Af­ter promis­ing M&A and buy­backs to re­vive long-term prospects, Bio­gen re­fresh­es board with three ap­point­ments to en­thuse in­vestors

Bruised by the ti­tan­ic fail­ure of its Alzheimer’s drug ad­u­canum­ab and ahead of gene ther­a­py com­pe­ti­tion for its flag­ship SMA treat­ment Spin­raza, Bio­gen is for­ti­fy­ing its board with three new ap­point­ments to pla­cate its in­creas­ing­ly dis­en­chant­ed share­hold­er base that has seen the US drug­mak­er cul­ti­vate its pipeline around the now aban­doned ad­u­canum­ab.

Je­sus Man­tas

Last Wednes­day, com­pa­ny ex­ec­u­tives at­tempt­ed to put a Band-Aid on the burn by telling an­a­lysts in a post-earn­ings con­fer­ence call that they felt an “oblig­a­tion to re­bound” and in­tend­ed to do so by en­gag­ing in M&A and buy­ing back shares with the $42 bil­lion they have in the bank, over the next five years.

John Chimin­s­ki

On Mon­day, Bio­gen said it was hir­ing Catal­ent chief John Chimin­s­ki; se­nior ad­vi­sor to life sci­ences PE firm EW Health­care Part­ners William Hawkins; and man­ag­ing part­ner of IBM Glob­al Ser­vices Je­sus Man­tas. “We have heard the calls from our share­hold­ers and have act­ed…” Bio­gen chair­man Ste­lios Pa­padopou­los said in a state­ment.

Ste­lios Pa­padopou­los

Ear­li­er in the first quar­ter, Bio­gen scrapped two large Phase III stud­ies of ad­u­canum­ab dis­sat­is­fied by the drug’s im­pact on the course of Alzheimer’s — and last week the com­pa­ny al­so dis­closed it had shelved a late-stage study test­ing the drug’s abil­i­ty to pre­vent on­set of the dis­ease, ef­fec­tive­ly dis­card­ing the drug. But it is still tak­ing a wait-and-see po­si­tion on its oth­er amy­loid be­ta Alzheimer’s drug BAN2401 — in stark con­trast to part­ner Ei­sai who quick­ly ini­ti­at­ed a new tri­al for the ex­per­i­men­tal treat­ment even as Wall Street and neu­ro ex­perts have ef­fec­tive­ly de­clared the amy­loid strat­e­gy of tar­get­ing the tox­ic clus­ters in the brain dead, fol­low­ing a spate of fail­ures.

Bio­gen record­ed a spike in first-quar­ter rev­enue dri­ven by Spin­raza, but No­var­tis’ $NVS gene ther­a­py Zol­gens­ma is un­der reg­u­la­to­ry re­view, and com­pe­ti­tion from Roche/PTC Ther­a­peu­tics $PTCT oral SMA med­i­cine-in-de­vel­op­ment ris­diplam could in­flict some dam­age to Spin­raza’s cur­rent mo­nop­oly. On Wednes­day, Bio­gen chief Michel Vounatsos dis­missed the like­li­hood that an­oth­er ther­a­py will push Spin­raza off its perch any­time soon, but the com­pa­ny’s shares slipped, sig­nal­ing a con­sen­sus that in­vestors were un­con­vinced by man­age­ment’s up­beat tone.

Michel Vounatsos

“While the stock ap­pears some­what dis­count­ed…it is hard to make a com­pelling case for own­er­ship, par­tic­u­lar­ly since many of the foun­da­tions of their port­fo­lio face es­ca­lat­ing com­pet­i­tive pres­sures in the im­me­di­ate fu­ture (MS – new orals, patent lit­i­ga­tion, CD20 – biosim­i­lars, Spin­raza – gene ther­a­py and ris­diplam). Bio­gen’s board and man­age­ment have still not fi­nal­ly for­sworn be­ta amy­loid as a de­vel­op­ment tar­get, and con­tin­ue to fund large piv­otal tri­als with their part­ner Ei­sai. In the next few months we would ex­pect the com­pa­ny to make fi­nal (dis­con­tin­u­a­tion) de­ci­sions on these pro­grams, and to se­vere their col­lab­o­ra­tion with Ei­sai and ab­sorb what­ev­er charges, penal­ties, write-offs and or­ga­ni­za­tion­al changes such de­ci­sions en­tail,” SVB Leerink’s Ge­of­frey Porges wrote in a note last week.

Ge­of­frey Porges

Jef­feries an­a­lysts sug­gest­ed that in the near term, Spin­raza sales may be in­su­lat­ed, de­spite com­pe­ti­tion.

“We do think ‘base’ of Spin­raza is OK near-term as gene ther­a­py pri­mar­i­ly im­pacts on­ly ‘de no­vo’ new in­fants, but new pa­tient share loss im­pacts the ‘tail’ and oral could al­so be a pre­ferred op­tion over time par­tic­u­lar­ly for kids/ado­les­cents giv­en no need for spinal tap in­fu­sion,” they wrote in a note.

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
Overview
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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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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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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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.

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.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

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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