Al­ny­lam kicks off #JPM18 with a re­struc­tured Sanofi deal, grab­bing glob­al rights to patisir­an

Four years ago Al­ny­lam $AL­NY jazzed the start of the JP­Mor­gan con­fer­ence with news that Sanofi had stepped up to pay $700 mil­lion for a chunk of its stock and the right to ex­pand its com­mer­cial rights to the biotech’s lead drug, patisir­an. But with patisir­an on the verge of win­ning like­ly reg­u­la­to­ry ap­proval this year, the com­pa­nies have once again re­struc­tured their deal in a way that gives Al­ny­lam glob­al con­trol over its fu­ture.

John Maraganore

Al­ny­lam will now han­dle the glob­al mar­ket­ing for patisir­an and ALN-TTRsc02, with the ex­pect­ed launch com­ing for AT­TR amy­loi­do­sis. In re­turn, Sanofi is land­ing glob­al rights to fi­tusir­an for he­mo­phil­ia A and B.

The rest of the deal terms re­main in place, with the two col­lab­o­ra­tors ex­chang­ing roy­al­ties on sales.

The move un­der­scores Al­ny­lam CEO John Maraganore’s con­fi­dence that the biotech can score big on patisir­an, which is head­ed in­to a com­mer­cial ri­val with Io­n­is $IONS, which has al­so racked up pos­i­tive da­ta for its hAT­TR amy­loi­do­sis drug. Most an­a­lysts, though, give Al­ny­lam a dis­tinct edge af­ter re­view­ing the piv­otal da­ta be­ing hus­tled to the FDA and EMA.

Al­ny­lam says it ex­pects to land an OK from the FDA in mid-2018, with a green light from the EMA fol­low­ing soon af­ter.

The new deal comes just weeks af­ter reg­u­la­tors lift­ed a clin­i­cal hold on fi­tusir­an, which was put in place fol­low­ing the death of a pa­tient due to a blood clot. Sanofi had paid $100 mil­lion to opt in on fi­tusir­an 10 months be­fore the hold was clamped down on the late-stage study.

Notes Leerink’s Paul Mat­teis:

Un­der the new agree­ment, AL­NY gains ROW com­mer­cial­iza­tion rights for patisir­an while re­tain­ing their rights to the US, Cana­da, and west­ern EU. SNY now stands to re­ceive tiered roy­al­ties of up to 25% on ROW sales for patisir­an, with the caveat that in Japan, SNY will re­ceive a flat roy­al­ty rate (not tiered) of 25%. AL­NY gain­ing ROW rights to patisir­an in ex­change for the roy­al­ty is like­ly to have a more mod­est im­pact on our mod­el. More im­pact­ful, the new agree­ment gives AL­NY full glob­al de­vel­op­ment and com­mer­cial rights to their fol­low-on TTR prod­uct ALN-TTRsc02 and AL­NY will pay SNY tiered roy­al­ties of 15%-30% on glob­al net sales. Fi­nal­ly, SNY will ob­tain full glob­al de­vel­op­ment and com­mer­cial­iza­tion rights to fi­tusir­an (he­mo­phil­ia). Per the agree­ment, AL­NY stands to re­ceive tiered roy­al­ties of 15%-30% on glob­al net sales of fi­tusir­an.

“This strate­gic re­struc­tur­ing en­ables stream­lined de­vel­op­ment and an op­ti­mized ap­proach to bring­ing in­no­v­a­tive med­i­cines to pa­tients with AT­TR amy­loi­do­sis and he­mo­phil­ia around the world, max­i­miz­ing the com­mer­cial op­por­tu­ni­ties for these pro­grams,” said Maraganore. “For Al­ny­lam, this pro­vides strate­gic clar­i­ty and op­er­a­tional align­ment with re­gard to the de­vel­op­ment and com­mer­cial­iza­tion of patisir­an and ALN-TTRsc02. This will al­low us to de­vel­op both prod­ucts in a com­pre­hen­sive man­ner, po­ten­tial­ly ad­dress­ing the full spec­trum of transthyretin-me­di­at­ed amy­loi­do­sis dis­ease treat­ment and pre­ven­tion. At the same time, we will con­tin­ue to sup­port and ben­e­fit – via roy­al­ties – from the fi­tusir­an op­por­tu­ni­ty through Sanofi’s sig­nif­i­cant de­vel­op­ment and com­mer­cial lead­er­ship.”

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.