May 31 2013, 11:27
Gilead Sciences (GILD) announced on May 21, 2013 that the European regulator EMA (European Medicines Agency) started the process of assessing the company's once daily oral treatment for hepatitis C virus (HCV) and will furnish an accelerated review.
Earlier, on May 13, Johnson & Johnson's (JNJ) experimental drug, still in mid-stage trial, got priority review status from the FDA. A week earlier, the FDA accorded breakthrough status to the Hepatitis C virus regimen of AbbVie (ABBV).
The race, therefore, is on.
Hepatitis C is caused by infection of the hepatitis C virus that attacks the liver causing inflammation and long term complications. 40% of the patients infected with HCV recover fully and the remaining 60% become chronic carriers, regardless of whether they have symptoms or not. 20% of these develop cirrhosis. 20% of patients suffering from cirrhosis develop liver cancer. Europe alone has roughly four million carriers and 3% of the world's population has HCV. That is roughly 80% of the U.S. population, in number terms.
An HCV positive individual has anti-HCV antibodies and/or HCV RNA or HCV core antigen in blood. All HCV positive individuals are potentially infected and contact with their blood -sharing infected injection needles, receiving blood or accidental exposure - can cause infection.
Currently, standard treatment for HCV is a 24-28 week therapy with ribavirin (a nucleoside inhibitor) and peg-IFN (pegylated interferon) injections, which cause significant side effects such as flu-like symptoms that persist through the course of the treatment. Protease inhibitors, Victrelis from Merck & Co (MRK) and Incivek, developed by Vertex Pharmaceuticals (VRTX) in partnership with Johnson & Johnson, helped improve cure rates but still involved side effects as these treatments also involved interferon injections.
Sofosbuvir was discovered by Pharmasset, a New Jersey company that Gilead acquired in November 2011 for $11 billion. Gilead submitted sofosbuvir for approval in early April. The FDA normally takes two months before accepting a new drug application (NDA) for a 10-month review. A priority review takes 6 months. Gilead's MAA (Marketing Authorization Application) before EMA was submitted on April 17, 2013 and validation by EMA is indeed good news for Gilead's investors.