Clo­vis soars as its PARP drug ru­ca­parib lines up for FDA re­view with pos­i­tive da­ta

Clo­vis On­col­o­gy stock $CLVS shot up 30% Tues­day af­ter­noon af­ter the biotech laid out com­pet­i­tive piv­otal da­ta for its PARP in­hibitor ru­ca­parib, which has now been ac­cept­ed by the FDA for a pri­or­i­ty re­view. The biotech says it is now start­ing the clock for a re­view that should wrap with a for­mal de­ci­sion by Feb­ru­ary 23 as sev­er­al late-stage ri­vals look to steal its thun­der. The move comes just a day af­ter Pfiz­er com­plet­ed a deal to buy Medi­va­tion and its Phase III PARP in­hibitor ta­la­zoparib for $14 bil­lion.

In­ves­ti­ga­tors for Clo­vis post­ed an over­all ob­jec­tive re­sponse rate of 54% from two small stud­ies with 106 pa­tients suf­fer­ing from ad­vanced ovar­i­an can­cer with BR­CA mu­ta­tions. The me­di­an du­ra­tion of re­sponse was 9.2 months with a 9% com­plete re­sponse rate. Clo­vis added that the “ORR was sim­i­lar for pa­tients with germline BR­CA-mu­tant ovar­i­an can­cer or so­mat­ic BR­CA-mu­tant ovar­i­an can­cer and for pa­tients with a BR­CA1 gene mu­ta­tion or BR­CA2 gene mu­ta­tion.”

That com­pares fa­vor­ably with As­traZeneca’s pi­o­neer­ing PARP Lyn­parza (ola­parib), which was ap­proved with a 34% ORR for an av­er­age of 7.9 months. The FDA over­ruled an FDA pan­el vote against Lyn­parza in 2014, de­spite frets over the drug’s ef­fi­ca­cy.

There’s a long way to go, though, be­fore Clo­vis can lay any claims to hav­ing a best-in-class drug. First, there’s a lot more da­ta to con­sid­er be­fore any fi­nal de­ci­sion ar­rives. Sec­ond, Tesaro $TSRO has al­ready laid out some im­pres­sive pos­i­tive ovar­i­an can­cer da­ta of its own for its PARP ni­ra­parib. Their da­ta high­light­ed a clear im­pact for the tar­get­ed drug in a pop­u­la­tion of germline BR­CA mu­ta­tion car­ri­ers, with a me­di­an PFS of 21 months in the drug group com­pared to 5.5 months in the con­trol arm — a 15.5-month ad­van­tage.

And, third, Pfiz­er has to fol­low up with a much clos­er look at ta­la­zoparib while Ab­b­Vie hus­tles along veli­parib in the clin­ic.

Tesaro shares were down 6% af­ter Clo­vis’s news hit, but the stock had slipped ahead of the news.

Clo­vis al­so has some lin­ger­ing cred­i­bil­i­ty is­sues to deal with. Its oth­er big can­cer drug, rocile­tinib, was scut­tled ear­li­er this year af­ter the FDA forced it to re­cal­cu­late the da­ta used in its sub­mis­sion. Ques­tion­able meth­ods were used to claim an im­pact that the fi­nal da­ta couldn’t sup­port. The ap­proval at­tempt im­plod­ed as an FDA ad­vi­so­ry pan­el turned thumbs down on the trou­bled drug and the biotech was forced to re­struc­ture in the wake of the de­ba­cle. And Clo­vis has re­port­ed in SEC fil­ings that it is un­der in­ves­ti­ga­tion by fed­er­al agen­cies ex­am­in­ing the tim­ing of the biotech’s da­ta sub­mis­sions and cor­rec­tions.

Clo­vis, though, re­tained the com­mer­cial in­fra­struc­ture it had built up, grim­ly de­ter­mined to fol­low through on ru­ca­parib. The biotech has ig­nored re­peat­ed re­quests for in­ter­views in re­cent months.

“Re­cur­rent ovar­i­an can­cer re­mains a very dif­fi­cult dis­ease to treat, even among women who car­ry, or whose tu­mors have a mu­ta­tion in the BR­CA genes. De­spite the avail­able treat­ment op­tions, few ef­fec­tive ther­a­pies are at our dis­pos­al. Thus, the op­por­tu­ni­ty to treat women with germline or so­mat­ic BR­CA mu­ta­tions with ru­ca­parib af­ter two pri­or lines of plat­inum-based ther­a­py, rep­re­sents a mean­ing­ful step for­ward for our pa­tients,” said Robert L. Cole­man, a pro­fes­sor at Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter in Hous­ton and one of the prin­ci­pal in­ves­ti­ga­tors in the ARIEL clin­i­cal tri­al pro­gram.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.