Theravance Announces Initiation of Phase 2 Study With TD-9855

Theravance Announces Initiation of Phase 2 Study With TD-9855 for the
Treatment of Fibromyalgia 
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 12/04/12 --  Theravance,
Inc. (NASDAQ: THRX) announced today the initiation of a fibromyalgia
Phase 2 study with TD-9855, the lead compound in Theravance's
Monoamine Reuptake Inhibitor program. TD-9855 is an investigational
norepinephrine and serotonin reuptake inhibitor (NSRI) for the
treatment of central nervous system (CNS) conditions such as chronic
pain and Attention-Deficit/Hyperactivity Disorder (ADHD). 
"We are enthusiastic about the potential of TD-9855 to treat patients
suffering from fibromyalgia," said Mathai Mammen, M.D., Ph.D., Senior
Vice President of Research and Early Clinical Development. "There
remains a substantial opportunity for therapies with an acceptable
tolerability profile that effectively manage both fibromyalgia and
commonly experienced comorbid symptoms such as fatigue. We believe
TD-9855's balance of inhibition of norepinephrine and serotonin
reuptake may provide a compelling and differentiated profile versus
current alternatives."  
About the Phase 2 Study in Fibromyalgia 
This Phase 2 proof-of-concept study will evaluate the safety and
efficacy of two doses of TD-9855 in patients with fibromyalgia.
Approximately 375 patients will be randomized to TD-9855 or placebo.
Study medication will be administered once-daily for up to 9 weeks.
The primary endpoint of the study is improvement in pain. Additional
secondary or exploratory endpoints will assess improvement in other
established fibromyalgia measures and impact on important
comorbidities, such as fatigue.  
About TD-9855 and the Monoamine Reuptake Inhibitor Program 
TD-9855 is an investigational NSRI discovered by Theravance for the
treatment of CNS conditions such as chronic pain and ADHD. TD-9855
has been administered to healthy volunteers in ascending single- and
multiple-dose studies evaluating safety, tolerability and
pharmacokinetics. The results of these studies showed that TD-9855
was generally well tolerated, had a predictable and linear
pharmacokinetic profile and a long pharmacokinetic half-life
supportive of once-daily dosing. Data collected from a Phase 1
positron emission tomography (PET) study confirmed CNS penetration
and
 selectivity for norepinephrine over serotonin transporters.
TD-9855 exhibits broad preclinical antinociceptive activity across a
range of models of pain, including acute inflammatory, neuropathic
and osteoarthritis models. TD-9855 does not interact with opioid
receptors but augments the analgesic effects of morphine. The
antinociceptive activity of TD-9855 reflects occupancy of both
norepinephrine and serotonin transporters, at exposures that were
associated with submaximal occupancy of central serotonin
transporters. In addition to the Phase 2 study in fibromyalgia,
TD-9855 is being evaluated in an ongoing Phase 2 safety and efficacy
study in adults with ADHD. The goal of the Monoamine Reuptake
Inhibitor program is to develop a best-in-class monoamine reuptake
inhibitor for the treatment of various CNS conditions such as chronic
pain, ADHD, and potentially depressive disorders. 
About Fibromyalgia 
Fibromyalgia is a chronic functional illness that is characterized by
pain, stiffness, and tenderness of muscles, tendons, and joints. It
has been estimated to affect as many as 5 million individuals in the
United States. In addition to widespread pain, fibromyalgia is
associated with other symptoms that may include sleep disturbances,
fatigue, anxiety, depression and problems with memory and
concentration.  
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 www.theravance.com. 
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
authority. 
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 st
udies
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. 
(THRX-G)  
Contact Information: 
Michael W. Aguiar 
Senior Vice President and Chief Financial Officer 
650-808-4100 
investor.relations@theravance.com