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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Clean-Needle
Law Heartens Fresno Officials, Who See High Drug Use
• Teva Gets Tentative FDA Nod for Hepatitis-C
Drug
• Latino Organization for Liver Awareness
(L.O.L.A.) Celebrates 10 Year Anniversary Monday September
27
• Effect of Liver Cirrhosis in Patients
Undergoing Laparotomy for Trauma
• Michigan Prisons Get $1.2 Million to
Test for Hepatitis C
• Gilead and Genelabs Announce Research
Collaboration and License Agreement for the Development of
Genelabs' Novel Hepatitis C Compounds
• Morgan County Man Uses Billboard to Get
a Liver
• Valeant Pharmaceuticals to Present Viramidine(TM)
End-of-Treatment Data from Phase 2 Clinical Trial
• Roche Launches New Hepatitis Patient
Internet Site Www.Hep-Links.Com in Support of First International
Hepatitis C Awareness Day
• October 1 to Be Observed as World Hepatitis-C
Awareness Day
• New Study Reports Results of Pegintron
and Rebetol Combination Therapy in Difficult-to-Treat Hepatitis
C Virus (HCV) Genotype 4; Predominant Virus Type in the Middle
East
• Furor over Hep C Cash Plan
September
25th, 2004
Clean-Needle Law Heartens Fresno
Officials, Who See High Drug Use
Juliana Barbassa
Source: Associated Press
FRESNO, Calif. (AP) - In one of the nation's
richest agricultural regions, where cotton, grapes and citrus
have long been king, the area's largest city finds itself
struggling with a new and more dubious distinction.
A national study found that the Fresno
area has the highest rate of intravenous drug users in the
country. Law enforcement agencies and treatment counselors
say they often are overwhelmed by the scope of the problem
in the Central Valley but were heartened this week when Gov.
Arnold Schwarzenegger made it easier for drug abusers to obtain
clean needles.
That gesture won't reduce the number of
addicts, they said, but it should prove a big step in controlling
HIV and hepatitis C cases spread by those who frequently shoot
up with used needles.
"We can't stop all the drug use in
this community," said Dennis Koch, administrator of Fresno
County's Alcohol and Drug Program.
"But there can be safer ways."
The city of nearly 500,000 residents has
the highest rate of intravenous drug users in the nation,
according a study published this month in the Journal of Urban
Health.
Fresno and its surrounding neighborhoods
have 173 intravenous drug users for every 10,000 people, nearly
three times the national average of 60 per 10,000 people,
according to the study.
Bakersfield, San Francisco and the Stockton-Lodi
area were the other California metropolitan areas in the top
10 for illegal IV drug use. Methamphetamine, which can be
produced with small amounts of common household and farming
chemicals, is the most popular injected drug.
Under the bill Schwarzenegger signed Monday,
cities and counties can authorize pharmacies to sell up to
10 sterile syringes to an adult without a prescription. Currently,
hypodermic needles can be sold without a prescription in only
a few circumstances, such as to diabetics who need insulin.
The consequences of shooting up with dirty
needles place a heavy burden on public health systems.
The governor said about 1,000 Californians
contract HIV every year, many through sharing infected needles.
Fresno County had 251 new HIV infections last year, a 17.3
percent increase from the previous year.
A recent Fresno County pilot study found
that 75 percent of the area's injection drug users had Hepatitis
C, compared to 2 percent of the general population.
Studies from other states have shown that
steps such as the clean-needle program reduced HIV infections
by up to 50 percent without increasing crime or the rates
of illegal drug use.
Signing the measure "took political
guts," said Glenn Backes, health policy director for
the Drug Policy Alliance in Sacramento. He said prosecuting
and imprisoning drug abusers can't be the only solution to
addiction.
"The Central Valley is a stalwart
of the drug war mentality," said Backes. "Rather
than listen to doctors and treatment professionals, we have
fallen back on jailers."
Schwarzenegger vetoed a related bill that
would have allowed local governments to establish needle-exchange
programs with a single, one-time authorization. The governor
said he is committed to reducing the spread of HIV but said
he favored the existing state law allowing needle exchanges
because it ensures that local officials are continuously reviewing
and examining the programs.
Central Valley health officials and treatment counselors said
providing drug users with quick and easy access to clean needles
is overdue and should help reduce disease. Weaning people
from dependency will be a more difficult struggle, they said.
"This town is so full of meth,"
said Amy Wilson, 28, whose red hair curls above bright blue
eyes as she sits in the residential program where she is receiving
treatment.
She was ordered to the center after her
daughter, now 3 1/2 months old, was born and tested positive
for methamphetamine. She feared losing her baby.
"My grasp on reality was gone,"
she said.
She described drug use in the Central Valley
as "like a cancer."
In the journal study, Fresno was ranked
with cities such as New York, Baltimore and Las Vegas as having
high rates of intravenous drug users.
The researchers created their rankings
by analyzing previously published data on drug use across
the country and obtaining the number of people seeking treatment,
counseling or testing in particular regions, said Samuel Friedman,
the study's primary author.
Fresno County spends $20 million a year
on county-supported treatment programs and in recent years
has succeeded in obtaining more money.
In 1998, the county had 5,435 substance
abusers cycle through its programs. By 2002, 9,036 had received
treatment, said Koch, of the county's alcohol and drug program.
Even so, the treatment programs strain
to keep up with demand.
