Syn­er­gy CEO pass­es torch to CCO Troy Hamil­ton; Pres­i­dent Steven Kaf­ka re­signs from Foun­da­tion; Ab­b­Vie vet John Leonard to helm In­tel­lia

Troy Hamil­ton

→ Mark­ing a new phase for the biotech, Syn­er­gy Phar­ma­ceu­ti­cals $SYGP an­nounced that co-founder and Tru­lance co-in­ven­tor Gary Ja­cob is pass­ing the CEO ba­ton to Troy Hamil­ton. Join­ing Syn­er­gy in 2015, Hamil­ton was chief com­mer­cial of­fi­cer and EVP, steer­ing the launch and com­mer­cial­iza­tion of Tru­lance. The chron­ic id­io­path­ic con­sti­pa­tion drug is right up Hamil­ton’s al­ley, as he man­aged the gas­troin­testi­nal unit at Shire for nine years af­ter spend­ing much of his ca­reer at Janssen and Mc­Neil Spe­cial­ty Prod­ucts. “One of my ini­tial ar­eas of fo­cus will be to work with our CFO, Gary Gemignani, and the Syn­er­gy man­age­ment team to con­tin­ue to re­fine our busi­ness plan and fo­cus on achiev­ing cost ef­fi­cien­cies through­out the com­pa­ny while pri­or­i­tiz­ing in­vest­ments that will dri­ve sig­nif­i­cant Tru­lance growth,” Hamil­ton said in the state­ment. He al­so made sure to thank Ja­cob, who will con­tin­ue his in­volve­ment with the com­pa­ny as ex­ec­u­tive chair­man of the board.

Steven Kaf­ka

→ Pres­i­dent and COO Steven Kaf­ka has in­formed Foun­da­tion Med­i­cine $FMI of his in­ten­tion to re­sign next Feb­ru­ary, trig­ger­ing a lead­er­ship reshuf­fle that adds the pres­i­dent ti­tle to CEO Troy Cox and COO role to SVP of in­ter­na­tion­al mar­kets Kon­stan­tin Fiedler. Kaf­ka’s tenure at Foun­da­tion last­ed al­most five years, no­tice­ably longer than his stints at oth­er biotechs in­clud­ing Mil­len­ni­um Phar­ma­ceu­ti­cals and Aileron Ther­a­peu­tics. Cox and Fiedler are both rel­a­tive­ly new to the biotech, but each had spent time at some big name com­pa­nies be­fore land­ing here.

→ Cam­bridge, MA-based start­up Dis­arm Ther­a­peu­tics has lured Pe­ter Keller to join as chief busi­ness of­fi­cer af­ter sev­en years at Se­lec­ta Bio­sciences. Keller hasn’t al­ways worked in biotech — he was a man­age­ment con­sul­tant for a decade — but while in the in­dus­try, he has been in­volved in an ac­qui­si­tion, a big IPO and a bil­lion-dol­lar deal. While we haven’t heard much about where Dis­arm’s ax­on­al de­gen­er­a­tion-pre­vent­ing tech is head­ed, we now know Keller will be shap­ing part of it.

Joe Jimenez

→ As Joe Jimenez con­tin­ues to search for his next big break af­ter No­var­tis (ide­al­ly in Sil­i­con Val­ley), he will spend some time in Cincin­nati as a mem­ber of Proc­ter & Gam­ble’s board of di­rec­tors. Con­sumer busi­ness is fa­mil­iar turf for Jimenez, who worked top jobs at Heinz be­fore tak­ing the reins of the Swiss phar­ma gi­ant.

→ In a clear sig­nal that CRISPR/Cas9 play­er In­tel­lia Ther­a­peu­tics is piv­ot­ing to a Phase I, John Leonard, found­ing chief med­ical of­fi­cer, is be­ing kicked up to the CEO’s of­fice. Hav­ing led the biotech $NT­LA through a quick and suc­cess­ful IPO in 2016, At­las part­ner Nes­san Berming­ham will re­turn to biotech ven­ture cap­i­tal. The R&D trek will like­ly be long, with ri­vals Ed­i­tas and CRISPR Ther­a­peu­tics — who are still fight­ing over the IP — de­ter­mined to have a slice of the mar­ket. The board is putting its faith in Leonard, the for­mer top sci­en­tist at Ab­b­Vie who worked on HIV and HCV while tak­ing a lead role on Hu­mi­ra dur­ing his 22-year tenure.

Gen­zyme vet Marc Beck­er will be Con­cert Phar­ma’s new CFO, af­ter a brief stint at CRISPR Ther­a­peu­tics. The Lex­ing­ton, MA-based biotech $CNCE is prepar­ing to broad­en its pipeline of deu­teri­um chem­istry prod­uct can­di­dates — a pipeline where four out of five pro­grams are cur­rent­ly part­nered — and Beck­er will be very much in­volved in that, ac­cord­ing to a state­ment.

