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Pharma Day

Television Coverage

Alex Gorsky Interview
May 20, 2015 | CNBC

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Initial Meg Terrell Report
May 20, 2015 | CNBC

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Squawk Box Analysis
May 20, 2015 | CNBC

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11AM CNBC Update
May 20, 2015 | CNBC

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TWC News Clip
May 20, 2015 | Time Warner Cable News

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CNBC Analyst Interview
May 20, 2015 | CNBC Power lunch

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CNBC Blockbuster Drug Segment
May 20, 2015 | CNBC Closing Bell

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National Outlets

Johnson & Johnson Says It Will File at Least 10 New Drugs by 2019
May 20, 2015 | Wall Street Journal
By Lisa Beilfuss

Johnson & Johnson said Wednesday that its Janssen Pharmaceutical segment plans to file for regulatory approval of at least 10 new drugs by 2019, each with the potential to exceed $1 billion in revenue.

Wires

J&J Plans Blockbuster Lineup to Revive Momentum in Drug Sales
May 20, 2015 | Bloomberg

Johnson & Johnson plans to seek regulatory approval for more than 10 new drugs by 2019 with potential annual sales of more than $1 billion apiece, reigniting a pharmaceutical unit whose results have dragged amid stiffer competition.
Johnson & Johnson Expects Lucrative Return on Drug Pipeline
May 20, 2015 | Associated Press

Johnson & Johnson says its pharmaceutical business expects to seek regulatory approval by 2019 for more than 10 new products, each with the potential to top $1 billion in annual sales.
J&J says will submit 10 medicines to regulators by 2019
May 20, 2015 | Reuters
By Caroline Humer

Drugmaker Johnson & Johnson said on Wednesday that it would submit 10 new medicines to regulators by 2019, forecasting that many of the drugs in its research and development pipeline will have more than $1 billion in peak annual sales.

Pharmaceutical Outlets

10 New Blockbusters by 2019, J&J's Janssen Predicts
May 20, 2015 | Genetic Engineering and Biotechnology News

Johnson & Johnson’s Janssen Pharmaceutical Cos. plans to seek regulatory approval of more than 10 new drugs, each one projected to reach blockbuster status by generating annual revenue of more than $1 billion, the company said today.
J&J promises new uses for old meds to keep pharma sales flying high
May 20, 2015 | FiercePharma
By Emily Wasserman

Johnson & Johnson ($JNJ) is riding high on strong sales for standout meds, but some slowdown could be on the horizon as competition increases for its top-selling drugs. And J&J is not going down without a fight, planning to roll out new versions of old meds to keep its pharma numbers in tip-top shape.
J&J plans to file 10 potential blockbusters by 2019
May 20, 2015 | PharmaTimes
By Selina McKee

Johnson & Johnson says it plans to file 10 new molecular entities - each with the potential of pulling in sales in excess of $1 billion - and 40 line extensions of existing and new medicines by 2019.
J&J touts a blockbuster-rich pipeline with 10 filings on the horizon
May 20, 2015 | FierceBiotech

Johnson & Johnson ($JNJ) says it's on track to submit more than 10 new drugs for FDA approval over the next four years, and the company believes each of those contenders has the potential to bring in $1 billion in peak revenue.

Financial Outlets

Early movers: LOW, JNJ, SPLS, HRL, NOC & more
May 20, 2015 | CNBC Online

Johnson & Johnson–The company said it expects to have 10 or more new drugs in the pipeline by 2019, each with potential sales of $1 billion.
Will Johnson & Johnson (JNJ) Stock be Helped by New Drug Lineup Plan?
May 20, 2015 | The Street
By Amanda Schiavo

Johnson & Johnson (JNJ - Get Report) announced on Wednesday morning that its pharmaceutical segment is looking to continue driving "above industry growth" by filing over 10 new drugs between 2015 and 2019, each with the potential to bring in over $1 billion in revenue.
J&J touts pipeline of potential billion-dollar blockbusters
May 20, 2015 | Philadelphia Business Journal
By John George

Johnson & Johnson said Wednesday its drug division, Janssen Pharmaceutical Cos., expects to seek regulatory approval for 10 new products, each with the potential to top $1 billion in sales, over the next five years.
Can Another 10 Blockbuster Drugs Really Come From Johnson & Johnson in 5 Years?
May 20, 2015 | 24/7 Wall Street
By Chris Lange

Johnson & Johnson (NYSE: JNJ) has been working on its pipeline for a while, and plans on continuing to do so. In an effort to strengthen its portfolio, this pharmaceutical giant released its plan to file for more products, which each stand to make a substantial amount of revenue.
J&J Pharmaceuticals to drive growth with more than 10 filings for blockbuster drugs by 2019
May 20, 2015 | SeekingAlpha
By Douglass House

At a meeting today with analysts, Johnson & Johnson's (NYSE:JNJ) Janssen Pharmaceuticals announced plans for regulatory approval of more than 10 new drugs between 2015 and 2019, each with the potential to generate at least $1B in sales, in addition to over 40 line extensions of existing and new medicines. It projects top-line growth above the industry average through 2019.
J&J Pegs Its Long-Term Growth Potential On Prevention
May 20, 2015 | Forbes
By Arlene Weintraub

During Johnson & Johnson’s Pharmaceutical Business Review Wednesday, several executives from the healthcare-products giant made a case to Wall Street analysts that its pipeline of new drugs is strong enough to drive strong short-term sales and profit growth. But behind the scenes, the company is making a huge bet that focusing on disease prevention will be the key to its long-term growth.
Johnson & Johnson Announces it Will File for Ten New Drugs by 2019
May 20, 2015 | TheStreet
By Michelle Rama-Poccia

Johnson & Johnson (JNJ - Get Report) said Wednesday its Janssen unit will file for regulatory approval of at least 10 new drugs by 2019.

