Sanofi faces a make-or-break year, say­ing it’s ready to put a 3-prong R&D strat­e­gy to a piv­otal test

With the help of some key de­vel­op­ment part­ners, Sanofi set out to­day to try and prove to an in­creas­ing­ly skep­ti­cal group of in­vestors that it can con­trol its own des­tiny with a late-stage pipeline bristling with block­buster con­tenders.

Oliv­er Brandi­court, Sanofi CEO

But with a decade-long track record large­ly ab­sent of big, in-house suc­cess sto­ries and its “block­buster” Deng­vax­ia in a sham­bles, caught up in a glob­al safe­ty cri­sis that has crushed its po­ten­tial, that’s no easy task.

Un­der CEO Olivi­er Brandi­court and chief sci­en­tist Elias Zer­houni, the phar­ma gi­ant has pur­sued a three-prong R&D strat­e­gy for two years: Shift from small mol­e­cules to bi­o­log­ics; ad­vance from a monother­a­py ap­proach to com­bos; and drop the re­liance on li­cens­ing with a new em­pha­sis on de­vel­op­ing their own, whol­ly-owned as­sets.

That’s a work in progress, though, even as Sanofi touts a shot at 9 reg­u­la­to­ry sub­mis­sions in 18 months with the launch of 10 piv­otal tri­als by the end of 2018. The out­line al­so in­cludes one shelved pro­gram and key part­ner­ships with Re­gen­eron, Al­ny­lam, Myokar­dia and Prin­cip­ia.

The key ques­tion here is whether a big op­er­a­tion like Sanofi, which has re­lied on al­liances to pro­duce in­no­va­tion, can ac­tu­al­ly do some­thing im­por­tant on its own. And this af­ter for­mer CEO Chris Viehbach­er con­clud­ed that it was too big and too slow to ac­com­plish any­thing sig­nif­i­cant with­out lots of help. In­vestors, mean­while, have been grum­bling through­out CEO Olivi­er Brandi­court’s rein that the com­pa­ny’s best hope for fast progress lies in M&A, which has yet to ma­te­ri­al­ize.

Elias Zer­houni

Sanofi’s R&D pre­sen­ta­tion starts with a boast about the Phase III po­ten­tial of Dupix­ent — part­nered with Re­gen­eron — for COPD. Sanofi al­so has high hopes for an­oth­er an­ti-in­flam­ma­to­ry, the an­ti-IL-33 drug SAR440340, part­nered with Re­gen­eron. And they sep­a­rate­ly her­ald­ed the pos­i­tive piv­otal da­ta for their PD-1 can­cer check­point drug cemi­plimab, al­so part­nered with Re­gen­eron.

The pipeline re­view notes that Sanofi is tak­ing this treat­ment in­to a piv­otal pro­gram for front­line lung can­cer — a field that has at­tract­ed the in­tense in­ter­est of every ma­jor check­point play­er.

Here’s the rest of the line­up now in the spot­light, with a break­down by dis­ease fo­cus:

On­col­o­gy

  • Isat­ux­imab, a home grown an­ti-CD38 an­ti­body, is in the clin­ic for mul­ti­ple myelo­ma and will be stud­ied as a com­bi­na­tion ther­a­py with their check­point cemi­plimab, with in­ves­ti­ga­tors pur­su­ing signs that the add-on could have an ef­fect on PD-1 re­sis­tance. This drug rep­re­sents some re­newed ex­pec­ta­tions in on­col­o­gy, close to three years af­ter a re­or­ga­ni­za­tion on the can­cer front fol­low­ing some sig­nif­i­cant fail­ures and the de­par­ture of Tal Zaks.

Mul­ti­ple scle­ro­sis

  • Lem­tra­da — ac­quired in the Gen­zyme buy­out — is be­ing stud­ied for the pri­ma­ry, pro­gres­sive form of mul­ti­ple scle­ro­sis. An­oth­er drug, GLD-52, is be­ing “de­pri­or­i­tized” to keep the spot­light on Lem­tra­da. And there’s a BTK drug for MS part­nered with Prin­cip­ia.

Rare dis­eases

  • There’s a drug called venglu­s­tat for rare cas­es of au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease. And the phar­ma gi­ant sees po­ten­tial here for Fab­ry Dis­ease, Gauch­er Dis­ease Type 3 and GBA Parkin­son’s Dis­ease.
  • Two oth­er rare dis­ease drugs — olipu­dase and aval­glu­cosi­dase al­fa — are get­ting the spot­light treat­ment to­day.
  • And the fo­cus on rare dis­eases fin­ish­es with the al­liance with Al­ny­lam, which is do­ing the de­vel­op­ment work for patisir­an and fi­tusir­an.