"Now at least we have a waiting list,"
he said. "Before, we used to not have these programs.
There was nothing to wait for."
Cheryl Freeman, 38, was relieved to be
admitted into a program for women who are pregnant or have
small children.
She had tried without success to quit her
heroin habit on her own. When she realized she was pregnant,
she desperately wanted her child to "be born clean."
She entered a hospital, replaced heroin
with methadone during the pregnancy, and quit methadone the
day she gave birth, she said.
The treatment program she's in now requires
a year commitment from its patients -- six months in a tree-lined
compound where the women live in small white homes with green
trim, and six months in transitional housing.
Freeman said the program works because
it deals not just with their addictions but teaches them the
skills they'll need after their release, such as how to manage
their finances and control their anger.
"It's a community," she said,
as she held her month-old daughter, Sydney Elizabeth. "This
time I know I'm going to make it."
Back to top
September 26th, 2004
Teva
Gets Tentative FDA Nod for Hepatitis-C Drug
Source: Reuters
JERUSALEM,--- Israel's Teva Pharmaceutical
Industries (TEVA.O: Quote, Profile, Research) (TEVA.TA: Quote,
Profile, Research) has received tentative U.S. Food and Drug
Administration approval to market its ribavirin drug to treat
hepatitis-C, the FDA said on its website.
Ribavirin is a generic version of Schering-Plough's
(SGP.N: Quote, Profile, Research) drug Rebetol, whose sales
are estimated at more than $700 million a year. Roche Holding
AG (ROG.VX: Quote, Profile, Research) also sells a branded
version of ribavirin.
No other details were available.
In April, Three Rivers Pharmaceuticals
LLC and Novartis (NVS.N: Quote, Profile, Research) (NOVN.VX:
Quote, Profile, Research) unit Sandoz received FDA approval
for ribavirin. At the time, the FDA said that no other drug
companies were allowed to sell ribavirin for 180 days.
A Teva spokeswoman said final FDA approval
was expected after the 180 days of exclusivity ends next month.
Shares of Teva, the world's largest generic
drugmaker, were up 2.3 percent in afternoon trading in Tel
Aviv, outpacing gains of 0.7 percent on the broader bourse.
Its Nasdaq shares rose 5.5 percent to $27.11 on Friday.
Back to top
September 27th, 2004
Latino
Organization for Liver Awareness (L.O.L.A.) Celebrates 10
Year Anniversary Monday September 27
Source: PRNewswire
Organization hosts reception during Hispanic
Heritage Month in honor of those who have raised awareness
of liver disease within the Hispanic community -
BRONX, N.Y.,-- The Latino Organization
for Liver Awareness (L.O.L.A.), the first national, bilingual
and bicultural organization dedicated to liver awareness,
will be hosting a banquet in honor of the group's 10th anniversary.
The celebration is to take place on Tuesday, September 28,
2004 at the Interchurch Center in New York, from 5:30 pm to
8:30 pm.
Among the special guests will be Bronx
Borough President Adolfo Carrisn, Jr., Senator Efrain Gonzalez,
Assemblyman & Chairman of the Bronx Democratic Committee
Jose Rivera, liver disease specialists, and transplant surgeons
to name a few, for their efforts in helping to raise awareness
of liver disease within the Hispanic community and for their
involvement with L.O.L.A throughout the last ten years.
"This event is to say thank you to those that have given
support and raised awareness for liver disease, particularly
hepatitis C virus and organ & tissue donation within the
Hispanic community," said Debbie Delgado-Vega, Founder
& CEO of L.O.L.A. "The support we have received has
enabled us to help save the lives of many individuals, especially
Latinos, who are hit hardest by liver diseases like hepatitis
C."
Also in attendance at the event will be
Debbie Vega, founder and CEO of L.O.L.A., herself a liver
transplant recipient, Elaine Berg, president of the New York
Organ Donor Network, Dr. Lewis Teperman, Director of Transplantation
at New York University Medical Center, Catherine Paykin, Director
of Organ Donation for the National Kidney Foundation, Jose
Nicot, former Mayor Rudy Giuliani's Chief of Staff, Miriam
Perez, Public & Professional Education Specialist for
the New York Organ Donor Network, Gladys Moreira-Olsen, Director
of Operations for L.O.L.A., staff and members of L.O.L.A.
Liver Disease and the Latino Community
Liver disease, such as hepatitis C (HCV), is a serious and
deadly problem, especially among the Latino community. HCV
is the most common blood-borne infection in the United States,
affecting some four million Americans and one out of every
50 Latinos. According to the New York City Department of Health
more Latinos die from end stage liver disease due to hepatitis
C and co- infection with hepatitis C and HIV/AIDS than any
other group. Unfortunately, socioeconomic factors such as
poverty, lack of insurance, language barriers, and general
lack of awareness, combine to limit access of Latinos to testing,
treatment and/or lifesaving transplants.
"Over 16,000 Americans are waiting
to receive liver transplants and not nearly enough donors
are available to provide these organs," said Delgado-Vega.
"This is why it is especially important to screen and
treat liver diseases, such as hepatitis C, before they progress
and cause severe liver damage requiring a transplant."
About L.O.L.A.