Television Coverage

Alex Gorsky Interview

May 20, 2015 | CNBC

Rough transcript: johnson & johnson, we've been talking about this interview, holding a pharmaceutical analyst meeting today. meg terrell is there and is joining us with a very special guest. meg. >> joe, thank you so much. joining us now is ceo alex gorsky. thank you for joining us. >> great to have you here in new brunswick. as you know, this is the home of johnson & johnson. who would have thought 125 years plus ago when the johnson brothers started j & j that we'd be talking about the kind of invags that we'll be reviewing today with the analysts and with you. >> and you're planning on filing for approval of ten new drugs in the next four years, each with the potential to bring in more than a billion dollars. does that assume basically everything in your late-stage pipeline is a success? >> look, we're really excited about the innovation that we'll talk today. as you said if you go back since 2009 we've launched 14 compounds. now if we look forward between now and 2019, yes, we expect to have about ten compounds. of course you're going to have 8:06 AMsome wins, you're going to have some that don't turn out quite the way you expect, but overall we're very confident in the ability, particularly based on what we've been able to do over the past several years, on our ability to really impact patients and drive this kind of innovation going forward. >> some of the other news you put out on your multiple mieloma drug, you're going to file for approval on midstage data. so what does that say about how good those data look in just a couple of weeks? >> i'm so proud of our oncology team. the compounds that we've been able to launch, now the phase two data, i'm sure that you probably know people who have been affected by multiple myeloma. i have had friends and colleagues that have been affected and died from it. to think we could have this kind of data and this kind of results, even in patients that have tried previous therapies, it's really promising. it's just one indication of the payoff the patients are getting, that we're getting from the investments that we made in the 8:07 AMoncology area and other innovations over the past several years. >> a lot of growth coming you're laying out today. what analysts are focused on is a potential competitor to remikasde. >> what we're talking about here today is all the innovation coming forward. we do understand biosimilars are part of the marketplace in which we compete. first of all, it's really important that we focus on the patients and we launched the first one more than ten years ago. when you look at biosimilars or generics, keeping the patient first and consider indications, safety, efficacy is the number one priority. second of course we'll protect our intellectual property rights. that's so important to our industry. that's what makes us -- gives us the ability frankly to invest in the innovation for the future. but we do feel there's a place for generics and biosimilars. third, if you look at our immunology portfolio, things 8:08 AMlike stellara that are already doing very well, you'll hear about others, aisle 6, aisle 23, new approaches, we think we've got a comprehensive approach to the way we'll go about defending our franchise and frankly helping even more patients in immunology. >> joe, do you want to ask a question? >> hi, alex. i know this is mostly about your pharmaceutical division today, but i look back on the last five, ten years at j & j and it seemed like bill welldon spent a lot of his time putting out fires, quality issues, that prevented him from maybe making more transformative moves. i wonder if you're considering, since this is the fastest-growing part, does this consumer products division and medical devices, does it still make sense to keep all those under one umbrella? do investment bankers come to you and say you could do this if you did this or if you focus on this, you could get, you know, shareholder value would go up? are there any things like that 8:09 AMthat you think about from time to time? >> well, thanks a lot for the question, joe. hey, maybe next time you can be out here to join us for this meeting as well. but whether it was bill welldon or ralph larson, i think if you go back in the history of johnsjohn z johnson & johnson, one thing we've been committed to is managing our business as a diversified portfolio. frankly that gave us the ability several years ago to reinvest in our pharmaceutical pipeline when we experienced about an $8.5 billion generic launch and patent expirery. but we have a strong medical device business, a strong consumer business and we've seen the benefit of that in our pharmaceutical pipeline over the past five years with all the launches and all the great innovations that we'll talk about today. so we think financially it gives us incredible flexibility and capabili capability. the other exciting thing is about the scientific opportunities. as we think about areas going forward, whether it's oncology, whether it's things in the back 8:10 AMof the eye, being able to combine devices and pharmaceutical products and even consumer approaches and perhaps wellness programs in new and innovative ways we think is particularly exciting. and finally it's really important for our colleagues here, giving them different career paths, different opportunities to develop their talent has also been a real benefit of having this diverse portfolio. while of course from time to time people are going to challenge you, saying you should be a pure play here or there, we think this approach in the long term is in the best interests of patients and frankly all of our stakeholders. >> just real quickly, one other thing that i think about a lot, i know ian reed and i know the man and i understood his rationale with pfizer. he made it clear that he could invest a billion dollars more with a lower tax rate into r & d if the tax rate in the united states was more competitive with the rest of the world. 8:11 AMso it was simple for him to try to change where pfizer would be domiciled. at this point in terms of the tax rate, do you see other companies able to outbid you on attractive acquisitions, other foreign companies, because of the inequitable tax structure globally? is that something that bothers you or you'd push to have changed? >> we've been working with the government and of course would like to see a more comprehensive tax reform package done in the united states. we think that would be good for all companies to help us be even more competitive. we also believe that tax is only one component of your overall m & a strategy. making sure you understand the science, making sure we understand the overall marketplace, putting all those things in the balance, we think that's what helps us remain very competitive. we think we've had actually a very good balance. if you look over the last 20 years, for example, with johnson & johnson, we've invested over 8:12 AM$200 billion, about half of that in internal r & d, half of that in m & a, so we think having a balanced approach is really what enables us to have long-term success. >> i want to ask you about your m & a strategy because yesterday you announced a deal with achileon so where are you looking at m & a? would you do a bigger deal? >> look, we think it's very important to ultimately go after the best science. we're really agnostic about whether it's internal or external. but if we get the best science, we ultimately know we'll help more patients and create the best business opportunities. we're always on the hunt for new scientific platforms. so whether it's in areas such as oncology, whether it's in viralology, whether it's in new neuroscience, making sure we're always on the hunt, sometimes it's complementary technology. so if you think about what we just announced this morning, we already were able to introduce alesia last year. we went out and did an acquisition. but when we do those acquisition, the other thing that we acquire beyond molecules are great scientists. people like larry blatt who will be working taking perhaps taking what we have and combine it with other things to come up with a great approach in hepatitis c that's going to be great for patients and great for our business. >> so many more questions but unfortunately we have to loef it there. thank you for joining us. >> meg, thank you so much. >> becky, back over to you guys. >> meg, thank you. and mr. gorsky, thanks to him too....

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Initial Meg Terrell Report

May 20, 2015 | CNBC

Rough transcript: Johnson & Johnson is holding its biannual pharmaceutical analysts meeting today that will focus solely on the largest of J&J's three business segments and Meg Terrell is there. Meg? >> good morning, joe. we're here in new brunswick where the pharma event is about to kick off in an hour. some breaking news coming to you right now. j & j saying that it plans ten new drug filings by 2019, each with the potential to exceed a billion dollars in revenue. so potentially ten new drugs 7:31 AMbeing filed by j & j by 2019. that's the breaking news crossing just now. the company also says its business has been going strong. it's the fastest growing part of j & j's entire business. it's launched 14 new products since 2009, seven of which are on track to bring in more than $1 billion in 2015. some of the new drugs will one for multiple myelopa, a drug for depression, resuarthritis and psorias psoriasis. based on phase 2 data that it will present in a couple of weeks, there's new news coming out from j & j. as the business has been doing really strong, though, potential generic competition coming to about a third of the business. just in the next few years. so some challenges potentially down the line but a lot of growth. j & j will detail all of that today and we'll talk with the ceo in the next half hour, so a lot to stay tuned for. 7:32 AMback to you guys. >> is that -- let me see, i'm trying to figure out where that ranks in terms of -- is that the biggest -- that might be the biggest. is it bigger than glaxo at this point? yeah, it's well above -- i think it's almost the biggest, is it not? >> j & j is the biggest health care company in the world. its pharmaceutical business is its biggest of the three. pharmaceuticals brings in $32 billion in revenue annually. they also say it's the second fastest-growing pharma company in the world. >> and they have done a lot of acquisitions in the past. nothing that i can recall that recently, though. i wonder if -- so their research is probably done with some of the biotech companies, a lot of it by some of the biotech companies they bought in the past? >> absolutely. they have been doing a lot of smaller deals, a lot of licensing deals. just yesterday after the close announced an equity stake in akiloon to focus on hepatitis c drugs. they're also said to be a bidder for another company so while they're thought to do mostly smaller deals, they clearly may not be afraid to spend more for the right product. >> yeah, i wonder where they'd go. we'll does gorsky -- what did you say, 33% goes off patent? >> potentially between 2017 and 2019. >> so they have got to deal with that. all right, meg, we'll see you -- that's at 8:00, right? top of the hour? >> that's right. >> perfect. all right. thanks. >>>...

