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GlaxoSmithKline ( GSK - Analyst Report ) and Theravance, Inc. ( THRX - Analyst Report ) recently announced that they have submitted a marketing application to the US Food and Drug Administration (FDA) for their chronic obstructive pulmonary disease (COPD) candidate, LAMA/LABA (proposed brand name: Anoro Ellipta). LAMA/LABA is a combination of a long-acting muscarinic antagonist/LAMA (GSK573719 or umeclidinium bromide/UMEC) and a long-acting beta2 agonist/LABA (vilanterol/VI).
Glaxo and Theravance are seeking approval for the candidate for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. Glaxo remains on track to submit regulatory applications for LAMA/LABA shortly in the EU and other countries in 2013.
Earlier in July 2012, Glaxo and Theravance had presented data from four pivotal phase III studies of LAMA/LABA. While two studies compared the efficacy and safety of LAMA/LABA with VI, UMEC and placebo, the two other studies compared the efficacy and safety of LAMA/LABA with Pfizer’s ( PFE - Analyst Report ) Spiriva. The four studies together enrolled over 4,000 COPD patients.
In both the placebo-controlled, 24-week, randomized, double-blind studies, LAMA/LABA showed a statistically significant benefit over VI, UMEC and placebo. In the first head-to-head comparison with Spiriva, LAMA/LABA showed a statistically significant improvement. However, in the second study, LAMA/LABA failed to do so although it demonstrated numerical difference.
LAMA/LABA, if approved, will be positioned as a replacement for Advair, one of Glaxo’s highest revenue earners with 2011 sales exceeding £5 billion. We note that Glaxo along with Theravance is also developing other COPD candidates including Breo (proposed brand name Relvar in the EU, formerly known as Relovair) and MABA (GSK961081).
Glaxo, in May 2012, had acquired 10,000,000 shares of Theravance for approximately $21.2887 per share. With this transaction, Glaxo increased its holding in Theravance to 26.7% from 18.3%. The increased holding by Glaxo reflects its confidence in the pipeline candidates.
We currently have a Neutral recommendation on both Glaxo and Theravance. Both stocks carry a Zacks #3 Rank (short-term Hold rating).
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