Scoop: Juno re­cruits Sunil Agar­w­al as R&D chief, open­ing a Bay Area fa­cil­i­ty in re­search re­vamp

Hans Bish­op, CEO of Juno Ther­a­peu­tics Vic­tor J. Blue/Bloomberg via Get­ty Im­ages

A trou­bled Juno Ther­a­peu­tics $JUNO has re­cruit­ed ex-Genen­tech sci­en­tist Sunil Agar­w­al to head up a re­vamped R&D or­ga­ni­za­tion as the Seat­tle-based biotech sets out to es­tab­lish a San Fran­cis­co group to help rev up its work on the biotech’s lead­ing CAR-T ther­a­pies and get back on tar­get af­ter its lead pro­gram jumped the tracks, End­points News has learned.

Ac­cord­ing to an in­ter­nal memo ob­tained by End­points, Juno CEO Hans Bish­op alert­ed staff on Fri­day af­ter­noon that the com­pa­ny plans to an­nounce the new hire be­fore the mar­ket opens on Mon­day. A com­pa­ny spokesper­son con­firmed the an­nounce­ment late Sun­day.

Agar­w­al has been named pres­i­dent of R&D with CMO Mark Gilbert, CSO Hy Lev­it­sky and Liz Smith, head of reg­u­la­to­ry and qual­i­ty as­sur­ance, re­port­ing di­rect­ly to him. The new R&D chief will al­so lead the new San Fran­cis­co or­ga­ni­za­tion.

Mark Frohlich, EVP of de­vel­op­ment and port­fo­lio strat­e­gy, an­nounced sev­er­al weeks ago that he was leav­ing the com­pa­ny.

“With Sunil’s ap­point­ment,” Bish­op not­ed in his com­pa­ny memo, “we are bring­ing re­search and de­vel­op­ment to­geth­er as a sin­gle in­te­grat­ed or­ga­ni­za­tion un­der his lead­er­ship.”

Juno has been bad­ly shak­en by back-to-back in­ci­dents with its ini­tial lead pro­gram for JCAR015. The drug killed 5 pa­tients, with the last two deaths in 2016 — which came af­ter the FDA had lift­ed a clin­i­cal hold on the drug — forc­ing the com­pa­ny to slam the brakes on its de­vel­op­ment for the sec­ond time. Bish­op lat­er de­cid­ed to scrap the drug, push­ing the one-time CAR-T leader far be­hind sched­ule for its first FDA ap­pli­ca­tion.

Juno is now more than a year be­hind Kite Phar­ma­ceu­ti­cals and No­var­tis, which are in a neck-and-neck race to the agency’s fin­ish line with ri­val CAR-Ts.

In the memo, Bish­op writes that Agar­w­al will be tasked with cre­at­ing and ex­e­cut­ing a clear strat­e­gy with an aim at de­creas­ing “the time it takes to get new tech­nolo­gies and trans­la­tion­al in­sights in­to the clin­ic.”

Based on the very pos­i­tive clin­i­cal da­ta as­so­ci­at­ed with JCAR014, JCAR017 and BC­MA, Juno has de­cid­ed to ful­ly in­vest in JCAR017 and JCAR025 to de­vel­op them as quick­ly as pos­si­ble. Start­ing im­me­di­ate­ly and over the next few years, we will need to sig­nif­i­cant­ly ramp up our clin­i­cal de­vel­op­ment ca­pa­bil­i­ties to achieve the qual­i­ty and speed of ex­e­cu­tion to be a mar­ket leader in the CAR T space and to bring this (sic) in­no­v­a­tive prod­ucts to pa­tients. The com­pet­i­tive land­scape is al­so heat­ing up, so our pri­or­i­ti­za­tion and de­ci­sion mak­ing as­so­ci­at­ed with tri­al ex­e­cu­tion and pipeline pri­or­i­ti­za­tion will need to be en­hanced as well.

Sim­i­lar to our of­fices in Boston and Ger­many, the ad­di­tion of a Bay Area of­fice en­ables the com­pa­ny to con­tin­ue our growth tra­jec­to­ry and puts us in the best po­si­tion to con­tin­ue to hire world-class tal­ent.

Agar­w­al is an un­con­ven­tion­al pick as head of R&D at Juno. At Genen­tech he led work on in­fec­tious dis­eases, me­tab­o­lism, neu­ro­science and oph­thal­mol­o­gy, then joined Ul­tragenyx, a rare dis­ease play­er, for a brief stint. More re­cent­ly he’s worked at Sofinno­va, a high-pro­file ven­ture group.

Juno isn’t the on­ly play­er to re­vamp its CAR-T R&D group. Last sum­mer No­var­tis dis­solved its CAR-T group and laid off 120 staffers as it ab­sorbed the unit in its on­col­o­gy di­vi­sion. And just weeks ago a top No­var­tis team mem­ber fo­cused on CAR-T, Karen Walk­er, left to take a new job at Seat­tle Ge­net­ics.

To cre­ate these CAR-Ts, in­ves­ti­ga­tors ex­tract T cells from pa­tients and then reengi­neer them to specif­i­cal­ly tar­get can­cer cells. This ap­proach has pro­duced some com­pelling da­ta, par­tic­u­lar­ly for blood can­cers. And the race to de­vel­op a port­fo­lio of mar­ket­ed prod­ucts has at­tract­ed con­sid­er­able in­vestor in­ter­est, with a group of lead­ers land­ing bil­lions in new in­vest­ments.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:

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