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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Maxim
Pharmaceuticals (MAXM) Presents Preclinical Data On Histamine's
Ability To Prevent Liver Damage
• Schering-Plough Reports New Data Showing
Patients With Hepatitis C Genotypes 2 And 3 May Benefit From
Shorter Course Of Treatment With PegIntron And Rebetol Combination
Therapy
• International Hepatitis C Study to Examine
New Approaches to Treat Patients Who Did Not Benefit From
Standard Therapy
• Religious Investors, Schering-Plough
Announce Agreement on Actions Regarding Access to Prescription
Drugs
• Growing Number of Patients With Advanced
Liver Disease Will Take the Hepatitis C Virus Drug Market
to $10 Billion In 2013
• Changing Compliance to the ACG Guidelines
for Variceal Hemorrhage
• Donor Livers Not Consistently Allocated
According to Medical Need
• Roche Q1 Sales Beat Forecasts as Pegasys
Flies
• Prison Hepatitis C Infection Nears 14
Percent
• Bioartificial Liver Reduces Mortality
by 44% in Acute Liver-failure Patients
• Sustained Virological Response in Transplant
Recipients with Recurrent Hepatitis C
• Schering-Plough Posts Loss, Sales Fall
6 Pct
April 19th, 2004
Maxim Pharmaceuticals (MAXM)
Presents Preclinical Data on Histamine's Ability To Prevent
Liver Damage
Source: Business Wire
Results Presented at the European Association
for the Study of the Liver (EASL)
SAN DIEGO--- Maxim Pharmaceuticals (Nasdaq:MAXM
- News; SSE:MAXM) announced preclinical results indicating
that histamine may prevent lipopolysaccharide (LPS)-induced
liver injury. The results were presented at the 39th annual
European Association for the Study of the Liver (EASL) meeting
in Berlin, Germany. In this preclinical study, LPS is used
to increase the severity of alcohol-induced damage. These
new results demonstrate the ability of histamine to prevent
LPS-induced liver injury in a rodent model by showing efficacy
when delivered in a manner mimicking oral administration.
Maxim scientists have previously shown
that histamine is protective against early alcohol-induced
liver injury in rats. Histamine is known to inhibit reactive
oxygen species and LPS-induced pro-inflammatory cytokines
like TNF-(alpha) in circulating inflammatory cell types in
blood. Similar cells in the liver called Kupffer cells, also
mediate inflammation by releasing pro-inflammatory cytokines
when stimulated by LPS. Maxim researchers tested histamine
in a rat model using alcohol in combination with a high-fat
diet to create liver injury. LPS was administered as a "second
insult" to dramatically increase damage and the markers
that measure this damage. Subcutaneous histamine pre-treatment
at all doses prevented serum transaminase (ALT, AST) levels
from elevating compared to when LPS was given alone. When
histamine was directly given into the intestine, a dose-dependent
protection was achieved. Histamine also dose-dependently decreased
LPS-induced TNF-(alpha) and IL-6 mRNA levels in the liver.
"These continued results were used
to support our oral histamine program now in phase 1 human
trials and the continued understanding of histamine's mechanism
of action in chronic liver diseases," says Kurt R. Gehlsen,
Senior Vice President and Chief Scientific Officer. "This
work will help to advance toward clinical trials of our oral
product candidate in the treatment of chronic liver diseases
including Hepatitis C, alcoholic liver disease (ALD) and non-alcoholic
steatohepatitis (NASH)."
Chronic liver diseases, including hepatitis,
ALD and NASH, affect an estimated 25 million people in the
U.S., approximately one in every ten. Hepatitis C is the leading
blood-borne infection in the United States. The U.S. Center
for Disease Control and Prevention estimates that over 4.5
million Americans are infected with the hepatitis C virus.
The World Health Organization and other sources estimate that
at least 200 million people are infected worldwide. Some experts
estimate that without substantial improvements in treatment,
deaths from hepatitis C will surpass those from HIV. Hepatitis
C is the leading cause of liver cancer and the primary reason
for liver transplantation in many countries. Even with recent
advances, approximately half of patients still do not attain
a sustained response with current therapies. NASH, non-alcoholic
steatohepatitis, also called 'fatty liver,' is an inflammation
of the liver associated with an increase of fat deposits in
liver cells that may lead to severe liver damage and cirrhosis.