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Squawk Box Analysis

May 20, 2015 | CNBC

Rough Transcript: johnson and johnson announcing plans to file 10 new by 2019 each with the potential of $29 billion in revenue. >> if you go back to 2009 we've launched 14 compounds and now we've had about 10 compounds. you're going to have some that don't turn out the way you expect but overall we're going to base what we've done on our 9:19 AMability to impact the nation going forward. >> johnson and johnson moving on that. >> it's been going up this week. i think they got the best of it. >> he's done a great job on the actual interview. i think it's really the right time. let's stay focussed on that. that's been the leader or is a lot of talk, pure talk about getting together. they say what do they know? it could happen. watch chatter take over. >> they can invert by doing an moe. 9:20 AM>> i know he's a hard charging guy. >> it still continues to be the eve split of the accompany. >> when we saw that gigantic over pay, people want deals in the segment and j and j is starting to get back to where it was. i like that stuff. >> they, of course, cannot operate with the advantage of being inverted in some way or having a lower tax rate. we should always point out they're taxable. we do anything your out where the tax rate is lower. >> you would buy that one. >> yeah, interesting. almost exactly flat for the year.

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11AM CNBC Update

May 20, 2015 | CNBC

Rough Draft: johnson & johnson holding its pharmaceutical analysts meeting today in new jersey. the ceo speaking out in an interview this morning. our meg tyrell at the meeting with morning. >> hey, carl, so j & j laying out its plans for growth for the next few years. its pharma business is the largest, fastest growing portion of all of johnson & johnson. but they do face some increased competition over the next few years. up to a third of its pharma business could face generic or biosimilar competition between 2017 and 2019. so really laying out where growth going to come from we spoke to the ceo alex gorski this morning. take a listen. >> if you go back since 2009, we've actually launched 14 compounds and now if we look forward between now and 2019, yes, we expect to have about ten compounds. 10:56 AMnow of course you're going to have some that don't turn out quite the way you expect. but overall we're very confident in the ability, particularly based on what we've been able to do over the past several years on our ability to impact patients and drive this kind of innovation going forward. >> now the company also said today that it plans to file for approval of its multiple myeloma drug by the end of the year, based on mid-stage data that will present in a couple of weeks at the asco cancer conference, a little earlier than analysts expected it could bring up in $1.3 billion in sales in 2019. we talked about m&a, the company has been active among mostly smaller deals, announced one yesterday with achillion, the stock is trading down today. investors may be hoping for a total takeout. it's just a partnership deal and an equity stake. also a bidder for pharma cycleix, we talked about alex divorce gorsky about this as well. >> whether it's an area that's in oncology, viralology. whether it's neuroskips, we make sure we're always on the hunt. looking for those new opportunities. >> a lot more coming up the rest of the day here, j & j will bring it all to you. simon, back to you

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TWC News Clip

May 20, 2015 | Time Warner Cable News

Rough Transcript: Johnson & Johnson is unveiling an ambitious pipeline drugs the world's biggest health care products maker seeking approval more than ten new products by twenty nineteen that could add up to a billion dollars in sales per product for the company j. j. also seeking approval forty additional uses for some of that other products after the ten new drives which the obvious seeking approval those include treatments for blood cancer remove toward arthritis and prostate cancer game day up mildly.

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CNBC Analyst Interview

May 20, 2015 | CNBC Power lunch

Rough Transcript: live at j and j's pharmaceutical meeting. over to you. >> thank you so much. here they are laying out the strategy for the growth and saying they plan to file for approval of the new drugs with the ability to potentially bring in more than a billion dollars in revenue. that's important because over the next years, up to a third of the pharma business could face 1:56 PMsimilar competition. this is a hume toyed arthritis drug or more here in the u.s. there is debate as to when that could hit the market here in the u.s. between 2016 and 2018. we have heard of pills like lipitor and these drugs are made from living cells. they are called that because they are not identical. to call them biosimilars. there a ton of these right now. three three drugs like that and others from amgen. the first has been approved here in THEs, but not yet on the market. it is tied up in legal paddles. to talk more about this with us 1:57 PMis mike weinstein. they will have the patent expire in late 2018. will key see biosimilar prior to that. there is a challenge to that that is being played out to change the patents and potential approval that you talked about sometime in the next year or two. that got delayed two months ago. there is a real question when that will product be approve and when will we see the competition. when is your expectation of seeing the biosimilar? >> exactly. the question will come down to the label discussions and the court activity. that will come down to the one question. 1:58 PMat that point it will issue part of fizer and they decide to launch at risk when they get fda approval. we are assuming and we think it will not. they will wait to play out the past which will be later in 2018. we don't think it will be an issue until late 2018, but that's part of the risk that people are discussing today and are worried about. and are they prepared to handle this? >> j and j for those of you who are not familiar with what they are, they are a big driver of the performances and the stock is the pharmaceutical business. it is 43% of sales and 55% of praft profits. it has done exceptionally well. 16 brs last year even if you backed out of a drug last year, it was growing in that range. we think it can continue over the next three to four years. they did a good job of convincing us that they are developing a line line that can help us manage through the challenges as we go out. >> everybody talks about them having more than $30 billion in cash. do you think they will do a big acquisition in pharma? they have done a fantastic job better on the pharma side and the consumer. that can be anything from large acquisitions, but more in licensing compounds and buying smaller companies. they haven't needed to do a large deal to get the growth that we are getting. i think they can continue to do the big deal. >> thank you so much for joining us.

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CNBC Blockbuster Drug Segment

May 20, 2015 | CNBC Closing Bell

Rough Transcript: are blockbuster drugs everything they're cracked up to be? meg tirrell. >> bill, thank you. we're here at j & j's pharma analysts day. when farm is analypharma analys they leave out a drug for hepatitis c. they model over the next few years for that revenue to essentially evaporate. we've seen this before. it's a tremendously fast rise and fall. we've only seen it in hepatitis c. in may of 2011, two drugs were approved back to back from hepatitis c. vertex and c-vec was hailed at the time as the drug launch ever. that quickly dropped off the following year and vertex pulled the drug from the market in 2014. a similar pattern followed for merck. you might wonder why this happened. in one word, gilead. sovaldi was approved and brought in more than $10 billion last year. j & j's olysio was approved and combined with sovaldi. but then at the end of last year, gilead's own combination pill, harvoni was approved. in two months it brought in $2 billion in revenue. that may lead to the erosion analysts are modeling for olysio. they do cure this disease. new generations of drugs have been coming on the market so fast. j & j reiterated its commitment to the hepatitis c space announcing a deal with gilead

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National Outlets

Johnson & Johnson Says It Will File at Least 10 New Drugs by 2019

May 20, 2015 | Wall Street Journal

By Lisa Beilfuss

Johnson & Johnson said Wednesday that its Janssen Pharmaceutical segment plans to file for regulatory approval of at least 10 new drugs by 2019, each with the potential to exceed $1 billion in revenue.

