Spurned by Ab­b­Vie, Abl­ynx wins an­oth­er Big Phar­ma part­ner of­fer­ing a block­buster prize for suc­cess

Sanofi CEO Olivi­er Brandi­court (left), flanked by CFO Jerome Con­t­a­mine, speaks dur­ing a Feb­ru­ary 2017 com­pa­ny pre­sen­ta­tion get­ty

Nine months af­ter Ab­b­Vie dealt Abl­ynx a blow by walk­ing away from a messy rheuma­toid arthri­tis drug it was part­nered on, the Bel­gian biotech has come back and added an­oth­er Big Phar­ma com­pa­ny to its list of part­ners for its Nanobody plat­form tech. And this one is dan­gling a trea­sure trove of mile­stone pay­ments if its re­searchers can turn in a block­buster per­for­mance.

Sanofi is jump­ing on board to­day, pay­ing a mod­est $28 mil­lion to get the part­ner­ship start­ed and of­fer­ing up to $2.8 bil­lion in mile­stones in the deal. Their fo­cus is on im­mune-me­di­at­ed in­flam­ma­to­ry dis­eases, which cov­ers quite a bit of bi­o­log­ic ter­ri­to­ry. But there wasn’t a lot of de­tail in­to what they planned to go af­ter to­geth­er.

Last Oc­to­ber Ab­b­Vie wrote off its pact with Abl­ynx along with its $175 mil­lion up­front af­ter its IL-6R drug vo­bar­il­izum­ab per­formed poor­ly in ad­vanced clin­i­cal tri­als for rheuma­toid arthri­tis. Not on­ly did the treat­ment flop on the ACR20 goal, it al­so failed on a score of im­proved phys­i­cal func­tion when com­bined with methotrex­ate against methotrex­ate alone. And ear­li­er the Abl­ynx pro­gram had proved at best a matchup to Roche’s Actem­ra, ap­proved sev­en years ago. And that hap­pened while a slate of ma­jor play­ers were ad­vanc­ing their own drugs through Phase III. Ab­b­Vie has an in-house pro­gram it’s al­so con­sid­er­ably pumped about.

Abl­ynx is al­ready aligned with both Mer­cks, No­var­tis and No­vo Nordisk, among oth­ers. Sanofi CEO Olivi­er Brandi­court is un­der con­sid­er­able pres­sure to build up its pipeline, though its part­ner­ship with Re­gen­eron has paid off with a string of ma­jor drug ap­provals, in­clud­ing re­cent OKs for their IL-6 rheuma­toid arthri­tis heavy­weight sar­ilum­ab and Dupix­ent.

Frank Nes­tle, Sanofi’s CSO for North Amer­i­ca, had this to say about the new pact:

This col­lab­o­ra­tion is the lat­est ex­am­ple of Sanofi’s strate­gic com­mit­ment to ex­pand our drug dis­cov­ery pipeline in im­munol­o­gy at a time when we are launch­ing new treat­ments for atopic der­mati­tis and rheuma­toid arthri­tis. We are par­tic­u­lar­ly ex­cit­ed by the Abl­ynx tech­nol­o­gy as a lead­ing bi­o­log­ics plat­form, en­abling the de­vel­op­ment of trans­for­ma­tive mul­ti-tar­get­ing treat­ment ap­proach­es. Through ex­ter­nal part­ner­ships like these, com­bined with our in­ter­nal R&D ex­per­tise, we aim to trans­form the treat­ment land­scape for pa­tients liv­ing with au­toim­mune and in­flam­ma­to­ry con­di­tions.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.