NASH may occur in middle-aged, overweight, and often in diabetic
patients who do not drink alcohol. ALD, caused by alcohol
abuse, is one of the ten leading causes of death in the United
States.
Overview of Histamine Therapy
Research has shown that oxygen free radicals released by certain
immune cells can suppress the immune system and damage normal
tissue, a process commonly referred to as oxidative stress.
Oxidative stress, implicated in numerous diseases, is most
pronounced in the liver and can damage or destroy liver tissue
in patients with hepatitis and other chronic liver diseases.
Histamine has been shown in preclinical testing to prevent
the production and release of oxygen free radicals, thereby
reducing oxidative stress. Accordingly, treatment with histamine
has the potential to prevent or reverse damage induced by
oxidative stress, thereby protecting critical cells and tissues,
including the liver. Preclinical research, including results
presented in 2003 at the annual meeting of the American Association
for the Study of Liver Diseases (AASLD) and published in Inflammation
(vol. 27 (5), p317-327), suggest that histamine can protect
and promote the healing of the liver in models of ALD, NASH
and partial surgical resection.
Research regarding histamine dihydrochloride
has been the subject of more than 80 presentations at major
scientific and clinical meetings, and has been published in
more than 300 scientific and clinical articles. Ceplene(TM),
Maxim's injectible form of histamine, has been tested in more
than 17 trials in 2,000 patients, including hepatitis C patients.
Maxim anticipates that any additional clinical testing of
histamine for the treatment of chronic liver diseases will
be with an oral formulation as in the completed Phase 1A trial
announced today. A three-minute animation of the histamine
mechanism of action in its injectible formulation as Ceplene(TM)
can be viewed on the Company's website at www.maxim.com.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company
with a diverse pipeline of therapeutic candidates for life-threatening
cancers and liver diseases. Maxim's research and development
programs are designed to offer hope to patients by developing
safe and effective therapeutic candidates that have the potential
to extend survival while maintaining quality of life.
Maxim's lead drug candidate Ceplene (subcutaneously
delivered histamine dihydrochloride) is designed to prevent
or inhibit oxidative stress, thereby reversing immune suppression
and protecting critical immune cells. In November 2003, Maxim
filed an application for market authorization in Europe for
approval to market Ceplene for the treatment of advanced malignant
melanoma. Ceplene is currently being tested in Phase 3 cancer
clinical trials for advanced malignant melanoma with liver
metastasis and acute myeloid leukemia. Phase 2 trials of Ceplene
are also underway for the treatment of hepatitis C and advanced
renal cell carcinoma.
In addition to Ceplene and oral-formulation
histamine, Maxim is developing small-molecule inhibitors and
activators of programmed cell death, also known as apoptosis,
which may serve as drug candidates for cancer, cardiovascular
disease and other degenerative diseases. Ceplene, the oral
histamine formulation and the apoptosis inducers are investigational
drugs and have not been approved by the U.S. Food and Drug
Administration (FDA) or any international regulatory agency.
This news release contains certain forward-looking
statements that involve risks and uncertainties. Such forward-looking
statements include statements regarding the efficacy, safety
and intended utilization of Ceplene, the oral histamine formulation
and the apoptosis inducers, and the conduct, results and timelines
associated with the Company's clinical trials. Such statements
are only predictions and the Company's actual results may
differ materially from those anticipated in these forward-looking
statements. Factors that may cause such differences include
the risk that products that appeared promising in early research
and clinical trials do not demonstrate safety or efficacy
in larger-scale clinical trials and the risk that the Company
will not obtain approval to market its products. These factors
and others are more fully discussed in the Company's periodic
reports and other filings with the Securities and Exchange
Commission.