Founded in 1994, L.O.L.A. is the first national bilingual
bicultural organization dedicated to raising awareness on
liver disease through informational materials, prevention
& education community outreach programs, treatment &
referral services, support groups, quarterly newsletters,
HCV Prison Educational Presentations and HCV Public Education
Campaigns to the Latino and Americans communities and other
underserved populations who suffer from liver disease in the
United States.
L.O.L.A. also provides culturally appropriate
bilingual information on liver transplantation, encourages
organ and tissue donation and provides support groups for
pre and post liver transplant recipients.
For more information about L.O.L.A., the
reception, or to find out more about liver disease or liver
transplantation, contact L.O.L.A. at (718) 892-8697 or visit
http://www.lola-national.org.
Source: Latino Organization for Liver
Awareness
Back to top
September 30th, 2004
Effect
of Liver Cirrhosis in Patients Undergoing Laparotomy for Trauma
Source: www.gastrohep.com
Cirrhotic trauma patients undergoing laparotomy
(abdominal surgery) are at high risk of serious complications
and death, even after fairly minor injuries, reports October's
issue of the Journal of American College of Surgeons.
Until now there has been little published
work on the effect of cirrhosis on outcomes in trauma patients
undergoing laparotomy.
Researchers in Los Angeles designed a study
to evaluate the risk of death or serious complications in
cirrhotic trauma patients undergoing laparotomy as compared
with that in a similar group of patients without cirrhosis.
The researchers had access to 46 patients
over a 12 year period, with the diagnosis of liver cirrhosis
made during laparotomy for trauma.
The group matched each individual patient
with 2 noncirrhotic controls on the basis of 7 criteria: age
(>55, ≤55 years), gender, mechanism of injury (blunt, penetrating),
Injury Severity Score (>15, 16-25, ≤25), head Abbreviated
Injury Score (<3, ≥3), chest Abbreviated Injury Score (<3,
≥3), and abdominal Abbreviated Injury Score (<3, ≥3).
The researchers excluded 6 cirrhotic patients
where matching was not possible.
The group matched each of the remaining
40 patients with 80 noncirrhotic control patients that had
been selected from a pool of 4,771 patients who had trauma
laparotomies.
Outcomes included mortality, ARDS, pneumonia,
renal failure, abdominal sepsis, disseminated intravascular
coagulopathy, ICU and hospital stay, and hospital charges.
"Overall mortality in the cirrhotic
group was significantly higher than that in the matched noncirrhotic
group" --Journal of the American College of Surgeons
The research group compared outcomes between
the two study groups using conditional logistic analysis and
derived the hazard ratio and adjusted p value with the stepdown
Bonferroni method.
They found that the overall mortality in
the cirrhotic group was significantly higher than that in
the matched noncirrhotic group (45% versus 24%).
Further analysis showed that mortality
in patients with Injury Severity Score <15 was 29% in the
cirrhotic group and 5% in the noncirrhotic group and in patients
with Injury Severity Score 16-25, mortality was 56% and 11%,
respectively.
In addition, the incidence of any of the
predetermined complications was 45% in the cirrhotic group
and 23% in the noncirrhotic group.
The mean surgical ICU stay was 11.5 days and 6.6 days, respectively,
and the mean hospital charges were $141,210 and $72,884, respectively.
Dr Demetriades, a co-author of the report,
commenting on the report said, "Cirrhotic trauma patients
undergoing laparotomy are at high risk of serious complications
and death, even after fairly minor injuries."
The group concluded, "This group of
patients should be admitted to the ICU for close monitoring
and aggressive management irrespective of the severity of
injuries."
Journal of the American College of
Surgeons; 2004: 199 (4): 538-542 30 September 2004
Back to top
Michigan
Prisons Get $1.2 Million to Test for Hepatitis C
Stacey Range
Source: Lansing State Journal
On Wednesday, Gov. Jennifer Granholm signed
legislation that provides $1.2 million for a new hepatitis
C testing and treatment program for inmates in Michigan’s
42 prisons. It is the first step in the state’s plan
to fight the spread of the disease among prisoners.
“By controlling the disease among the inmate population,
the state is taking great strides at addressing what could
otherwise become a public health issue for all Michigan citizens,”
Granholm said in a statement.
The new program is part of the Department of Corrections’
$1.79 billion budget for the fiscal year that begins Oct.
1. Russ Marlan, department spokesperson, said prison officials
will determine in the coming weeks how many inmates they can
test and treat in the program’s first year. Currently,
about 55 inmates are being treated. Granholm proposed the
program earlier this year. In September 2003, the Lansing
State Journal reported that up to 18,000 of Michigan’s
48,000 inmates are believed to be infected with hepatitis
C.
Prison officials had asked legislators for $2.3 million to
test and treat 465 inmates in 2005 and $11 million to treat
an additional 3,720 in 2006. Officials said Michigan’s
budget problems forced them to reduce the initial funding
but they will push for more next year.
Back to top
Gilead
and Genelabs Announce Research Collaboration and License Agreement
for the Development of Genelabs' Novel Hepatitis C Compounds
Source: Business Wire
Research Effort Targets Significant Unmet Medical Need
Gilead Sciences (Nasdaq:GILD) and Genelabs
Technologies, Inc. (Nasdaq:GNLB) today announced that the
companies have signed an agreement to collaborate in the research,
development and commercialization of novel compounds for the
treatment of infection caused by the hepatitis C virus (HCV).
In this collaboration, Genelabs will lead research efforts
and Gilead will lead development and commercialization efforts
for novel nucleoside inhibitors of HCV polymerase.