The company also said it plans more than 40 line extensions of existing and new medicines.

“We look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines,” said Joaquin Duato, world-wide pharmaceuticals chairman. “We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients.”

J&J said late-stage products expected to drive growth in the next several years include daratumumab for multiple myeloma, sirukumab for rheumatoid arthritis, and guselkumab for psoriasis.

The company meets with industry analysts Wednesday.

Shares, down 0.6% this year, rose 0.5% to $104.50 in premarket trading.

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Wires

J&J Plans Blockbuster Lineup to Revive Momentum in Drug Sales

May 20, 2015 | Bloomberg

Johnson & Johnson plans to seek regulatory approval for more than 10 new drugs by 2019 with potential annual sales of more than $1 billion apiece, reigniting a pharmaceutical unit whose results have dragged amid stiffer competition.

The medications will focus on five areas: immunology; infectious diseases and vaccines; neuroscience; cardiovascular and metabolism; and oncology, the world’s biggest maker of health-care products said in a statement. The company holds a meeting with investors Wednesday in New Brunswick, New Jersey.

The potential blockbusters in the pipeline could help J&J regain some momentum in its biggest division. Analysts estimate J&J’s sales of new drugs -- approved in 2009 or after -- will climb 8 percent a year through 2020 -- about one-third the median rate of its competitors, according to Bloomberg Intelligence.

The growth is being dragged down by hepatitis C treatment Olysio, whose sales are declining as better medications enter the market. Remicade, an arthritis treatment that’s J&J’s top-selling product, is under competitive threat from a copycat drug by Celltrion Inc. and Hospira Inc.

J&J has counted on diabetes treatment Invokana to propel the growth of its drug division, with sales climbing 38 percent in the first quarter from a year earlier.

Among the drugs J&J has under development are daratumumab, a treatment for the blood cancer multiple myeloma that is on the FDA’s fast track for approval. Esketamine, for depression, and ARN-509, for prostate cancer, are in clinical trials.

J&J’s drug unit isn’t the only part of the company that has struggled. Sales in the consumer division, which makes over-the-counter products like Tylenol and Motrin, fell 4.7 percent last quarter from a year earlier to $3.39 billion. Revenue for the medical-device business, which has been under pressure from cost-cutting by insurers and hospitals, dropped 11 percent to $6.26 billion.

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Johnson & Johnson Expects Lucrative Return on Drug Pipeline

May 20, 2015 | Associated Press

Johnson & Johnson is predicting big returns from its prescription drug business, both financially and medically, as it develops treatments and strategies to intervene earlier and prevent or reduce the damage from several conditions, including Alzheimer's disease and diabetes.
The world's biggest maker of health care products said Wednesday that it plans to seek approval by 2019 for more than 10 new medicines, each with blockbuster potential — at least $1 billion in annual sales.
During a daylong review of its pharmaceutical business with analysts, J&J said its Janssen Pharmaceutical Companies business also will pursue approvals of more than 40 additional uses for existing drugs.
"We believe we will continue to deliver above-industry growth through the end of the decade," Joaquin Duarto, global head of pharmaceutical marketing, told the analysts.
The company expects growth to come from several drugs currently in late-stage patient testing, usually the last phase before a drugmaker seeks approval. Those include potential treatments for the bone marrow cancer multiple myeloma, rheumatoid arthritis and prostate cancer that has not spread.
New Brunswick, New Jersey-based Johnson & Johnson has launched 14 new medicines since 2009, including Invokana for diabetes and Xarelto for preventing heart attacks and strokes, and boosted its drug revenue to $32 billion of its $74.3 billion total last year.
J&J focuses its medicine marketing and research on five areas: cancer, cardiovascular and metabolic disorders, immunology, infectious diseases and vaccines, and neurologic disorders such as schizophrenia and Alzheimer's.
Those fields all require treatments that work better, with fewer side effects and in more patients. Not coincidentally, any successes there are likely to be very lucrative.
"We're imagining a healthier future, based on disease prevention and interception," said global research director Dr. William Hait.
He referred to his ambitious, long-term initiative to combine gene-based diagnostic tests — another big segment at J&J — with advanced new medicines to either prevent diseases with vaccines or other methods, or to intervene early enough to slow their course and limit damage, which could give millions of patients more productive years.
Many of the drugs in Johnson & Johnson's pipeline were developed with or licensed from other pharmaceutical companies.
On Tuesday, Janssen announced it will partner with Achillion Pharmaceuticals Inc. to develop and sell new hepatitis C treatments, a lucrative market dominated by recent blockbusters Harvoni, Sovaldi and Viekira Pak that have boosted cure rates from about 60 percent after 24 weeks to roughly 95 percent in 8 to 12 weeks.

Those drugs have hurt sales of Johnson & Johnson's Olysio, which saw revenue tumble 34 percent to $234 million in the first quarter. The company now is developing a combination hepatitis C pill that could bring cures in only six weeks and work in patients with all subtypes of the virus, unlike current medicines, said Lawrence Blatt, co-director of infectious disease research.

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J&J says will submit 10 medicines to regulators by 2019

May 20, 2015 | Reuters

By Caroline Humer

U.S. healthcare conglomerate Johnson & Johnson said on Wednesday it expects to submit more than 10 new medicines with annual revenue potential of at least $1 billion each to regulators by 2019, and is testing dozens of new uses for existing medicines.
J&J said it would file for approval of daratumumab for the blood cancer multiple myeloma in the United States and Europe this year based on mid-stage clinical data.
Wells Fargo analyst Larry Biegelsen forecast daratumumab sales reaching $1.3 billion by 2019.
The company is looking to bounce back from previous failure in Alzheimer's disease with multiple programs, including an early-stage drug it believes has the potential to prevent amyloid plaque buildup in the brain and another that aims to clear it.
Pharmaceuticals has been a bright spot for the company at a time when its medical devices and consumer products have seen sharp declines, hurt by competition and the strong dollar.
During a pharmaceutical pipeline review for analysts and investors, J&J outlined an ambitious portfolio of drugs in development aimed at sustaining above-industry compound annual growth through 2019. The industry rate over that period is expected to be about 3 percent.
The review comes as the industry prepares for the introduction of copycat versions of expensive biologic drugs, such as J&J's rheumatoid arthritis (RA) treatment Remicade, which has annual U.S. sales of more than $4 billion and a patent that expires in 2018.
J&J's worldwide pharmaceuticals head Joaquin Duato said he believes Remicade's established safety would be an advantage over eventual biosimilar newcomers.
"Biosimilars are not generics and we expect the market to behave quite differently," Duato said.
Still, the company highlighted a new antibody for RA being developed with GlaxoSmithKline, and one for psoriasis that it touted as more effective that Abbott's big-selling Humira.
The company is targeting Crohn's disease with a new drug being developed along with a companion diagnostic aimed at identifying patients likely to have the best response, and is beginning Phase III trials of a promising drug for treatment resistant depression.
J&J is jumping on the immuno-oncology bandwagon with programs for lung, prostate and blood cancers aimed at harnessing the immune system to attack tumors.

It also aims to become a major player in the hepatitis C market now dominated by Gilead Sciences through a deal announced Tuesday with Achillion Pharmaceuticals.

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Pharmaceutical Outlets

10 New Blockbusters by 2019, J&J's Janssen Predicts

May 20, 2015 | Genetic Engineering and Biotechnology News

Johnson & Johnson’s Janssen Pharmaceutical Cos. plans to seek regulatory approval of more than 10 new drugs, each one projected to reach blockbuster status by generating annual revenue of more than $1 billion, the company said today.
The company cited a dozen late-stage drug candidates it said will drive that projected growth. The plurality, four, have oncology indications.
They include: The human anti-CD38 antibody daratumumab for multiple myeloma, developed under an up-to-$1 billion licensing deal with Genmab inked in 2012; the modified oligonucleotide imetelstat for myelofibrosis, co-developed with Geron under an up-to-$935 million collaboration; the FGFRi kinase inhibitor JNJ-493 for urothelial cancer; and the androgen receptor signaling inhibitor JNJ-927 (ARN-509) for pre-metastatic prostate cancer, inherited when J&J acquired Aragon Pharmaceuticals for up to $1 billion in 2013.
Oncology is one of J&J’s five therapeutic areas of focus. The other four are cardiovascular and metabolism, infectious diseases and vaccines, immunology, and neuroscience. Within those other areas, Janssen cited as drivers of future growth:Three infectious disease compounds—The uridine-based nucleotide analog AL-335 for hepatitis C; the oral nucleoside analog AL-8176 for respiratory syncytial virus; and JNJ-872 (VX-787), a first-in-class oral polymerase inhibitor for influenza A. J&J inherited the first two last year when it acquired Alios BioPharma for about $1.75 billion, and is co-developing JNJ-872 under a $30 million-plus collaboration with Vertex Pharmaceuticals inked last year.Three neuroscience compounds—the NMDA receptor antagonist esketamine for treatment-resistant depression; the anti-nerve growth factor antibody fulranumab for osteoarthritic pain, licensed from Amgen under an up-to-$434 million licensing deal signed in 2008; and the Orexin-2 antagonist JNJ-922 for primary insomnia.Two immunology compounds—guselkumab for psoriasis, licensed from MorphoSys, which developed the anti-Interleukin-23 monoclonal antibody through its Human Combinatorial Antibody Library (HuCAL); and the human anti-interleukin-6 monoclonal antibody sirukumab for rheumatoid arthritis, co-developed with GlaxoSmithKline.
Daratumumab and esketamine have both received Breakthrough Therapy Designations from the FDA.
Janssen also said it plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the European Medicines Agency this year for daratumumab in double refractory multiple myeloma. The submission will be based on Phase II data, which the company said will be presented at the upcoming American Society of Clinical Oncology annual meeting, to be held May 29–June 2 in Chicago.
Additionally, Janssen told analysts, it will also pursue approvals for more than 40 line extensions of existing and new medicines by 2019.
Four of those are Phase III indications being pursued for daratumumab as part of combination therapies—Relapsed/refractory multiple myeloma in combination with lenalidomide/dexamethasone (MMY3003); relapsed/refractory multiple myeloma in combination with bortezomib/dexamethasone (MMY3004); frontline multiple myeloma transplant ineligible patients in combination with bortezomib, melphalan, and prednisone (MMY 3007); and frontline multiple myeloma transplant ineligible patients in combination with lenalidomide and low dose dexamethasone (MMY 3008).

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J&J promises new uses for old meds to keep pharma sales flying high

May 20, 2015 | FiercePharma

By Emily Wasserman

Johnson & Johnson ($JNJ) is riding high on strong sales for standout meds, but some slowdown could be on the horizon as competition increases for its top-selling drugs. And J&J is not going down without a fight, planning to roll out new versions of old meds to keep its pharma numbers in tip-top shape.
The New Brunswick, NJ-based pharma giant will pursue 40 line extensions of new and existing meds, it said Wednesday. And on top of that, it'll seek regulatory approval for more than 10 new drugs by 2019, each with potential annual sales of more than $1 billion, J&J said in a statement. If J&J has its way, its current portfolio and pipeline will offer "momentum to sustain above-industry compound annual growth through 2019," the company said in a statement.
"Our innovation strategy has delivered transformational products for patients and also created a cycle of success that positions us for continued growth across the entire Johnson & Johnson enterprise," Paul Stoffels, Chief Scientific Officer and Worldwide Chairman of Pharmaceuticals, said in a statement. "With a single-minded focus on unmet medical need and true differentiation, we've built an industry-leading pipeline to improve and extend people's lives and also create value for society and our business."
But J&J will have its work cut out for it as it looks to keep up the momentum in its pharma business. Analysts estimate the company's sales of drugs approved in 2009 or after will grow 8% a year through 2020--one-third the median rate of its competitors, Bloomberg reports. Part of the explanation is increased competition to top-selling drugs. Sales for the company's hep C powerhouse Olysio are taking a beating as rival treatments from Gilead Sciences ($GILD) and AbbVie ($ABBV) flood the market, with a 34% drop in revenues during the first quarter. And J&J's blockbuster arthritis med Remicade faces competition from a copycat version of the drug made by Hospira ($HSP) and Celltrion.
Still, J&J is counting on strong numbers for some of its new launches to keep it riding high. Clot-fighter Xarelto jumped almost 40% to $441 million in Q1, and psoriasis drug Stelara was up by one-fifth to $549 million. Diabetes med Invokana raked in $278 million in worldwide sales over that stretch, too.
And J&J is hoping that its recent FDA approval for a new, thrice-yearly version of antipsychotic powerhouse Invega will keep numbers northbound. The company earlier this week got the agency's signoff for Invega Trinza, a schizophrenia med with the longest dosing option available on the market, J&J said. But the injectable drug will have some ground to cover, as patients continue to deflect to oral, easier-to-take pills.

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J&J plans to file 10 potential blockbusters by 2019

May 20, 2015 | PharmaTimes

By Selina McKee

Johnson & Johnson says it plans to file 10 new molecular entities - each with the potential of pulling in sales in excess of $1 billion - and 40 line extensions of existing and new medicines by 2019.

Coupled with 14 new product launches since 2009, seven of which are already blockbusters or close to it, the firm says its robust portfolio and late-stage pipeline have placed it in good stead to achieve above-industry compound annual growth over the next four years.

