Theravance, Inc. recently announced the commencement of a phase II study (n~375) regarding its pipeline candidate TD-9855. The proof-of-concept study is designed to evaluate the safety and efficacy of two doses of TD-9855 versus placebo in patients suffering from fibromyalgia, a chronic functional illness.
The disease, which is estimated to affect 5 million people in the US, is characterized by pain, stiffness and tenderness of muscles, tendons and joints. Moreover, sleep disturbances, fatigue, anxiety, depression and memory and concentration related problems are also associated with fibromyalgia.
The primary aim of the phase II study is to evaluate whether treatment with TD-9855 results in pain improvement versus placebo. We note that TD-9855 is also being evaluated in a phase II study in another indication- attention-deficit/hyperactivity disorder.
Though impressed by the initiation of the phase II study on TD-9855 for the fibromyalgia indication, we believe that investor focus will remain on the development of Theravance’s pipeline programs in collaboration with GlaxoSmithKline (GSK - Free Report) . A key action date is coming up in May 2013 when the US Food and Drug Administration (FDA) is expected to decide on whether to approve Glaxo/Theravance’s candidate FF/VI (proposed brand name Breo in the US and Relvar in the EU, formerly known as Relovair) for treating patients suffering from chronic obstructive pulmonary disease.
In the EU, a regulatory application for the asthma indication was submitted in July 2012. The regulatory applications for both COPD and asthma in the EU have been validated by the European Medicines Agency (EMA).
Currently, we have a Neutral stance on Theravance. The stock carries a Zacks #2 Rank (Buy rating) in the short run.