J&J to File 10 New Products, 40 Line Extensions by 2019

May 20, 2015

At a meeting with industry analysts and leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) 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 more than 40 line extensions of existing and new medicines.

The company has a portfolio focused on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology. 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.

“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 release stated that 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. 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.

Read the full release

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