At a meeting last week with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson announced 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 revenue, as well as plans to file for more than 40 line extensions of existing and new medicines. So what is behind the optimistic outlook? DCAT Value Chain Insights (VCI) takes an inside look.

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, according to the company. Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma, sirukumab for rheumatoid arthritis, and guselkumab for psoriasis, among others. So what are some key pipeline candidates?

A reason for optimism
“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, in a company release. “We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients.”

Johnson & Johnson posted 2014 revenues of $74.3 billion, of which its pharmaceutical business accounted for 43%, or $32.3 billion. Medical devices ($27.5 billion) and consumer products ($14.5 billion) account for the balance. Within pharmaceuticals, immunology products achieved sales of $10.2 billion in 2014, representing an increase of 10.9% as compared to the prior year. The increased sales of Stelara (ustekinumab) and Simponi/Simponi Aria (golimumab) were primarily due to market growth and market-share gains. Remicade (infliximab) growth was primarily due to market growth. The patents for Remicade in certain countries in Europe (Germany, Spain, United Kingdom, Sweden, Austria, Belgium, Switzerland, Denmark, France, Greece, Italy, Luxembourg and the Netherlands) expired in February 2015. Loss of exclusivity will likely result in a reduction in sales as biosimilar versions are introduced to the market.

Infectious disease products achieved sales of $5.6 billion in 2014, representing an increase of 57.7% as compared to the prior year. Major contributors to the growth were the launch of Olysio/Sovriad (simeprevir); Prevista (darunavir) due to market growth; and sales of Edurant (rilpivirine). This was partially offset by lower sales of Incivo (telaprevir) due to competitive pressures, and lower sales of vaccine products. The approval of competitive products to Olysio/Sovriad (simeprevir) had a negative impact in the fourth quarter of 2014 and is expected to continue to have a significant negative impact on future sales of Olysio/Sovriad (simeprevir).

Neuroscience product sales were $6.5 billion, a decline of 2.7% as compared to the prior year. Strong sales of Invega Sustenna/Xeplion (paliperidone palmitate) and Invega (paliperidone palmitate) were partially offset by lower sales of Risperdal Consta. Additionally, a decline in sales of Concerta /methylphenidate and Topomax (topiramate) were due to continued generic competition. Oncology products achieved sales of $4.5 billion in 2014, representing an increase of 18.1% as compared to the prior year. Major contributors to the growth were strong sales of Zytgia (abiraterone acetate), as well as the recent launch of Imbruvica (ibrutinib). Sales growth of Velcade (bortezomib) was more than offset by negative currency. Other pharmaceutical sales were $5.6 billion, an increase of 12.8% as compared to the prior year.

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 US Food and Drug Administration (FDA). Janssen 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 PhaseII data, which will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting. Table I outlines expected filing dates for these key products.

In its early-stage pipeline, the company has more than 25 new molecular entities (NMEs) for what the company terms as potential “next-generation” NME filings.

Key to the company’s growth going forward its a focus on new growth platforms, which include mmuno-oncology, vaccines and biological platforms, and preventive and precision medicine. The company also has launched new ways to cultivate and build innovation.These include the Johnson & Johnson Innovation Centers (London, California, Boston, Shanghai) which focus on early-stage development, alliances, and related opportunities. This has produced more than 3,800 opportunities explored since 2013 and more than 200 alliances in the last two years. Johnson & Johnson Innovation (JLABS) consists of five incubators across the US with 88 companies in residence. The company’s venture capital arm, Johnson & Johnson Innovation (JJDC) has more than 30 years of venture capital investing and has invested more than $1 billion since its inception. In 2014, it made 43 investments and invested more than $200 million. Also, Johnson & Johnson Innovation–Janssen Business Development is focused on late-stage opportunities and develops deals with established pharmaceutical and biotech companies.

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 understanding the origins of disease and intercepting progression to disease for people at-risk before they get sick. 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.