) recently announced positive top-line results on TD-1211 from a
phase IIb study, 0084. TD-1211 is an oral peripherally selective
mu-opioid receptor antagonist (PμMA) being developed for the
treatment of opioid-induced constipation (OIC) in patients
suffering from chronic non-cancer pain. The company expects to move
the candidate into phase III development based on these results.
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The phase IIb program evaluated doses and dosing regimens for phase
III trials. The phase IIb program comprises three studies 0074,
0076 and 0084. The 5-week, randomized, double-blind key study 0084
enrolled 217 patients and compared TD-1211 in 5 mg, 10 mg and 15 mg
dosages versus placebo.
TD-1211 demonstrated significant benefit in complete spontaneous
bowel movements (CSBMs) from the baseline average of 0.1 to 0.3
CSBMs per week and met the primary efficacy endpoint for all doses.
The candidate was found to be well tolerated. The
treatment-emergent adverse event was 39%-55% for TD-1211 and 44%
In the phase IIb program, study 0074 evaluated the frequency and
severity of treatment-emergent adverse events in patients with OIC
and study 0075 is evaluating the safety and tolerability profile of
TD 1211. Detailed data from the three studies are expected to be
presented in upcoming medical conferences.
The OIC market currently is insufficiently served by laxatives.
Many patients do not show adequate response to laxative treatment.
Salix Pharmaceuticals, Ltd.
) Relistor, a subcutaneous injection, is currently approved for the
treatment of OIC in patients with advanced illness who are
receiving palliative care and do not show sufficient response to
We currently have a Neutral recommendation on Theravance. The stock
carries a Zacks #2 Rank (Buy rating) in the short run. We are
impressed by Theravance's efforts to develop its pipeline. We
believe that the Relovair, LABA/LAMA and MABA combination programs,
in collaboration with
), hold immense potential and could bring significant royalties to
However, we remain concerned by the challenges faced by Theravance
regarding Vibativ supplies following the termination of its deal
with Astellas. Moreover, the Committee for Medicinal Products for
Human Use's (CHMP) recommendation to suspend the marketing approval
for Vibativ for the nosocomial pneumonia (NP) indication in the EU
is another setback for the company.