【出版时间及名称】:2010年5月美国制药行业研究报告
【作者】:瑞士信贷
【文件格式】:pdf
【页数】:39
【目录或简介】:
No Pain Means Gain: Unraveling the $11Bn
Market Opportunity
■
A new way to treat pain, so far receiving little attention from investors,
could be seen as more plausible in 2010, a positive for Pfizer and the
sector: Pfizer’s tanezumab is a first in class nerve growth factor (NGF)
inhibitor and will be reporting pivotal phase 3 data this year. Program
success could draw more attention to the NGF inhibitor class and illustrate
the optionality on Pfizer’s pipeline. JNJ, Regeneron, Abbott and AstraZeneca
are also pursuing earlier stage versions of NGF Inhibitor agents.
■
NGF Inhibitors, with full success, could become a new $11Bn drug
category. Discussions with investigators universally suggest they are
impressed with noteworthy pain reductions and minimal side effects,
consistent with tanezumab’s phase 2 data. Confirmation in phase 3 could
result in revenues around $11 Bn, which assumes only 1% biologics
penetration of the 241MM people in the U.S. and Europe with osteoarthritis
and chronic back pain, or only 4% of those who have severe forms of the
disease. Additional pain indications are also being pursued, but are not
included in our forecast.
■
The risk to NGF Inhibitors is so far theoretical. Cautious commentary
pertains to the unknown tolerability of inhibiting nerve growth factor over
prolonged periods of time. More experience will reveal if this is warranted.
■
Stock Implications:
o Pfizer (PFE). Adjusting tanezumab sales upward to account for our
diligence and 40% probability of success (POS) implies 2015
revenues increase from $600MM to $1.2 Bn, suggesting an
$0.03/share EPS contribution. Full probability of success would
imply $3 Bn revenues or $0.16/share in 2015. PharmaValues
methodology implies new forecast (40% POS) is $0.5/share with
total value for PFE at $25.70.
o Regeneron. REGN475 is in Phase 2 development for
osteoarthritis of the knee and other pain indications. Phase 3
results from PFE's tanezumab would be a positive catalyst for
REGN in validating the mechanism of action. Proof of concept data
is expected in 1H10, with launch anticipated in 2015; a 34% POS
implies sales of approximately $600MM in 2019.
o JNJ, ABT & AZN. Tanezumab success would benefit these
stocks by increasing attention on their NGF inhibitor programs.
Table of Contents
Portfolio Manager’s Summary 3
Thesis on Pfizer 3
Can the Pipeline Deliver, and What Can Tanezumab Contribute? 3
Model Updates 5
Valuation 6
NGF Inhibitors an Important New Class; Tanezumab Leading the Way 7
Impressive efficacy for tanezumab in osteoarthritis pain and chronic
low back pain 8
Osteoarthritis data first attracted our interest to the NGF inhibitor
approach 8
2009 Brought Signs of Efficacy in Lucrative Chronic Back Pain
Market 9
Tanezumab’s safety profile has been satisfactory to date, but longerterm
exposure is still needed 11
Heavy newsflow in 2010/2011 will increase focus on tanezumab 13
Limited data disclosed on NGF inhibitor efforts by JNJ, REGN and
others 15
NGF Inhibition Provides New Potential Pathway to Treating Pain 18
Real and theoretical safety concerns need to be investigated 18
Osteoarthritis and Back Pain Provide Largest Opportunities 20
Concern Over Opioids, OTC Pain Meds May Help NGF Inhibitors 26
Earnings Sensitivity for Pfizer 28
PharmaValues Analysis of Pfizer and the Tanezumab Opportunity 30
Pfizer Financial Statements