Under the terms of the agreement, Gilead will pay to Genelabs
a nonrefundable $8 million upfront payment and will provide
research funding over the next three years. In return Genelabs
will devote a specified number of scientists to the program
and provide Gilead with exclusive access to certain compounds
developed in the program. Genelabs could also earn milestone
payments of up to $38 million for each compound developed
by Gilead under the agreement, based upon the achievement
of specified development and regulatory goals. Gilead will
receive exclusive worldwide license rights and will pay Genelabs
a royalty on any net sales of future products arising from
the collaboration.
"We are pleased to partner with Genelabs, a company whose
mission closely aligns with ours," said John C. Martin,
PhD, President and Chief Executive Officer of Gilead Sciences.
"There is a significant unmet medical need in hepatitis
C therapy today, and Genelabs' research expertise and capabilities
uniquely position the company to work with Gilead to develop
compounds that can address this life-threatening disease.
We look forward to working with the Genelabs team in this
collaboration to advance novel product candidates forward
to the clinic."
"Gilead has proven to be a potent force in the development
and commercialization of antiviral products and is an ideal
partner for Genelabs' HCV program," said James A. D.
Smith, President and Chief Executive Officer of Genelabs.
"Our program goal is simple -- to discover and develop
best-in-class compounds for treatment of HCV. We believe Gilead
shares this goal and see them as the best partner to successfully
execute our mutual vision for bringing new HCV therapies to
market. We very much look forward to working closely with
the Gilead team over the coming years."
Hepatitis C is a viral liver disease, caused by infection
with the hepatitis C virus. Globally, more than 170 million
people have chronic hepatitis C. Hepatitis C is one of the
primary causes of liver failure and transplantation in the
United States. Currently, there is no vaccine that can protect
against hepatitis C infection.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that
discovers, develops and commercializes therapeutics to advance
the care of patients suffering from life-threatening diseases
worldwide. The company has seven marketed products, and focuses
its research and clinical programs on anti-infectives. Headquartered
in Foster City, CA, Gilead has operations in North America,
Europe and Australia.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company
pioneering the discovery and development of novel pharmaceutical
products to improve human health. The company is concentrating
its clinical development capabilities on Prestara(TM), an
investigational drug for women with systemic lupus erythematosus.
The company is concentrating its drug discovery capabilities
on novel antiviral compounds for treatment of hepatitis C
virus infections.
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act
of 1995, that are subject to risks, uncertainties and other
factors, including risks related to the companies' ability
to move compounds into the clinic and to successfully discover,
develop and/or commercialize any compounds under the collaboration.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to
rely on these forward-looking statements. These and other
risks are described in detail in the Gilead Annual Report
on Form 10-K and the Genelabs Annual Report on Form 10-K,
each for the year ended December 31, 2003 and in each company's
Quarterly Reports on Form 10-Q, all of which are on file with
the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to
Gilead and Genelabs, and neither company assumes any obligation
to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the
company's web site at www.gilead.com or call the Gilead Public
Affairs Department at 1-800-GILEAD-5 or 1-650-574-3000.
For more information on Genelabs Technologies, Inc., please
visit the company's web site at www.genelabs.com
or call Genelabs at 1-650-369-9500.
CONTACT: Gilead Sciences
Amy Flood, 650-522-5643
or
Genelabs Technologies, Inc.
Matthew M. Loar, 650-562-1424
SOURCE: Gilead Sciences
Back to top
October 1st, 2004
Morgan
County Man Uses Billboard to Get a Liver
Source: www.whnt19.com
A Morgan county man diagnosed with liver disease has been
told if he doesn't get a liver transplant he will die. His
family says they aren't going to wait around for a phone call
that may not come before it's too late--so they're turning
to drivers on I-65.
I-65 is a heavily traveled interstate. Byron Jones and his
family are hoping to take advantage of that fact. They want
to catch the attention of just one of the millions of people
who drive on I-65--someone who just may be able to save his
life. You see, Byron is dying of cirrhosis of the liver. His
only hope of survival is a liver transplant, so his family
has decided to take this sign and put it on a billboard. It
directs you to a website, if you would like to donate Byron
a liver.
"There are over 17,000 people on the liver list alone,
and over half of them will die," said Lisa Jones, Byron's
wife.
Byron's family doesn't want him to die waiting. They got the
billboard idea from a Texas man. He used billboards to try
to find a liver donor. In less than three weeks, someone who
saw his billboard had a family member die. The Texas man got
the liver. Byron and his family are hoping the same could
happen for him.
"I know people think, why should I have the right to
step in front of somebody [else who is on the waiting list
for a liver]. I don't have that right, but obviously God has
a plan for me," said Byron Jones.
Byron says his plan is to see his grandchildren grow up and
he wants to spend many more years with his wife Lisa.
"I don't want to lose him. I don't think anyone wants
to lose a loved one," said Lisa Jones.
More importantly, Byron says he hopes his billboard will inspire
more people to become organ donors.
"If one person passes away, the organs in his body could
save six people," said Byron Jones.
The billboard goes up in less than two weeks, at the I-65
and I-20/59 interchange in Birmingham. NewsChannel 19 spoke
with someone from the Alabama Organ Center to get their take
on the billboard. Charles Patrick says he's glad people are
taking more initiative to get the word out about organ donation.
