J&J to submit at least 10 new drugs for approval by 2019

[May 21, 2015]  By Bill Berkrot and Caroline Humer

(Reuters) - U.S. healthcare conglomerate Johnson & Johnson said on Wednesday it expects to submit more than 10 new medicines with annual revenue potential of at least $1 billion each to regulators by 2019, and is testing dozens of new uses for existing medicines.

J&J said it would file for approval of daratumumab for the blood cancer multiple myeloma in the United States and Europe this year based on mid-stage clinical data.

Wells Fargo analyst Larry Biegelsen forecast daratumumab sales reaching $1.3 billion by 2019.

The company is looking to bounce back from previous failure in Alzheimer's disease with multiple programs, including an early-stage drug it believes has the potential to prevent amyloid plaque buildup in the brain and another that aims to clear it.

Pharmaceuticals has been a bright spot for the company at a time when its medical devices and consumer products have seen sharp declines, hurt by competition and the strong dollar.

During a pharmaceutical pipeline review for analysts and investors, J&J outlined an ambitious portfolio of drugs in development aimed at sustaining above-industry compound annual growth through 2019. The industry rate over that period is expected to be about 3 percent.

The review comes as the industry prepares for the introduction of copycat versions of expensive biologic drugs, such as J&J's rheumatoid arthritis (RA) treatment Remicade, which has annual U.S. sales of more than $4 billion and a patent that expires in 2018.

J&J's worldwide pharmaceuticals head Joaquin Duato said he believes Remicade's established safety would be an advantage over eventual biosimilar newcomers.

"Biosimilars are not generics and we expect the market to behave quite differently," Duato said.

Still, the company highlighted a new antibody for RA being developed with GlaxoSmithKline, and one for psoriasis that it touted as more effective that Abbott's big-selling Humira.

The company is targeting Crohn's disease with a new drug being developed along with a companion diagnostic aimed at identifying patients likely to have the best response, and is beginning Phase III trials of a promising drug for treatment resistant depression.

J&J is jumping on the immuno-oncology bandwagon with programs for lung, prostate and blood cancers aimed at harnessing the immune system to attack tumors.

It also aims to become a major player in the hepatitis C market now dominated by Gilead Sciences through a deal announced Tuesday with Achillion Pharmaceuticals.

Investors, however, appear underwhelmed. J&J shares slipped 0.3 percent to $103.65.

(Reporting by Caroline Humer; editing by Nick Zieminski)

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