2010年3月美国医疗行业研究报告

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【出版时间及名称】：2010年3月美国医疗行业研究报告
        【作者】：OPPENHEIMER        
【文件格式】：pdf
        【页数】：37
        【目录或简介】：

Portrait of a Landscape:
Gout
SUMMARY
After decades with no new gout therapies, multiple treatment options from biotech
and pharma companies are emerging and one branded therapy has reached the
market. In anticipation of growing interest this year, we conducted a comprehensive
review of the current and future gout treatment dynamics, which included
discussions with several thought leaders. Based on our work, we believe gout is a
large and expanding market, early trials are highly predictive of future efficacy, the
registration path is straightforward, and current treatments have limitations—all
positives for companies developing gout drugs. On the flip side, eroding the share
of dominant generics like allopurinol will likely take time, particularly given the PCP
prescriber base and lack of standardized treatment guidelines. These challenges
have been illustrated by the gradual adoption of Takeda's Uloric. We believe
companies that will be most successful achieving pricing power and uptake will be
those that target gout subpopulations—such as refractory/severe pts or acute
treatment—rather than the first-line chronic market. Among covered companies,
RDEA and SVNT are our favorite names in the gout space.
KEY POINTS
n RDEA (Outperform): We believe RDEA594 will find a niche as an add-on
treatment for allopurinol-refractory pts, with peak sales of $400M. Based on
prior results, we believe NT data from ph.IIb studies of '594 as monotherapy
(end-Mar/early-Apr) and combo allopurinol (2Q10) will confirm '594's sUA
lowering effects and increase comfort on safety. We believe this will drive
additional share upside and are raising our tgt to $25 from $23. Although
experience with parent compound '806 increases our confidence no unexpected
AEs will be observed in these trials, LT safety remains an important
unknown—and a key determinant of where '594 could fit vs. currently-available
uricosurics.
n SVNT (Outperform): Despite initial concerns over CV events and anaphylaxis,
we are now confident in the approval and commercial uptake of SVNT's
Krystexxa. We believe the company will overcome outstanding manufacturing
issues and launch the drug 4Q10. We expect Krystexxa to play a significant role
in poorly-controlled tophaceous gout pts for whom there are few alternative
therapies. We expect pricing in the $27K/yr range to be supportable for the
infused enzyme and est. peak WW Krystexxa sales of >$800M.
n BCRX (Perform): Ph.I/II data shows BCRX's BCX 4208 effectively lowers sUA.
This is unsurprising, as PNP inhibitors, like '4208, act in the same pathway as
XO inhibitors. We expect significant sUA reductions in ph.II trials of '4208 in
gout, both as monotherapy in 2Q10 and in combination with allopurinol in 4Q10.
However, 4208's safety profile is still an open question, and we believe ph.II
data is necessary to assess the drug's ultimate commercial potential.

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关键词：行业研究报告 医疗行业 研究报告 美国医疗 行业研究 美国 研究报告 行业 医疗

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