Sanofi is team­ing with Ver­i­ly on a $500M JV aimed at mar­ry­ing tech with di­a­betes drugs

A year af­ter the phar­ma gi­ant Sanofi $SNY agreed to col­lab­o­rate with Ver­i­ly Life Sci­ences (for­mer­ly Google Life Sci­ences) to spawn a new tech plat­form for man­ag­ing di­a­betes, the glob­al com­pa­nies are fol­low­ing up by es­tab­lish­ing a new joint ven­ture that will be tasked with ac­com­plish­ing the alpine goals they’ve set out for them­selves.

Joshua Riff, On­duo

Based in Kendall Square — ground ze­ro in the glob­al biotech hub in Cam­bridge, MA — the new On­duo will be led by Joshua Riff, a vet­er­an of the U.S. man­aged care world, where dis­ease man­age­ment has be­come a core fo­cus for some of the coun­try’s biggest in­sur­ers.

On­duo will tack­le a glob­al mar­ket, look­ing to wire mil­lions of pa­tients with minia­tur­ized elec­tron­ics and soft­ware in a way that will make it eas­i­er to mon­i­tor and con­trol di­a­betes on a day-to-day ba­sis. The chron­ic ail­ment has been ex­plod­ing at a pan­dem­ic lev­el, cur­rent­ly count­ing some 400 mil­lion vic­tims. And the new com­pa­ny, god­fa­thered by multi­na­tion­al com­pa­nies with hun­dreds of bil­lions in mar­ket caps, will start out with a joint com­mit­ment of close to $500 mil­lion to make it all hap­pen.

The next step will be to glean in­sights di­rect­ly from pa­tients and physi­cians, Riff tells me, tap­ping in on Sanofi’s glob­al di­a­betes net­work. Ver­i­ly will con­tribute its ex­per­tise on com­put­er chips, deep an­a­lyt­ics and ma­chine learn­ing, and start de­sign­ing the mi­cro­elec­tron­ics and soft­ware that will be need­ed to tie it all to­geth­er, giv­ing pa­tients some di­rect feed­back on how their lifestyle choic­es, ex­er­cise, drug use and more help man­age di­a­betes.

“We be­lieve you can take a dis­ease like di­a­betes and take a dif­fer­ent ap­proach,” says Riff. “We ap­proach it from a to­tal­ly dif­fer­ent an­gle and come up with dif­fer­ent so­lu­tions.”

All the big play­ers work to build re­la­tion­ships with pa­tients. But if this is any kind of game-chang­er, it will take years to play out. And pres­sure con­tin­ues to build on CEO Olivi­er Brandi­court, who just got beat out on the Medi­va­tion buy­out, to do some­thing with a big­ger near-term im­pact than a JV start­up.

Sanofi out­lined the fi­nanc­ing for On­duo in a state­ment to End­points News:

Sanofi has com­mit­ted $248M to the ven­ture, with Ver­i­ly pro­vid­ing an equiv­a­lent cap­i­tal con­tri­bu­tion.  On­duo’s cur­rent fi­nanc­ing strong­ly po­si­tions the com­pa­ny to ex­e­cute on its near-term and long-term goals. At this stage, On­duo is not in the po­si­tion to dis­cuss the com­pa­ny’s spe­cif­ic cash run­way or fu­ture fi­nan­cial plans at this time.

For Ver­i­ly, op­er­at­ing un­der the big um­brel­la cre­at­ed for Google’s Al­pha­bet, it’s a chance to take a lead­ing role in the con­ver­gence of mi­cro­elec­tron­ics and health. Ver­i­ly has mapped out an am­bi­tious ef­fort in health­care, and it’s col­lab­o­rat­ing with some of the biggest play­ers in bio­phar­ma. Just weeks ago Ver­i­ly signed a longterm pact with Glax­o­SmithK­line to de­vel­op elec­tro­ceu­ti­cals, which are still in a pre­clin­i­cal phase of de­vel­op­ment. And there are al­so part­ner­ships un­der­way with Bio­gen (us­ing wear­ables to test MS drugs) and J&J (in sur­gi­cal ro­bot­ics.)

For Sanofi, the part­ner­ship of­fers a chance to shore up its block­buster di­a­betes fran­chise, where rev­enue has be­gun to erode. Fix­ing that predica­ment has be­come a top pri­or­i­ty for Brandi­court since he was named to the helm 17 months ago. Sanofi is up against some tough ri­vals, in­clud­ing Eli Lil­ly and No­vo Nordisk. And they all have carved out big mar­ket shares for a dis­ease where one-third of pa­tients are be­ing treat­ed prop­er­ly, a third have been di­ag­nosed and aren’t man­ag­ing their dis­ease, and a third that have nev­er even been di­ag­nosed.

At the same time, di­a­betes has been spread­ing fast, with more than 200 mil­lion pa­tients ex­pect­ed to be added in com­ing years.

A lot of com­pa­nies have been try­ing to solve the di­a­betes dilem­ma in dif­fer­ent ways, says Riff, but once you get past the in­sulin that has been on the mar­ket, there’s not been tremen­dous progress.

Pe­ter Guenter, Sanofi

So one of the world’s largest tech com­pa­nies is part­ner­ing with one of the world’s largest phar­ma com­pa­nies with this man­date: “Lets cre­ate an en­ti­ty, take the de­vel­op­ment process to­ward un­der­stand­ing the dis­ease and then find in­sights to lead to so­lu­tions to man­age di­a­betes,” ex­plains Riff.

Who pays for it? “Even­tu­al­ly any­one who pays for health­care,” says Riff. And that’s a long and grow­ing list.

For now, Riff says one of many im­me­di­ate tasks is or­ga­niz­ing the lead­er­ship group for On­duo and then build­ing a staff. Just how many em­ploy­ees are ex­pect­ed, though, he isn’t say­ing right now.

Pe­ter Guenter, Sanofi’s head of glob­al di­a­betes & car­dio­vas­cu­lar busi­ness unit, said:

“The in­te­gra­tion of mul­ti­ple in­ter­ven­tions, such as da­ta-dri­ven pa­tient sup­port and de­vices in ad­di­tion to treat­ment, can help im­prove out­comes, which is im­por­tant from the per­spec­tive of pa­tients, health­care pro­fes­sion­als and the over­all health­care sys­tem,” said  “The new com­pa­ny Sanofi and Ver­i­ly in­vest­ed in will adopt a more ser­vice-cen­tric ap­proach and sup­port doc­tors in their ef­forts to treat their pa­tients more ef­fec­tive­ly. In ad­di­tion to de­vel­op­ing in­no­v­a­tive ther­a­pies for di­a­betes which will re­main a key fo­cus for Sanofi, we see these so­lu­tions which com­bine in­no­v­a­tive ther­a­pies and ser­vices as the fu­ture for di­a­betes care. We be­lieve this will help so­ci­eties cope with the bur­den of this epi­dem­ic.”

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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