J&J-Medivir Hepatitis C Drug Recommended by EU Regulator

Johnson & Johnson (JNJ) and Medivir AB (MVIRB)’s pill to treat chronic hepatitis was recommended for approval by the European Union’s drug regulator.

The medicine, known as simeprevir, was recommended by a European Medicines Agency panel as a treatment for chronic hepatitis C in adult patients, the regulator said in a statement today. The drug was approved by the U.S. Food and Drug Administration in November. If backed by the European Commission, the pill would be marketed as Olysio.

J&J, Medivir, Gilead Sciences Inc. and Bristol-Myers Squibb Co. (BMY) are among companies that have been developing new pills for the virus that reduce the need for interferon shots, which cause flu-like symptoms. The market for hepatitis C drugs may reach more than $100 billion over a decade, according to Bloomberg Industries. Simeprevir may generate $326 million for New Brunswick, New Jersey-based J&J in 2016, according to the average of four analysts’ estimates compiled by Bloomberg.

Gilead’s hepatitis C treatment Sovaldi was cleared by the FDA in December. While simeprevir can cut the current treatment time in half to 24 weeks, Sovaldi works in 12 weeks for most patients.

AbbVie Inc. (ABBV) is also developing a 12-week combination treatment that cured 99 percent of patients in a late-stage trial, the company said this month.

Hepatitis C, which affects 150 million people globally, can be passed through infected blood or body fluids, commonly through needle-sharing by drug users. The virus may be carried for years without symptoms, and the U.S. Centers for Disease Control and Prevention has recommended that baby boomers born between 1945 and 1965 get tested for the infection.

The European agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Kristen Hallam, Robert Valpuesta

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