Piper: CV Therapeutics, Inc.
Outperform
Volatility: Medium
Price Tgt -- $25.00
Price: $13.86
52 Week High: $36.65
52 Week Low: $12.20
Shares Out (mil): 31.5
Market Cap. (mil): $436.6
Avg Daily Vol (000): 977
Book Value/Share: $3.64
Cash Per Share: $13.19
Debt to Total Capital: 3%
thomas.a.wei@pjc.com
CV Signs Second SPA For Ranexa In ACS
KEY POINTS:
* CV Therapeutics Announces Agreement With FDA On Second Special Protocol Assessment (SPA). Along with 2Q earnings, CVTX announced an agreement with the FDA on a second SPA for the use ofRanexa in acute coronary syndrome
(ACS), treatment of long-term coronary patients, and also for possibly broadening the indication of Ranexa into first-line treatment of chronic angina.
Enrollment in this study is expected to begin in 4Q04, with preliminary data by the end of 2006. An indication in ACS or
first-line treatment in chronic angina would provide significant upside to our $350 million Ranexa peak sales estimate.
* Large Trial Well-Powered To Show Benefit. The Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Acute Coronary Syndrome (MERLIN) study, carried out by the
TIMI group, is a 5,500 patient, double-blind, randomized, placebo controlled, parallel group trial powered at 90% with the primary endpoint a composite of time to first occurrence of cardiovascular death, heart attack, or recurrent ischemia. Patients arriving at the hospital will be placed on IV Ranexa or placebo within 48 hours of admission, dosed to approximate an outpatient oral regimen of 500-1000 mg twice a day, and then placed on an oral regimen of Ranexa or placebo. The analysis of the study is event driven, and an interim analysis will be performed when half of the events have occurred.
* First-Line Indication Dependent On Safety Data. Regardless of whether the primary endpoint of the MERLIN trial is met, the SPA allows for the possibility of using Ranexa in first-line treatment of chronic angina if the safety data from the trial show no adverse trend towards death or arrhythmia.
* Ranexa On Track For 2006 Approval. The trial from the first SPA of Ranexa versus placebo in patients failing 10 mg Norvasc is expected to start shortly and we believe that the trial design will allow for quick enrollment. We continue to expect approval in restricted patients by the end of 2006.
INVESTMENT RECOMMENDATION: We continue to view CVTX as a long- term turnaround story and believe that long-term, value-oriented shareholders will be rewarded on positive Ranexa data and a favorable regulatory outcome. |