The US healthcare giant noted that the total global branded pharmaceuticals market is expected to grow at a compound annual operational growth rate of around 3% from 2014 to 2019, according to IMS Health data, and that its pharmaceuticals unit is currently growing around 16.5% a year.

“In the past two years, our performance and growth rates have been industry-leading, and we look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines,” said Joaquin Duato, worldwide chairman of Pharmaceuticals at Johnson & Johnson.

Expected near-term growth drivers (after approval) include ‘breakthrough’ multiple myeloma drug daratumumab; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 for urothelial cancer; ‘breakthrough’ esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus; fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.

J&J also announced that its Janssen unit is planning to submit a Biologic Licensing Application to regulators on both sides of the Atlantic this year for daratumumab in double refractory multiple myeloma, based on Phase II data which will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting.

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J&J touts a blockbuster-rich pipeline with 10 filings on the horizon

May 20, 2015 | FierceBiotech

Johnson & Johnson ($JNJ) says it's on track to submit more than 10 new drugs for FDA approval over the next four years, and the company believes each of those contenders has the potential to bring in $1 billion in peak revenue.
Meeting with analysts and investors on Wednesday, J&J unveiled its vision for the near term, touting its 19 successful drug launches since 2009 as evidence that it's on an R&D hot streak. Now the New Jersey drugmaker says it's at the cusp of a bright future, touting its late-stage pipeline of treatments for cancer and inflammatory disease.
Leading the way among those would-be billion-sellers is daratumumab, a breakthrough-designated multiple myeloma treatment J&J plans to submit for approval this year. Behind that are sirukumab, an antibody for rheumatoid arthritis, and the psoriasis-treating guselkumab, each in the midst of Phase III development in blockbuster indications.The Biotech Primer: An insider's guide to the science driving the biotech and pharma industries
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J&J is also working up late-stage treatments for depression, respiratory syncytial virus, osteoarthritic pain, influenza, insomnia, hepatitis C and a slew of cancers, comprising a wide pipeline of in-house, in-licensed and acquired assets the company believes can come through in Phase III.
That stable of candidates is a testament to what J&J calls its best-in-pharma R&D productivity, and Chief Scientific Officer Paul Stoffels said the company is looking past 2019 with a crop of promising early-stage assets.
"Our innovation strategy has delivered transformational products for patients and also created a cycle of success that positions us for continued growth across the entire Johnson & Johnson enterprise," Stoffels said in a statement. "With a single-minded focus on unmet medical need and true differentiation, we've built an industry-leading pipeline to improve and extend people's lives and also create value for society and our business."

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Financial Outlets

Early movers: LOW, JNJ, SPLS, HRL, NOC & more

May 20, 2015 | CNBC Online

Check out which companies are making headlines before the bell:

Lowe's–The home improvement retailer missed estimates by four cents with quarterly profit of 70 cents per share. Revenue missed forecasts, and same-store sales rose less than expected. JPMorgan Chase analyst Chris Horvers told CNBC that rival Home Depot has an advantage over Lowe's in both execution and store location.

Johnson & Johnson–The company said it expects to have 10 or more new drugs in the pipeline by 2019, each with potential sales of $1 billion.

Staples– The office supplies retailer matched estimates with adjusted quarterly profit of 17 cents per share, but revenue fell short and sales fell more than anticipated. Staples is in the process of merging with rival Office Depot, just two years after acquiring OfficeMax.

Hormel Foods–Hormel reported quarterly profit of 67 cents per share, five cents above estimates, although revenue was shy of forecasts. Hormel does say that its Jennie-O turkey business could be "significantly challenged" due to the impact of the bird flu outbreak in the U.S. However, Hormel did reaffirm its full-year earnings forecast.

Northrop Grumman–The aerospace company raised its quarterly dividend to 80 cents per share from 70 cents, an increase of 14 percent.

Lions Gate–Jefferies initiated coverage on the movie studio's stock with a "buy" rating, saying it's an attractive "pure play" for premium content.

FireEye–Evercore began coverage on the cybersecurity products maker's stock with a "buy" rating.

Autodesk—The maker of design software reported adjusted quarterly profit of 30 cents per share, two cents above estimates. Revenue also beat forecasts, but Autodesk also forecast lower than expected earnings and revenue for the current quarter because of a stronger dollar.

Etsy–Etsy lost 84 cents for its latest quarter, though revenue matched estimates. The online crafts seller's quarterly loss was more than seven times larger than the loss it posted in the year ago quarter. Etsy said it would hire more people this quarter and spend more on marketing.

Analog Devices–Analog Devices reported adjusted quarterly profit of 73 cents per share, beating estimates by a penny. Revenue was slightly above forecasts, and the chip maker said it is seeing stable order rates in its various markets.

Bunge–Bunge announced a new $500 million stock buyback program, and the grain trading firm also said it was raising its quarterly dividend by four cents to 38 cents per share, an increase of 12 percent.

United Technologies–The company is in talks with possible buyers for its Sikorsky Aircraft unit, according to sources quoted by The Wall Street Journal. The company has previously said it is considering its options for that business.

UBS–The Swiss bank will pay $545 million to settle an investigation by U.S. officials into alleged rigging for currency markets.

Time Warner Cable–The cable company could be in play once again today, with French telecom company Altice announcing a deal to buy Suddenlink Communications of the U.S., and reportedly having held talks to buy TWC, according to Reuters.

Salesforce.com–Salesforce is unlikely to be sold, in the opinion of SAP CEO Bill McDermott. McDermott also told reporters his company does not have any interest in buying the software company.

Yahoo–Yahoo shares came under pressure on concern that possible U.S. tax law changes could affect the company's planned spinoff of its Alibaba stake. However, Yahoo issued a statement saying it understands that the latest IRS statement on the matter is not specific to the planned move.

Norwegian Cruise Lines–The cruise line operator said its Norwegian Dawn cruise ship will be inspected in Bermuda today for any possible damage after it ran aground on a reef. The company said all were safe and there were no injuries.

Pep Boys–Pep Boys has been approached by possible buyers, according to The Wall Street Journal, which said Golden Gate Capital is among the suitors interested in the auto parts retailer.

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Will Johnson & Johnson (JNJ) Stock be Helped by New Drug Lineup Plan?

May 20, 2015 | The Street

By Amanda Schiavo

Johnson & Johnson (JNJ - Get Report) announced on Wednesday morning that its pharmaceutical segment is looking to continue driving "above industry growth" by filing over 10 new drugs between 2015 and 2019, each with the potential to bring in over $1 billion in revenue.

The company, which researches, develops, manufactures, and sells a variety of health care related products said it met with industry analysts, adding that senior leaders from its Janssen Pharmaceutical Companies will announce plans to file for regulatory approval of the new drugs as well as over 40 line extensions of existing and new medicines.

"In the past two years, our performance and growth rates have been industry-leading, and we look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines," Joaquin Duato, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson said in a statement announcing the plan.

"We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients," Duato continued.

Shares of Johnson & Johnson are up by 0.40% to $103.96 in pre-market trading on Wednesday morning.

