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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.