Contact:
Maxim Pharmaceuticals Larry G. Stambaugh, Chief Executive
Officer or
Anthony E. Altig, Chief Financial Officer or
Burns McClellan Aline Schimmel (Investors), 212-213-0006 or
CCG Investor Relations Sean Collins (Media)
or Valerie Bent (Media) 818-789-0100
Source: Maxim Pharmaceuticals
Back to top
Schering-Plough
Reports New Data Showing Patients With Hepatitis C Genotypes
2 And 3 May Benefit From Shorter Course Of Treatment With
PegIntron And Rebetol Combination Therapy
Source: PRNewswire
BERLIN, Germany,-- Independent Study
Presented at European Association for the Study of the Liver
(EASL) Meeting
Schering-Plough Europe today reported that
results from a large, independent investigator -initiated
study(1) showed patients with hepatitis C genotypes 2 and
3 may benefit from a short 12-week course of treatment with
weight-based PegIntron(R) (peginterferon alfa-2b) and Rebetol(R)
(ribavirin) combination therapy compared in the study to a
24-week course of treatment. Moreover, these patients may
achieve a sustained virologic response (SVR)(2) with only
12 weeks of this combination therapy. Researchers used rapid
viral response(3) measured at week four as a time point to
determine length of treatment. PegIntron is approved in the
European Union for a 48-week course of therapy. Infection
rates with Genotypes 2 and 3 vary by geography and account
for approximately 30 percent to 50 percent of HCV infections
among European patients.
Results of this study were reported in
an oral presentation at the 39th annual meeting of the European
Association for the Study of the Liver (EASL) in Berlin, Germany.
In all, clinical investigators made 17 presentations on PegIntron
data.
"Our research indicates that patients
with genotypes 2 and 3 may achieve a sustained virological
response with only 12 weeks of PegIntron combination therapy,
and early viral clearance at week four might serve as a useful
stopping rule to decide the length of treatment," said
lead investigator Alessandra Mangia, M.D., IRCCS San Giovanni
Rotondo, Italy. "These results are important clinically
in that 12 weeks of therapy achieved strong efficacy and the
shorter treatment regimen was better tolerated by patients,"
she said.
In the study (HCV Genotype 2 and 3 Can
Be Cured by Peg-IFN-ALFA-2B and RBV for 12 Weeks: A Randomized
Controlled Study, Oral Presentation, April 18), researchers
explored whether patients with hepatitis C genotypes 2 and
3 who achieve a rapid viral response (4 weeks) benefit from
a shorter duration of therapy (12 weeks) by comparing virological
response, relapse rate and compliance to therapy after 12
and 24 weeks of treatment with a weight-based regimen of PegIntron
(1.0 mcg/kg/once weekly) and Rebetol (1,000-1,200 mg/daily)
combination therapy. A total of 283 patients were randomized
to either Group A (n=70), all of whom received 24-week dosing,
or Group B (N=213), who had the option of receiving 12-week
dosing. Patients in Group B with viral clearance at week four
stopped treatment at week 12 and those without viral clearance
at week four continued treatment until week 24.
Study Results
Results showed that in Group B, of the patients who achieved
a rapid viral response at four weeks, 88 percent went on to
achieve an SVR with 12 weeks of therapy as compared to 64
percent of patients in Group B who did not achieve a rapid
viral response and 76 percent of patients in Group A, both
of which received 24 weeks of treatment (p=0.001). In patients
treated for 12 weeks, the relapse rate was slightly higher,
but the drop-out rate was lower, than for patients treated
for 24 weeks. The study also showed that the overall SVR rate
was higher for genotype 2 (82 percent) than for Genotype 3
(64 percent) (p=0.03), indicating that genotype 3 may be more
difficult to treat.
"These results further underscore
the efficacy of weight-based 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. "By better understanding the early
predictors of viral response, physicians can individualize
treatment to improve therapeutic outcomes. This important
study as well as the many other PegIntron reports presented
at EASL this year continue to demonstrate the value in all
HCV genotypes of maximizing efficacy through individualized
care."
While Schering-Plough has made unrestricted
grants to IRCCS San Giovanni Rotondo, it did not support this
study.
