ASCEND Phase 3 TrialInterMune provided an update on patient enrollment in the company's Phase 3 "ASCEND" study, which is designed to confirm the efficacy and safety of pirfenidone and to support an NDA re-submission for FDA approval of Esbriet (pirfenidone) in the United States. The company now expects ASCEND to be fully enrolled around the end of 2012. InterMune's previous guidance was the second quarter of 2012.
Steve Porter, M.D., Ph.D., Chief Medical Officer for InterMune, said, "Our primary mission for ASCEND is to deliver a high-quality result, which we aim to achieve by concentrating on a select number of high-quality sites. While a number of factors have contributed to the extended timeline, we are firmly convinced that the trade-off between data quality and time is a very good one. We believe the trial design and refined entry criteria of ASCEND significantly increase our probability of a successful outcome because they provide that patients enrolled in the study have the characteristics that we know from our many studies in IPF predict disease progression. We are extremely pleased with the continued enthusiasm of IPF physicians for ASCEND and look forward to sharing the results at the end of the study."
InterMune noted that it will discuss the status and projected timing for completion of the ASCEND Phase 3 clinical trial of Esbriet during today's conference call and webcast.
About Esbriet® (pirfenidone) in FranceEsbriet is the first-ever drug approved by the EU regulatory authorities in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). In its assessment, the CT cited 7,700 mild-to-moderate IPF patients in France. The CT is the agency in France responsible for assessing medicinal products and advising the health authorities on whether those products provide sufficient benefit to be covered by French National Health Insurance. About SMR and ASMR Under the French system, a new medicine may be granted one of four SMR levels. Of these, three are considered "sufficient" for the CT to recommend favorable inclusion on the reimbursed drug list. The three sufficient SMR ratings are: Important, Moderate and Low. Each rating is associated with different levels of reimbursement. The fourth SMR level, "Insufficient," is a recommendation by the CT that is unfavorable to inclusion on the reimbursed drug list and if assigned to an application, no ASMR rating is given by the CT. In this case, the manufacturer does not proceed to price negotiations with the Pricing Committee (CEPS). There are five levels of ASMR rating:
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV