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GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
Date:1/3/2008

Compound 642444 and Compound 685698 advance in clinical development for the

treatment of asthma

LONDON, PHILADELPHIA and SAN FRANCISCO, Jan. 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (Nasdaq: THRX) today announced the start of large Phase 2b asthma dose-optimization studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon' program to develop a next-generation combination product.

GSK began enrolling patients with mild to severe asthma in the '698 Phase 2b clinical program on 21st December 2007 and began enrolling patients with persistent asthma in the '444 Phase 2b clinical program on 29th December 2007. These clinical programs will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD program with '444 is also on schedule to commence in 1H 2008.

Darrell Baker, SVP GSK Respiratory Medicines Development Centre said, "The program is progressing well and we are delighted to have two very strong assets to progress into our large Phase 2b studies." He continued, "We have seen encouraging results in previous studies and have confidence in our ongoing program. Both asthma and COPD are serious, debilitating diseases where there remains a considerable unmet need. We believe through this program we will introduce a meaningful option for the treatment of patients with these conditions."

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SOURCE GlaxoSmithKline
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