If someone does request to have a liver donated specifically
to Byron--that's not illegal--he will get it. If you would
like to learn more about Byron, he has a website. It's www.Byrons-Liver.com.
Back to top
Valeant
Pharmaceuticals to Present Viramidine(TM) End-of-Treatment
Data From Phase 2 Clinical Trial
Source: PRNewswire
COSTA MESA, Calif.,-- Valeant Pharmaceuticals (NYSE:VRX) announced
that an abstract based on Viramidine(TM) 48-week end-of-treatment
study data will be posted to the American Association for
the Study of the Liver Conference (AASLD) Web site. Valeant
submitted the abstract for presentation at AASLD based on
data from a Phase 2 clinical trial of Viramidine, a nucleoside
(guanosine) analog Valeant is developing in oral form for
the treatment of chronic hepatitis C (HCV) in conjunction
with a pegylated interferon. Valeant will present the data
at AASLD in Boston in October 2004.
The Viramidine Phase 2 study consists of 180 treatment-naive
subjects with chronic HCV. The on-going study is an open-label,
randomized, active control trial, being conducted at multiple
centers in the United States and with patients stratified
by genotype. The study consists of four demographically comparable
treatment groups: Viramidine 400 mg BID (800 mg daily), Viramidine
600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg
daily) and ribavirin 1000/1200 mg daily all in combination
with peginterferon alfa-2a. Treatment duration was based on
genotype, with genotypes two and three receiving 24 weeks
of treatment and genotype one receiving 48 weeks of treatment,
each with a post-treatment follow-up period of 24 weeks. The
24-week follow-up period is considered the medically therapeutic
standard evaluation of efficacy.
The end-of-treatment analysis was conducted to determine the
incidence of anemia (hemoglobin<10g/dL) and also assessed
HCV RNA levels (Bayer TMA assay; sensitivity to 5 IU/mL, 25
copies/mL).
At end of treatment, fewer patients developed anemia in the
Viramidine arms than in the ribavirin arm (4 percent versus
27 percent; p<0.001). Among patients receiving the 400
mg BID dosage of Viramidine, there were no cases of defined
anemia and among patients receiving the 600 mg BID dosage
there was only one case of defined anemia (2 percent). In
contrast, there was an 11 percent incidence of defined anemia
in the 800 mg BID arm and a 27 percent incidence in the ribavirin
arm. Other types of adverse events were similar between treatment
arms. (The most common adverse events associated with combination
therapy are fatigue, headache, insomnia, depression and myalgia.)
Differences noted in efficacy were not statistically significant
between the Viramidine arms versus ribavirin (Viramidine 400
mg BID - 55 percent, 600 mg BID - 63 percent, 800 mg BID -
56 percent, versus ribavirin - 62 percent; p=NS), all in combination
with pegylated interferon alfa-2a, in the proportion of patients
with undetectable HCV RNA levels.
Two Phase 3 clinical trials of Viramidine 600mg BID, known
as VISER1 and VISER2 (VIramidine's Safety and Efficacy vs.
Ribavirin), are being conducted with approximately 100 sites
and approximately 1,000 patients in each study. VISER1 compares
Viramidine to ribavirin, in combination with Schering-Plough's
Peg-Intron(R), and completed enrollment in July. VISER2 compares
Viramidine to ribavirin, in combination with Roche's Pegasys(R),
and is currently enrolling patients. Phase 3 is the last phase
in a multi-phase clinical evaluation that may lead to the
filing of a New Drug Application.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global,
publicly traded, research-based specialty pharmaceutical company
that discovers, develops, manufactures and markets a broad
range of pharmaceutical products. More information about Valeant
can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of the federal securities laws relating to expectations,
plans or prospects for Valeant Pharmaceuticals, including
funding and conducting clinical trials and expected research
and development expenses. These statements are based upon
the current expectations and beliefs of Valeant Pharmaceuticals'
management and are subject to certain risks and uncertainties
that could cause actual results to differ materially from
those described in the forward- looking statements. These
risks and uncertainties include market conditions and other
factors beyond Valeant Pharmaceuticals' control, the company's
success in identifying and enrolling patients in the clinical
trials program, the absence of adverse events that would require
the clinical trials to be prematurely terminated, clinical
results that indicate continuing clinical and commercial pursuit
of Viramidine is advisable, and the risk factors and other
cautionary statements discussed in Valeant Pharmaceuticals'
filings with the U.S. Securities and Exchange Commission.
For further information please contact: Jeff Misakian of Valeant
Pharmaceuticals, +1-714-545-0100 ext. 3309
Source: Valeant Pharmaceuticals
CONTACT: Jeff Misakian of Valeant Pharmaceuticals,
+1-714-545-0100 ext. 3309
Back to top
Roche
Launches New Hepatitis Patient Internet Site www.Hep-links.com
in Support of First International Hepatitis C Awareness Day
Source: PRNewswire
BASEL, Switzerland,-- Website puts people in touch with local
patient groups . Every year the number of people newly infected
with the hepatitis C virus (HCV) increases by three to four
million worldwide, adding to the 170 million people already
infected. For people who have been newly diagnosed with the
virus or for anyone who is interested in seeking information
about hepatitis C, there is now a new website resource, www.Hep-links.com,
which is launching today, on the first annual international
Hepatitis C Awareness Day.
