Profile: Theravance Inc (THRX.O)
Theravance, Inc. (Theravance), incorporated on September 19, 2001, is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. The Company 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. Its programs include RELVAR or BREO (fluticasone furoate/vilanterol), ANORO (umeclidinium bromide/vilanterol) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc (GSK), and its oral Peripheral Mu Opioid Receptor Antagonist program.
RELVAR or BREO (Fluticasone Furoate/Vilanterol, FF/VI)
Fluticasone Furoate/Vilanterol (FF/VI) is an investigational once-daily inhaled ICS/ LABA combination treatment, comprising fluticasone furoate (FF) and vilanterol (VI), for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) and patients with asthma. FF/VI is administered by a new dry powder inhaler called ELLIPTA.
ANORO (Umeclidinium Bromide/Vilanterol, UMEC/VI)
The Company’s UMEC/VI is a once-daily investigational medicine, combining a LAMA, UMEC, and a LABA, VI, for the maintenance treatment of patients with COPD. UMEC/VI is administered by the ELLIPTA dry powder inhaler.
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA)
The Company’s GSK961081 (081) is an investigational, single molecule bifunctional bronchodilator with both muscarinic antagonist and beta2 receptor agonist activities. Based on the results from the Phase 2b study, GSK and Theravance plan to advance 081 monotherapy into Phase III in 2013 and the 081/FF combination into Phase III-enabling studies.
Oral Peripheral Mu Opioid Receptor Antagonist-TD-1211
TD-1211 is an investigational once-daily, orally administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed with a goal of alleviating gastrointestinal side effects of opioid therapy without affecting analgesia. The Phase 2b program consisted of three studies (0074, 0076 and 0084) designed to evaluate doses and dosing regimens for Phase III. It is evaluating its Phase III strategy due to evolving Food and Drug Administration (FDA) requirements for this class of drug.
Monoamine Reuptake Inhibitor-TD-9855
TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor for the treatment of central nervous system conditions, such as Attention-Deficit/Hyperactivity Disorder (ADHD) and chronic pain. TD-9855 is being evaluated in an ongoing Phase II safety and efficacy study in adults with ADHD. In addition, it initiated a Phase II study with TD-9855 in patients with fibromyalgia during the year ended December 31, 2012.
Long-Acting Muscarinic Antagonist-TD-4208
The Company’s Phase 2a single-dose COPD study of TD-4208 is an investigational inhaled LAMA discovered by Theravance. In December 2012, it initiated a Phase 2b study to evaluate the safety and pharmacokinetics of multiple doses of TD-4208.
The Company’s Velusetrag is an oral, investigational medicine dosed once-daily, is a selective agonist with high intrinsic activity at the human 5-HT4 receptor. In October 2012, it entered into a development and commercialization agreement with Alfa Wassermann for velusetrag, its lead compound in the 5-HT4 program, covering the EU, Russia, China, Mexico and certain other countries. In January 2013, Theravance and Alfa Wassermann announced the initiation of a Phase II proof-of-concept study to evaluate the efficacy and safety of velusetrag for the treatment of patients with diabetic or idiopathic gastroparesis.
The Company competes with AstraZeneca PLC, Merck & Co Inc., Boehringer-Ingelheim, Pfizer Inc., Cubist Pharmaceuticals, Forest Laboratories Inc. and Novartis AG.
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