piper: CVTX :Details From Phase III Regadenoson Study
2005-10-04 02:25 (New York)
Hot Comment
(CVTX - $27.95)
Outperform Volatility: Medium
Thomas Wei, Senior Research Analyst
212 284-9305, thomas.a.wei@pjc.com
Rachel L. McMinn, Ph.D., Research Analyst
415 277-1549, rachel.l.mcminn@pjc.com
Gur A. Roshwalb, M.D., Research Analyst
212-284-9314, gur.a.roshwalb@pjc.com
KEY POINTS:
* Regadenoson Shows Improvements In Severity Of Key Side Effects. Detailed
Phase 3 data were presented on October 2 for CV Therapeutics' regadenoson
for myocardial perfusion imaging. As a reminder, CVT announced in August
that the trial had met its primary endpoint of non-inferiority compared to
market-leading Adenoscan. Details from the study showed a statistically
significant benefit on a summed symptom score (flushing, chest pain, and
dyspnea), a pre-specified secondary endpoint, with mean scores of 1.1 for
Adenoscan and 0.9 for regadenoson (p=0.018). In this scale, there were four
choices, with no event scored as zero, a mild event scored as 1, a moderate
event scored as 2 and a severe event scored as 3. Regadenoson showed
improvements on both flushing (0.4 vs. 0.2 for Adenoscan vs. regadenoson)
and chest pain (0.5 vs 0.3 for Adenoscan vs. regadenoson), but was slightly
worse for dyspnea (0.2 vs 0.3 for Adenoscan vs. regadenoson). Moreover, in a
patient questionnaire, 91% of regadenoson patients felt comfortable or a
little uncomfortable vs. 82% of Adenoscan patients. Additionally, 58% of
regadenoson patients reported a somewhat or much better second test vs. 43%
of regadenoson patients (note that all patients received Adenoscan in their
first test). These data show that regadenoson was generally better tolerated
than Adenoscan, with a higher proportion of mild or no events in this score.
* Regadenoson Shows Improvements In Frequency Of Key Side Effects. Key side
effects reported in the study were flushing, chest pain, and dyspnea. Fewer
patients on regadenoson experienced flushing (29% vs 20%), chest pain (35%
vs 26%), although more regadenoson patients experienced dyspnea (18% vs
25%), dizziness (3% vs 6%), headache (15% vs 28%), and GI discomfort (11% vs
19%). Overall, we view these data as encouraging and expect physicians to
greet these data positively, particularly in light of the improved mode of
delivery (regadenoson is an IV bolus while Adenoscan is an IV pump).
* $300+ Million Potential Market Opportunity. Astellas, CVT's marketing
partner for regadenoson, currently projects sales of Adenoscan of $323m for
the fiscal year ending March 2006. We currently model peak sales of $190m in
2009 for regadenoson, with an estimated 20% royalty rate to CVT. At this
royalty rate, every $10m in incremental sales would yield $0.02 to our
outer-year CVTX EPS estimates.
PRICE TARGET AND JUSTIFICATION:
Our $34 PT is based on a 40x 2009E EPS, disc. at 30%.
RISKS TO ACHIEVEMENT OF TARGET PRICE:
Risks include but are not limited to: 1) failure to achieve Ranexa sales
estimates, 2) inability to expand Aceon managed care coverage, and 3) clinical
risk in label expansion for Ranexa.
Related Companies:
CVTX: 27.95
Important Research Disclosures
------------------------------------------------------------------------------
Analyst Certification - Thomas Wei, Senior Research Analyst... |
