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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.