Ex­or­cis­ing Mar­tin Shkre­li’s ghost, Kalo­Bios steps out of Ch. 11 and back in­to the biotech busi­ness

Six months af­ter Mar­tin Shkre­li’s brief, tur­bu­lent role as the con­tro­ver­sial sav­ior of the trou­bled Kalo­Bios end­ed in Chap­ter 11 and near ex­tinc­tion, new CEO Cameron Dur­rant is turn­ing the last page on that chap­ter of pulp fic­tion dra­ma.

This morn­ing Kalo­Bios says it has emerged from bank­rupt­cy with $14 mil­lion in fi­nanc­ing, a new­ly re­or­ga­nized board and a com­plet­ed deal with Sa­vant Ne­glect­ed Dis­eases to de­vel­op ben­znida­zole for the treat­ment of rare cas­es of Cha­gas dis­ease.

Cameron Dur­rant, Kalo­Bios CEO

“We re­al­ly see this as a clean slate,” Dur­rant tells me. “And it was pret­ty much dead twice over.”

The first near death ex­pe­ri­ence came af­ter a se­ries of big clin­i­cal set­backs in the com­pa­ny left in­vestors won­der­ing what man­age­ment was think­ing. Backed in­to a cor­ner, ex­ecs threat­ened to file for bank­rupt­cy un­less they could work out a deal.

And then Shkre­li ar­rived on the scene, bring­ing a horde of jour­nal­ists in his wake.

The biotech CEO had been boot­ed out of Retrophin and start­ed Tur­ing, grab­bing an old drug called Dara­prim and jack­ing up the price more than 5000%. But rather than duck­ing out a back door in the face of an on­line lynch mob, a de­fi­ant Shkre­li fa­mous­ly of­fered a one-fin­ger salute to all of his crit­ics, in­clud­ing me and every oth­er jour­nal­ist who ques­tioned his ac­tions. In short or­der he en­gi­neered a takeover of Kalo­Bios and ev­i­dent­ly was look­ing to re­peat his price goug­ing with ben­znida­zole.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

In­stead, he was ar­rest­ed, perp walked and charged with bla­tant fi­nan­cial fraud, which he has de­nied. Kalo­Bios was kicked off Nas­daq and left in a sham­bles. Now Dur­rant wants to make it clear that Shkre­li has no role left at the com­pa­ny—and hasn’t since the blow up last De­cem­ber—had his eq­ui­ty stake in the biotech cut to 14% and that the com­pa­ny is work­ing on get­ting that back as well.

While Shkre­li may be long gone, some of the ba­sic build­ing blocks he had been as­sem­bling will be key to the biotech’s re­cov­ery. Dur­rant is work­ing with the FDA on es­tab­lish­ing a de­vel­op­ment plan for ben­znida­zole, look­ing to win a po­ten­tial pri­or­i­ty re­view vouch­er from the FDA that by it­self could be worth a for­tune on the bio­phar­ma mar­ket.

“We’re hop­ing for a 505(b)(2) ap­proach,” says Dur­rant, re­fer­ring to an ab­bre­vi­at­ed clin­i­cal de­vel­op­ment plan that can use da­ta from oth­er stud­ies the com­pa­ny didn’t con­duct it­self. But they need to spend some time work­ing that out with the FDA.

Dur­rant al­so wants to get its an­ti­body KB003, a GM-CSF an­tag­o­nist, in the clin­ic for chron­ic myelomono­cyt­ic leukemia. And he’ll look for part­ners to take over 004 and 002.

The new CEO is work­ing on ar­rang­ing some fresh fi­nanc­ing and has lots on his plate. But Dur­rant al­so wants to ex­or­cise the ghost of Mar­tin Shkre­li once and for all, vow­ing a new ap­proach on drug pric­ing that is the po­lar op­po­site to the pro­tag­o­nist’s role Shkre­li played.

As for Shkre­li, he’s as un­re­pen­tant as ever. Just yes­ter­day, he had this to of­fer me.

https://twit­ter.com/Mar­tin­Shkre­li/sta­tus/748476570789109760

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.”

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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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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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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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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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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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