2010年4月丙肝疫苗行业研究报告

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【出版时间及名称】：2010年4月丙肝疫苗行业研究报告
        【作者】：摩根大通
        【文件格式】：pdf
        【页数】：100
        【目录或简介】：

Hepatitis C (HCV) is one of the more exciting therapeutic markets in biotech
given a large patient population, a significant unmet medical need and rapid
advancements in the clinic. The HCV market is on the verge of a revolution that
brings significant changes to the treatment paradigm with new therapies that may
nearly double the cure rates over current standard of care and with dramatically
better tolerability and convenience. The timing of these paradigm changes is ideal
with many patients who were infected in the 1970s / 80s beginning to show
disease progression that now warrants active treatment. Given the large HCV
opportunity, the proximity to new phase 3 data (Vertex and Merck), and the
EASL meeting this week (Vienna; April 14-18), we have dedicated this week
"HCV WEEK." Today, we’re providing an in-depth view of the HCV market
and a clinical data review. Tomorrow (4/13), we’ll tackle the commercial
considerations and provide thoughts on companies. We’ll have updates from
EASL and will be hosting a “Live from EASL” conf call on Friday (4/16).
• Conf call details. We are hosting a call TODAY at 10:00 am ET for our HCV
market overview and a call tomorrow (4/13) at 10:00 am ET to discuss a
proprietary HCV survey, the commercial landscape and companies. On Friday,
our "Live from EASL" call is at 10:00 am ET featuring Dr. Fred Poordad, a
KOL in HCV from Cedars Sinai Medical Center. The dial-in for all three calls
is 888-889-1309 (US); 773-756-0161 (OUS); passcode: BIOTECH.
• An ideal time for new agents. Many patients who contracted HCV in the 1970s
/ 1980s (when incidence peaked) have been delaying treatment. Disease
progression is occurring and the influx of new HCV patients into therapy could
be robust. Indeed, the number of treatment naïve genotype 1 patients on therapy
in the US today (35-45k / year) could double by 2015. New targeted HCV
agents (known as STAT-C therapies) may increase the cure rates from 40%
today to 75%, and in half the time. From a market perspective, WW HCV sales
could grow from $2B today to $13B by 2015 with a new wave of therapies.
• Treatment experienced patients the low hanging fruit. While naïve patients
will be a key component of patient growth, the ~400k treatment experienced
patients are even more desperate for therapy, and STAT-C therapies have the
potential to significantly improve cure rates in these patients as well (going from
~15% currently to >50%). These patients are expected to provide a large bolus
of patients in the first few years that STAT-C agents are available.
• Telaprevir and boceprevir will be first; competition is coming. Telaprevir
(Vertex/JNJ) and boceprevir (Merck) will have phase 3 data in the next few
months that should set the stage for FDA approval in 2011. We see telaprevir as
the better of the two, but there are dozens of others that could come to market
over the next 5 years that could be game changers in the HCV paradigm.
• STAT-C combo is the ultimate goal. Following the approval of STAT-C
agents in combo with PEG-IFN/RBV, the focus will then shift to STAT-C
combos that exclude PEG-IFN/RBV. We think having a strong STAT-C combo
will be critical to the long-term success of any HCV company

Table of Contents
HCV Overview...........................................................................3
HCV WEEK Agenda..................................................................4
HCV 101.....................................................................................9
The Current HCV Treatment Paradigm.................................11
The Future HCV Treatment Paradigm...................................18
Clinical Data for PEG-IFN + Ribavirin ...................................25
Understanding Classes of Therapy ......................................29
Protease Inhibitor Review......................................................30
Nucleoside/tide Polymerase Inhibitor Review .....................64
Non-nucleoside/tide Polymerase Inhibitor Review..............76
Other HCV Therapies in Development..................................88
STAT-C Combos All the Rage ...............................................92

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