Reimag­in­ing med­i­cine? No­var­tis wraps phar­ma’s first big glob­al pot deal

In a wa­ter­shed mo­ment for med­ical cannabis ad­vo­cates in the Unit­ed States, Swiss gi­ant No­var­tis’ $NVS San­doz AG unit has tied up with Cana­di­an med­ical cannabis pro­duc­er Tilray, mark­ing the first big en­dorse­ment of the con­tro­ver­sial plant by a large, multi­na­tion­al phar­ma­ceu­ti­cal com­pa­ny.

The deal ex­em­pli­fies chang­ing at­ti­tudes in the US, where more Amer­i­cans live in states that have le­gal­ized the sale of med­ical and/or recre­ation­al cannabis than in an­ti-cannabis ju­ris­dic­tions. Tilray, which sup­plies cannabis flower and ex­tract prod­ucts to pa­tients, physi­cians, health­care fa­cil­i­ties and re­searchers in 12 coun­tries, has an ex­ist­ing al­liance with San­doz Cana­da.

Un­der the so-called frame­work agree­ment, San­doz AG may sup­port Tilray in com­mer­cial­iz­ing and brand­ing the Nanaimo, British Co­lum­bia-based com­pa­ny’s non-smok­able/non-com­bustible prod­ucts; the Cana­di­an pot pro­duc­er may sup­ply and/or li­cense such prod­ucts to and from San­doz AG; and sig­nif­i­cant­ly, the two may col­lab­o­rate in de­vel­op­ing such prod­ucts.

“The (ex­pand­ed) part­ner­ship al­so helps le­git­imize cannabis in in­ter­na­tion­al mar­kets, which could im­pact preva­lence with­in ex­ist­ing mar­kets as well as help in­flu­ence coun­tries con­sid­er­ing med­ical cannabis le­gal­iza­tion,” Cowen’s Vivien Az­er wrote in a note.

The land­mark FDA ap­proval of GW Phar­ma’s $GW­PH cannabis-de­rived med­i­cine Epid­i­olex ear­li­er this year paved the way for a pletho­ra of small and mid-sized drug de­vel­op­ers — in­clud­ing In­sys Ther­a­peu­tics $IN­SY, Zyner­ba $ZYNE, In­Med Phar­ma, Kan­nal­ife and Ax­im Biotech $AX­IM — that are hop­ing to hitch their wag­on to the cannabis star, ei­ther by de­vel­op­ing syn­thet­ic or nat­ur­al cannabis-de­rived ther­a­peu­tics or de­vis­ing nov­el de­liv­ery mech­a­nisms for its ab­sorp­tion.

Two big deals over the course of this year have al­so un­der­scored the lu­cra­tive po­ten­tial of the plant, with al­co­hol gi­ant Con­stel­la­tion Brands $STZ spend­ing a mam­moth $4 bil­lion to se­cure a 38% stake in Cana­di­an cannabis com­pa­ny Canopy Growth $CGC, and cig­a­rette mak­er Al­tria $MO fork­ing out $1.8 bil­lion to take a 45% stake in an­oth­er Cana­di­an pot com­pa­ny Cronos $CRON.

Marc Feld­mann

Mean­while, the US fed­er­al gov­ern­ment con­tin­ues to con­sid­er cannabis as a sched­ule 1 sub­stance — on par with LSD and hero­in — with no med­ical val­ue, in­fu­ri­at­ing re­searchers who con­tend the clas­si­fi­ca­tion has dra­mat­i­cal­ly slowed the sci­en­tif­ic and med­ical in­ves­ti­ga­tion of the plant. Nev­er­the­less with House De­moc­rats tak­ing back seats this No­vem­ber, pro-mar­i­jua­na leg­is­la­tion is ex­pect­ed to heat up.

“There is am­ple ev­i­dence that the cannabis plant has nu­mer­ous use­ful ap­pli­ca­tions in med­i­cine and the law is ob­so­lete,” said Marc Feld­mann, an Ox­ford pro­fes­sor and im­mu­nol­o­gist whose work  led to the dis­cov­ery and sub­se­quent com­mer­cial­iza­tion of the world’s largest sell­ing drug class, an­ti-TNF. “This clas­si­fi­ca­tion is chang­ing around the world – it has al­ready hap­pened in Cana­da and will hap­pen in more states in the US in due course,” he said in a pre­vi­ous in­ter­view with End­points News. Feld­mann al­so serves as CEO of CannBioRex, a Cana­da-based com­pa­ny that is de­vel­op­ing syn­thet­ic cannabis-de­rived med­i­cines.

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.