Additional PegIntron Studies Presented
at EASL
Clinical investigators reported data from several independent
studies of PegIntron and Rebetol combination therapy in difficult-to-treat
patient populations. Data highlighted include:
- Identification of non-responders with
genotype 1 using HCV Core Antigen testing (Poster #466)(4);
- PegIntron plus Rebetol combination
therapy in the retreatment of non- responders previously
treated with interferon alfa-2b or interferon alfa-2b plus
ribavirin (Poster #457)(5);
- PegIntron plus Rebetol combination
therapy for the treatment of recurrent HCV infection after
liver transplant (Poster #489)(6);
- PegIntron monotherapy or in combination
with lamivudine in patients with hepatitis B (Posters #446,
447 and 423)(7-9); and
- The use of PegIntron monotherapy in
patients with acute hepatitis C (Posters #469, 510 )(10,11).
About PegIntron and Rebetol Combination
Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis
C was approved in the European Union (EU) in March 2001. 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 the only peginterferon approved
for dosing according to patient body weight. It is a longer-acting
form of Intron(R) A (interferon alfa-2b, recombinant) Injection
that uses proprietary PEG technology developed by Enzon, Inc.
of Bridgewater, N.J. PegIntron, recombinant interferon alfa-2b
linked to a 12,000 dalton polyethylene glycol (PEG) molecule,
is a once-weekly therapy 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, formerly ICN Pharmaceuticals Inc., of Costa
Mesa, Calif., USA.
Schering-Plough Europe, based in Brussels,
Belgium, is part of Schering-Plough Corporation (NYSE: SGP)
of Kenilworth, N.J., USA, a research-based company engaged
in the discovery, development, manufacturing and marketing
of pharmaceutical products worldwide.
Note to Editors: PegIntron and Rebetol
are licensed to Aesca in Austria, Essex Pharma in Germany
and Essex Chemie in Switzerland.
References:
(1) Mangia, A.1, N.Minerva3, GL
Ricci10, M.Romano8, V.Carretta4, M.Persico9, D.Bacca6, F.Spirito1,
F.Vinelli2, M.Annese5, A.Giangaspero7, G. Scotto2, A.Andriulli1,
Gastroenterology - IRCCS "CSS" San Giovanni Rotondo1,
Ospedali Riuniti Foggia2, Medicina Ospedali di Canosa3, Venosa4,
Policoro5, Casarano6, Bari7, Ospedale "S.Pertini"
Roma8, Universita Napoli9, "La Sapienza" Roma10,
HCV Genotype 2 and 3 Can Be Cured by Peg-IFN-ALFA-2B and RBV
for 12 Weeks: A Randomized Controlled Study
(2) Sustained Virological response
(SVR) is defined as the sustained undetectability of HCV-RNA
in the blood six months following the end of treatment. SVR
is the standard criterion for efficacy.
(3) Rapid viral response is defined as achieving
undetectable HCV-RNA in
the blood at week four of treatment.
(4) M. Buti et al, HCV Core AG as a Predictor of
Non-Response in Genotype 1 Chronic Hepatitis C Patients Treated
with PegInterferon Alfa-2B Plus Ribavirin
(5) C. Bapin et al, Retreatment with Pegylated Interferon
Alpha-2B and Ribavirin in Patients with Chronic Hepatitis
C Non-Responders to Interferon Monotherapy or Interferon and
Ribavirin Combination. A Prospective Randomized Pilot Study
of Two Regimens: Induction versus Regular Dose Pegylated Interferon
(6) S. Lorenzini et al, Pegylated Interferon Plus
Ribavirin for the Treatment of Recurrent HCV Infection After
Liver Transplantation
(7) M. van Zonneveld et al, Liver Histology in Chronic
Hepatitis B Patients After 1 Year of Treatment with Pegylated
Interferon Alpha-2B in Combination with Lamivudine or Placebo
(8) M. van Zonneveld et al, Viral Dynamics During
Peg-Interferon Alone and in Combination with Lamivudine
(9) H.L.Y. Chan et al, A Randomized Trial of PegInterferon
Alfa-2B and Lamivudine Combination Treatment versus Lamivudine
Monotherapy in Chinese Patients with HBEAG-Positive Chronic
Hepatitis B
(10) G. Calleri et al, Short Course of Pegylated
Alfa Interferon in Acute HCV Hepatitis
(11) T. Santantonio et al, Efficacy of Peg-Interferon
Alpha-2B (PegIntron) Monotherapy in Acute Hepatitis C: A Preliminary
Analysis
Media: Robert J. Consalvo +1 (908) 298-7409
+447766728282 (onsite at EASL)
Mary-Frances Faraji +1 (908) 298-7109
+1 (908) 265-6695(onsite at EASL)
Investors: Lisa W. DeBerardine +1 (908) 298-7437
Janet M. Barth +1 (908) 298-7417
Web site: http://www.schering-plough.com
Back to top
April
20th, 2004
International
Hepatitis C Study to Examine New Approaches to Treat Patients
Who Did Not Benefit From Standard Therapy
Rush University Medical Center’s
Dr. Donald Jensen Leads US Study
Chicago, IL, --A new study seeks to answer
one of the most challenging and important questions in hepatitis
C therapy today: What is the best option for patients in whom
one of the most widely prescribed treatments has failed?
