tol-My­ers will sell Op­di­vo in Chi­na at half of US cost, set­ting prece­dent for check­point wave — re­port

Bris­tol-My­ers Squibb is con­tin­u­ing to set prece­dents in Chi­na with Op­di­vo, the first PD-1/L1 check­point ap­proved in the coun­try, as it re­port­ed­ly prices the drug at around $84,000 per year — about half of its list price in the US.

A 100mg/10ml vial of Op­di­vo will cost around $1,352 (RMB 9260) while the 40mg/4ml vial comes in at $670 (RMB 4591), ac­cord­ing to Chi­nese fi­nan­cial news out­let Caix­in. The rec­om­mend­ed dosage is 240 mg every two weeks or 480 mg every four weeks.

That’s a steep cut from the US list price of $150,000, and a rel­a­tive­ly low price com­pared to neigh­bor­ing Japan, Ko­rea, Sin­ga­pore and even Hong Kong.

Caix­in not­ed that Bris­tol-My­ers will of­fer dis­counts through a pa­tient as­sis­tance pro­gram, like­ly on a “buy five months get six months free” ba­sis.

The com­pa­ny, how­ev­er, said it has not an­nounced the rec­om­mend­ed re­tail price for Op­di­vo in Chi­na. Here’s the rest of the state­ment from spokesper­son Priyan­ka Shah:

BMS and the Chi­nese Gov­ern­ment have a shared goal of im­prov­ing pa­tient ac­cess and health in Chi­na. We are work­ing with the gov­ern­ment to com­plete the process as soon as pos­si­ble, so that the pa­tients can quick­ly ac­cess to the Op­di­vo in Chi­na. We will con­tin­ue to col­lab­o­rate with the Chi­nese gov­ern­ment, pay­ers and third-par­ty through di­ver­si­fied pro­grams to launch po­ten­tial project, with an aim to joint­ly im­prove the ac­ces­si­bil­i­ty of Op­di­vo in Chi­na.

In­de­pen­dent biotech in­vestor Brad Lon­car — founder of the Lon­car Can­cer Im­munother­a­py In­dex and Lon­car Chi­na Bio­Phar­ma In­dex — told IBD that if the re­port on the price and as­sis­tance pro­gram is true, one would have to “do the math.”

“That $84,000 is like­ly the equiv­a­lent to what we have here as the list price,” said Lon­car. “No one ac­tu­al­ly pays that price; there’s a hid­den dis­count.”

Any suc­cess or fail­ure here will have ma­jor im­pli­ca­tions for the field as Mer­ck gained ap­proval last month for its PD-1 star Keytru­da in record time, sig­nalling an im­pend­ing wave of check­point in­hibitors that will in­clude a siz­able crop from Chi­nese biotechs.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

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.

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.