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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Link
Between Hepatitis and Heart Disease Found
• Non-Absorbable Disaccharides for Hepatic
Encephalopathy
• Roche Boasts 12 Blockbuster Drugs to
Drive Growth
• Valeant Posts Loss, Warns on Further
Declines
• Genelabs Technologies (GNLB) Presents
Hepatitis C Virus Drug Discovery Data At International Conference
On Antiviral Research
April 29th, 2004
Link
Between Hepatitis and Heart Disease Found
Jules Levin
Source: HeartCenterOnline
Italian researchers have found a link between
hepatitis C virus (HCV) and coronary artery disease (CAD).
The findings add weight to the theory that infection has a
role in the development of atherosclerosis and coronary artery
disease.
The study, published in the April issue
of Heart, found that people who showed signs of HCV
also had higher incidence of coronary artery disease, supporting
the theory that a virus infection might contribute to the
development of atherosclerosis. In addition, the likelihood
of infection increased with the number of coronary vessels
affected.
Also known as "hardening of the arteries,"
atherosclerosis is a disease in which the arteries are hardened
and narrowed as a result of plaque that has built up along
the inside of the artery walls.
Atherosclerosis is a dangerous condition
because it increases the risk of serious heart conditions
such as heart attack or cardiac arrest (the total stopping
of the heart).
The researchers noted that more studies
are needed to determine the extent the HCV infection could
predict atherosclerosis risk as compared to other pathogens.
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May 4th, 2004
Non-Absorbable
Disaccharides for Hepatic Encephalopathy
Source: www.gastrohep.com
There is insufficient evidence to support
the use of non-absorbable disaccharides for hepatic encephalopathy,
find physicians in the latest issue of the British Medical
Journal.
In this study, physicians from Denmark
assessed the effects of non-absorbable disaccharides (lactulose
and lactitol) in patients with hepatic encephalopathy.
The team searched the Cochrane Hepato-Biliary
Group controlled trials register, Cochrane Library, Medline,
and Embase for relevant studies. They also examined the reference
lists of relevant articles, and contacted authors and pharmaceutical
companies.
The physicians included 22 randomized trials
comparing non-absorbable disaccharides with placebo, no intervention,
or antibiotics for hepatic encephalopathy.
The team found that non-absorbable disaccharides
reduced the risk of no improvement in patients with hepatic
encephalopathy (relative risk 0.62), when compared with placebo
or no intervention.
Non-absorbable disaccharides were inferior
to antibiotics.
However, 2 high quality trials found no
significant effect (0.92).
They found that compared with placebo or
no intervention, non-absorbable disaccharides had no significant
effect on mortality (0.41).
Furthermore, non-absorbable disaccharides
were inferior to antibiotics in reducing the risk of no improvement
(1.24) and lowering blood ammonia concentration.
Dr Bodil Als-Nielsen's team concluded,
"There is insufficient evidence to support or refute
the use of non-absorbable disaccharides for hepatic encephalopathy".
"Antibiotics were superior to non-absorbable
disaccharides in improving hepatic encephalopathy, but it
is unclear whether this difference is clinically important".
"Non-absorbable disaccharides should
not serve as comparator in randomized trials on hepatic encephalopathy".
BMJ 2004; 328: 1046
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May 5th, 2004
Roche
Boasts 12 Blockbuster Drugs to Drive Growth
Source: Reuters
ZURICH-- Roche Holding AG (ROG.VX: Quote,
Profile, Research) has 12 blockbuster drugs on the market
or in late-stage development, each with annual peak sales
potential of more than one billion Swiss francs ($777.6 million),
the Swiss pharmaceutical group said on Wednesday.
The line-up includes new treatment for
diabetes, asthma and rheumatoid arthritis in addition to fast-growing
cancer medicines, it said in a release at the start of its
closely watched research and development day.
Three years ago, Roche was the sick man
of the European drug industry following a series of product
setbacks. But times have changed and the stock now trades
at a hefty 25 times consensus 2004 earnings, the highest among
its peers, on high hopes for its new drug pipeline.
Roche said future pillars of growth were
expected to include R483, a diabetes drug that has moved into
final Phase III testing, and R411 for asthma, which has successfully
completed Phase II.
The company also expects a new stream of
revenue from a treatment for rheumatoid arthritis that uses
established cancer drug MabThera and a new experimental compound
called MRA.
Meanwhile, full Phase II data on a depression
drug, R673, are expected by the end of 2004.
Many of Roche's new drugs are the result
of partnerships with other companies -- notably U.S. biotech
Genentech Inc (DNA.N: Quote, Profile, Research) and Japan's
Chugai Pharmaceutical Co Ltd (4519.T: Quote, Profile, Research)
, in both of which it holds a majority stake.
Including expenditure at Genentech and
Chugai, Roche said it would spend more than five billion Swiss
francs on research and development in 2004.
A key sales driver recently has been hepatitis
C treatment Pegasys/Copegus. The group on Wednesday revised
up peak sales forecasts for the product to two billion francs
from 1.5 billion, based on new clinical data showing that
it also works for hepatitis B.
Roche said it planned to submit a total
of 25 regulatory filings over the next five years, including
one for osteoporosis medicine Boniva in the United States
this quarter.
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May 6th, 2004
Valeant
Posts Loss, Warns on Further Declines
Source: Reuters
NEW YORK-- Valeant Pharmaceuticals (VRX.N:
Quote, Profile, Research) on Thursday reported a quarterly
loss, hurt by a 48 percent drop in royalty revenue from its
hepatitis C drug ribavirin, and warned that generic competition
would cause further declines, sending shares down more than
7 percent.