The web portal is a result of a cooperative initiative among
hepatitis C and liver disease patient associations in countries
from across Europe and the Middle East. Supported by an unrestricted
grant from Roche, Hep-links.com provides access to the websites
of established local patient groups throughout the world.
"The internet has been identified by nearly two-thirds
of patients as being their key source of information on hepatitis
C," said Ciro Caravaggio, Hepatitis Franchise Leader
at Roche. "However, patients also said that they realised
that not all of the information on the internet was credible.
Hence our decision to work with patient groups to create a
trustworthy resource."
Hep-links.com currently contains information on patient groups
and resources in 15 countries and there are plans to continue
to expand with additional countries in 2005. The web portal
has been developed with input from a steering committee of
patient groups: +VE Magazine (UK); SOS Hépatites (France);
The German Liver Help Association (Germany); The Dutch National
Hepatitis Centre (The Netherlands) and The Egyptian Hepatitis
Patient Care Society (Egypt).
Information found on www.Hep-links.com
includes:
- Facts about hepatitis C
- Frequently ask questions and answers
- Links to patient associations and liver organisations
- Information about relevant scientific/medical congresses
and
- Links to relevant journals and publications
"You Have Company" theme
of first international Hepatitis C Awareness Day
Today also marks the first international Hepatitis C Awareness
Day, a day that will be recognised annually on October 1.
A consortium of European and Middle Eastern patient groups(i)
have designated this day to draw attention to a virus that
is a major global healthcare problem, infecting approximately
three per cent of the world's population. In Western Europe
alone, it is estimated that five million people have chronic
hepatitis C. Hepatitis C is one of the main causes of liver
disease, cirrhosis, liver cancer and also the leading cause
of liver transplantation worldwide.
The theme of the first international awareness day is "You
Have Company". Patient groups will initiate local activities
to let newly diagnosed patients know that this disease affects
many and that they are not alone. Red foam livers with "Hep
C" on one side and the web portal address on the other,
will be given out today to physicians, nurses, and the public
through a variety of means. One aim of directing people to
the web portal is to show that they "have company"
and that support and the ability to meet others affected by
hepatitis C may only be a mouse-click away.
About hepatitis C
Hepatitis C is a blood-born viral infection of the liver that
was first identified only in 1989. Few people realise that
they are infected as the symptoms are non-specific (such as
fatigue) and people tend to become aware when their disease
is quite advanced. Transmission by blood products has been
reduced to almost zero due to screening for the virus so today
the most common route of transmission is use of unsterilised
needles (such as those used in tattooing and by intravenous
drug users) and syringes.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-intensive healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. As a supplier of innovative
products and services for the prevention, diagnosis and treatment
of disease, the Group contributes on a broad range of fronts
to improving people's health and quality of life. Roche is
number one in the global diagnostics market, the leading supplier
of medicines for cancer and transplantation and a market leader
in virology. In 2003, the Pharmaceuticals Division generated
19.8 billion Swiss francs in prescription drug sales, while
the Diagnostics Division posted sales of 7.4 billion Swiss
francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech
and Chugai.
(i)Patients groups who are in support of Hepatitis C Awareness
Day include: Carrefour Hepatite - Aide et Contact (Belgium);
Vereniging voor Hepatitis C Patiënten (Belgium); Danish
Hepatitis Association (Denmark); The Egyptian Hepatitis Patients
Care Society (Egypt); SOS Hépatites France (France);
Hépatites Ecoute et Soutien (France); The German Liver
Help Association (Germany); EpaC (Italy); The Dutch Society
for Liver Patients (The Netherlands); The Dutch National Hepatitis
Centre (The Netherlands); National Union of Hepatitis C (Sweden);
SOS Hépatites Génève (Switzerland); National
Hepatitis C Resource Center (United Kingdom); National Hepatitis
C Resource Center (Scotland); Hepatitis C Trust (United Kingdom);
Plymouth Eddystone Trust (United Kingdom); +VE Magazine (United
Kingdom).
Source: Roche Pharmaceuticals
Contact: Sheila Gies, Roche, +1-973-687-0188; Chris Fowler,
Axon Communications, +44-20-88-22-6779
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October
1 to Be Observed as World Hepatitis-C Awareness Day
Source: www.pharmabiz.com
With the objective of educating people
about hepatitis C, October 1 will be observed as the world
Hepatitis-C awareness day by the WHO.
In India alone, it is estimated that 1.09 crore people have
chronic hepatitis C. National trends indicate a sizeable concentration
of hepatitis C cases in North Eastern India. Among the metros,
4 lakh Delhiites are suffering from Hepatitis C and Mumbai
accounts for 3 lakh cases. Gujarat also carries a patient
load of 3.37 lakh.
The objective of the World Hepatitis-C awareness day is to
draw the attention of people towards a virus that has emerged
as a major global healthcare problem, infecting approximately
three per cent of the world's population.
Every year the number of people infected with the Hepatitis
C virus (HCV) increases by 30-40 lakh worldwide, adding to
the 17 crore people already infected. The spurt in number
is primarily attributed to low awareness about the disease.
"Today, new therapies have been shown to successfully
treat between to 50 to 80 per cent of people infected with
Hep C. Currently Roche offers Pegylated Interferon Alpha 2A
(40KD)," said Dr. G. L. Telang, Managing Director, Roche
Scientific Company India Pvt. Ltd.
