As­traZeneca is pay­ing In­nate Phar­ma at least $242M in near-term cash to sew up rights to mon­al­izum­ab-plus

Just 2 days af­ter rolling out a pos­i­tive snap­shot of ac­tiv­i­ty for its NKG2A im­mune check­point in­hibitor mon­al­izum­ab at ES­MO, In­nate Phar­ma SA (Eu­ronext: $IPH) has struck a rich add-on col­lab­o­ra­tion deal with As­traZeneca, which is bulk­ing up its I/O pipeline in a deal that in­cludes $170 mil­lion in up­front pay­ments, a $72 mil­lion eq­ui­ty deal plus bil­lions in added mile­stone pay­ments cov­er­ing a range of de­vel­op­ment pro­grams.

With $242 mil­lion in cash on the ta­ble this year and next, and an­oth­er $100 mil­lion in near-term cash on the ta­ble for piv­ot­ing in­to a late-stage study, As­traZeneca is mak­ing an un­usu­al­ly big pay­out rel­a­tive to its track BD record over the last few years, clear­ly in­di­cat­ing that it sees a big fu­ture for these In­nate ther­a­pies. And they’re get­ting $50 mil­lion back by out-li­cens­ing US and EU rights to a new­ly ap­proved drug in the port­fo­lio, al­low­ing In­nate to be­gin com­mer­cial­iza­tion work in the US.

Shares of In­nate rock­et­ed up 29% on the news.

Let’s break it down.

The jew­el in this crown is mon­al­izum­ab, which promis­es to re­store an im­mune re­sponse by NK and T cells, half of the heart of the I/O ap­proach, where As­traZeneca sees a big fu­ture for Imfinzi, its PD-L1 check­point that al­lows a more ef­fec­tive as­sault by im­mune cells, tak­ing the brakes off the sys­tem.

Pas­cal So­ri­ot

As­traZeneca is pay­ing $100 mil­lion in up­front cash for the on­col­o­gy rights to the ther­a­py, with $100 mil­lion due at the start of Phase III with $825 mil­lion due on a full slate of mile­stones. As­traZeneca will pay 70% of the late-stage de­vel­op­ment cost with In­nate cov­er­ing a capped 30% fig­ure. In­nate has an op­tion on co-pro­mo­tion rights in Eu­rope.

Why mon­al­izum­ab? In Mu­nich in­ves­ti­ga­tors un­veiled ear­ly da­ta on a com­bi­na­tion of mon­al­izum­ab and ce­tux­imab for squa­mous cell car­ci­no­ma of the head and neck.

The da­ta, says the com­pa­ny, re­flect­ed:

(T)he over­all re­sponse rate was 27.5% (by RE­CIST) in­clud­ing 1 con­firmed com­plete re­sponse (2.5%) and 10 par­tial re­spons­es (25%). Dis­ease con­trol rate at 24 weeks (DCR) was 35%. Me­di­an pro­gres­sion-free sur­vival (PFS) and over­all sur­vival (OS) reached 5.0 and 10.3 months, re­spec­tive­ly. In ad­di­tion, there were 3 (18%) re­spon­ders among the 17 pa­tients who had been pre­vi­ous­ly treat­ed with PD-1/L1 an­ti­bod­ies.

Then there’s IPH5201, CD39.

As­traZeneca is pay­ing $50 mil­lion for an op­tion on the rights to the drug, with $835 mil­lion in mile­stone mon­ey. If As­traZeneca takes the op­tion up, they will cov­er the Phase III un­less In­nate steps in on 50% of the cost in ex­change for co-pro­mo­tion rights in Eu­rope.

As­traZeneca is pay­ing $20 mil­lion on op­tions for 4 ad­di­tion­al pre­clin­i­cal pro­grams, with $355 mil­lion in mile­stones on each. Then there’s $72 mil­lion go­ing in­to the ac­qui­si­tion of 9.8% of In­nate’s eq­ui­ty.

In­nate, mean­while, agreed to pay $50 mil­lion for Lu­mox­i­ti, the new­ly ap­proved drug for rare cas­es of third-line hairy cell leukemia that As­traZeneca has planned to sell for $150,000 cov­er­ing 6 treat­ment cy­cles.

That all amounts to an un­usu­al big-mon­ey deal for As­traZeneca, which has been sell­ing as­sets re­cent­ly to help cov­er costs as Pas­cal So­ri­ot bets big on new can­cer drugs like Lyn­parza and Tagris­so and Imfinzi to turn things around at the phar­ma gi­ant. With those drugs ac­cel­er­at­ing on the mar­ket, he’s now adding a drug with hu­man da­ta to start back­ing up its promise.

So­ri­ot said that the deal al­lows his com­pa­ny to “fur­ther strength­en our lead­er­ship in im­muno-on­col­o­gy, and to ex­plore the po­ten­tial of next gen­er­a­tion im­muno-on­col­o­gy path­ways, to­geth­er with the world-class sci­en­tif­ic team of In­nate.”

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.