Separately, TheStreet Ratings team rates JOHNSON & JOHNSON as a Buy with a ratings score of A-. TheStreet Ratings Team has this to say about their recommendation:

"We rate JOHNSON & JOHNSON (JNJ) a BUY. This is based on the convergence of positive investment measures, which should help this stock outperform the majority of stocks that we rate. The company's strengths can be seen in multiple areas, such as its largely solid financial position with reasonable debt levels by most measures, notable return on equity, reasonable valuation levels, expanding profit margins and increase in stock price during the past year. We feel its strengths outweigh the fact that the company has had sub par growth in net income."

Highlights from the analysis by TheStreet Ratings Team goes as follows:

JNJ's debt-to-equity ratio is very low at 0.28 and is currently below that of the industry average, implying that there has been very successful management of debt levels. To add to this, JNJ has a quick ratio of 1.80, which demonstrates the ability of the company to cover short-term liquidity needs.

The return on equity has improved slightly when compared to the same quarter one year prior. This can be construed as a modest strength in the organization. Compared to other companies in the Pharmaceuticals industry and the overall market, JOHNSON & JOHNSON's return on equity exceeds that of both the industry average and the S&P 500.

JOHNSON & JOHNSON's earnings per share declined by 6.7% in the most recent quarter compared to the same quarter a year ago. This company has reported somewhat volatile earnings recently. But, we feel it is poised for EPS growth in the coming year. During the past fiscal year, JOHNSON & JOHNSON increased its bottom line by earning $5.70 versus $4.82 in the prior year. This year, the market expects an improvement in earnings ($6.13 versus $5.70).

Regardless of the drop in revenue, the company managed to outperform against the industry average of 8.0%. Since the same quarter one year prior, revenues slightly dropped by 4.1%. Weakness in the company's revenue seems to have hurt the bottom line, decreasing earnings per share.

You can view the full analysis from the report here: JNJ Ratings Report

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J&J touts pipeline of potential billion-dollar blockbusters

May 20, 2015 | Philadelphia Business Journal

By John George

Johnson & Johnson said Wednesday its drug division, Janssen Pharmaceutical Cos., expects to seek regulatory approval for 10 new products, each with the potential to top $1 billion in sales, over the next five years.

Janssen — which includes Janssen Biotech in Horsham, Pa., and Janssen Research and Development, which has a large campus in Spring House, Pa. — also plans to seek approval for 40 line extensions of existing and new medicines during the same time period.

The company’s portfolio of experimental therapies is focused on five core therapeutic areas: immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism and oncology.

Janssen has launched 14 new products since 2009, seven of which already exceed or are on track to achieve sales in excess of $1 billion during 2015.

The late-stage products expected to drive revenue growth in pharmaceutical sales for Johnson & Johnson (NYSE: JNJ) of New Brunswick, N.J., during the next several years — provided the experimental therapies get regulatory approval — include new treatments for multiple myeloma, rheumatoid arthritis, osteoarthritic pain, psoriasis, pre-metastatic prostate cancer, urothelial cancer, depression, influenza A, hepatitis C, and insomnia.

“The future of health care lies in not only treating disease but also preventing and intercepting diseases before illness occurs,” said Dr. William N. Hait, the global head of Janssen Research & Development during a meeting with industry analysts Wednesday morning.

Hait said Janssen's goal is combining its extensive in-house capabilities with its external partnerships with smaller biopharmaceutical companies to "deliver the next generation of medical innovations that prevent, intercept and treat disease.”

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Can Another 10 Blockbuster Drugs Really Come From Johnson & Johnson in 5 Years?

May 20, 2015 | 24/7 Wall Street

By Chris Lange

Johnson & Johnson (NYSE: JNJ) has been working on its pipeline for a while, and plans on continuing to do so. In an effort to strengthen its portfolio, this pharmaceutical giant released its plan to file for more products, which each stand to make a substantial amount of revenue.
The total pharmaceutical market reached the $1 trillion mark in 2014. Nearly 40% of the growth came from specialty medicines, which included oncology, autoimmune, respiratory and anti-viral medications.

Looking ahead, the total global branded pharmaceuticals market is expected to grow at a compound annual operational growth rate of roughly 3% from 2014 to 2019, according to IMS Health. Among the top 10 global pharmaceutical companies, IMS Health also reports that the Pharmaceutical segment of Johnson & Johnson was among the fastest growing in the United States, Europe and Japan in 2014. This segment had sales of $32.3 billion, representing an operational increase of 16.5% compared to 2013.

To continue this growth, Johnson & Johnson announced plans to file over 10 new products for approval, as well as 40 line extensions of existing and new medicines. The kicker is that each one of these candidates has the potential to generate $1 billion in revenue each.

Johnson & Johnson has launched 14 new products since 2009, seven of which already exceed or are on track to achieve sales in excess of $1 billion during 2015. Ultimately this has been a strong driver for growth within the company and according to Joaquin Duato, Worldwide Chairman of Pharmaceuticals at Johnson & Johnson:
In the past two years, our performance and growth rates have been industry-leading, and we look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines. We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients.

The company focuses its portfolio on five core therapeutic areas: Immunology, Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology. The combined strength of Johnson & Johnson’s in-market portfolio and robust near-term pipeline provides the momentum to sustain above-industry compound annual growth through 2019.

Johnson & Johnson named its indications:

Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.4 In addition, daratumumab and esketamine have both received Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA). Janssen is also announcing today that it plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA this year for daratumumab in double refractory multiple myeloma. The submission will be based on Phase 2 data, which will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting.

Shares of Johnson & Johnson were up 0.3% at $104.24 Wednesday morning. The stock has a consensus analyst price target of $109.02 and a 52-week trading range of $95.10 to $109.49.

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J&J Pharmaceuticals to drive growth with more than 10 filings for blockbuster drugs by 2019

May 20, 2015 | SeekingAlpha

By Douglass House

At a meeting today with analysts, Johnson & Johnson's (NYSE:JNJ) Janssen Pharmaceuticals announced plans for regulatory approval of more than 10 new drugs between 2015 and 2019, each with the potential to generate at least $1B in sales, in addition to over 40 line extensions of existing and new medicines. It projects top-line growth above the industry average through 2019.

Janssen's product portfolio is focused on five core therapeutic areas: Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology. It has launched 14 new products since 2009, seven of which will achieve blockbuster status (sales of $1B+) this year.

Late stage products include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN0509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 for urothelial cancer; esketamine for treatment-resistant depression and AL-8176 for hepatitis C.

In February of this year, Janssen announced the launch of three new research platforms focused on disease prevention, disease intervention and the microbiome, with the intent to potentially change the way diseases are managed.According the IMS Health, the global pharmaceutical market reached $1T last year with 40% of the growth coming from specialty drugs. It is expected to grow ~3% per annum through 2019.

