J&J Wins European Panel’s Backing of Cancer, Hepatitis Drugs
By Allison Connolly and Alex Nussbaum - Jul 22, 2011 12:09 PM ET .
Johnson & Johnson (JNJ) won the backing of a European panel today for approval of its hepatitis C treatment Incivo and prostate-cancer drug Zytiga, each projected by analysts to top $1 billion in worldwide sales.
The recommendations by a European Medicines Agency committee extended a winning streak for the pharmaceutical division at New Brunswick, New Jersey-based J&J. The company won U.S. regulatory approvals earlier this year for Zytiga as well as AIDS treatment Edurant and Xarelto, a blood thinner shared with Bayer AG of Leverkusen, Germany.
The cancer and hepatitis C drugs are “potential blockbusters for J&J that, along with Xarelto and Edurant, could contribute $5 billion-plus in sales,” said Larry Biegelsen, a Wells Fargo & Co. analyst in New York, in a note to clients today. J&J will likely introduce Zytiga and Incivo in Europe by year’s end, after negotiating prices around the continent, he said.
The drugs need final approvals from the European Commission before they can be sold. Zytiga may reach peak worldwide sales of $1.1 billion a year by 2015 while Incivo, also known as telaprevir, may reach $1.4 billion that year, said Matthew Dodds, a Citigroup Inc. analyst in New York, in a May 27 note to clients.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the use of Incivo in combination with pegylated-interferon and ribavirin, the current standard of care, for patients with chronic genotype-1 hepatitis C virus and liver disease, the London-based agency said in a statement today.
Commission Ruling
The European Commission typically rules within a few months of the committee’s decisions and the drug could be on the market within days of an approval, said Jim Witek, the Incivo medical leader for J&J’s Janssen Pharmaceutical Companies. Pricing hasn’t been determined yet, he said.
About 170 million people worldwide, including 5 million in Western Europe, have chronic hepatitis C, Witek said. The bloodborne disease can lead to liver cirrhosis and cancer, according to the Centers for Disease Control and Prevention in Atlanta. No vaccine exists for the virus, which is commonly spread by sharing needles and can be transmitted sexually in rare cases.
In May, the Food and Drug Administration approved sales of telaprevir by Vertex Pharmaceuticals Inc. (VRTX) of Cambridge, Massachusetts, which owns U.S. rights to the drug.
The European committee also backed Zytiga in combination with prednisone or prednisolone to treat a certain type of prostate cancer. The drug was assessed under an accelerated timetable because it offered an alternative therapy to the target patient population of adult men who had seen their disease progress after chemotherapy, the agency said.
Incivo was developed by Tibotec Virco-Virology BVBA, a Jannsen unit. It was co-developed by Vertex and Mitsubishi Tanabe Pharma Corp. (4508) of Osaka, Japan.
