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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Robert Spurr, President Salix Pharmaceuticals

Bausch Health’s Sal­ix pi­lots study to shine light on chron­ic liv­er dis­ease and push back on stereo­types

October is both breast cancer awareness and liver disease awareness month. While there’s no doubt which condition draws more attention during the month, Salix wants to change that.

Salix, Bausch Health’s gastroenterology arm, piloted its first chronic liver disease report and physician survey with results out this week aimed at raising awareness and dispelling stereotypes.

While 4.5 million people have chronic liver disease or cirrhosis – which is even more than 3.8 million women diagnosed with breast cancer – the research found chronic liver disease “has not received the attention or level of effort needed for adequate prevention, diagnosis, and standardization of its management.”

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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