THC ther­a­py tanks in PhI, send­ing Zyner­ba's stock tum­bling yet again

Zyner­ba’s stock $ZYNE is get­ting crushed yet again af­ter news that its THC ther­a­py has flopped in a Phase I tri­al. At least this time, they’re find­ing out ear­ly.

The De­von, Penn­syl­va­nia-based com­pa­ny was test­ing its trans­der­mal patch meant to de­liv­er THC, the psy­choac­tive cannabi­noid in cannabis, as a pro-drug in healthy vol­un­teers. The hope was to make a THC ther­a­py that didn’t have to be tak­en oral­ly, which can cause high peak lev­els of THC in the blood caus­ing in­creased psy­choac­tive side ef­fects. Un­for­tu­nate­ly, the com­pa­ny wasn’t able to get ZYN001 to take. The Phase I study re­sults in­di­cat­ed that tar­get blood lev­els of 5 to 15 ng/ml THC were not achieved.

Of­ten com­pared to GW Phar­ma­ceu­ti­cals, which has had some strik­ing suc­cess­es in the field, Zyner­ba has watched its stock yo-yo over the past year. This morn­ing, the com­pa­ny’s stock is down 22% in pre-mar­ket trad­ing. And it’s not the first time Zyner­ba has crashed on bad clin­i­cal tri­al news. Last sum­mer, its oth­er pipeline drug ZYN002, a CBD gel, flopped in mid-stage tri­als in epilep­sy and knee pain from os­teoarthri­tis.

The com­pa­ny has had more luck with ZYN002 in Frag­ile X syn­drome, an autism spec­trum dis­or­der that’s tough to treat at the source. Zyner­ba didn’t go af­ter the dis­ease it­self, but rather symp­toms that can make life mis­er­able for the pa­tients and their fam­i­lies. Since its THC pro-drug has flopped in Phase I, Zyner­ba said it’s go­ing to fo­cus its ef­forts on Frag­ile X and de­vel­op­men­tal and epilep­tic en­cephalopa­thy (DEE), and adult re­frac­to­ry epilep­sy pro­grams.

Ar­man­do Anido

We spoke with Zyner­ba’s CEO Ar­man­do Anido back in April about how the com­pa­ny might com­pete with GW Phar­ma­ceu­ti­cals. At the time, Anido said he was con­fi­dent there was room for both play­ers.

“We do be­lieve that we have a dif­fer­ent way of de­liv­er­ing CBD, it is trans­der­mal, it by­pass­es the GI tract, of which we know GW has had a num­ber of GI dis­tur­bances with their prod­uct,” he said. “It al­so by­pass­es first-pass me­tab­o­lism, which we be­lieve ac­tu­al­ly may min­i­mize some of the is­sues that GW faced with el­e­vat­ed transam­i­nas­es in the liv­er.”

Anido al­so not­ed the com­pa­ny has enough cash to get “well in­to 2019,” in­clud­ing the mid-stage tri­als they’re do­ing in DEE and Frag­ile X. The com­pa­ny’s press re­lease this morn­ing clar­i­fied that it has $52 mil­lion in cash and cash equiv­a­lents.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.

Green-light­ed in Japan, FDA quick­ly spurns Dai­ichi Sanky­o's flawed ap­pli­ca­tion for AML drug

Three days af­ter win­ning Japan­ese ap­proval for its acute myeloid leukemia drug quizar­tinib, Dai­ichi Sankyo is be­ing forced to en­dure an em­bar­rass­ing re­jec­tion at the hands of the FDA.

US reg­u­la­tors wast­ed no time in bat­ting back quizar­tinib af­ter first high­light­ing the messy da­ta in its ap­pli­ca­tion in an in­ter­nal re­view, that in turn per­suad­ed a large ma­jor­i­ty of out­side ex­perts to rec­om­mend a re­jec­tion for the drug, which tar­gets FLT3-ITD–pos­i­tive AML cas­es.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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HIV, pneu­mo­coc­cal — and what? Mer­ck­'s un­ex­pect­ed pipeline high­light ex­cites a lit­tle biotech

In an R&D update dominated by oncology — mostly Keytruda, followed by Lynparza and Lenvima — Merck chose to highlight a program in sensory pathology, an HIV drug, and a group of pneumococcal vaccines. And that has made at least one biotech very happy.

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