Janssen Pharma (JNJ) Plans to Gain FDA Approval for 10 New Products by 2019
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At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (Janssen) will announce plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue1, as well as more than 40 line extensions of existing and new medicines.
With a portfolio focused on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology – the Pharmaceutical segment of Johnson & Johnson (NYSE: JNJ) is delivering transformational new medicines for unmet medical needs worldwide. 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 2015.2 These new products, coupled with core growth brands, have fueled industry-leading sales growth and contributed significantly to the earnings growth of Johnson & Johnson. The combined strength of Janssen's in-market portfolio and robust near-term pipeline provides the momentum to sustain above-industry compound annual growth through 2019.
"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, Pharmaceuticals, Johnson & Johnson. "We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients."
The total pharmaceutical market reached $1 trillion in 2014 with nearly 40 percent of the growth coming from specialty medicines, including oncology, autoimmune, respiratory and anti-viral medications. Going forward, the total global branded pharmaceuticals market is expected to grow at a compound annual operational growth rate of approximately 3 percent from 2014 to 2019, 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 Pharmaceutical segment of Johnson & Johnson was among the fastest growing in the U.S., Europe and Japan in 2014, with sales of $32.3 billion, representing an operational increase of 16.5 percent3 versus 2013.
"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," said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "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."
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.
"Our innovation model and capital allocation framework provide us the flexibility to source both internal and external innovations to create an industry-leading portfolio that is advancing our vision of a world without disease," said Dominic J. Caruso, Vice President, Finance and Chief Financial Officer, Johnson & Johnson.
In February 2015, Janssen announced the launch of three new research platforms focused on disease prevention, disease interception, and the microbiome, to underpin ongoing research and propel scientific knowledge in these areas of significant potential to change the way diseases are managed. The Janssen Prevention Center focuses on prevention of chronic, non-communicable diseases; the Disease Interception Accelerator is focused on tackling the origins of disease and intercepting progression to disease for people at-risk – before they get sick; and the Janssen Human Microbiome Institute focuses on the diverse population of bacteria living in and on the human body to develop therapeutic targets and diagnostic capabilities that have the potential to transform human health.
"The future of health care lies in not only treating disease but also preventing and intercepting diseases before illness occurs," said William N. Hait, M.D., Ph.D., Global Head of Janssen Research & Development. "Using our powerful research platforms in combination with our five focused therapeutic areas, underpinned by strong in-house capabilities and cutting-edge external partnerships, we are striving to deliver the next generation of medical innovations that prevent, intercept and treat disease."
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