Di­a­betes and car­dio

  • There’s a once-week­ly GLP-1 drug look­ing to join the field. It’s called ef­pe­gle­natide.
  • An oral dual ag­o­nist of GLP-1/GCG is get­ting a shoutout for a Phase III in obe­si­ty next year, along with a mid-stage pro­gram for NASH.
  • The big part­ner­ship hope here lies at Myokar­dia, which is al­lied with Sanofi on mava­camten, their lead drug for ge­net­i­cal­ly de­fined cas­es of car­diomy­opa­thy.

Vac­cines

  • Af­ter two huge dis­as­ters in vac­cines in the last few days, Sanofi high­lights its work on RSV, but it’s still in Phase II.

R&D chief Zer­houni summed it up:

“2018 will be an im­por­tant year as we ex­pect mul­ti­ple mile­stones for Sanofi’s late-stage pipeline, made pos­si­ble through the pri­or­i­ti­za­tion prin­ci­ples we have con­sis­tent­ly ap­plied to our ear­ly-stage re­search pro­grams.”

Daniel O'Day [via AP Images]

UP­DAT­ED: Look­ing to re­solve lin­ger­ing doubts, Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

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Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Eli Lil­ly's Christi Shaw bows out of top post at the Bio-Med­i­cines unit

Less than 3 years after Eli Lilly CEO David Ricks recruited Novartis vet Christi Shaw to run their big Bio-Medicines business, she’s out.

In a statement put out Thursday morning, Lilly said that Shaw’s last day will come at the end of August. Patrik Jonsson, currently president and general manager of Lilly Japan, will succeed Shaw once he gets the paperwork sorted out.

Lilly’s shares dropped 4% on the news.

Jeff Poulton

Al­ny­lam’s Maraganore switch­es ‘per­haps the best CFO in mid-cap biotech’ with Shire vet Jeff Poul­ton

There’s a new CFO taking charge of the numbers at RNAi pioneer Alnylam.

Alnylam chief John Maraganore says that CFO Manmeet S. Soni is leaving in the proverbial pursuit of new opportunities. And he’s being replaced by ex-Shire CFO Jeff Poulton, not long after the Takeda takeover obliterated that position.

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Analy­sis: In most of the Big Phar­ma world, R&D spend­ing tow­ers over rev­enue from new drugs. Guess who beat the odds

It’s always been the case that there’s no medicine less useful than one that doesn’t make it to patients (unless you regard the task of R&D to be perpetually learning about swimming, while under water…). Yet, launching new medicines that physicians want, that payers will cover, and that patients will take, is a discipline that is unevenly distributed among the big players.

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President Donald Trump at State of the Union. AP Images

White House changes course to kill re­bate re­form

So what exactly is the White House’s plan to tackle rising drug prices? It doesn’t look like we will get definitive answers anytime soon. On the heels of President Donald Trump’s surprise revelation that an executive order is in the works to implement a “favored nations clause,” his administration is now putting out word that it has abandoned an earlier proposal to overhaul rebates.

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Janet Woodcock, AP Images

The FDA's Janet Wood­cock talks about some big changes she's push­ing for in drug de­vel­op­ment, and agency re­views

Janet Woodcock is perhaps the most influential regulator at the FDA. And when the head of CDER talks about the changes being made at the agency when it comes to clinical trial designs, or the need to reorganize for a specific disease arena, an assessment of the expansion of gene therapy or I/O, common development mistakes, and so on, you can be sure the industry pays attention to every word.

So it was with some eagerness that I opened up Geoffrey Porges’ summary of their recent conversation about the FDA. And I wasn’t disappointed. In a wide-ranging exchange with the SVB Leerink analyst, Woodcock discussed the growing importance of patient-reported outcomes in clinical trials, a campaign underway now to see if CROs would help spur more basket studies to compare drugs head-to-head, and much, much more.

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Ex-DARPA di­rec­tor pur­sues all-in-one can­cer pill as NED CEO; Karyopharm los­es com­mer­cial chief ahead of drug roll­out

“Why not try?”

That’s what Geoffrey Ling told me over the phone when asked about what led him to his journey to the position of CEO at NED Biosciences — a company with a lofty goal of creating an all-in-one oral drug to treat all types of cancer and making this drug available to not only developed nations, but also the developing world. 

Ling comes from an extensive background in medicine and the government. He is the co-leader of The Brain Health Project, a professor of neurology and an attending neurocritical care physician at John Hopkins University and Hospital, as well as the assistant director for Medical Innovation of the Science Division in president Obama’s White House Office of Science and Technology Policy (OSTP).