- Company expects more than 10 new blockbuster products to launch or file for regulatory approval by 2021
- More than 50 line-extension regulatory filings projected by 2021
- Beyond 2021, early-stage pipeline will continue delivering breakthrough medicines, while also strengthening focus on eliminating disease through prevention, interception and cures
New Brunswick, N.J. (May 17, 2017) – At a meeting today with industry analysts, senior leaders of Johnson & Johnson and its Janssen Pharmaceutical Companies 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 existing and new medicines that will bring the company’s transformational medicines to an even broader patient population. The company will also 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 Chief Executive Officer. “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.”
An industry leader in research productivity, Janssen has received US FDA approval for 11 new molecular entities (NMEs) since 2011. With a portfolio focused on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology – the Pharmaceutical segment of Johnson & Johnson is delivering transformational new medicines for unmet medical needs worldwide, and expects to add a sixth therapeutic area in Pulmonary Arterial Hypertension upon the completion of the acquisition of Actelion, which is expected to close by the end of the second quarter.
In 2016, the company filed two NMEs that it anticipates will be approved and launched later this year:
- guselkumab for psoriasis; and
- sirukumab for rheumatoid arthritis.
Additional late-stage blockbuster products1 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.
About Today’s Meeting
The meeting will be webcast starting at 8:30 a.m. EDT today and can be accessed along with full copies of the presentations and speaker biographies via the Johnson & Johnson Investor Relations website: www.investor.jnj.com. A replay and podcast will be available shortly after the live webcast. A live Twitter feed for today’s meeting is accessible via #PBR17JNJ.
Users of the Johnson & Johnson Investor Relations mobile app for the iPad? and iPhone? mobile digital devices can also access the event. This 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 130,800 employees at more than 250 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product research and development, regulatory submissions and approvals, market position, impact of planned acquisitions, and business strategy. The viewer 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 known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product research and development, including uncertainty of clinical success and decisions of regulatory authorities regarding approval, labeling, and other matters that could affect the availability or commercial potential of product candidates; uncertainty of commercial success for new and existing products; the satisfaction of closing conditions for the acquisition of Actelion Ltd., the possibility that the Actelion acquisition will not be completed in the expected timeframe or at all, and the potential that the expected benefits and opportunities of the Actelion acquisition, if completed, may not be realized or may take longer to realize than expected; the ability of the company to successfully execute strategic plans; challenges to patents; the impact of patent expirations; competition, including technological advances, new products, and patents attained by competitors; future clinical data and analysis, including post marketing surveillance; impact of business combinations and divestitures; significant adverse litigation or government action; changes to applicable laws and regulations, including global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of these release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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1 Many of these products are being developed in collaboration with strategic partners or are licensed from other companies; see webcast presentation for more information.