J&J to submit at least 10 medicines for approval by 2019

21 May, 2015

US 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 the experimental drug daratumumab for the blood cancer multiple myeloma in the United States and Europe this year based on mid-stage clinical data that will be presented at a major cancer meeting this month.
Wells Fargo analyst Larry Biegelsen forecast daratumumab sales reaching $1.3 billion by 2019. 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 in a meeting with analysts, J&J outlined an ambitious list of programs aimed at continuing the strong momentum for medicines. It said it expects to sustain above-industry compound annual growth through 2019. The industry compound growth 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.
J&J's world-wide pharmaceuticals head Joaquin Duato said that the company would defend its Remicade patent, which expires in September of 2018. In addition, he said he believed its established safety would be an advantage. Complicated biologic drugs are harder to copy than traditional pills. Biosimilars are on the market in Europe, but none have been launched yet in the United States. "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 also targeting the lucrative Crohn's disease market with a drug in mid-stage trials along with a companion diagnostic aimed at identifying patients likely to have the best response.
J&J also discussed plans to become a major player in the fast-growing hepatitis C market now dominated by Gilead Sciences through a deal announced on Tuesday that gives it rights to promising anti-viral drugs being developed by Achillion Pharmaceuticals. J&J shares were up 0.4 percent at $104.33 on the New York Stock Exchange.

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