Kite lines up a JV in Chi­na while Dai­ichi Sankyo strikes $250M-plus deal to launch CAR-T drug in Japan

He­len Kim, Kite

With its new drug ap­pli­ca­tion for the pi­o­neer­ing CAR-T drug KTE-C19 in the fi­nal weeks from be­ing com­plet­ed and shipped to reg­u­la­tors in search of an ac­cel­er­at­ed ap­proval, Kite Phar­ma $KITE has now lined up two part­ners to man­age their prospec­tive leap in­to two key Asian mar­kets. Kite has pulled the wraps off a joint ven­ture for Chi­na while ink­ing a $250 mil­lion-plus deal to break in­to the Japan­ese mar­ket along­side Dai­ichi Sankyo.

Kite is tak­ing a $50 mil­lion up­front and $200 mil­lion in mile­stones for the Japan­ese deal, while Dai­ichi Sankyo is re­serv­ing an­oth­er $200 mil­lion in ad­di­tion­al mile­stones for each new drug can­di­date that Kite takes to the FDA over the next three years. Roy­al­ties will range from the low to mid-dou­ble dig­it range.

The biotech has com­plet­ed a deal to cre­ate a JV in Chi­na with Fo­s­un Phar­ma, which is hand­ing over $40 mil­lion up­front, $20 mil­lion for ini­tial fund­ing for clin­i­cal ac­tiv­i­ties and man­u­fac­tur­ing and a set of mile­stone pay­ments for their CAR-T in a 50/50 deal.

The deal for Japan part­ners Kite with one of the biggest play­ers in that coun­try’s phar­ma in­dus­try, and one that is com­mit­ted to build­ing up the in­fra­struc­ture to pro­duce and mar­ket these in­di­vid­u­al­ly tai­lored ther­a­pies, which ex­tract T cells from pa­tients and en­gi­neer them in­to at­tack weapons point­ed at can­cer cells.

“Dai­ichi Sankyo made a strate­gic de­ci­sion to get in­to cell ther­a­py,” says He­len Kim, Kite’s chief of busi­ness de­vel­op­ment. “The struc­ture is a more tra­di­tion­al li­cens­ing agree­ment. We will pro­vide tech­nol­o­gy trans­fer on the man­u­fac­tur­ing. It’s their de­sire to do the man­u­fac­tur­ing” in Japan.

“They’re very strong in on­col­o­gy,” she added about Fo­s­un. “They just have a huge pres­ence” in Chi­na.

Kite’s been en­gaged in a race with No­var­tis for the first ap­proval for a CAR-T ther­a­py, while one-time ri­val Juno strug­gles with a lead pro­gram which has been linked to five pa­tient deaths due to brain tox­i­c­i­ty. These first CAR-Ts have been as­so­ci­at­ed with cy­tokine re­lease syn­drome, but have al­so shown great promise in treat­ing ag­gres­sive non-Hodgkin lym­phoma, where Kite has been tar­get­ing its first ap­proval.

Kite has a Eu­ro­pean sub­sidiary that plans to wres­tle for an ap­proval on the con­ti­nent.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.