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.”

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.