The study will evaluate different regimens
of combination therapy in patients with hepatitis C who failed
to generate a sustained virological response after treatment
with Peg-Intron/Rebetol therapy. Patients in the new study
will receive Pegasys® peginterferon alfa-2a) and Copegus
(ribavirin), already approved as a first-line treatment for
patients with hepatitis C.
The REPEAT Trial (REtreatment with PEgasys
in PATients Not Responding to Peg-Intron Therapy) is led in
the U.S. by hepatologist Dr. Donald Jensen of Rush University
Medical Center. The US portion of the study will enroll approximately
330 patients at 33 centers including Rush.
Hepatitis C, a blood-borne infectious disease
of the liver, is transmitted through body fluids, primarily
blood or blood products, and by sharing needles. Hepatitis
C chronically infects an estimated 2.7 million Americans and
170 million people worldwide and is the leading cause of cirrhosis
and liver cancer and the number one reason for liver transplants
in the U.S.
“Although we have seen significant improvements in hepatitis
C therapy over the past few years, many patients still do
not respond to treatment on their first attempt,” said
Dr. Donald Jensen, director of Hepatology at Rush University
Medical Center and lead U.S. investigator in the REPEAT trial.
“We hope that this trial will provide patients a proven
option with another pegylated interferon if Peg-Intron combination
therapy failed to work for them.”
The REPEAT Trial is an international study
enrolling approximately 888 patients at 98 centers in 14 countries
worldwide. Approximately 330 patients will be enrolled at
the 33 participating centers in the United States. In order
to be eligible for the trial, patients must have undergone
at least 12 weeks of treatment with Peg-Intron/Rebetol therapy
with no response. Patients who discontinued therapy because
of adverse events alone are not eligible for this study. In
addition, patients must be over 18 years of age. Nationwide
enrollment is currently underway for the study.
Patients will be randomized to the following
treatment arms:
• Group A: Initial high induction dose of Pegasys 360
mcg/week and Copegus 1000/1200mg daily for the first 12 weeks;
additional treatment period of 60 weeks with Pegasys 180 mcg/week
and Copegus 1000/1200mg daily.
• Group B: Initial high induction dose of Pegasys 360
mcg/week and Copegus 1000/1200mg daily for the first 12 weeks;
additional treatment period of 36 weeks with Pegasys 180 mcg/week
and Copegus 1000/1200mg daily.
• Group C: Treatment period of 72 weeks with Pegasys
180 mcg/week and Copegus 1000/1200mg daily.
• Group D: Treatment period of 48 weeks with Pegasys
180 mcg/week and Copegus 1000/1200mg daily.
All patients will have a 24-week follow-up
period to evaluate whether they have achieved a sustained
virologic response. Sustained virological response refers
to a patient’s continued undetectable serum hepatitis
C RNA levels 24 weeks after finishing a course of treatment.
“Although the two pegylated interferons
in this study belong to the same class of medications, there
are differences between the two,” said Jensen. “We
hope that the differences between the medications and the
different dosing regimens will lead to a good alternative
for patients who currently have no proven options.”
Pegasys and Copegus combination therapy
is marketed in the U.S. by Hoffmann-La Roche Inc. (Roche),
based in Nutley, N.J. Peg-Intron and Rebetol combination therapy
is marketed by Schering-Plough Corporation, based in Kenilworth,
NJ.
