This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Theravance, Inc. CEO Discusses Q2 2012 Earnings Results - Earnings Call Transcript

Now turning to the second respiratory program LAMA/LABA or UMEC/VI. UMEC/VI is a once a day investigational medicine combining a long acting Muscarinic Antagonist, Umeclidinium Bromide or UMEC and a LABA, VI, for the maintenance treatment of patients with COPD. UMEC/VI is also administered by the new Ellipta inhaler. Earlier this month GSK and Theravance announced positive result from four pivotal Phase 3a studies of UMEC/VI involving over 4,000 patients with COPD.

These four studies include two 24 week efficacy studies that compared the combination UMEC/VI, its components and placebo and two 24 week active comparator studies that compared the combination with tiotropium. Tiotropium, as you know, is a widely prescribed maintenance bronchodilator for COPD.

The data from these four studies form part of the overall evaluation of efficacy and safety of the UMEC/VI combination and the individual components in approximately 6,000 COPD patients. The ongoing registration program includes a 52 week safety study and two replicate 12 week crossover exercise studies. Subject to the successful completion of these additional studies, GSK plans to commence global regulatory submission for UMEC/VI from the end of 2012 which is ahead of schedule.

Turning now to our third respiratory program the MABA program, ‘081 the lead asset is a single molecule bifunctional bronchodilator with both a muscarinic antagonist and a beta2 receptor agonist activity. The result from the Phase 2b study and a number of non-clinical enabling studies will inform the selection of the most appropriate dose and dosing interval for ‘081 and progression to Phase 3 will be dependent upon successful completion of these ongoing enabling studies.

In September, several presentations covering data from these respiratory programs will be given at the European Respiratory Society Annual Congress in Vienna. Importantly, data form a majority of the studies of the Phase 3a FF/VI programs for both COPD and asthma will be presented including the exacerbation studies. Also a late breaker presentation will describe data from the Phase 2b low dose crossover study of UMEC and COPD. Data from the Phase 2b study for MABA will also be presented at ERS.

Read the rest of this transcript for free on

3 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $92.89 -0.38%
FB $118.50 0.59%
GOOG $706.33 0.70%
TSLA $211.24 -0.14%
YHOO $36.87 -0.19%


Chart of I:DJI
DOW 17,625.75 -34.96 -0.20%
S&P 500 2,041.56 -9.07 -0.44%
NASDAQ 4,689.3940 -27.70 -0.59%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs