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J&J Analyst Day 5-17
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Johnson & Johnson plans to file for approval 10 potential blockbusters in next 4 years
May 17, 2017 | MarketWatch
By Tomi Kilgore
Johnson & Johnson JNJ, +0.61% said Wednesday that it, along with its Janssen Pharmaceutical Companies, plans to file for regulatory approval 10 new potential blockbuster drugs between this year and 2021. -
J&J CEO: We have to pay attention to out-of-pocket drug costs
May 17, 2017 | CNBC
Alex Gorsky, Johnson & Johnson CEO, speaks with CNBC's Meg Tirrell about the company's pharmaceutical business, drug pricing and health-care reform. -
BRIEF-J&J says expects more than 10 new products to launch or file for regulatory approval by 2021
May 17, 2017 | Reuters
* J&J says expects more than 10 new products to launch or file for regulatory approval by 2021 * J&J says more than 50 line-extension regulatory filings projected by 2021 -
Johnson & Johnson updates investors today on extensive pipeline of drug candidates, 50+ regulatory filings expected by 2021
May 17, 2017 | Seeking Alpha
By Douglas House
Johnson & Johnson (NYSE:JNJ) will host a business review this morning updating analysts on its pharmaceutical pipeline, including Actelion. -
J&J, steering through a rough patch, draws blockbuster roadmap with 10 new meds
May 17, 2017 | FiercePharma
By Eric Sagonowsky
Johnson & Johnson had a "disappointing" first quarter, but its fortunes for the second half of the year are looking up, one influential analyst figures. And partly on the strength of some expected launches J&J highlighted Wednesday, the years ahead looked good enough for that long-skeptical analyst to turn bullish. -
Johnson & Johnson targets over 10 drug launches, filings through 2021 with blockbuster potential
May 17, 2017 | FirstWord Pharma
By Joe Barber
Johnson & Johnson said Wednesday at a meeting with industry analysts that it plans to launch or seek approval of more than 10 new drugs with blockbuster potential between 2017 and 2021. The company added that it is also targeting more than 50 line extensions of existing and new medicines through 2021. -
Johnson & Johnson aims for 10 billion-dollar drugs by 2021
| USA Today
By Nathan Bomey
Global health giant Johnson & Johnson said Wednesday that it expects more than 10 of its billion-dollar products in development to reach the market or file for regulatory approval within the next four years. -
J & J executive says volume accounted for three quarters of company's recent pharma growth, not price increases
May 17, 2017 | Seeking Alpha
By Douglas House
In this morning's Pharmaceutical Business Review, Johnson & Johnson's (JNJ -0.6%) Worldwide Chairman, Pharmaceuticals, Joaquin Duato said 75% of the company's growth in drug sales were driven by volume growth as opposed to price hikes over the period 2012 - 2016. -
The world's largest drugmaker thinks it has 11 billion-dollar drugs in the pipeline — here's what they treat
May 17, 2017 | Business Insider
By Lydia Ramsey
Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be "blockbusters." -
Johnson & Johnson sets sights on introducing 11 blockbusters by 2021
May 17, 2017 | FierceBiotech
By Nick Paul Taylor
Johnson & Johnson has listed the pipeline prospects it expects to drive the growth in its biopharma business for years to come. The company is hoping to get 11 potential blockbusters ready for market by 2021, starting with regulatory green lights for psoriasis candidate guselkumab and rheumatoid arthritis prospect sirukumab. -
J&J Unveils Future Plans for Blockbuster Drug Launches
May 17, 2017 | Drug Discovery and Development
By Ryan Bushey
Johnson & Johnson (J&J) revealed on Wednesday plans to bolster its drug portfolio over the next five years. -
J&J claims higher R&D productivity than peers
May 17, 2017 | BioPharmaDive
By Suzanne Elvidge
At its biennial Pharmaceutical Business Review Meeting, Johnson & Johnson announced that its pharma arm, Janssen Pharmaceutical, expected to submit or launch around 14 new drugs between now and 2021, with more than ten having potential blockbuster status. -
Brainstorm Health Daily: May 17, 2017
| Fortune
By Clifton Leaf and Sy Mukherjee
Johnson & Johnson plots ambitious five-year plan -
Confident Johnson & Johnson Flexes Its Muscles, Plans 10 Blockbuster Approvals by 2021
May 17, 2017 | BioSpace
By Mark Terry
Johnson & Johnson (JNJ) decided to show its pipeline muscle. In meeting with industry analysts, the company indicated it expects to have 10 new products approved between 2017 and 2021 that have blockbuster potential—annual sales of $1 billion each. And if that wasn’t enough, they have more than 50 line extensions on existing and new medicines planned. -
Johnson & Johnson Execs Discuss Drug Pipeline
May 17, 2017 | TheStreet
By Armie Margaret Lee
Johnson & Johnson (JNJ) executives said Wednesday there are more than 10 new products with blockbuster potential that they plan to either launch or for file for regulatory approval by 2021. -
