) 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.
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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
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
). 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
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.