Johnson & Johnson Pharmaceuticals Segment Poised to Continue Driving Growth with More than 10 Potential New Product Filings by 2017

NEW BRUNSWICK, N.J., May 23, 2013 /PRNewswire/ -- At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.

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With a unique model of innovation, the Pharmaceuticals segment of Johnson & Johnson (NYSE: JNJ) has built an industry-leading pipeline that has yielded 11 new product launches since 2009, more than doubling its productivity over the past four years.  These new products, coupled with core growth brands, have fueled 12 consecutive quarters of operational sales growth in the segment and contributed significantly to the Company's recent earnings growth.

"Our investment in transformational innovation has enabled strong growth that has allowed us to continue investing in our future portfolio," said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson, and Worldwide Chairman, Pharmaceuticals Group.  "With a steadfast focus on the most serious unmet medical needs, our approach is to identify the best science — internal and external — to deliver new options and solutions to patients.  Today, we have an industry-leading pipeline of truly differentiated products and a track record of success resulting in more new molecular entity (NME) approvals per year at a lower development cost than the industry average."

"We've spent the past five years transforming our business, and the growth we're seeing today is the direct impact of that effort," said Joaquin Duato, Worldwide Chairman, Pharmaceuticals Group.  "The innovative new therapies in our pipeline will drive our next wave of growth.  With strong momentum across our global Pharmaceuticals segment, we are executing well against our commercial strategy to gain market share and ensure greater access to our medicines.  We're also strengthening our presence in critical geographies and have nearly doubled our footprint in emerging markets during the last five years."

The total global pharmaceuticals market is expected to grow about 4.5% annually and reach an approximate market size of $1.2 trillion by 2017, according to IMS Health, the independent analysis and market research service that tracks the industry.  Among the top 10 global pharmaceutical companies, IMS Health also reports that the Pharmaceuticals business of Johnson & Johnson was the fastest growing in the U.S., Europe and Japan in 2012, with sales of $25.4 billion, an operational^* increase of nearly 7% versus 2011.  Strong sales growth in the segment continued in the first quarter of 2013, with worldwide sales of $6.8 billion, an operational^* increase of over 11% versus the prior year.  Emerging markets, including China, Brazil, Russia and India, comprised nearly 20% of worldwide pharmaceutical sales in the first quarter of 2013.

"We're proud to be one of the most productive pharmaceutical organizations in the world, with a portfolio that includes many 'firsts,' representing meaningful innovations that create significant benefits for patients, enhanced access to markets, and value for shareholders," said William Hait, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.  "We are working to sustain our cycle of success into the next decade and beyond by leveraging the scientific expertise we've built in our core disease areas to identify the best science and deliver innovative solutions for patients."

The Company's approach to innovation has resulted in a revitalized product portfolio for the Janssen Pharmaceutical Companies of near- and long-term compounds in the areas of Immunology, Neuroscience, Infectious Diseases and Vaccines, Cardiovascular and Metabolism, and Oncology.

Late stage products Janssen plans to file by 2017 for regulatory approval, are aimed at addressing serious unmet needs.  Some of these products include: simeprevir for Hepatitis C, which is filed in Japan, Europe and in the U.S., where it was recently granted Priority Review status by the Food and Drug Administration (FDA); ibrutinib and daratumumab for the treatment of hematologic malignancies, which together have both received a record number of Breakthrough Therapy Designations by the FDA; sirukumab and guselkumab for important immune mediated diseases; a three-month formulation of INVEGA^® SUSTENNA^®/XEPLION^®, with a potential to change the treatment paradigm for schizophrenia, and novel vaccines for treating influenza, rabies and polio.

With its substantial growth in the Asia Pacific region pipeline, Janssen plans to continue accelerating its development stage pipeline in both Japan and China.  Three NMEs and three brand line extensions are currently in registration in Japan, and Janssen plans to file two additional NMEs and six brand line extensions by 2017.  In China, four NMEs and four line extensions are currently in registration, and Janssen plans to file nine NMEs and six brand line extensions by 2017.

With a focus on precision medicine, the company has also invested best-in-class research capabilities in genomics, biotechnology, biomarkers, companion diagnostics, and vaccine platforms, and in accessing early stage breakthrough innovation from the leading innovation hotspots around the world.  New products launched since 2009 comprised 17% of total pharmaceutical sales in 2012, up from 9% in 2011.  Driven by new indications, label extensions and additional country launches of these products, as well as the potential new products expected to emerge from our pipeline, products launched since 2009 are planned to account for nearly half of the total sales in the segment by 2017.  Some of these products include:

• INVEGA^® SUSTENNA^®/XEPLION^® (paliperidone palmitate), a once-monthly, long-acting, injectable atypical antipsychotic for the acute and maintenance treatment of schizophrenia in adults;
• SIMPONI^® (golimumab), a biologic approved to treat adults with moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis;
• STELARA^® (ustekinumab), a biologic approved for the treatment of moderate to severe plaque psoriasis;
• ZYTIGA^® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer;
• XARELTO^® (rivaroxaban), an oral anticoagulant;
• INCIVO^® (telaprevir), a direct acting antiviral protease inhibitor for the treatment of genotype-1 chronic hepatitis C virus;
• INVOKANA™ (canagliflozin), the company's first pharmaceutical product for the treatment of adults with type 2 diabetes, launched in March 2013; and
• SIRTURO™ (bedaquiline) for the treatment of pulmonary multi-drug resistant tuberculosis, the first new mechanism of action against tuberculosis in over 40 years

"With our focus on innovation and our best-in-class commercial capabilities, Janssen expects to continue to make significant contributions to global human health and deliver strong business results," Duato said.  "Our number one priority is to build upon our strong momentum with the goal of transforming patients' lives well into the future."

About Today's Meeting
The meeting will be webcast starting at 8:30 a.m. today and can be accessed along with full copies of the presentations via the Johnson & Johnson Investor Relations web site www.investor.jnj.com.  A replay and podcast will be available approximately two hours after the live web cast. A live Twitter feed for today's meeting is accessible via #JNJPharm13. Media can access the meeting agenda, list of speakers, speaker bios, presentation summaries and background materials on the company's Pharm Day Media Resource Web site.

Users of the Johnson & Johnson Investor Relations mobile app for the iPad^® and iPhone^® can also access the event. This newly launched free app is available in the iTunes^® store and includes stock information, news releases, Company information, webcasts, SEC filings, the Company's pharmaceutical product pipeline and Annual Reports, among other information.

About Johnson & Johnson
Caring for the world, one person at a time...inspires and unites the people of Johnson & Johnson. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.  Our approximately 128,000 employees at more than 275 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. We aim to empower people through disease awareness, education and access to quality care. Our research and development strategy focuses on identifying medical needs, and harnessing the best science in the world, whether from our own laboratories, or through strategic relationships and collaborations.

*Operational sales growth excludes currency impact and is a non-GAAP financial measure. It should not be considered a replacement for, and should be read together with, the most comparable GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Investor Relations section of the Company's website at www.investor.jnj.com

(This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; complex global supply chains with increasing regulatory requirements; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.investor.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies, nor Johnson & Johnson, undertake to update any forward-looking statements as a result of new information or future events or developments.) 

SOURCE Johnson & Johnson