J&J pitches its top 11 drugs in the pipeline — with a peak sales promise of $1B-plus
May 17, 2017 | Ednpoints News
By John Carroll
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. -
J&J: 10 products with “blockbuster potential” to be filed by 2021
May 17, 2017 | Drug Store News
By Brian Berk
Johnson & Johnson and its Janssen Pharmaceutical Cos. will announce plans to launch or file for regulatory approval more than 10 new products with “blockbuster potential” between 2017 and 2021, as well as 50-plus line extensions of new medicines, senior executives said Wednesday during an industry analysts meeting. -
J&J opens down despite promise of 11 new blockbusters
May 18, 2017 | Pharma Letter
US healthcare giant Johnson & Johnson’s (NYSE: JNJ) and its Janssen pharmaceutical companies expect more than 10 of its new ‘blockbuster’ products to be launched or filed for regulatory approval by 2021. -
Johnson & Johnson Unveils Ambitious Multi-Billion Dollar Plan
May 18, 2017 | Fortune
By Sy Mukherjee
Johnson & Johnson isn't resting on its laurels. The drug giant said on Wednesday that it wants to get more than ten of it experimental "blockbuster" drugs—i.e., those that could rake in at least $1 billion in sales every year—either on the market or filed for FDA approval by 2021. -
J&J (JNJ) Plans to Seek Approval for 10 New Drugs by 2021
May 18, 2017 | Zacks
Johnson & Johnson, Inc.(JNJ - Free Report) discussed its future plans and showcased a strong pipeline of transformational medicines at a meeting held yesterday with industry analysts. -
J&J showcases its 10 blockbuster prospects
May 18, 2017 | Pharmaphorum
By Andrew McConaghie
Johnson & Johnson says is it will have more than 10 new drugs filed or on the market within the next four years – and all likely to exceed $1bn in annual revenues. -
CNBC - Squawk Box
May 17, 2017 | CNBC
http://app.criticalmention.com/app/#clip/view/27363352?token=3a0167dc-62b8-4079-b8cb-5be58e26342c -
CNBC - Alex Gorsky Interview
May 17, 2017 | CNBC
http://app.criticalmention.com/app/#clip/view/27363400?token=3a0167dc-62b8-4079-b8cb-5be58e26342c -
CNBC: Fast Money Halftime Report
May 17, 2017 | CNBC
http://app.criticalmention.com/app/#clip/view/27370098?token=3a0167dc-62b8-4079-b8cb-5be58e26342c -
CNBC: Power Lunch
May 17, 2017 | CNBC
http://app.criticalmention.com/app/#clip/view/27370188?token=3a0167dc-62b8-4079-b8cb-5be58e26342c
Traditional Media
Broadcast Clips
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Johnson & Johnson plans to file for approval 10 potential blockbusters in next 4 years
May 17, 2017 | MarketWatch
By Tomi Kilgore
Johnson & Johnson JNJ, +0.61% said Wednesday that it, along with its Janssen Pharmaceutical Companies, plans to file for regulatory approval 10 new potential blockbuster drugs between this year and 2021. The company said it also plans more than 50 line extensions of existing and new medicines through 2021. "With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world," said J&J Chief Executive Alex Gorsky. The company is hosting an analyst meeting on Wednesday. The stock, which was still inactive in premarket trade, has rallied 11% year to date, while the SPDR S&P Pharmaceuticals ETF XPH, -0.70% has climbed 8.5% and the Dow Jones Industrial Average DJIA, -0.01% has advanced 6.2%.
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J&J CEO: We have to pay attention to out-of-pocket drug costs
May 17, 2017 | CNBC
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BRIEF-J&J says expects more than 10 new products to launch or file for regulatory approval by 2021
May 17, 2017 | Reuters
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May 17, 2017 | Seeking Alpha
By Douglas House
Johnson & Johnson (NYSE:JNJ) will host a business review this morning updating analysts on its pharmaceutical pipeline, including Actelion. Key highlights:
More than 50 regulatory submissions expected by 2021, including 10 with blockbuster ($1B+ sales/year) potential.
Two major launches expected this year: guselkumab for psoriasis and sirukumab for rheumatoid arthritis.
Additional top late-stage candidates are: apalutamide for pre-metastatic prostate cancer; esketamine for treatment-resistant depression; talacotuzumab for acute myeloid leukemia; erdafitinib for solid tumors; niraparib for prostate cancer; imetelstat for myelofibrosis; pimodivir for influenza A; lumicitabine for respiratory syncytial virus (RSV) infection and JNJ-7922 (orexin-2 antagonist) for adjunctive treatment of major depressive disorder.
The meeting kicks off at 8:30 am ET.
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J&J, steering through a rough patch, draws blockbuster roadmap with 10 new meds
May 17, 2017 | FiercePharma
By Eric Sagonowsky
Johnson & Johnson had a "disappointing" first quarter, but its fortunes for the second half of the year are looking up, one influential analyst figures. And partly on the strength of some expected launches J&J highlighted Wednesday, the years ahead looked good enough for that long-skeptical analyst to turn bullish.
Facing a variety of competitive pressures to key meds, Johnson & Johnson on Wednesday rolled out plans to launch or file for approval 10 potential blockbusters by 2021.
J&J plans to launch or file for approval with meds to treat prostate cancer, depression, acute myeloid leukemia, myelofibrosis and more over the next few years, the company announced. It also aims to continue expanding markets for its current meds, with 50 label updates planned over that same period.
That's one reason why J.P. Morgan analyst Michael Weinstein this week raised his view of Johnson & Johnson after staying neutral for several years. Weinstein sees a boost later this year: After a second quarter that'll feature no shortage of challenges, prior-year comparators get easier for J&J, making its growth numbers look a lot better for the last two quarters of the year.
Pharma growth should pick up to between 5% and 7% in the second half of 2017 and in 2018, according to Weinstein. New approvals and clinical data “become potential catalysts for an improving pharma business and a reacceleration of top-line growth,” he wrote.
Along with easier comparators and continued growth of existing meds, J&J has three big approvals coming over the next 18 months, and those are key to Weinstein's bullish turn.
Those are sirukumab to treat rheumatoid arthritis, which the drugmaker submitted last September, guselkumab to treat moderate-to-severe plaque psoriasis, submitted in November last year, and apalutamide to treat prostate cancer, which J&J is expected to file late this year, according to the note.
Consensus analyst estimates place sirukumab's 2020 sales at $463 million and guselkumab's sales that year at $533 million. J&J said it expects the drugs to be "approved and launched" this year. J&J's shares are up about 3% since J.P. Morgan published the report.
As MarketWatch notes, Weinstein has been neutral on J&J since April 2013. He raised his rating to overweight on Monday in what he called a “notably contrarian call.”In its first quarter, Johnson & Johnson reported adjusted earnings of $1.83 per share, up 5.8% year over year and 3% better than consensus expectations, thanks to some "disciplined" cost moves and a lower tax rate, according to CFO Dominic Caruso. Sales of some key meds weren't up to snuff, however, raising eyebrows among pharma-watchers. Weinstein described the quarter as "disappointing" and predicted similar results for Q2.
J&J reported pharma sales of $8.24 billion for the first quarter, a figure that came up short of consensus analyst expectations by 2%. Pricing and discount pressure continued to play a role in stifling growth.
Speaking with analysts last month, execs said a Pfizer biosim to the big-selling rheumatoid arthritis med Remicade isn’t hurting the brand much, but that blood thinner Xarelto is taking a beating from tough payer negotiations.
Earlier this year, Johnson & Johnson rolled out a “transparency report” aimed at demonstrating high-level trends the business faces. The drugmaker raised list prices an average of 8.5% in 2016 but paid out a total of $11 billion in rebates and discounts. Its average net price increases were 3.5%, according to the report.
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Johnson & Johnson targets over 10 drug launches, filings through 2021 with blockbuster potential
May 17, 2017 | FirstWord Pharma
By Joe Barber
Johnson & Johnson said Wednesday at a meeting with industry analysts that it plans to launch or seek approval of more than 10 new drugs with blockbuster potential between 2017 and 2021. The company added that it is also targeting more than 50 line extensions of existing and new medicines through 2021.
"With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world," remarked CEO Alex Gorsky, adding "our pharmaceutical business will continue to be a significant driver of innovation and growth."
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Johnson & Johnson aims for 10 billion-dollar drugs by 2021
| USA Today
By Nathan Bomey
Global health giant Johnson & Johnson said Wednesday that it expects more than 10 of its billion-dollar products in development to reach the market or file for regulatory approval within the next four years.
The drugs, which include therapies for cancer, depression and the flu, could be navigating the federal approval process at an opportune time, with the Trump administration seeking to loosen Food and Drug Administration approval standards for new treatments.
But the announcement also comes as pharmaceutical companies are under pressure from Washington, including President Trump, to cap skyrocketing prices for specialized treatments that critics blame for increasing health care costs.
J&J pharmaceuticals chairman Joaquin Duato said Wednesday that the company backs the move to "eliminate the unnecessary bureaucracy" at the FDA while preserving a process that validates "safety and efficacy."
J&J conducted some 400 clinical trials with 110,000 patients in 2016.
"We share the goals of this administration to be able to look at how we can fine-tune and improve access for patients and at the same time how we can approve the regulatory process," Duato said.
Amid growing scrutiny of drug prices, Duato said J&J will face "some headwinds putting pressure on pricing."
But he said "most of our growth comes from volume, not price."
Among the new drugs J&J expects to deliver through 2021 are treatments for prostate cancer, acute myeloid leukemia, myelofibrosis and respiratory syncytial virus (RSV) infection.
William Hait, R&D chief of J&J's Janssen Research & Development, said the company would also seek to expand applications of more than 50 current product lines.
J&J executives also said they expected to close the company's $30 billion acquisition of Swiss biopharmaceutical giant Actelion by the end of the second quarter, including the company's coveted treatment for pulmonary arterial hypertension.
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May 17, 2017 | Seeking Alpha
By Douglas House
In this morning's Pharmaceutical Business Review, Johnson & Johnson's (JNJ -0.6%) Worldwide Chairman, Pharmaceuticals, Joaquin Duato said 75% of the company's growth in drug sales were driven by volume growth as opposed to price hikes over the period 2012 - 2016.
He added that the company expects a re-acceleration of growth in its pharma business this year which should continue through 2021.
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May 17, 2017 | Business Insider
By Lydia Ramsey
Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be "blockbusters."
These are drugs that haven't been approved yet, but by 2021, they could be making more than $1 billion in annual sales each.
Right now, the world's largest drugmaker is known for its immunology drugs like Remicade, which made $4.8 billion in sales in 2016 and Stelara, as well as the bloodthinner Xarelto, which made $2.2 billion in sales in 2016.
Here's the list of drugs J&J plans to file for approval over the next four years that could hit that blockbuster threshold, including cancer and depression treatments:
· guselkumab - psoriasis (Filed for approval in 2016)
· sirukumab - rheumatoid arthritis (Filed for approval in 2016)
· apalutamide - pre-metastatic prostate cancer
· esketamine - treatment-resistant depression
· talacotuzumab - acute myeloid leukemia, a type of blood cancer
· erdafitinib - solid tumors
· niraparib - prostate cancer
· imetelstat - myelofibrosis, a bone marrow disorder
· pimodivir - influenza A
· lumicitabine - respiratory syncytial virus (RSV) infection
· JNJ-7922 - adjunctive treatment for major depressive disorder
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Johnson & Johnson sets sights on introducing 11 blockbusters by 2021
May 17, 2017 | FierceBiotech
By Nick Paul Taylor
Johnson & Johnson has listed the pipeline prospects it expects to drive the growth in its biopharma business for years to come. The company is hoping to get 11 potential blockbusters ready for market by 2021, starting with regulatory green lights for psoriasis candidate guselkumab and rheumatoid arthritis prospect sirukumab.
J&J filed for approval of anti-IL-23 monoclonal antibody guselkumab and anti-IL-6 drug sirukumab last year, putting them at the tip of its pipeline plans. The Big Pharma has reached further back into its pipeline to identify the next nine candidates in which it sees blockbuster potential.
Nonsteroidal antiandrogen apalutamide, CD123-targeting talacotuzumab, FGFR inhibitor erdafitinib, PARP inhibitor niraparib and oligonucleotide imetelstat all made J&J’s list. That means more than half of its top nine development-stage prospects target cancers.
The rest of the list is made up of mix of neuroscience and infectious disease candidates. Major depressive disorder prospect JNJ-7922 and treatment-resistant depression candidate esketamine make up the neuroscience part of the list. The top infectious disease prospects are influenza A drug pimodivir and RSV candidate lumicitabine.
William Hait, M.D., Ph.D., global head of research and development at Janssen, thinks the list of drugs gives J&J “one of the most robust and sustainable pipelines in the industry.” To Joaquin Duato, worldwide chairman, pharmaceuticals at J&J, that pipeline represents an opportunity to pull off the lofty ambition of redefining “the cyclical nature of our industry.”
J&J has had more success than some in the clinic in recent years but plenty of pitfalls await it that could undermine Hait and Duato’s bullish outlooks.
If J&J succeeds in getting the 11 assets through development and onto the market—or sees some of them fail but also brings through less-heralded drugs—it will beat its historic rate of approvals. Of J&J’s last 11 new molecular entities approved by FDA, the oldest got a regulatory nod in 2011. That means J&J is currently averaging around a respectable two approvals a year.
J&J unveiled a similar filing target in 2015. Back then, J&J listed 10 potential blockbusters it hoped to file for approval of within four years. Now, halfway through that period, J&J has trimmed its target to nine filings.
The rate of attrition in late-phase development suggests other programs may fall away and never come to market, or suffer setbacks that push their approval dates out beyond the window targeted by J&J. Those that do succeed in winning FDA approval may encounter a commercial environment less conducive to delivering blockbuster sales than the one in which J&J operates today.
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J&J Unveils Future Plans for Blockbuster Drug Launches
May 17, 2017 | Drug Discovery and Development
By Ryan Bushey
Johnson & Johnson (J&J) revealed on Wednesday plans to bolster its drug portfolio over the next five years.
The healthcare giant’s pharmaceutical unit intends to launch or file for regulatory approval more than 10 novel therapies with blockbuster potential between 2017 and 2021.
J&J’s announcement notes it anticipates two notable products could gain approval and be launched later this year.
The first one is psoriasis treatment guselkumab, which has delivered strong efficacy and safety data in comparison studies against the rival therapy Humira developed by AbbVie.
Another treatment for rheumatoid arthritis developed in conjunction with GlaxoSmithKline could give the company an advantage in this market as well. The injectable biotech drug sirukumab was shown to significantly produce less joint erosion and joint space narrowing compared to a placebo.
Also, a filing for prostate cancer treatment apalutamide could came later this year, according to FiercePharma. J&J acquired this asset from Aragon Pharmaceuticals in 2013 for a deal worth an estimated $1 billion.
Consensus sales from Wall Street analysts predict sales for guselkumab could hit $533 million by 2020 while sirukumab could reach $463 million that year.
“With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world,” said J&J’s Chairman and Chief Executive Officer Alex Gorsky, in a statement. Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.”
Other aspects of this plan to drive growth will also entail filing for more than 50 line extensions of existing and new medicines in order to expand patient access.
First quarter sales for J&J were trimmed slightly due to an industry wide slowdown in consumer health product sales and by payers demanding bigger rebates for certain prescription drugs.
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J&J claims higher R&D productivity than peers
May 17, 2017 | BioPharmaDive
By Suzanne Elvidge
Dive Brief:
· At its biennial Pharmaceutical Business Review Meeting, Johnson & Johnson announced that its pharma arm, Janssen Pharmaceutical, expected to submit or launch around 14 new drugs between now and 2021, with more than ten having potential blockbuster status.
· Also planned are over 50 line-extension filings. The company has received approval for 11 new molecular entities from the Food and Drug Administration since 2011.
· Janssen expects to add a sixth therapeutic area, pulmonary arterial hypertension, as it closes its acquisition of Actelion this year. It currently focuses on immunology, infectious Diseases & vaccines, neurosciencee, cardiovascular & metabolism, and oncology.
Dive Insight:
Johnson & Johnson expects the 12 blockbusters in the current portfolio, with growth of these predicted as by volume rather than price, and the innovation in its current pipeline to rocket growth over the next two years.
In 2016, the company invested $7 billion into R&D, 55% more than was spent on on sales and marketing in the previous year. While the anticipated acquisition of Actelion, which will add in marketed and late-stage pipeline products in pulmonary arterial hypertension, to be another major growth driver.
"We have made more submissions to the FDA since 2011 than any other pharma company," said William N. Hait, global head of R&D. "Since 2010, our Phase 1 to Phase 3 median cycle time has fallen. We can now move drugs through the cycle 1.5 years faster than our competitors. Our success rate has tripled whereas that of others has doubled; we can now expect to start development of seven pre-clinical assets per successful launch, compared with 16 for other pharma companies," said Hait.
Janssen's immunology franchise currently has three blockbuster products – Remicade (infliximab), Simponi (golimumab) and Stelara (ustekinumab), but Remicade is facing biosimilar competition and so its sales are in decline. As Joaquin Duato, worldwide chair of pharmaceuticals, explained, this franchise will be boosted by the addition of guselkumab for psoriasis and sirukumab for rheumatoid arthritis, both of which are expected to be approved in 2017.
"We expect five products to be the cornerstone of our portfolio in the next five years, bringing in more than $4 billion by 2021," said Duato. "These are Darzalex (daratumumab) for multiple myeloma, the oral anticoagulant Xarelto (rivaroxaban), Invega Sustenna/Xeplion (paliperidone palmitate), Imbruvica (ibrutinib) in chronic lymphocytic leukemia and Stelara."
The company isn't just focusing on diversification across products, but geographies, as well. China is rapidly becoming one of the most important markets globally. Johnson and Johnson has R&D operations in Shanghai and Beijing.
"We are working to develop drugs for diseases that are unique to people in China. As an example, lung cancer is a massive problem in China, and a focus for the Chinese R&D group," said Hait.
While the management team on the call would not confirm the Chinese R&D budget, they confirmed that money in the global budget could be allocated to work in China.
It's not necessarily going to go all J&J's way over the next few years, however, despite the very upbeat tone of the call, as Duato said: "There are some headwinds putting pressure on pricing. The company has also hit a snag with its type 2 diabetes drug Involana/Invokamet (canagliflozin), and yesterday, the FDA issued a warning about an increased risk of leg and foot amputations.
"We have seen this in patients that are at high risk of cardiovascular events, or who have had prior amputations. The incidence is low and we have to put this in context," said Hait.
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Brainstorm Health Daily: May 17, 2017
| Fortune
By Clifton Leaf and Sy Mukherjee
Johnson & Johnson plots ambitious five-year plan. Drug giant Johnson & Johnson has quite the goal for 2021: more than 10 new drugs, each with the potential to rake in more than $1 billion in sales each year, either on the market or filed for FDA approval. These experimental treatments run the gamut from flu drugs to cancer medicines to depression therapies. And these are just brand new products—as is the norm in the biopharma industry, J&J will also be looking to add on new indications to its existing product line.
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Confident Johnson & Johnson Flexes Its Muscles, Plans 10 Blockbuster Approvals by 2021
May 17, 2017 | BioSpace
By Mark Terry
Johnson & Johnson (JNJ) decided to show its pipeline muscle. In meeting with industry analysts, the company indicated it expects to have 10 new products approved between 2017 and 2021 that have blockbuster potential—annual sales of $1 billion each. And if that wasn’t enough, they have more than 50 line extensions on existing and new medicines planned.
“With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world,” said Alex Gorsky, J&J’s chairman and chief executive officer, in a statement. “Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.”
Since 2011, the company and its subsidiary, Janssen Pharmaceutical Companies, has received approval by the U.S. Food and Drug Administration (FDA) for 11 new molecular entities (NMEs). The company’s portfolio is spread amongst five core areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology. It’s planning to add a sixth area, Pulmonary Arterial Hypertension, when it completes the acquisition of Actelion, which should close this quarter.
Joaquin Duato, the company’s worldwide chairman for pharmaceuticals, has indicated that J&J hopes to see its branded drug market maintain a 5 percent annual growth through 2020, despite downward pressure on drug pricing. At this point, they’re hoping for three approvals this year and four more in 2018.
“These new drugs,” writes John Carroll, for Endpoints News, “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 a new core focus on pulmonary arterial hypertension through the Actelion (ALIOF.PK) buyout.“
The first two drugs that have already been filed are guselkumab for psoriasis and sirukumab for rheumatoid arthritis. The next nine are:
• Apalutamide (ARN-509) — the company acquired it when it bought Aragon. It’s for pre-metastatic prostate cancer.
• Esketamine — an intranasal version of ketamine for treatment-resistant depression.
• Talacotuzumab (JNJ-560222473/CSL362) — for acute myeloid leukemia.
• Erdafitinib — an FGFR inhibitor for solid tumors.
• Niraparib — for prostate cancer, approved earlier this year in the U.S. as Zejula.
• Imetelstat — for myelofibrosis. John Carrol notes, “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) — acquired with Vertex in 2014, for influenza A.
• Lumicitabine (JNJ-1575) — for respiratory syncytial virus (RSV).
• JNJ-7922 (lrexin-2 antagonist) — for adjunctive treatment for major depressive disorder.
Johnson & Johnson, of course, is offering this up optimistically as a done deal, but in reality, some of these drugs may not make it past Phase III. Carrol writes, “It’s important to remember that the success rate for Phase III drugs is about 50 percent, and payers have been radically altering the landscape for new drug prices.”
On the other hand, J&J has an R&D budget of $7 billion annually, so the company clearly wants investors updated on what’s going on with its spending.
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Johnson & Johnson Execs Discuss Drug Pipeline
May 17, 2017 | TheStreet
By Armie Margaret Lee
Johnson & Johnson (JNJ) executives said Wednesday there are more than 10 new products with blockbuster potential that they plan to either launch or for file for regulatory approval by 2021.
Speaking with industry analysts at the pharmaceutical business review meeting at the Hyatt Regency Hotel in Johnson & Johnson's hometown of New Brunswick, N.J., company executives also said there are more than 50 line-extension regulatory filings they plan to make by 2021.
Shares of Johnson & Johnson were trading at $127.42 on Wednesday, down 0.3%, amid a broader decline in the stock market.
Joaquin Duato, worldwide chairman of Johnson & Johnson's pharmaceutical business, said there are three key drivers for the company to deliver above-market growth through 2021.
Among them is its roster of 11 blockbuster products, or those with $1 billion-plus in annual sales. These include Remicade, a treatment for arthritis, ulcerative colitis and Crohn's Disease; Stelara, a treatment for a number of immune-mediated inflammatory diseases; Xarelto, an oral anticoagulant and Imbruvica, a therapy approved for the treatment of certain B-cell malignancies.
Darzalex, a treatment for multiple myeloma, is on track to become Johnson & Johnson's 12th blockbuster brand, Duato said.
The second driver is the company's drug pipeline.
Duato said the company has applied for a priority review voucher from U.S. regulators for psoriasis treatment guselkumab.
Another drug Johnson & Johnson anticipates will launch this year is sirukumab, a treatment for rheumatoid arthritis.
The company also said that between this year and 2021, it plans to file for regulatory approval for potential blockbuster products including apalutamide (ARN-509) for pre-metastatic prostate cancer, esketamine for treatment-resistant depression, talacotuzumab (CSL362) for acute myeloid leukemia, erdafitinib (FGFR Inhibitor) for solid tumors, niraparib for prostate cancer, imetelstat for myelofibrosis, pimodivir (JNJ-3872) for influenza A, lumicitabine (JNJ-1575) for respiratory syncytial virus infection and JNJ-7922 (orexin-2 antagonist) for adjunctive treatment for major depressive disorder.
The third driver, Duato said, is Johnson & Johnson's proposed purchase of Swiss biotech Actelion Ltd. Johnson & Johnson in January said it will acquire Actelion for $30 billion and plans to spin out the latter's research and development unit into a separate business.
Besides the pharmaceutical unit, Johnson & Johnson has two other business segments, medical devices and consumer. In the first quarter of 2017, the company's pharmaceutical sales worldwide totaled $8.2 billion, medical devices sales were $6.3 billion and consumer sales were $3.2 billion.
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J&J pitches its top 11 drugs in the pipeline — with a peak sales promise of $1B-plus
May 17, 2017 | Ednpoints News
By John Carroll
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.
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:
· Apalulamide (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.
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J&J: 10 products with “blockbuster potential” to be filed by 2021
May 17, 2017 | Drug Store News
By Brian Berk
Johnson & Johnson and its Janssen Pharmaceutical Cos. will announce plans to launch or file for regulatory approval more than 10 new products with “blockbuster potential” between 2017 and 2021, as well as 50-plus line extensions of new medicines, senior executives said Wednesday during an industry analysts meeting.
Among the late-stage blockbusters projected to file for regulatory approvals between 2017 and 2021, include:
· apalutamide (ARN-509) for pre-metastatic prostate cancer;
· esketamine for treatment-resistant depression;
· talacotuzumab (CSL362) for acute myeloid leukemia;
· erdafitinib (FGFR Inhibitor) for solid tumors;
· niraparib for prostate cancer;
· imetelstat for myelofibrosis;
· pimodivir (JNJ-3872) for influenza A;
· lumicitabine (JNJ-1575) for respiratory syncytial virus (RSV) infection; and,
· JNJ-7922 (orexin-2 antagonist) for adjunctive treatment for major depressive disorder.
The company also said it will share its plans to continue driving sustainable growth by leveraging its strong portfolio of core blockbuster products, the “industry-leading” productivity of its innovation model, and the pending acquisition of Swiss-based biotech company Actelion.
“With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world,” said Alex Gorsky, chairman and CEO. “Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.”
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J&J opens down despite promise of 11 new blockbusters
May 18, 2017 | Pharma Letter
US healthcare giant Johnson & Johnson’s (NYSE: JNJ) and its Janssen pharmaceutical companies expect more than 10 of its new ‘blockbuster’ products to be launched or filed for regulatory approval by 2021.
The company shared this and other news during a pharma business review meeting on Wednesday morning, after which J&J’s share price opened 0.6% down at $127.
As well as the claim over products with blockbuster potential, J&J predicted at least 50 line-extension regulatory filings by 2021.
Alex Gorsky, J&J’s chief executive, said: “With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world.
“Our pharmaceutical business will continue to be a significant driver of innovation and growth for J&J. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.”
Giving credence to these predictions, J&J can point to 11 US Food and Drug Administration (FDA) approvals for new molecular entities (NMEs) since 2011.
The company expects two NMEs to receive approval and be launched later this year, namely guselkumab for psoriasis and sirukumab for rheumatoid arthritis.
As well as J&J’s focus on five core therapeutic areas – immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism and oncology – a sixth of pulmonary arterial hypertension will be added through the $30 billion acquisition of Swiss biotech Actelion.
After an hour of trading, J&J's share price was still 0.5% down at $127.18, but a reason for this dent might have been the news that the FDA has judged that canagliflozin, the diabetes drug marketed by J&J as Invokana, causes an increased risk of leg and foot amputations and merits a label warning to this effect.
Additional late-stage blockbuster products projected to file for regulatory approvals between 2017 and 2021 include:
· apalutamide (ARN-509) for pre-metastatic prostate cancer
· esketamine for treatment-resistant depression
· talacotuzumab (CSL362) for acute myeloid leukemia
· erdafitinib (FGFR Inhibitor) for solid tumors
· niraparib for prostate cancer
· imetelstat for myelofibrosis
· pimodivir (JNJ-3872) for influenza A
· lumicitabine (JNJ-1575) for respiratory syncytial virus (RSV) infection
· JNJ-7922 (orexin-2 antagonist) for adjunctive treatment for major depressive disorder
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Johnson & Johnson Unveils Ambitious Multi-Billion Dollar Plan
May 18, 2017 | Fortune
By Sy Mukherjee
Johnson & Johnson isn't resting on its laurels. The drug giant said on Wednesday that it wants to get more than ten of it experimental "blockbuster" drugs—i.e., those that could rake in at least $1 billion in sales every year—either on the market or filed for FDA approval by 2021.
The company's Janssen biopharmaceutical unit is developing this eclectic mix of treatments. The drug candidates would tackle everything from neurological disorders like depression to cancer and deadly respiratory diseases.
J&J has been on a mission to hustle as many new therapies onto the market as possible. For instance, the company's rare blood cancer drug Darzalex nabbed an FDA approval in 2015 and has shown continued promise in followup clinical trials when combined with other cancer treatments.
And this latest goal doesn't even include the company's plans—typical of biopharma—to get the FDA to approve J&J therapies already on the market for different kinds of diseases.
