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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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