Theravance S-1.
We currently have seven programs focused on discovering and developing new medicines. Three of these programs have product candidates in Phase 1 or Phase 2 clinical trials:
Asthma and COPD: Long-Acting Beta2 Agonists (LABA). We and GSK each have contributed four product candidates to our LABA collaboration. Of the pool of eight candidates, five are in clinical trials, two completed Phase 2a clinical trials in the fourth quarter of 2003, one completed a Phase 1 clinical trial in the fourth quarter of 2003 and two are in Phase 1 clinical trials. The current lead product candidate, GSK 159797, which was discovered by us, and a product candidate discovered by GSK are undergoing further safety and efficacy studies necessary before commencing Phase 2b clinical trials. The market for inhaled products containing long-acting beta2 agonists in the United States, Japan and Europe was approximately $4.5 billion in 2003.
Bacterial Infections. Our lead antibiotic product candidate, telavancin, is a rapidly bactericidal, injectable antibiotic. In January 2004, we completed a Phase 2 clinical trial in complicated skin and skin structure infections comparing the safety and efficacy of telavancin with current standard antibiotic therapy. We are currently in discussions with the U.S. Food and Drug Administration regarding our plans to initiate Phase 3 clinical trials for telavancin. The primary market that we are targeting represents approximately 32 million patient treatment days with antibiotics effective against infections caused by drug-resistant Gram-positive bacteria. From 1998 to 2003, treatment days in this category grew at a rate of 12% annually. Worldwide sales in this category totaled $730 million in 2003. Vancomycin, a generic medicine, leads this portion of the injectible antibiotic market with annual worldwide sales of approximately $370 million.
Overactive Bladder (OAB). Our lead product candidate for OAB is TD-6301. We initiated the first Phase 1 clinical trial of TD-6301 in December 2003. This clinical trial demonstrated that the drug was safe and well-tolerated in healthy volunteers. We plan to initiate additional Phase 1 clinical trials in 2004. The market for medicines to treat OAB in the United States, Japan and Europe was approximately $1.5 billion in 2003.
In addition, we have three other programs in preclinical studies in the areas of asthma and COPD, gastrointestinal disease and anesthesia. The seventh program, in the areas of asthma and COPD, is in the lead-optimization stage.
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