Biotech vet Paul Bren­nan takes helm at re­gen­er­a­tive med biotech; Ax­cel­la names CFO

Paul Bren­nan

→ Re­gen­er­a­tive med­i­cine com­pa­ny, Nerv­Gen Phar­ma — fo­cused on the treat­ment of nerve dam­age — has tapped Paul Bren­nan to head the helm of the com­pa­ny as CEO and pres­i­dent. Bren­nan is the suc­ces­sor to Ernest Wong, who will con­tin­ue to serve as a con­sul­tant to the com­pa­ny. In ad­di­tion, the com­pa­ny has en­list­ed Lloyd Macken­zie in the new­ly cre­at­ed po­si­tion of COO. Bren­nan’s pre­vi­ous stints in­clude roles at Eu­prax­ia Phar­ma­ceu­ti­cals, Aquinox Phar­ma­ceu­ti­cals, Ar­bu­tus Bio­phar­ma (for­mer­ly Tek­mi­ra Phar­ma­ceu­ti­cals) and AnorMED among oth­ers. Bren­nan played roles in han­dling the sale of As­pre­va to Vi­for Phar­ma for $915 mil­lion, the sale of AnorMED to Gen­zyme for $580 mil­lion and the merg­er of Tek­mi­ra and On­Core Bio­phar­ma to form Ar­bu­tus Bio­phar­ma, val­ued at over $1 bil­lion on the day of the trans­ac­tion. Macken­zie hails from his re­cent role as chief de­vel­op­ment of­fi­cer at No­table Labs and pri­or to that was the COO at Aquinox Phar­ma­ceu­ti­cals.

Lau­rent Chardon­net

Bill Hen­shaw-led Ax­cel­la Health — which closed its IPO ear­li­er in May, bag­ging $71.4 mil­lion — has ap­point­ed Lau­rent Chardon­net as CFO and pro­mot­ed VP of le­gal, Hei­dy King-Jones, to gen­er­al coun­sel. Chardon­net joins the com­pa­ny af­ter a 15-year stint at In­cyte, where he helped build the com­pa­ny from a $500 mil­lion de­vel­op­ment-stage or­ga­ni­za­tion in­to a com­mer­cial bio­phar­ma com­pa­ny. Pri­or to In­cyte, Chardon­net served as con­troller, VP of fi­nance and act­ing CFO at Dru­gAbuse Sci­ences. King-Jones joined Ax­cel­la in Jan­u­ary 2018 and pri­or to her time with the com­pa­ny, man­aged the cor­po­rate law de­part­ment and was lead com­mer­cial coun­sel at Sarep­ta Ther­a­peu­tics.

MiMedx — which yes­ter­day had the feds add fraud charges to the pil­ing ac­cu­sa­tions made against the com­pa­ny’s for­mer ex­ecshas wel­comed William Butch Hulse as its new gen­er­al coun­sel and sec­re­tary. Most re­cent­ly, Hulse served as a mem­ber of na­tion­al law firm Dyke­ma. Pri­or to that he served as chief com­pli­ance of­fi­cer and SVP of qual­i­ty, reg­u­la­to­ry and en­ter­prise risk man­age­ment at Aceli­ty LP.

Hei­dy King-Jones Ax­cel­la

In­ter­sect ENT — fo­cused on the treat­ment of ear, nose and throat con­di­tions — has ap­point­ed Richard (Randy) Meier as EVP and CFO. Meier pre­vi­ous­ly served in the same role as CFO, along with oth­er ex­ec po­si­tions, of Owens & Mi­nor. Pri­or to that, he was the EVP and CFO of Tele­flex and COO of Ad­vanced Med­ical Op­tics.

→ Acor­da Ther­a­peu­tics — where CEO Ron Co­hen re­struc­tured the com­pa­ny af­ter re­port­ing mea­ger sales from its new drug — has elect­ed for­mer Tenax Ther­a­peu­tics CEO John Kel­ley to serve as non-ex­ec­u­tive board chair. Kel­ley has been a mem­ber of the board since 2008.

→ IVER­IC bio —fo­cused on the treat­ment of reti­nal dis­eases — has wel­comed the cur­rent pres­i­dent of the Amer­i­can So­ci­ety of Gene and Cell Ther­a­py (AS­GCT), Guang­ping Gao — a pi­o­neer in AAV gene de­liv­ery tech­nol­o­gy — as chief strate­gist, gene ther­a­py. Gao will help shape the com­pa­ny’s strat­e­gy mov­ing for­ward in his new role. In ad­di­tion, Gao is the co-di­rec­tor, Li Wei­bo In­sti­tute for Rare Dis­eases Re­search and di­rec­tor, Ho­rae Gene Ther­a­py Cen­ter and Vi­ral Vec­tor Core.

Guang­ping Gao Gao Lab

No­vo Seeds, the ear­ly-stage in­vest­ment arm of No­vo Hold­ings, has an­nounced that sev­er­al en­tre­pre­neurs will be join­ing its ad­vi­so­ry unit, BiO­ri­gin. For­mer ex­ecs Mar­tin Bonde of Vac­ci­body, John Hau­rum of F-star and An­ders Hins­by of Or­p­hazyme have all hopped aboard as en­tre­pre­neurs-in-res­i­dence. In ad­di­tion, the com­pa­ny has en­list­ed co-founder and for­mer CEO of Plexxikon Pe­ter Hirth and for­mer Lund­beck ex­ec An­ders Gersel Ped­er­sen as ad­vi­sors.

→ As Re­zo­lute gears up to start Phase IIb tri­als for its an­ti­body, RZ358, for the ul­tra-or­phan in­di­ca­tion of con­gen­i­tal hy­per­in­sulin­ism, the com­pa­ny has wel­comed Nek­tar Ther­a­peu­tics COO and CFO Gil Labrucherie to its board of di­rec­tors as chair­man of the au­dit com­mit­tee.

George Tid­marsh

La Jol­la Phar­ma­ceu­ti­cal has to re­con­sid­er its fu­ture with­out CEO George Tid­marsh. He hit the ex­it af­ter a 7-year stint at the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties, fol­low­ing a key tri­al fail­ure. The com­pa­ny’s board di­rec­tors Kevin Tang and Craig John­son will step in to over­see the man­age­ment team, along with be­ing tasked with max­i­miz­ing sales of Gi­apreza — a vaso­con­stric­tor ap­proved to in­crease blood pres­sure in adults with sep­tic or oth­er dis­trib­u­tive shock in the US, and to treat re­frac­to­ry hy­poten­sion for the same pop­u­la­tion in Eu­rope — and seek an FDA green light for the malar­ia ther­a­py LJPC-0118. La Jol­la has re­cent­ly filed an NDA for the drug.

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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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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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.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.