J&J pharma segment poised with over 10 potential new product filings by 2017
At a meeting with industry analysts, senior leaders from the Janssen Pharmaceutical companies of Johnson & Johnson announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.
With a unique model of innovation, the Pharmaceuticals segment of J&J 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, J&J, 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."
Joaquin Duato, worldwide chairman, pharmaceuticals group, said, "We've spent the past five years transforming our business, and the growth we're seeing today is the direct impact of that effort. 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 J&J 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 R&D. "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, 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 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."