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J&J (JNJ) Plans to Seek Approval for 10 New Drugs by 2021
May 18, 2017 | Zacks
Johnson & Johnson, Inc.(JNJ - Free Report) discussed its future plans and showcased a strong pipeline of transformational medicines at a meeting held yesterday with industry analysts.
J&J intends to seek approval for 10 new products between 2017 and 2021. The company said that each of these products have blockbuster potential. Also, the company is targeting more than 50 line extensions of existing and new drugs as well.
Shares of Johnson & Johnson closed at $126.67 on Wednesday, down 0.86%, amid a broader decline in the stock market. Moreover, the company’s shares are up 10% so far this year, outperforming the Zacks Classified Large Cap Pharmaceuticals industry, which has increased 8.2% in the same time frame.
Meanwhile, Johnson & Johnson also said it expects approval and launch of its two pipeline candidates this year - guselkumab for psoriasis and sirukumab for rheumatoid arthritis. Both the candidates are under review in the U.S. and EU.
The acquisition of Swiss-based biotech company Actelion, which is expected to be closed this quarter, will diversify Johnson & Johnson’s revenue stream to include pulmonary arterial hypertension (PAH) category.
The drugmaker has a record of making blockbuster drugs. The company’s immunology drugs like Remicade generated $1.7 billion in sales in the first quarter of 2017 while Stelara recorded $823 million. Blood thinner Xarelto recorded sales of $513 million in the same period. The company recorded total drug sales of $8.2 billion in the quarter.
However, the company is facing a slowdown in its pharmaceutical product sales. The Pharma segment is expected to see slower growth in 2017 as a number of key growth drivers like Remicade (rheumatoid arthritis) and Concerta (attention deficit hyperactivity disorder) are facing competition.
Remicade is facing biosimilar competition in Europe since Feb 2015 while Pfizer Inc. (PFE - Free Report) launched a biosimilar in the U.S. in Nov 2016.
Zacks Rank & Key Picks
Johnson & Johnson currently has a Zacks Rank #3 (Hold). A couple of better-ranked medical stocks are VIVUS, Inc. (VVUS - Free Report) and Catabasis Pharmaceuticals, Inc. (CATB - Free Report). Vivus sports a Zacks Rank #1 (Strong Buy) while Catabasis carries a Zacks Rank #2 (Buy).
Vivus’ loss per share estimates narrowed 22% to 39 cents for 2017 over the last 60 days. The company posted positive surprises in all the four trailing quarters with an average beat of 233.69%.
Catabasis’ loss per share estimates narrowed 13% to $1.61 for 2017 over the last 60 days. The company posted positive earnings surprises in all the four trailing quarters, with an average beat of 8.65%.
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J&J showcases its 10 blockbuster prospects
May 18, 2017 | Pharmaphorum
By Andrew McConaghie
Johnson & Johnson says is it will have more than 10 new drugs filed or on the market within the next four years – and all likely to exceed $1bn in annual revenues.
J&J believes that this consistent delivery of pipeline assets to the market will help it meet its goal of growing sales by 5% ever year up to 2020.
Head of R&D William Hait and pharma business leader Joaquin Duato presented the company’s bullish forecast yesterday at an R&D meeting, and highlighted the breadth of its pipeline across immunology, cancer and CNS therapy areas.
In immunology, the company has two late-stage drugs: anti-IL-23 antibody guselkumab for psoriasis and sirukumab, an IL-6 inhibitor for rheumatoid arthritis, and both look set to gain approval by the end of 2017.
In oncology, there is apalutamide (ARN-509) for pre-metastatic prostate cancer, an anti-IL3 receptor alpha antibody talacotuzumab for acute myeloid leukaemia (AML), FGFR blocker erdafitinib for solid tumours and PARP inhibitor niraparib in prostate cancer. The latter is already approved as Zejula for ovarian cancer, having acquired the rights from Tesaro last year.
J&J is working with Geron to co-develop imetelstat for myelofibrosis, and in CNS, esketamine for treatment-resistant depression will be filed shortly. The drug is a new intranasal formulation of the well-known tranquiliser and street drug ketamine, which gained a breakthrough designation from the FDA last year.
Meanwhile in the area of major depressive disorder, JNJ-7922 is an orexin-2 antagonist being developed as an adjunctive therapy.
Finally, the company also has two strong candidates in the field of antivirals. Lumicitabine for respiratory syncytial virus (RSV) infection has shown promise in trials involving infants with RSV infection, while pimodivir (JNJ-3872) could offer protection against serious flu infections, including H1N1 (pandemic) and H5N1 (avian) strains.
Many of these molecules were acquired from external licensing, but the company has also recently bought out an entire company. It will shortly complete its $30billion acquisition of Actelion. This will add a sixth therapeutic area to its portfolio, pulmonary arterial hypertension, based around the Swiss-headquartered company’s products Tracleer and Opsumit.
Analysts EP Vantage currently predict that J&J will stand fifth in the overall pharma market by revenues in 2022. In R&D spending terms, the company is expected to be third behind Roche and Novartis, with research spending rising to $8 billion in five years’ time.
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