Label Restrictions Sought On Vanada Pharmaceuticals Inc.' Sleep Drug

Vanda Pharmaceuticals Inc.

fell sharply on Tuesday after a consumer group petitioned regulators to add restrictive labeling to Vanda's sleep disorder drug. http://www.citizen.org/documents/2265.pdf The petition, dated Thursday, was reported by The Wall Street Journal, and seeks to have Vanda's Hetlioz' labeling restricted to patients who are totally blind. http://blogs.wsj.com/pharmalot/2015/06/11/fda-mistakenly-widened-the-market-for-a-rare-sleep-disorder-drug-petition/ The drug aims to treat non-24 sleep-wake disorder, a condition that affects almost exclusively blind people. The consumer group is also seeking additional label warnings about risks of cancer and to pregnancies, as well as further safety studies. Vanda, which obtained approval for the drug last year, expects 2015 Hetlioz sales of between $40 million and $45 million, or more than 40 percent of its expected total sales. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=irol-newsArticle&ID=2044890 Vanada hasn't commented on the Public Citizen petition, but noted in its FDA application that there are an estimated 100,000 totally blind people in the U.S. suffering from the disorder. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000MedR.pdf The advocacy group said that an initial approval letter last year from the Food and Drug Administration included the blind-only restriction, which is "inexplicably" omitted from current labeling. The group is also seeking additional label warnings about risks of cancer and to pregnancies, as well as further safety studies. Vanada shares, which saw a dramatic downward spike earlier, traded recently at $12.79, of $0.14 cents.