Johnson & Johnson Announced 10 New Approval Applications with $1 Billion Revenue Potential Each

Published: May 27, 2015

Johnson & Johnson Announced 10 New Approval Applications with $1 Billion Revenue Potential Each
May 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Senior executives from the Johnson & Johnson company Janssen Pharmaceutical Companies announced at an analyst meeting today that it plans to file 10 new products for regulatory approval over the next four years. In addition to looking for approval for those 10 drugs, Janssen is looking to extend 40 existing product lines.

Analysts believe the 10 new drugs have an annual sales potential of more than $1 billion—each. One of the drugs J&J plans to file approval for in the U.S. and Europe is daratumumab for the treatment of double refractory multiple myeloma. The company paid more than $1.1 billion to Genmab A/S to license and develop the drug in 2012. Larry Biegelsen, an analyst at Wells Fargo & Co. indicates that the timeline for this drug is faster than expected.

In addition, the company plans to defend its patent for Remicade, which expires in September 2018. Two companies, Celltrion and Hospira, Inc., are working to develop biosimilars to Remicade, a treatment for arthritis. “Biosimilars are not generics and we expect the market to behave quite differently,” said Joaquin Duato, Worldwide Chairman, Pharmaceuticals for J&J in a statement.

The company’s new products will be in Immunology, Neuroscience, Infectious Diseases & Virology, Cardiovascular/Metabolism and Oncology.

In addition to the newly announced drug applications, the company notes that it may have other submissions on the near horizon. “Historically our growth has been driven by inorganic activity and you should expect that to continue in the future,” said Duato during today’s presentation.

Analysts with Bloomberg Intelligence have projected that J&J’s new drug sales, those approved in the last six years, will increase by eight percent each year through 2020. This is slower than the median rate of its competitors.

Competition is fierce. J&J’s hepatitis C treatment, Olysio, doesn’t compete with new and better products on the market such as AbbVie ’s Viekira Pak and Gilead Sciences, Inc. ’s Sovaldi and Harvoni. Merck & Co. announced in April 2015 the first data from its Phase II/III clinical trial for a drug, grazoprevir/elbasvir, to treat patients with advanced chronic kidney disease (CKD) that also have chronic hepatitis C (HCV) genotype 1 (GT1).

J&J also plans to develop and sell Achillion Pharmaceuticals, Inc. ’s HCV drugs with an investment of $225 million in the company and a combined deal hitting $1.1 billion. Janssen Pharmaceuticals will be responsible for developing and selling the treatments. Achillion’s lead HCV compounds include ACH-3102, ACH-3422 and sovaprevir.

Despite this competition, according to IMS Health, Johnson & Johnson is among the fastest growing companies among the top 10 global pharmaceutical companies in the U.S., Europe and Japan in 2014. Each of the 10 new products J&J is submitting regulatory filings for has the potential to generate $1 billion in revenue each.

“In the past two years,” said Duato in today’s webcast, 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. We are working with our partners to advance the innovative products in our pipeline and to delivery significant benefits to patients.”



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