Spotlight on Hepatitis-C Market - Analyst Blog
December 06 2011 - 7:31AM
Zacks
Is the hepatitis-C market the next Mecca for the pharma/biotech
sector? It seems so if we go by the flurry of activity and
heightened interest in this market in the past few quarters. The
hepatitis-C virus (HCV) market seems to have caught the eye of
several pharma/biotech companies - as evident by the deals being
signed for the development of drugs for the treatment of HCV.
We are talking about the recent announcements made by big
players like Johnson & Johnson (JNJ),
Bristol-Myers Squibb (BMY) and Gilead
Sciences, Inc. (GILD). All three companies have made it
clear they want a piece of the HCV market pie.
Johnson & Johnson’s Tibotec Pharmaceuticals and
Bristol-Myers Squibb recently announced that they have decided to
join forces for the development of Bristol-Myers’ daclatasvir
(BMS-790052) in combination with Tibotec’s TMC435, for the
treatment of chronic HCV. What the partners are aiming to do is
create an oral once-daily interferon-free cocktail treatment for
HCV patients.
Bristol-Myers and Johnson & Johnson’s announcement comes on
the heels of Gilead’s announcement regarding its intention to buy
Pharmasset, Inc. (VRUS), a company focused on
developing HCV treatments. We think the main attraction for Gilead
in this $11 billion deal is Pharmasset’s HCV pipeline. Lead
candidate PSI-7977 is currently in two phase III studies, with a
third phase III study scheduled to commence in the first half of
2012. Successful development could lead to US approval in 2014
thereby making Gilead a front-runner in the oral once-daily
interferon-free cocktail treatment HCV market.
We note that both TMC435 and daclatasvir are being evaluated
separately in combination with Pharmasset's PSI-7977.
The Allure of the HCV Market
HCV is a hot development area which has come into the limelight
with the launch of two new treatments – Vertex
Pharmaceuticals’ (VRTX) Incivek and
Merck’s (MRK) Victrelis. Both drugs gained
approval in the US earlier this year. Incivek, which was launched
in May 2011, posted a whopping $419.6 million in sales in the first
full quarter of its launch.
So, with two new recently launched products in the market, why
is the HCV market considered so attractive? Firstly, it is
estimated that about 170 million people suffer from HCV infection
across the world. However, the treated population is much lower. In
major markets like the US, EU, Japan, Australia, Turkey, Canada,
etc. only 200,000 HCV patients out of a total of more than 12
million are estimated to receive treatment each year. This means a
huge number of HCV patients go untreated, leaving the field open
for new treatments.
Secondly, the current standard of care comes with several side
effects which make it difficult for patients to remain on
treatment. A 48-week course of both peg-interferon (peg-INF -
weekly injections) and ribavirin (RBV - oral drug), are the
standard treatment for genotype 1 HCV infection. However, this
treatment regimen is associated with significant side-effects like
fatigue, flu-like symptoms, rash, depression and anemia.
With a large number of HCV patients failing to achieve a
sustained viral response (SVR) on the current standard of care,
there are several patients who would be open to treatment with new
and potentially more effective therapies.
These factors have made the HCV market an attractive commercial
opportunity for pharma and biotech companies. Victrelis and Incivek
are examples of the changing treatment regimen in the HCV market.
Both are protease inhibitors which when added to the standard of
care reduce the treatment period and also improve the treatment
outcome. However, both need to be administered with peg-IFN and RBV
– this leaves the path open for the introduction of treatments with
fewer side effects.
Cocktail Therapy – The Next Big Thing in
HCV
Companies like Johnson & Johnson and Gilead are trying to
develop the next crop of drugs, which are expected to change the
treatment paradigm for HCV patients by providing them with all-oral
treatment regimens. The aim is to develop a treatment which does
not require the administration of interferon, thereby doing away
with a whole range of side effects. The treatment duration will
also be shorter.
Treatments being developed include HCV polymerase inhibitors and
HCV NS5A inhibitors. The future HCV market will most likely consist
of cocktail treatment regimens developed by combining different
oral treatments.
Vertex Pharma has also recognized the need to continually evolve
the HCV treatment pattern and is developing an all-oral combination
of VX-222 (a polymerase inhibitor) and Incivek without peg-IFN.
Who Will Win the Race?
With several companies pursuing cocktail therapies for HCV, it
will be interesting to see which of these companies will be the
first to hit the market with a new treatment option. Currently, it
looks like Gilead might be the front-runner assuming the Pharmasset
acquisition goes through.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
VERTEX PHARM (VRTX): Free Stock Analysis Report
PHARMASSET INC (VRUS): Free Stock Analysis Report
Zacks Investment Research
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From May 2024 to Jun 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jun 2023 to Jun 2024