Human Genome Sciences (HGSI)
Drug/indication: Zalbin for hepatitis C
Approval decision date: Oct. 4, 2010
Recent stock performance: At just under $30, the stock has rebounded 35% off its July low but is still just flat for the year.In June, Human Genome Sciences said approval of Zalbin was unlikely after the FDA expressed concerns about the risk-benefit of the drug. Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons require once-weekly dosing.
Alexza Pharmaceuticals (ALXA) Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder Approval decision date: Oct. 11, 2010 Recent stock performance: At around $3, stock is still far from the 52-week high of nearly $4 reached in May. AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail (BVF) will market AZ-004 in the U.S. and Canada, if approved.
Jazz Pharmaceuticals (JAZZ) Drug/indication: JZP-6 for fibromyalgia Approval decision date: Oct. 11, 2010 Recent stock performance: Shares tumbled to around $8.50 from more than $10 after the negative FDA advisory panel vote. On July 20, an FDA advisory panel voted against approval of JZP-6 due to unacceptable risks of the drug being misused and potentially abused. JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.