Trade Resources Industry Views Johnson&Johnson's Is Planning to Submit More Than 10 New Drugs for Regulatory Approval

Johnson&Johnson's Is Planning to Submit More Than 10 New Drugs for Regulatory Approval

Johnson & Johnson's Pharmaceuticals unit Janssen is planning to submit more than 10 new products for regulatory approval and extend the brand pipeline of 25 existing drugs by 2017.

The late stage products to be submitted for approval include drugs targeting varying diseases such as hepatitis C, immune diseases and schizophrenia, and vaccines for flu, rabies and polio.

Johnson & Johnson chief scientific officer and pharmaceuticals group worldwide chairman Paul Stoffels said the company focuses on identifying the best science to deliver new options and solutions to patients with serious unmet medical needs.

"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," Stoffels added.

The company plans to file medicines including simeprevir for hepatitis C, ibrutinib and daratumumab for blood cancers, sirukumab and guselkumab for diseases of the immune system and vaccines for influenza, rabies and polio, for approval.

The company believes that the new medicines will account for almost half of pharmaceutical sales by 2017.

Janssen Research & Development global head William Hait said, "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."

At present three of the company's new molecular entities (NMEs) and three brand line extensions are in registration in Japan, while two additional NMEs and six brand line extensions are to be filed by 2017.

Four NMEs and four line extensions are currently in registration in China, and by 2017, the company intends to file nine NMEs and six brand line extensions.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/johnson-johnson-plans-to-submit-over-10-new-drugs-for-regulatory-approval-by-2017-240513
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Johnson&Johnson Plans to Submit Over 10 New Drugs for Regulatory Approval by 2017