SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 04/25/13 -- Theravance, Inc. (NASDAQ: THRX) (the "Company") reported today its financial results for the quarter ended March 31, 2013. Revenue for the first quarter of 2013 was $1.3 million. Net loss for the first quarter of 2013 was $37.4 million or $0.39 per share. Cash and cash equivalents, short-term investments and marketable securities totaled $558.4 million as of March 31, 2013.
"Theravance is off to a strong start in 2013 highlighted by the recent FDA Advisory Committee meeting which recommended approval of BREO ELLIPTA for the treatment of COPD," said Rick E Winningham, Chief Executive Officer. "This positive outcome marks another important milestone for Theravance in a year of transformation and potential growth. Today we issued a press release announcing our intention to separate the late-stage respiratory assets partnered with GSK from our biopharmaceutical operations to create two independent publicly traded companies. We believe this will provide investors with the opportunity to unlock potential value from two disparate sets of assets. Overall, we believe that Theravance is extremely well positioned both strategically and financially."
Respiratory Programs with GlaxoSmithKline plc (GSK)
RELVAR or BREO ELLIPTA (Fluticasone Furoate/Vilanterol, FF/VI)
FF/VI is an investigational once-daily inhaled corticosteroid/long-acting beta2 agonist (LABA) combination treatment, comprising FF and 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. RELVAR (FF/VI for the European Union (EU) and Japan), BREO (FF/VI for the United States (U.S.)), and ELLIPTA (for the EU, U.S. and Japan) are proposed brand names and use of these brand names has not yet been approved by any regulatory authority.
On April 17, 2013, the Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended approval of BREO ELLIPTA for the treatment of COPD. The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for FF/VI is May 12, 2013.
On April 19, 2013, an article on the two replicate double-blind, parallel-group, randomized controlled trials comparing three doses of FF/VI with VI alone on the annual rate of exacerbations in patients with COPD became available in the online publication of the Lancet Respiratory Medicine.
In May 2013, GSK will be presenting data from Phase 3 studies of FF/VI at the American Thoracic Society International Conference held in Philadelphia, Pennsylvania.
ANORO ELLIPTA (Umeclidinium Bromide/Vilanterol, UMEC/VI)
UMEC/VI is a once-daily investigational medicine, combining a long-acting muscarinic antagonist (LAMA), UMEC, and a LABA, VI, for the maintenance treatment of patients with COPD. UMEC/VI is administered by the ELLIPTA dry powder inhaler. ANORO and ELLIPTA are proposed brand names and use of these brand names has not yet been approved by any regulatory authority.
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