About Hepatitis C
Hepatitis C is a blood-born viral infection of the liver that
was first identified only in 1989. Few people realise that
they are infected as the symptoms are non-specific (such as
fatigue) and people tend to become aware when their disease
is quite advanced. Transmission by blood products has been
reduced to almost zero due to screening for the virus so today
the most common route of transmission is use of unsterilised
needles (such as those used in tattooing and by intravenous
drug users) and syringes.
Hepatitis C is the most infectious virus having 50 per cent
chronicity and is responsible for large number of patients
affected with cirrhosis. If not treated early may require
liver transplant or may further develop to liver cancer.
If 100 people became infected with hepatitis C, approximately
25 people would be able to clear the virus without any medication
within six months of being infected. The majority, however
(the other 75 people), would develop ongoing (called "chronic")
infection that will require medication to help get rid of
it. Some people will unfortunately not know they are infected
and will develop damage to their liver before the infection
is diagnosed. Untreated, hepatitis C can lead to cirrhosis
(scarring of the liver) or liver cancer and some may require
a liver transplant.
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New
Study Reports Results of PegIntron and Rebetol Combination
Therapy in Difficult-to-Treat Hepatitis C Virus (HCV) Genotype
4; Predominant Virus Type in the Middle East
Source: PRNewsire
BRUSSELS, Belgium----- Study in Middle Eastern Populations
Published in American Journal of Gastroenterology
Patients infected with chronic hepatitis C virus (HCV) genotype
4 can be treated effectively and safely with individualised,
weight-based PegIntron(R) (peginterferon alfa-2b) and Rebetol(R)
(ribavirin) combination therapy, according to results of a
new study published in the American Journal of Gastroenterology(1).
HCV genotype 4, one of the more difficult-to-treat strains
of the virus, is the most predominant variant of the hepatitis
C virus in the Middle East and North Africa(2-4), where the
prevalence of HCV infection is one of the highest in the world(5-6).
"Our study establishes an important clinical benchmark
for patients infected with HCV genotype 4," said Prof.
Fuad Hasan, M.D., F.A.C.P., Department of Medicine, Faculty
of Medicine, Kuwait University, and lead author of the study.
"Additionally, establishing responsiveness of HCV genotype
4 to weight-based peginterferon alfa-2b and ribavirin combination
therapy advances our understanding of how to best treat this
serious disease. Further clinical studies are needed to determine
the optimal duration and dose regimen in this patient population,"
he said.
Genotype is considered one of the most important predictors
of treatment response. Of the six distinct known genotypes,
HCV genotype 1, the most difficult-to-treat, is the most common
genotype in Europe and North America (about 70% of patients);
and while infection rates for genotypes 2 and 3 vary by geography,
the two strains account for approximately 30% to 50% of HCV
infections among European patients. The efficacy of peginterferon
and ribavirin combination therapy in treating these HCV genotypes
is well documented. However, while patients with HCV genotype
4 comprise approximately 20% of the world's HCV-infected population,
these patients are underrepresented in clinical trials conducted
mostly in the West where genotype 4 is rare. As a result,
data regarding the responsiveness of genotype 4 has been limited.
"The results of this study have significance for the
treatment of genotype 4 patients of Middle Eastern descent
living worldwide, including in Europe and the United States,
and further underscore the value of PegIntron and Rebetol
combination therapy," said Robert J. Spiegel, M.D., chief
medical officer and senior vice president of medical affairs,
Schering-Plough Research Institute. "This study is consistent
with our research strategy to conduct and support clinical
studies with PegIntron and Rebetol combination therapy in
hepatitis patients with unmet medical needs, particularly
patients with difficult-to-treat forms of the disease."
Study and Results
In this prospective open-label study, 66 Middle Eastern patients
with HCV genotype 4 received PegIntron (1.5 mcg/kg) and Rebetol
(1,000 mg/day and 1,200 mg/day for patients weighing 75 kg
or less and more than 75 kg, respectively) for 48 weeks. The
overall sustained viral response (SVR) rate among patients
with genotype 4 was 68%. SVR, defined as the sustained undetectability
of the virus six months following the end of treatment, was
the primary endpoint of the study. The end-of-treatment (EOT)
response was 77%. Using baseline viral load and the degree
of fibrosis as predictors of virologic response, the study
demonstrates the correlation of these factors to SVR.
During this same period, study investigators also treated
20 consecutive patients infected with HCV genotype 1 with
the same regimen of PegIntron and Rebetol combination therapy.
The SVR rate among patients with genotype 1 was lower than
for those with genotype 4, but the difference did not reach
statistical significance (48% vs. 68%; p=0.11), possibly due
to the small number of genotype 1 patients. This is in keeping
with results of previously reported studies, where SVR rates
in patients with HCV genotype 1 have been lower than those
in patients with other virus genotypes. There were no patients
with HCV genotype 2 or 3 in the study.
PegIntron and Rebetol combination therapy was well tolerated
by most patients in the study, with low rates of treatment
discontinuation (4%) or depression (15%). The most common
side effects reported were flu-like symptoms (79%), weight
loss (38%) and anemia (30%). Three patients dropped out due
to severe flu-like symptoms and were considered nonresponders
to treatment. Dose reductions of PegIntron and Rebetol occurred
in 6% and 15% of patients, respectively.
The study was supported in part by research grants from Schering-Plough.
