Sanofi inks an al­liance pact with chron­ic dis­ease-fo­cused dig­i­tal ther­a­peu­tics play­er

Over the past few years, the dig­i­tal health space has been rapid­ly ex­pand­ing and draw­ing the at­ten­tion of Big Phar­ma. Now, one com­pa­ny has grabbed Sanofi’s at­ten­tion — and sealed a deal.

New-York based Dar­i­o­Health an­nounced it en­tered in­to a strate­gic al­liance agree­ment with Sanofi’s US sub­sidiary in a mul­ti-year, $30 mil­lion deal. The agree­ment will push Dario’s “dig­i­tal ther­a­peu­tics” mar­ket ex­pan­sion and com­mer­cial adop­tion, the com­pa­ny said in a state­ment.

This is just the most re­cent de­vel­op­ment in the dig­i­tal health space. Dig­i­tal ther­a­peu­tics com­pa­nies like Ak­ili with its pre­scrip­tion video game and Ada Health — build­ing a di­ag­nos­tics app and rais­ing $30 mil­lion a few weeks ago — have al­ready start­ed to make their foot­print on the space.

In short, Dario’s AI-based plat­form is pri­mar­i­ly a high­ly per­son­al­ized health man­age­ment sys­tem — ty­ing cus­tom de­vices such as a glu­cose mon­i­tor­ing sys­tem, blood pres­sure cuff and weight scale to Dario’s mo­bile app — which users with di­a­betes, hy­per­ten­sion and oth­er ail­ments can use to man­age their con­di­tions. And ad­di­tion­al ex­pan­sion is on­go­ing, with the com­pa­ny go­ing in­to mus­cu­loskele­tal pain and be­hav­ioral health af­ter it ac­quired two small­er com­pa­nies.

Rick An­der­son

As Dar­i­o­Health pres­i­dent Rick An­der­son told End­points News, part of the plat­form is to learn user’s rou­tines — “would un­der­stand when to com­mu­ni­cate to them, what they re­spond­ed to, what they didn’t re­spond to, and the abil­i­ty to ad­just that com­mu­ni­ca­tion over a pe­ri­od of time.” And on top of an AI en­gine that runs the plat­form, Dar­i­o­Health has been build­ing so­lu­tions and ap­pli­ca­tions and cross-in­te­grat­ing them in­to one app.

Ac­cord­ing to An­der­son, that cross-in­te­gra­tion al­lows for a “uni­fied user ex­pe­ri­ence.” And while the com­pa­ny orig­i­nal­ly went to con­sumers first when they got their start in 2011, Dar­i­o­Health now is look­ing to bring health plans and pay­ers in­to the mix.

Sanofi orig­i­nal­ly reached out to Dario, An­der­son said — and they have been build­ing the re­la­tion­ship for the last 9-10 months. The deal is a mix be­tween mar­ket­ing and co-de­vel­op­ment: Sanofi will help pro­mote Dar­i­o­Health’s so­lu­tions, and every­thing that gets de­vel­oped as part of the sev­er­al-year agree­ment will be com­mer­cial­ized on Dario’s plat­form.

Sanofi is train­ing their mar­ket ac­cess teams around Dario’s plat­form, ac­cord­ing to An­der­son — and with the fo­cus on health plans, the Sanofi deal gives them greater reach in­to that space.

Even­tu­al­ly, there may be an op­tion to link Sanofi’s drugs in­to the app, ac­cord­ing to An­der­son — but that is not part of to­day’s an­nounced agree­ment.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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