It’s a tie: Sanofi and No­vo come in neck-and-neck at the FDA with two new di­a­betes com­bo OKs

Sanofi and No­vo Nordisk tried might­i­ly to beat each oth­er to the fin­ish line first with a com­bi­na­tion of their long-last­ing in­sulin with their GLP1 drugs. But the FDA de­cid­ed to call it a draw.

Olivi­er Brandi­court, Sanofi CEO

Reg­u­la­tors in the US si­mul­ta­ne­ous­ly ap­proved No­vo’s Xul­to­phy — a com­bi­na­tion of Tre­si­ba and Vic­toza on the mar­ket in Eu­rope for the past two years — and Sanofi’s Soli­qua, which com­bines Lan­tus and Lyx­u­mia.

Xul­to­phy’s edge en­cour­aged an­a­lysts to project a blend­ed $1.2 bil­lion an­nu­al sales pro­jec­tion for 2021, as tracked by Thom­son Reuters, while Sanofi may not hit half that amount.

Both of these com­pa­nies rep­re­sent the top ranks of big play­ers which dom­i­nate the di­a­betes mar­ket. In­tense­ly com­pet­i­tive, reg­u­la­tors tend to work at a slow and steady pace when it comes to their re­views. As a re­sult, Sanofi squan­dered its $245 mil­lion pri­or­i­ty re­view vouch­er on Soli­qua, forced to take ex­tra time to an­swer the agency’s ques­tion on its de­liv­ery de­vice.

Both of these com­pa­nies have had to suf­fer through de­clin­ing ex­pec­ta­tions for their di­a­betes fran­chis­es. In Sanofi’s case, the set­back on di­a­betes helped push them to part­ner close­ly with Re­gen­eron in oth­er ar­eas. But (rel­a­tive­ly) new CEO Olivi­er Brandi­court was left stand­ing at the al­tar in his bid for Medi­va­tion and the part­ners’ first com­mer­cial prod­uct in PC­SK9 has called far, far be­hind ini­tial ex­pec­ta­tions as pay­ers con­tin­ue to refuse re­im­burse­ment.

You can ex­pect both com­pa­nies to hit the ground run­ning in 2017. The US mar­ket re­mains the most im­por­tant are­na in the glob­al drug mar­ket. And in di­a­betes, speed and com­pet­i­tive zeal is para­mount. In ad­di­tion, nei­ther phar­ma com­pa­ny can af­ford to be lax in pur­su­ing new sales.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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