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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.