J&J pitch­es its top 11 drugs in the pipeline — with a peak sales promise of $1B-plus

Joaquin Du­a­to at an End­points News event in San Fran­cis­co on Jan­u­ary 10, 2017


Over the last six years, J&J has nailed 11 new drug ap­provals. Look­ing for­ward over the next five years, the phar­ma gi­ant is fore­cast­ing that it can dou­ble that, with more than 10 new ap­provals for block­buster meds out of its late-stage pipeline. And it needs them all to keep up with an am­bi­tious growth fore­cast for its phar­ma di­vi­sion rev­enue.

Joaquin Du­a­to, J&J’s world­wide chair­man for phar­ma­ceu­ti­cals, com­mit­ted to see­ing J&J’s brand­ed drug mar­ket main­tain a clip of 5% an­nu­al growth through 2020, de­spite some stiff “head­winds” on prices — “where price growth is flat­ten­ing” — with three ap­provals slat­ed for 2017 and four more which the phar­ma gi­ant ex­pects to ush­er in­to the mar­ket in 2018.

These new drugs are one leg of the com­pa­ny’s three-leg strat­e­gy for grow­ing rev­enue, with a promise that it can im­prove sig­nif­i­cant­ly on ex­ist­ing drugs — like Ste­lara, In­vokana and Xarel­to — while beef­ing up on a new core fo­cus on pul­monary ar­te­r­i­al hy­per­ten­sion through the Acte­lion buy­out.

Bill Hait, glob­al head of R&D, said he ex­pects 14 new meds to ar­rive in next five years, with 50 line ex­ten­sions on al­ready ap­proved ther­a­pies.

Bill Hait

First up, the two new im­munol­o­gy drugs al­ready filed for ap­proval and well known to in­vestors: guselkum­ab for pso­ri­a­sis; and sirukum­ab for rheuma­toid arthri­tis.

The next nine po­ten­tial block­busters cov­er a range of core fo­cus­es, with a ma­jor con­cen­tra­tion on on­col­o­gy. They are:

  • Apa­lu­tamide (ARN-509) for pre-metasta­t­ic prostate can­cer. J&J picked up this drug with its $1 bil­lion deal for Aragon.
  • Es­ke­t­a­mine for treat­ment-re­sis­tant de­pres­sion. This is an in­tranasal ver­sion of ke­t­a­mine, a horse tran­quil­iz­er and well known par­ty drug (Spe­cial K) known for rapid on­set with a host of side ef­fects.
  • Ta­la­co­tuzum­ab (JNJ-56022473/CSL362) for acute myeloid leukemia. This drug, orig­i­nal­ly from CSL, us­es Xen­cor’s an­ti­body tech.
  • Erdafi­tinib (an FGFR In­hibitor) for sol­id tu­mors.
  • Ni­ra­parib for prostate can­cer. Al­ready ap­proved in the US ear­li­er this year as Ze­ju­la, J&J picked up com­mer­cial rights on this PARP in­hibitor in a $500 mil­lion deal.
  • Ime­tel­stat for myelofi­bro­sis. Geron re­vealed a few weeks ago that J&J’s re­view of the da­ta from two stud­ies of its drug ime­tel­stat war­rant­ed con­tin­ued work in myelodys­plas­tic syn­dromes and myelofi­bro­sis. But the phar­ma gi­ant $JNJ is still re­serv­ing the right to quit if the da­ta doesn’t hold up lat­er in the year. That’s not a big vote of con­fi­dence.
  • Pi­modi­vir (JNJ-3872) for in­fluen­za A. J&J picked up this one from Ver­tex in 2014. Not much has been heard about it since then.
  • Lu­mic­itabine (JNJ-1575) for res­pi­ra­to­ry syn­cy­tial virus (RSV) in­fec­tion. J&J got this in their $1.75 bil­lion buy­out of Alios in 2014, which al­so net­ted drugs for hep C — a mar­ket that is be­ing flat­tened by some very ef­fec­tive cures.
  • JNJ-7922 (orex­in-2 an­tag­o­nist) for ad­junc­tive treat­ment for ma­jor de­pres­sive dis­or­der. This is a new one on me.

Ge­off Meacham at Bar­clays gave J&J’s pre­sen­ta­tion to­day sol­id marks for the longterm, but he sees an up­hill strug­gle at the phar­ma gi­ant as it wres­tles with some dis­ap­point­ing rev­enue num­bers. His note:

JNJ’s in­creas­ing em­pha­sis on on­col­o­gy (Darza­lex, apa­lu­tamide, ni­ra­parib, ta­la­co­tuzum­ab for AML) is a pos­i­tive step, which should of­fer bet­ter pric­ing pro­tec­tion vs. oth­er ther­a­peu­tic cat­e­gories such as im­munol­o­gy (biosim­i­lars) and di­a­betes (SGLT-2s).  JNJ is tar­get­ing above-mar­ket growth over the next decade, which we think is like­ly achiev­able, but our sense is that in­vestor con­vic­tion is low in con­vert­ing the port­fo­lio from lega­cy as­sets to new launch­es (e.g. apa­lu­tamide for Zyti­ga, guselkum­ab/sirukum­ab for Rem­i­cade). In­deed, while there is like­ly a sus­tained pe­ri­od of ac­cel­er­a­tion of in­ter­nal­ly dri­ven, or­gan­ic growth in the in­ter­me­di­ate-to-longer term, the next 1-2 years may be tough with the pend­ing Acte­lion deal pro­vid­ing a fix but not one that is like­ly to dri­ve mul­ti­ple ex­pan­sion.

It’s im­por­tant to re­mem­ber that the suc­cess rate for Phase III drugs is about 50%, and pay­ers have been rad­i­cal­ly al­ter­ing the land­scape for new drug prices. That all presents J&J with some big po­ten­tial pit­falls along the way to achiev­ing its goals. But with a $7 bil­lion an­nu­al bud­get for R&D, Du­a­to and Hait want in­vestors to know what they can ex­pect for the mon­ey.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Take­da earns win for its TKI in­hibitor in tiny lung can­cer group — but GI side ef­fects could be an ear­ly red flag

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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