→ Paris-based Ac­ti­cor Biotech has tapped Yan­nick Plé­tan as its first chief med­ical of­fi­cer. A spin­off from the French Na­tion­al In­sti­tute of Health and Med­ical Re­search, the 4-year-old com­pa­ny is de­vel­op­ing an an­tithrom­bot­ic agent for the acute phase of is­chemic stroke. Plé­tan’s clin­i­cal and med­ical ex­pe­ri­ence at Roche and Pfiz­er will be im­por­tant as Ac­ti­cor nav­i­gates the next tri­al phase for its lead can­di­date ACT017.

Ra­jesh Shrotriya, the 15-year chair­man and CEO of Spec­trum Phar­ma­ceu­ti­cals, has been fired, the com­pa­ny an­nounced Sun­day. The ter­mi­na­tion trig­gered a chain of lead­er­ship changes: cur­rent pres­i­dent and COO Joseph Tur­geon is now pres­i­dent and CEO, as well as a board of di­rec­tor mem­ber; di­rec­tor Stu­art Krass­ner fills the chair­man seat; and Thomas Riga (EVP, CCO and head of busi­ness de­vel­op­ment) be­comes COO. Tur­geon is an Am­gen vet who used to over­see com­mer­cial ac­tiv­i­ties for Spec­trum.

→ For­est Labs vet Charles Ryan will take the CEO’s job at Neu­rotrope $NTRP fol­low­ing the res­ig­na­tion of Su­sanne Wilke.

→ In line with CEO George Scan­gos’ vi­sion for Vir Biotech­nol­o­gy to be a sci­ence-dri­ven com­pa­ny, im­mu­nol­o­gist An­to­nio Lan­za­vec­chia has been brought on as SVP and se­nior re­search fel­low. His main charge is to pro­vide sci­en­tif­ic lead­er­ship for Vir’s tech­ni­cal pro­grams look­ing in­to se­ri­ous in­fec­tious dis­eases. While do­ing that for the San Fran­cis­co up­start, he will con­tin­ue his roles as di­rec­tor of the In­sti­tute for Re­search in Bio­med­i­cine in Bellinzona, Switzer­land and as pro­fes­sor at the Uni­ver­sità del­la Svizzera ital­iana.

→ Fol­low­ing No­vem­ber’s IPO, Apel­lis Phar­ma­ceu­ti­cals $APLS has ap­point­ed Tim­o­thy Sul­li­van, for­mer­ly a VC firm part­ner, as CFO. Sul­li­van has spent the past three years as an ob­serv­er on Apel­lis’ board of di­rec­tors, as the Ken­tucky biotech took its Soliris ri­val drug and age-re­lat­ed mac­u­lar de­gen­er­a­tion ther­a­py fur­ther along the pipeline, rais­ing mon­ey even af­ter a foiled first IPO at­tempt. Now Apel­lis is ready to en­ter Phase III tri­als for both pro­grams in 2018, and in his new role, Sul­li­van will lead the de­vel­op­ment of its fi­nanc­ing and growth strat­e­gy.

→ Long­time EVP and CFO Ryan May­nard is re­sign­ing from South San Fran­cis­co-based Rigel Phar­ma­ceu­ti­cals $RIGL for undis­closed rea­sons (but cer­tain­ly not due to a dis­pute or dis­agree­ment with the com­pa­ny, ac­cord­ing the to SEC fil­ing). Nel­son Ca­bat­u­an, cur­rent VP of fi­nance, will step in as the in­ter­im prin­ci­pal ac­count­ing of­fi­cer while the biotech search­es for a re­place­ment ahead of its lead drug’s PDU­FA date.

Bellerophon Ther­a­peu­tics $BLPH has qui­et­ly hired a new CFO, As­saf Ko­rner, to re­place Megan Schoeps, who re­signed a cou­ple weeks ago. Ko­rner has worked a slate of fi­nan­cial jobs at med­ical de­vice and con­sumer prod­uct com­pa­nies such as Syneron Med­ical, Ilu­mi­nage Beau­ty and KP­MG.

→ Af­ter wow­ing in­vestors with its BC­MA-tar­get­ing CAR-T at ASH, blue­bird bio $BLUE turned to its in­ter­nal op­er­a­tions and named Ko­ry Went­worth VP of fi­nance and prin­ci­pal ac­count­ing of­fi­cer. A vet­er­an of big pub­lic ac­count­ing firms, Went­worth cut his teeth in biotech con­troller­ship dur­ing his 9-year run at Alex­ion. He fills the shoes of Jef­frey Walsh, the biotech’s chief fi­nan­cial and strat­e­gy of­fi­cer, who will con­tin­ue to serve in the prin­ci­pal fi­nan­cial role.

→ British dis­cov­ery and de­vel­op­ment ser­vice provider Con­cept Life Sci­ences has hired An­drew Scott as head of bioas­say de­vel­op­ment and screen­ing, and Ma­g­a­lie Fer­bach as busi­ness de­vel­op­ment di­rec­tor for South­ern and Cen­tral Eu­rope. Scott has ex­pe­ri­ence span­ning phar­ma, biotech and CRO, while Fer­bach’s back­ground is in agro­chem­i­cals. These ap­point­ments wrap up Con­cept’s ex­pand­ing year, marked by the ac­qui­si­tion of Aquila Bio­med­ical in Ed­in­burgh and open­ing of new lab­o­ra­to­ry space at Alder­ly Park.

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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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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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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