Gilead­'s sto­ried hep C fran­chise will now in­clude a gener­ic drug op­er­a­tion

Faced with a dwin­dling stream of rev­enue for its he­pati­tis C fran­chise amid an on­go­ing na­tion­al de­bate on drug pric­ing, Gilead has come up with an un­con­ven­tion­al plan.

Through a new sub­sidiary named Asegua Ther­a­peu­tics, Gilead will sell gener­ic ver­sions of the he­pati­tis C com­bo drugs Ep­clusa and Har­voni at a price of $24,000 — a frac­tion of the list prices of the drugs, which cost $75,000 and $94,500 re­spec­tive­ly for a 12-week reg­i­men.

John Mil­li­gan

While pro­vid­ing a pain­less cure for he­pati­tis C was a ma­jor suc­cess in biotech, it turned out to be a bit of a mixed sto­ry for Gilead, which saw the huge, prof­itable mar­ket quick­ly shrink as the pa­tient pop­u­la­tion got small­er and cheap­er ri­vals emerged from Mer­ck and Ab­b­Vie. Chair­man John Mar­tin and CEO John Mil­li­gan — the duo cred­it­ed for ex­e­cut­ing this break­through — al­so en­dured end­less crit­i­cism for their ag­gres­sive strat­e­gy, which trig­gered a con­tro­ver­sy that nev­er re­al­ly went away.

Nei­ther Mil­li­gan nor Mar­tin will over­see the launch of these gener­ic drugs, sched­uled for Jan­u­ary of 2019, as they are both step­ping down at the end of the year. But to hear Mil­li­gan tell it, this ini­tia­tive is an at­tempt to solve a com­plex prob­lem they have ob­served for the past five years: Even though re­bates have shaved more than 60% off the av­er­age price paid for their hep C cures, these dis­counts are “ef­fec­tive­ly in­vis­i­ble” and “ac­cess to these cures has been lim­it­ed.”

Over the past sev­er­al months, we have searched for a vi­able path to re­duce the list price of our brand­ed HCV med­ica­tions so that their cost to pay­ers is more eas­i­ly un­der­stood. Un­for­tu­nate­ly, ex­ist­ing con­tracts with in­sur­ers, to­geth­er with laws as­so­ci­at­ed with gov­ern­ment pric­ing poli­cies, make it un­ac­cept­ably dif­fi­cult to quick­ly low­er the list price to re­flect the dis­count­ed cost of our med­ica­tions.

Set­ting up their own gener­ic op­er­a­tion, Mil­li­gan writes, is “the fastest way to low­er list prices for our HCV cures with­out sig­nif­i­cant dis­rup­tion to the health­care sys­tem and our busi­ness, as a bridge to longer term so­lu­tions aimed at re­duc­ing pa­tients’ out-of-pock­et med­ica­tion costs.”

Specif­i­cal­ly, this could save Medicare pa­tients up to $2,500 in out-of-pock­et costs in the Part D set­ting, as well as “sub­stan­tial sav­ings” to state man­aged Med­ic­aid plans.

Ep­clusa and Har­voni both con­tain so­fos­bu­vir, the orig­i­nal hep C med­i­cine that Gilead sells as So­val­di. In the first half of 2018, their com­bined sales reg­is­tered at $1.7 bil­lion, com­pared with $4.8 bil­lion dur­ing the same pe­ri­od in 2017.

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.