May the can­dle burn for­ev­er: Po­lite re­minders about the JP­Mor­gan con­fab

Ed­i­tor’s Note: Biotech Voic­es is a con­tributed col­umn from se­lect End­points News read­ers. Be­low is an anony­mous com­men­tary from a pub­lic biotech CEO who was in­spired to write a de­fense of JP­Mor­gan fol­low­ing a litany of com­plaints.


Every year we start the biotech cal­en­dar with a busy Jan­u­ary pil­grim­age where JP­Mor­gan hosts a wide­ly at­tend­ed get to­geth­er that at­tracts big and small to the San Fran­cis­co Union Square neigh­bor­hood. De­spite the peren­ni­al suc­cess of this event, it is in­ter­est­ing to hear re­cent com­plaints from mul­ti­ple voic­es, sug­gest­ing di­min­ish­ing re­turns and wan­ing en­thu­si­asm for fu­ture par­tic­i­pa­tion. While all of these com­plaints may be valid, let’s not go over­board and for­get why this event is a key land­mark.

On be­half of the many ben­e­fi­cia­ries of the JP­Mor­gan con­fab, I would like to pro­vide re­spect­ful and po­lite re­minders re­gard­ing the un­par­al­leled val­ue of this meet­ing. I have been com­ing to JP­Mor­gan for ap­prox­i­mate­ly 20 years, no spe­cif­ic fi­nan­cial con­nec­tion with JP­Mor­gan it­self, but I like many oth­ers hope and pray that our in­dus­try’s can­dle burns bright­ly, and that the Jan­u­ary mo­men­tum cre­at­ed by JP­Mor­gan’s con­fab is peren­ni­al.

Re­minder #1: The core pur­pose is pub­lic bio­phar­ma com­pa­ny guid­ance. The heart of this event, lo­cat­ed on the mez­za­nine floor of the West­in St. Fran­cis, is the need for each pub­lic com­pa­ny to es­tab­lish guid­ance for what they seek to achieve dur­ing the cal­en­dar year. An as­ton­ish­ing­ly high num­ber of well-qual­i­fied pub­lic mar­ket in­vestors come to pre­sen­ta­tions, have 1-on-1 sched­uled meet­ings with com­pa­nies and ex­change ideas in­side the hall­ways of the West­in through­out the week. The qual­i­ty and quan­ti­ty of in­flu­en­tial in­vestors at JP­Mor­gan al­lows large phar­ma, and fledg­ling pub­lic biotechs, to reach a wide au­di­ence in per­son on a sin­gle trip. This is why the event ex­ists and is high­ly re­spect­ed.

Re­minder #2: Gets the buzz go­ing. An enor­mous, per­haps un­re­al­ized, ben­e­fit of JP­Mor­gan is how it tends to ig­nite in­dus­try mo­men­tum each year. We should all re­mem­ber that we are in a high­ly risky busi­ness with more fre­quent fail­ures than suc­cess­es, and it would be easy for us to be­come dour on the chal­lenges of drug de­vel­op­ment. The in­ten­tion­al hold-back of good news by many com­pa­nies un­til JP­Mor­gan cre­ates a spring-load ef­fect that like­ly dri­ves in­vest­ment and risk cap­i­tal cy­cles through the rest of the year. The event ma­te­ri­al­izes themes re­gard­ing how phar­ma is like­ly to be­have, how the mar­kets are like­ly to play and what tech­nol­o­gy waves are go­ing to be an­tic­i­pat­ed for the rest of the year. With­out this, we would like­ly grap­ple for pos­i­tive news, or even di­rec­tion, for months in the new year.

Re­minder #3: The by­stander ef­fect. Many, many biotech com­pa­nies have been launched, fi­nanced, bought and part­nered dur­ing this week with­out hold­ing an ac­tu­al in­vite to JP­Mor­gan it­self. A by­stander ef­fect is cre­at­ed be­cause every ma­jor phar­ma hosts meet­ings out­side of the core meet­ing, pro­vid­ing a tar­get rich en­vi­ron­ment for emerg­ing com­pa­nies to sell their wares. Even if these meet­ings are short, and mere­ly in­tro­duc­to­ry in na­ture, they pro­vide an av­enue for phar­ma mon­ey to meet biotech as­sets. Al­lows phar­ma to triage who they want to li­cense or buy for their strate­gic ther­a­peu­tic area needs dur­ing the com­ing year. This is worth gold for every emerg­ing biotech com­pa­ny that wants to con­tem­plate a part­ner­ship to fur­ther their busi­ness. While per­haps not as large as some oth­er part­ner­ing-on­ly fo­cused events, the by­stander ef­fect of JP­Mor­gan is a life-line for key parts of the in­dus­try.

Re­minder #4: The de­mand-and-sup­ply pen­du­lum. The cost of at­tend­ing JP­Mor­gan, or be­ing a by­stander, has in­creased re­mark­ably over the years. The in­dus­try is gath­er­ing mo­men­tum, hir­ing more peo­ple, de­ploy­ing more cap­i­tal and there­fore it is no sur­prise that peo­ple are will­ing to spend more to at­tend the bio­phar­ma su­per­bowl. We are at a tip­ping point where peo­ple are dis­gust­ed, but this will not lead to a dra­mat­ic pull back but more of a grad­ual re­cal­i­bra­tion. De­pend­ing on busi­ness mod­els, some com­pa­nies ap­pro­pri­ate­ly will not find the cost to be worth­while and will hence make de­ci­sions ac­cord­ing­ly next year, which will bring the pen­du­lum back to a point where San Fran­cis­co ho­tels and restau­rants will ad­just prices clos­er to nor­mal lev­els. For most of us, the cost is def­i­nite­ly worth­while.

Re­minder #5: Thank you JP­Mor­gan an­a­lysts. If any­one has the right to com­plain, it’s the JP­Mor­gan an­a­lyst team that is re­spon­si­ble for cov­er­ing >200 pre­sent­ing com­pa­nies at this con­fer­ence. It is their work that at­tracts pub­lic com­pa­nies and in­vestors to at­tend. I can­not imag­ine the hours they (Chris, Cory, Anu­pam, Jes­si­ca, Er­ic and oth­ers) must put in to pre­pare for com­pa­ny guid­ance and then write re­ports on each com­pa­ny post-pre­sen­ta­tion. Every pub­lic com­pa­ny CEO ap­pre­ci­ates your ef­fort.

I wrote this anony­mous­ly in or­der to avoid dis­trac­tion from my of­fi­cial com­pa­ny nar­ra­tive, but I rep­re­sent a con­tin­gent of bio­phar­ma CEOs that are thank­ful for what our in­dus­try has be­come and the role that the JP­Mor­gan con­fer­ence has played over the years. May the can­dle burn for­ev­er.


Im­age: West­in St. Fran­cis ho­tel SHEHLA SHAKOOR for END­POINTS NEWS

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.

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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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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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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche. File photo

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

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