The Sen­ate fum­bles its first stab at phar­ma prof­i­teer­ing, keep­ing the is­sue front and cen­ter in 2017

End­points News as­sess­es the big bio­phar­ma R&D sto­ry this week in a spe­cial year-end send­off. Chances are, this is al­so what we’ll be talk­ing about in 2017. And it will cer­tain­ly be front and cen­ter at the up­com­ing J.P. Mor­gan Health­care Con­fer­ence.

The Sen­ate of­fers a weak re­sponse to price goug­ing

The Sen­ate this week high­light­ed just how lit­tle the bio­phar­ma in­dus­try needs to fear from law­mak­ers when it comes to con­trol­ling drug prices right now. In­ves­ti­gat­ing four clear cas­es of price goug­ing on old prod­ucts, two or­ches­trat­ed by Mar­tin Shkre­li, the Sen­ate pol­ished off a mix of dusty reg­u­la­to­ry in­cen­tives as their sug­ges­tion for rein­ing in prof­i­teer­ing: “spe­cial” pri­or­i­ty re­views when need­ed, vouch­ers to help re­ward a fast re­sponse, maybe a spe­cial reim­por­ta­tion pass to pro­vide cheap com­pe­ti­tion, a man­date to move gener­ics through the FDA faster. None of it would ac­tu­al­ly nip the whole thing in the bud. “It is pos­si­ble that the busi­ness mod­el pur­sued by the Valeants and Tur­ings of the world was at­trac­tive in part be­cause it was le­gal,” the re­port states, in a mas­sive un­der­state­ment. (Ya think?) Noth­ing the sen­a­tors sug­gest­ed would ac­tu­al­ly pre­vent the next Shkre­li from do­ing ex­act­ly the same thing. If law­mak­ers are un­will­ing to tack­le ob­vi­ous price goug­ing, then what are the chances they can ever come to grips with the much big­ger is­sue of sys­temic rip-offs, the an­nu­al price spikes that have kept Big Phar­ma look­ing healthy as their R&D ef­forts con­tin­ue to un­der­per­form?

It’s time to get re­al

Drug pric­ing as a po­tent po­lit­i­cal is­sue, though, isn’t go­ing any­where. As Shkre­li told mein a Twit­ter ex­change on Thurs­day, the two deals he en­gi­neered for Tur­ing and Retrophin are still mak­ing plen­ty of “guap” as law­mak­ers fud­dle about. Don­ald Trump has made his own broad, un­de­fined pledge to con­trol pric­ing. And elect­ed of­fi­cials have to be acute­ly aware that the pub­lic’s anger will on­ly grow. One of the most com­pelling in­dus­try re­spons­es has been Al­ler­gan CEO Brent Saun­ders’ pledge to hold an­nu­al price in­creas­es to sin­gle dig­its.

Fair pric­ing prac­tices on old­er drugs will be es­sen­tial to main­tain­ing greater con­trol over the price of new drugs. It’s im­por­tant to re­mem­ber that pub­lic anger is not fixed on the price of im­por­tant new drugs that make a dif­fer­ence in peo­ple’s lives. It’s the old­er drugs, where the price goes up when the fran­chise should be fad­ing in val­ue, that rile the peo­ple and of­fend their sense of fair­ness. No one likes be­ing ripped off. And with­out ag­gres­sive pric­ing on many, though not nec­es­sar­i­ly all, new drugs, R&D will be­come un­sus­tain­able.

If this is­sue has your at­ten­tion, I’d en­cour­age you to come to End­points News’ first live event dur­ing the J.P. Mor­gan Health­care Con­fer­ence in San Fran­cis­co, where we’ll be joined by Saun­ders and a great pan­el dis­cussing the sin­gle most press­ing is­sue of the year.

Your tick­et rev­enue will be used to help grow the pub­li­ca­tion in 2017. So you can view this as a way to par­tic­i­pate in a great dis­cus­sion, a net­work­ing event you won’t want to miss, and a sign of your sup­port for what we’re do­ing here.

John Car­roll, Ed­i­tor

Hap­py hol­i­days, and I hope to see you in San Fran­cis­co Jan­u­ary 10.— John Car­roll

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.”

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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.”

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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.

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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.

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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.

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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.

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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.

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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.

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