Theravance Announces Initiation of Phase 2b Study With Its LAMA

Theravance Announces Initiation of Phase 2b Study With Its LAMA
Candidate, TD-4208, for the Treatment of COPD 
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 12/11/12 --  Theravance,
Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase
2b study with TD-4208 as a nebulized aqueous solution in patients
with moderate to severe COPD. TD-4208 is an investigational inhaled
long-acting muscarinic antagonist (LAMA), discovered using
Theravance's multivalent approach to drug design. This compound is
under development by Theravance for the treatment of chronic
obstructive pulmonary disease (COPD).  
"We are very pleased with the progression of TD-4208 into a Phase 2b
study in patients with COPD," said Mathai Mammen, M.D., Ph.D., Senior
Vice President of Research and Early Clinical Development. "We
believe that certain patients may prefer long-acting medicines
delivered in the aqueous nebulized platform used in this study over
handheld inhalation devices. In addition, TD-4208 may offer these
patients the convenience of once-a-day dosing compared to currently
nebulized medicines which must be dosed multiple times daily." 
About the Phase 2b Study
 The Phase 2b study will evaluate the
bronchodilatory effect, pharmacokinetics, safety and tolerability of
multiple doses of TD-4208 in patients with COPD. Approximately 60
patients will be randomized to receive four of six doses of TD-4208
(22 mcg, 44 mcg, 88 mcg, 175 mcg, 350 mcg or 700 mcg) and placebo
once daily via a nebulizer during five 7-day study periods in an
incomplete crossover study design. The primary endpoint of the study
is trough forced expiratory volume in one second (FEV1) after the
seventh dose of each treatment period. Secondary endpoints include
measurements of FEV1: Peak and area under the curve from 0 to 24
hours (AUC0-24), AUC0-12, and AUC12-24 after the seventh dose of each
treatment period. 
About TD-4208 and the LAMA Program
 TD-4208 is an inhaled,
long-acting muscarinic antagonist (LAMA) discovered by Theravance
through the application of multivalent design in a drug discovery
program dedicated to finding new medicines for respiratory diseases
such as COPD and asthma. In preclinical studies, TD-4208 has
demonstrated high specificity for muscarinic receptors, sustained
activity in the lung after inhalation, and minimal effects outside of
the lung. The goal of Theravance's LAMA program for respiratory
disease is to develop a once-daily inhaled medicine in a nebulizer
that offers improved efficacy and tolerability relative to current
therapies, and provides the basis for combination nebulized products
with other medicines. Positive results of a single-dose Phase 2a
study in patients with COPD were previously reported.  
About Theravance
 Theravance is a biopharmaceutical company with a
pipeline of internally discovered product candidates and strategic
collaborations with pharmaceutical companies. Theravance is focused
on the discovery, development and commercialization of small molecule
medicines across a number of therapeutic areas including respiratory
disease, bacterial infections, and central nervous system (CNS)/pain.
Theravance's key programs include: Relvar(TM) or Breo(TM) (FF/VI),
umeclidinium bromide/vilanterol (UMEC/VI) and MABA (Bifunctional
Muscarinic Antagonist-Beta2 Agonist), each partnered with
GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor
Antagonist program. By leveraging its proprietary insight of
multivalency to drug discovery, Theravance is pursuing a
best-in-class strategy designed to discover superior medicines in
areas of significant unmet medical need. For more information, please
visit Theravance's web site at 
THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A
DIFFERENCE(R) are registered trademarks of Theravance, Inc.  
Relvar(TM) or Breo(TM) (FF/VI) is an investigational medicine and is
not currently approved anywhere in the world. Relvar(TM) and Breo(TM)
are trademarks of the GlaxoSmithKline group of companies. The use of
these brand names has not yet been approved by any regulatory
This press release contains certain "forward-looking" statements as
that term is defined in the Private Securities Litigation Reform Act
of 1995 regarding, among other things, statements relating to goals,
plans, objectives and future events. Theravance intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E of
the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to the status and timing of clinical studies,
statements regarding the potential benefits and mechanisms of action
of drug candidates, statements concerning the enabling capabilities
of Theravance's approach to drug discovery and its proprietary
insights and statements concerning expectations for product
candidates through development and commercialization. These
statements are based on the current estimates and assumptions of the
management of Theravance as of the date of this press release and are
subject to risks, uncertainties, changes in circumstances,
assumptions and other factors that may cause the actual results of
Theravance to be materially different from those reflected in its
forward-looking statements. Important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements include, among others, risks related to
delays or difficulties in commencing or completing clinical studies,
the potential that results of clinical or non-clinical studies
indicate product candidates are unsafe or ineffective, our dependence
on third parties in the conduct of our clinical studies, delays or
failure to achieve regulatory approvals for product candidates, risks
of relying on third-party manufacturers for the supply of our product
and product candidates and risks of collaborating with third parties
to develop and commercialize products. These and other risks are
described in greater detail under the heading "Risk Factors"
contained in Theravance's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on October 31, 2012 and
the risks discussed in our other period filings with SEC. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance assumes no obligation to
update its forward-looking statements. 
Contact Information: 
Michael W. Aguiar 
Senior Vice President and Chief Financial Officer
Press spacebar to pause and continue. Press esc to stop.