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

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,400+ biopharma pros reading Endpoints daily — and it's free.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,400+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,400+ biopharma pros reading Endpoints daily — and it's free.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.