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J&J Pegs Its Long-Term Growth Potential On Prevention

May 20, 2015 | Forbes

By Arlene Weintraub

During Johnson & Johnson’s Pharmaceutical Business Review Wednesday, several executives from the healthcare-products giant made a case to Wall Street analysts that its pipeline of new drugs is strong enough to drive strong short-term sales and profit growth. But behind the scenes, the company is making a huge bet that focusing on disease prevention will be the key to its long-term growth.
At today’s meeting, J&J announced a lofty goal of filing 10 completely new drugs and 19 line extensions for FDA approval by 2019. The potential short-term growth drivers include daratumumab for multiple myeloma, sirukumab for rheumatoid arthritis and guselkumab for psoriasis, the company said. In announcing the plan, its executives pointed to the recent track record of Janssen, its pharma unit, which has launched 14 drugs since 2009, half of which are predicted to earn the “blockbuster” label this year by bringing in $1 billion in sales a piece.
Before introducing the unit chiefs who would delve into J&J’s late-stage pipeline, William Hait, global head of Janssen R&D, made a nod towards the company’s long-term strategy. “Looking into the future, we at Janssen can envision a world without disease and have made substantial investments to make that vision a reality,” he said. Hait told investors the company has set up prevention-focused research units, staffed by scientists who are “imagining a healthier future where suffering from a disease is a historical artifact.”
J&J’s analyst confab arrived amid a mix of triumphs and challenges for the company’s drug business. On Tuesday, the FDA approved Invega Trinza, a long-acting version of J&J’s schizophrenia blockbuster Invega (paliperidone palmitate) that only has to be administered four times a year. Many analysts predict the product will be among the company’s short-term growth drivers, as the overall market for long-acting anti-psychotics is booming.ForbesBrandVoice?Northwestern MutualVoiceChanging Careers At 50 Without Missing A Beat
But just a few days before the approval, on May 15, the FDA announced that it is exploring safety concerns regarding diabetes drugs that are in a class known as “SGL2 inhibitors.” These drugs, which include J&J’s hit product Invokana (canagliflozin), may raise the risk of ketoacidosis, a dangerous elevation of blood acids, the agency said. The FDA is now considering whether or not the drugs’ labels need to be changed, it added. That could put pressure on sales of Invokana, which came in at $278 million in the first quarter of this year—nearly triple its sales in the same period a year ago.
And J&J has been suffering from competitive pressure, particularly on its top-selling drug, Remicade, a rheumatoid arthritis treatment that’s facing biosimilar rivals. Its hepatitis C treatment Olysio is quickly losing ground to newer, more effective drugs like Gilead Sciences’ Sovaldi. During the first quarter, which J&J reported April 14, its sales fell 4% year-over-year to $17.4 billion and its net profit dropped from $4.73 billion ($1.64 per share) to $4.32 billion ($1.53 per share). Citing unfavorable currency exchange rates, the company cut its full-year earnings-per-share estimate to $6.04 to $6.19 from $6.12 to $6.27. Analysts on average expect J&J’s full-year sales to dip 5% to $70.5 billion.

It may seem strange that one of the world’s most storied makers of prescription and over-the-counter products to treat diseases sees a big future in preventing them, but it does, Hait said in a phone interview prior to today’s meeting. That’s because the company’s leadership believes that getting to the root of what causes the world’s most vexing diseases will help J&J come up with whole new classes of therapies—drugs, devices, and the like—to interrupt those processes.
William Hait, global head of Janssen R&D (Credit: photo courtesy of J&J)

“The basic idea is that people are interested in learning what their DNA sequence tells them about their susceptibility to disease,” Hait says. “If we could go from susceptibility to understanding risk, then the problem becomes what do you do about it? I believe the first company that begins to answer that question with a variety of different types of products will be the major healthcare company of the future.”
So Hait is overseeing the creation of three new units at J&J. The first is the Janssen Prevention Center, which will be headquartered in the Netherlands, with outposts in the U.S. and U.K. The center will focus on developing vaccines—both to prevent disease, Hait says, and to treat it—and will capitalize on expertise J&J acquired when it bought Crucell in 2011.
J&J is also creating a startup incubator that it calls the Disease Interception Accelerator. The mission of the center, Hait says, is to capitalize on the rapidly growing understanding of how each person’s genetic makeup predicts their risk of disease—and then invent ways to reverse or slow down the progression of those illnesses.
Those interventions won’t necessarily be drugs, Hait says. “Being part of Johnson & Johnson, we can make consumer products and all sorts of devices,” he says. “We have an array of capabilities. Drugs and vaccines may be part of it, but we’re agnostic to the approach.”
In February, J&J announced the first major initiative of the Disease Interception Accelerator: The company will work with the association JDRF to develop new diagnostic and therapeutic approaches to Type 1 diabetes. Their goal is to figure out how to halt the loss of insulin-producing cells—in essence stopping the disease before it causes insulin dependence.
The third new prevention-focused initiative is the Janssen Human Microbiome Institute, which is focused on studying the vast population of bacteria that live in everyone’s guts. Scientists specializing in the microbiome believe it plays a role in several diseases, and therefore could open up new routes of both prevention and treatment. J&J was one of the first companies to make a major commitment to microbiome research, forming research partnerships with microbiome startups such as Vedanta Biosciences and Second Genome. The new J&J unit will build upon those alliances, Hait says.
These new prevention-focused units are part of an ongoing quest at J&J to look for growth in unconventional places. Just last month, J&J signed up withIBM to use Watson artificial intelligence—the basis of the robot that won Jeopardy—to create a concierge service that will prepare patients for knee surgery and to help them recover from it.
Investors, for now, seem to be taking a wait-and-see stance on J&J’s growth strategy. The company’s stock price, which has been flat to slightly down since the beginning of the year, nudged up by about $0.63 in pre-market trading on Wednesday to $104.59.

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Johnson & Johnson Announces it Will File for Ten New Drugs by 2019

May 20, 2015 | TheStreet

By Michelle Rama-Poccia

Johnson & Johnson (JNJ - Get Report) said Wednesday its Janssen unit will file for regulatory approval of at least 10 new drugs by 2019.

Each product has the potential to exceed $1 billion in revenue, the company said in a statement.

The company also announced more than 40 line extensions of existing and new medicines.

"Our innovation strategy has delivered transformational products for patients and also created a cycle of success that positions us for continued growth across the entire Johnson & Johnson enterprise," Paul Stoffels, the company's chief scientific officer, said in the statement.

The new drugs will help the stock price, TheStreet.com's Jim Cramer said, but currency concerns remain an issue.

"Recalls are behind them," Cramer said.

"Now they're talking about growth in drugs; that's what's going to get the stock higher," he added. "You do need to see a weaker dollar. It's the most exposed of the big companies to a strong dollar in the currency translation."

Still, Cramer said he likes the stock at these levels, noting, "It's done nothing for a long time."

Shares of Johnson & Johnson were trading Wednesday at 2:46 p.m. EDT at $103.60, down about .35% for the day.

Johnson & Johnson said late-stage products for multiple myeloma, rheumatoid arthritis and psoriasis are expected to drive its growth over the next several years.

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