Clo­vis shares tank af­ter in­vestors size up the dis­ap­point­ing da­ta on ru­ca­parib

Clo­vis On­col­o­gy’s shares got ham­mered this morn­ing af­ter the biotech re­vealed some mixed re­sults for its PARP in­hibitor ru­ca­parib.

The biotech re­port­ed a 54% ob­jec­tive re­sponse rate for the drug for BR­CA-mu­tat­ed ovar­i­an can­cer, with nine (9%) com­plete re­spon­ders and 48 (45%) par­tial re­spon­ders. Bor­ing down in­to the da­ta, in­ves­ti­ga­tors al­so re­port­ed ze­ro re­sponse among the 7% of the pa­tients who were plat­inum-re­frac­to­ry, a 25% re­sponse rate for plat­inum-re­sis­tant pa­tients and 66% for plat­inum-sen­si­tive re­spons­es.

The me­di­an pro­gres­sion-free sur­vival time in the sin­gle-arm study was ten months.

Clo­vis faces tough com­pe­ti­tion in this field. And in­vestors didn’t like the way the da­ta was break­ing down com­pared to ri­vals like Tesaro’s ni­ra­parib, which was put through a ran­dom­ized study with a con­trol arm.

Clo­vis’s stock, which has been zoom­ing up in an­tic­i­pa­tion of the da­ta, quick­ly plunged 28% Fri­day morn­ing. By the end of the day Clo­vis saw the loss­es cut to a still painful 18%.

Some an­a­lysts quick­ly not­ed that the drug doesn’t ap­pear to look good in com­par­i­son to As­traZeneca’s Lyn­parza, ap­proved in late 2014 with its own set of mixed da­ta that drew a re­buke from an FDA pan­el. As­traZeneca’s da­ta in­clud­ed this note on plat­inum-re­sis­tant pa­tients:

Kauf­man et al eval­u­at­ed ola­parib 400 mg bid in a co­hort of pa­tients with germline BR­CA mu­ta­tions and ad­vanced sol­id tu­mors in­clud­ing 193 pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. In this sub­set of pa­tients, a tu­mor re­sponse rate of 31.1% was ob­served with an ad­di­tion­al 40% of pa­tients achiev­ing sta­ble dis­ease for at least 8 weeks

Tesaro re­port­ed ear­li­er that the ni­ra­parib arm hit the pri­ma­ry end­point of their study with a me­di­an PFS of 12.9 months com­pared to 3.8 months for the con­trol arm. Among germline BR­CA mu­ta­tion pa­tients, the me­di­an PFS for pa­tients treat­ed with ni­ra­parib was 21.0 months, com­pared to 5.5 months for con­trol. And it has more da­ta com­ing up at ES­MO this week­end.

The painful re­cep­tion for the Boul­der, CO-based biotech’s da­ta to­day un­der­score some se­ri­ous is­sues at Clo­vis On­col­o­gy. The com­pa­ny was forced to re­state its da­ta sub­mit­ted for an ap­proval of rocile­tinib, prompt­ing an em­bar­rass­ing and dev­as­tat­ing drop in the num­ber of re­spons­es that the biotech had claimed for their drug. An FDA pan­el sub­se­quent­ly re­ject­ed the drug, prompt­ing Clo­vis to re­struc­ture and lay off staffers.

Now all of its wag­ons are cir­cled around ru­ca­parib, a PARP that will go head to head with As­traZeneca’s Lyn­parza as well as quite pos­si­bly ni­ra­parib. And now Pfiz­er has ta­la­zoparib, an­oth­er PARP in­hibitor now in a piv­otal tri­al that’s shown con­sid­er­able promise. Ru­ca­parib is ahead of Tesaro’s drug on the reg­u­la­to­ry front, with a PDU­FA date of Feb­ru­ary 23.

Clo­vis can’t af­ford an­oth­er fail­ure. But some an­a­lysts had been up­beat about ru­ca­parib af­ter the FDA waved a pan­el re­view for the drug, which might in­di­cate their sup­port.

(Cor­rec­tion: This sto­ry was cor­rect­ed to take out a ref­er­ence to the 9 peo­ple who died in the study. The Clo­vis drug was not linked with any of their deaths, ac­cord­ing to the biotech.)

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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