PegIntron and Rebetol Combination Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis
C was approved in the European Union (EU) in March 2001. The
recommended dose in the EU for combination therapy is PegIntron
1.5 mcg/kg/once weekly plus Rebetol 800-1,200 mg daily, adjusted
to body weight. PegIntron had previously received centralized
marketing authorization in the EU and is marketed as a monotherapy
in cases of intolerance or contraindication to ribavirin for
the treatment of adult patients with chronic hepatitis C.
PegIntron is a longer-acting form of Intron(R) A (interferon
alfa-2b, recombinant) Injection that uses proprietary PEG
technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater,
N.J., USA. PegIntron, recombinant interferon alfa-2b linked
to a 12,000 dalton polyethylene glycol (PEG) molecule, is
a once-weekly therapy dosed according to patient body weight
that is designed to achieve an effective balance between antiviral
activity and elimination half-life. Schering-Plough holds
an exclusive worldwide license to PegIntron.
Rebetol is an oral formulation of ribavirin, a synthetic nucleoside
analog with broad-spectrum antiviral activity. It is approved
worldwide for use in combination with PegIntron or Intron
A for the treatment of adult patients with chronic hepatitis
C. Schering-Plough has rights to market oral ribavirin for
hepatitis C in all major world markets through a licensing
agreement with Valeant Pharmaceuticals International (NYSE:
VRX; formerly ICN Pharmaceuticals Inc.) of Costa Mesa, Calif.,
USA.
Schering-Plough Europe, based in Brussels, Belgium, is part
of Schering-Plough Corporation (NYSE: SGP).
Schering-Plough is a global science-based health care company
with leading prescription, consumer and animal health products.
Through internal research and collaborations with partners,
Schering-Plough discovers, develops, manufactures and markets
advanced drug therapies to meet important medical needs. Schering-Plough's
vision is to earn the trust of the physicians, patients and
customers served by its more than 30,000 people around the
world. The company is based in Kenilworth, N.J., USA, and
its Web site is http://www.schering-plough.com.
Source: Schering-Plough Corporation
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October 2nd, 2004
Furor
over Hep C Cash Plan
Rob Ferguson and Robert Benzie
Source: www.thestar.com
Tainted-blood victims still waiting
for promised payouts - Claim new Ontario program fails to
ease financial plight
Tainted-blood victims with hepatitis C are outraged at a new
Ontario government program to prevent and treat their deadly
illness, saying it falls millions short of the money they
were promised years ago.
Health Minister George Smitherman announced yesterday that
"every penny" of $66.3 million in hepatitis C money
received from the federal government in the last couple of
years has been spent on patient care and treatment.
Smitherman is also creating a task force to better track the
needs of 70,000 Ontarians suffering from the liver disease,
and a new secretariat will administer payouts of the remainder
of the Ontario Hepatitis C Assistance Program set up by the
Mike Harris government. The government didn't say when money
might flow.
But hep C victims spending hundreds or more dollars a month
on life-prolonging drugs say they need financial help right
now.
"I'm looking for what money was given to victims,"
said Jeremy Beaty, past president of the Hepatitis C Society
of Canada. "I don't see anything here."
Another victim, who is on long-term disability leave and whose
husband recently lost his job and was diagnosed with hep C,
said her family is having trouble staying afloat financially.
"This has made me angry and it's not often I get this
way," said Janice Reid of Brampton, who was near death
before her two liver transplants. "My house is falling
apart."
The federal money, a total of $300 million to be distributed
by the provinces, was first announced in 1998 by former federal
health minister Allan Rock. Ontario's share is $132.6 million,
to be handed out by 2015.
Rock said in 1998 the money was for "anyone who got hepatitis
C through the blood system" and promised "access
to the needed medical services and drugs for treatment and
care without paying out of their own pockets."
The program was established for the so-called "forgotten
victims" of the tainted-blood scandal who contracted
hepatitis C before 1986 and after 1990. Canadians who got
hep C, HIV and AIDS from blood in that four-year window, when
Ottawa admitted liability for the quality of the blood supply,
were eligible for a larger $1.2-billion federal-provincial
fund.
Almost $1 billion remains in that fund, and the "forgotten
victims" are pressing Ottawa to open it up.
Smitherman said $66.3 million of Rock's promised money has
been received so far but the province has spent more than
that --$82.5 million-- on lab work, drugs, hospital treatments,
physicians, home care and public health for hep C.
"We are ensuring that every penny of the federal fund
goes to care for people living with hepatitis C," Smitherman
said in a statement, promising "new initiatives to improve
the health of people living with hepatitis C" through
the task force.
But it appears the federal money went to the Ontario Health
Insurance Plan instead of victims, said Tony Clement, provincial
health minister under Harris. "People expect OHIP to
be there, that's why they pay taxes," he said, adding
his government was preparing to pay federal money to hep C
victims before its defeat last October.
Conservative health critic John Baird (Nepean-Carleton) estimated
$130 million remains in the $200-million Ontario Hepatitis
C Assistance Program.
Payouts of $25,000 were made to several thousand tainted-blood
victims.
"It is a disgrace the government is sitting on this money,"
he said.
Hepatitis C activist John Plater, tapped by Smitherman to
head the new task force, said he's has been pushing for years
for the province to pay federal money directly to victims.
"Their sick bodies will continue to bang the doors of
MPs and MPPs demanding to know where the money's gone,"
he vowed.
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