Citing the recent launch of three generic
versions of ribavirin, the company said, "These actions
and the concomitant loss of royalties from Roche in the United
States are expected to result in a significant decline in
royalty revenue in the U.S. market in future periods."
The Costa Mesa, California-based company
reported a loss of $13.6 million, or 16 cents per share, compared
with a profit of $13.7 million, or 16 cents, a year earlier.
The results were also hurt by costs associated
with an acquisition, the company said.
Excluding those costs, the company lost
4 cents per share. The three analysts who follow the company
on average were looking for a profit of 6 cents per share.
Sales of ribavirin, which made the company
prominent when it was called ICN Pharmaceuticals, have been
slumping as partner Schering-Plough Corp. (SGP.N: Quote, Profile,
Research) faced stiff competition from Roche Holding (ROG.VX:
Quote, Profile, Research) for its hepatitis C drug combination
that includes the medicine.
Although Valeant also has a deal to supply
the drug to Roche, price competition that followed Roche's
entry into the market sent total royalties to Valeant plunging.
Ribavirin royalties for the quarter were
$25.4 million, down from $48.6 million a year ago.
Chief Executive Robert O'Leary said the
company had increased research and development spending and
made "strategic investments that we believe will drive
future growth in our business."
The company on Thursday said it had acquired
the U.S. rights to the Parkinson's Disease drug Tasmar from
Roche for $13.5 million in cash, plus royalties.
Valeant shares closed down $1.70, or 7.2
percent, at $21.90 on the New York Stock Exchange.
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May 7th, 2004
Genelabs
Technologies (GNLB) Presents Hepatitis C Virus Drug Discovery
Data At International Conference On Antiviral Research
Source: PRNewswire
REDWOOD CITY-- Genelabs Technologies, Inc.
announced today the presentation of data from its hepatitis
C virus drug discovery program at the 17th International Conference
on Antiviral Research (ICAR) being held in Tucson, Arizona.
Presentations were made by Ronald C. Griffith, Ph.D., Vice
President, Research; Lillian Lou, Ph.D., Senior Director,
Biology; and Christopher Roberts, Ph.D., Director, Chemistry.
Genelabs' drug discovery resources are
focused on discovering novel antiviral compounds for treatment
of hepatitis C virus (HCV) infections. The World Health Organization
has estimated that 170 million people worldwide are chronically
infected with HCV, including 4 million in the United States,
where HCV is the most common chronic blood-borne virus. Currently
available treatments are effective in only approximately 50%
of the patients infected with HCV genotype 1, the genotype
most prevalent in the United States.
Genelabs' HCV drug discovery program is
focused on inhibition of hepatitis C virus replication by
selectively targeting an HCV-specific enzyme known as the
RNA-dependent RNA polymerase. Genelabs scientists are actively
synthesizing two distinct classes of compounds, nucleoside
analogues, which are structurally similar to the building
blocks of RNA, and non-nucleosides, which are structurally
distinct from nucleosides. The presentations at ICAR focus
on Genelabs' nucleoside compounds.
In the presentations, Genelabs scientists
describe data on several nucleoside compounds that are potent
inhibitors of HCV replication in a cell-based replicon system,
with anti-HCV activity shown at concentrations as low as 90
nanomolar (0.09 micromolar). The compounds described were
also shown to be highly selective in their activity, with
concentrations necessary to observe toxicity to human liver
cells exceeding 50 micromolar, the highest concentration tested.
Because the hepatitis C virus replicates in human liver cells,
Genelabs incorporates human liver toxicity testing as an early
stage of its drug discovery process. In the ICAR presentations,
additional data were described demonstrating that the nucleoside
compounds discovered at Genelabs function by incorporating
into and terminating the growth of the HCV genome as it replicated.
Based on the progress made to date, Genelabs'
HCV drug discovery program has advanced into preclinical development.
Genelabs Technologies, Inc. is a biopharmaceutical
company pioneering the discovery and development of novel
pharmaceutical products to improve human health. We are concentrating
our clinical development capabilities on Prestara(TM), an
investigational drug for women with systemic lupus erythematosus.
We are concentrating our drug discovery capabilities on novel
antiviral compounds for treatment of hepatitis C virus infections.
NOTE: This press release contains
forward-looking statements including statements regarding
Genelabs' drug discovery efforts and preclinical development
of its antiviral compounds for treatment of hepatitis C virus.
These forward-looking statements are based on Genelabs' current
expectations and are subject to uncertainties and risks that
could cause actual results to differ materially from the statements
made. Uncertainties and risks include, without limitation,
the early stage of Genelabs' research programs and uncertainties
associated with the preclinical development of compounds,
including whether a compound will advance to preclinical testing,
clinical trials, or ultimately become a product, and the uncertainty
of the timing of any of these; the validity, scope and enforceability
of patents related to the company's technologies; the company's
capital requirements and history of operating losses; and
uncertainties and risks regarding the company's ability to
consummate strategic or corporate partner transactions on
favorable terms or at all. Please see the information appearing
in the company's filings with the Securities and Exchange
Commission, including the most recent Quarterly Report on
Form 10-Q and Annual Report on Form 10-K, under the captions
"Risk Factors," "Business Risks" and "Forward-Looking
Statements" for more discussion regarding these uncertainties
and risks and others associated with the company's research
programs, early stage of development and other risks which
may affect the company or cause actual results to differ from
those included in the forward-looking statements. Genelabs
does not undertake any obligation to update these forward-looking
statements or risks to reflect events or circumstances after
the date of this release.
Contact: Matthew M. Loar Chief Financial
Officer, Phone: 650-562-1424
Genelabs Technologies, Inc.
CONTACT: Matthew M. Loar, Chief Financial Officer of GenelabsTechnologies,
Inc., +1-650-562-1424
Web site: http://www.genelabs.com/
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