For more information about the REPEAT trial
and to locate a study site, patients can visit the “Clinical
Trials” section of the American Liver Foundation website
at www.liverfoundation.org
or call 1-800-GO-LIVER.
Rush University Medical Center includes
the 729-bed Presbyterian-St. Luke’s Hospital; 79-bed
Johnston R. Bowman Health Center; Rush University (Rush Medical
College, College of Nursing, College of Health Sciences and
the Graduate College).
Important Safety Information
About Pegasys (Peginterferon alfa-2a) in Combination with
Copegus
Alpha interferons, including PEGASYS (Peginterferon
alfa-2a), may cause or aggravate fatal or life-threatening
neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic clinical
and laboratory evaluations. Therapy should be withdrawn in
patients with persistently severe or worsening signs or symptoms
of these conditions. In many, but not all cases, these disorders
resolve after stopping PEGASYS therapy.
Use with Ribavirin. Ribavirin, including
COPEGUS®, may cause birth defects and/or death of the
fetus. Extreme care must be taken to avoid pregnancy in female
patients and in female partners of male patients. Ribavirin
causes hemolytic anemia. The anemia associated with ribavirin
therapy may result in a worsening of cardiac disease. Ribavirin
is genotoxic and mutagenic and should be considered a potential
carcinogen.
PEGASYS, alone or in combination with COPEGUS,
is indicated for the treatment of adults with chronic hepatitis
C virus infection who have compensated liver disease and have
not been previously treated with interferon alpha. Patients
in whom efficacy was demonstrated included patients with compensated
liver disease and histological evidence of cirrhosis (Child-Pugh
class A).
PEGASYS is contraindicated in patients
with hypersensitivity to PEGASYS or any of its components,
autoimmune hepatitis, and decompensated hepatic disease (Child-Pugh
class B and C) before or during treatment with PEGASYS. PEGASYS
is also contraindicated in neonates and infants because it
contains benzyl alcohol. Benzyl alcohol is associated with
an increased incidence of neurological and other complications
in neonates and infants, which are sometimes fatal. PEGASYS
and COPEGUS therapy is additionally contraindicated in patients
with a hypersensitivity to COPEGUS or any of its components,
in women who are pregnant, men whose female partners are pregnant,
and patients with hemoglobinopathies (eg, thalassemia major,
sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS
A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY
PRIOR TO INITIATION OF THERAPY. Women of childbearing potential
and men must use two forms of effective contraception during
treatment and during the 6 months after treatment has concluded.
Routine monthly pregnancy tests must be performed during this
time. If pregnancy should occur during treatment or during
6 months post-therapy, the patient must be advised of the
significant teratogenic risk of COPEGUS therapy to the fetus.
Physicians and patients are also strongly encouraged to report
any pregnancies that do occur to Roche by calling 1-800-526-6367.
The most common adverse events reported
for PEGASYS and COPEGUS combination therapy observed in clinical
trials (N=451) were fatigue/asthenia (65%), headache (43%),
pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness
(33%), insomnia (30%), alopecia (28%), neutropenia (27%),
nausea/vomiting (25%), rigors (25%), anorexia (24%), injection
site reaction (23%), arthralgia (22%), depression (20%), pruritus
(19%) and dermatitis (16%).
Serious adverse events included neuropsychiatric
disorders (suicidal ideation and suicide attempt), serious
and severe bacterial infections (sepsis), bone marrow toxicity
(cytopenia and rarely, aplastic anemia), cardiovascular disorders
(hypertension, arrhythmias and myocardial infarction), hypersensitivity
(including anaphylaxis), endocrine disorders (including thyroid
disorders and diabetes mellitus), autoimmune disorders (including
psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia,
bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis),
colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis,
and ophthalmologic disorders (decrease or loss of vision,
retinopathy including macular edema and retinal thrombosis/hemorrhages,
optic neuritis and papilledema).
Back to top
Religious
Investors, Schering-Plough Announce Agreement on Actions Regarding
Access to Prescription Drugs
Source: PRNewswire
KENILWORTH, N.J-- Fourteen faith-based
investors and Schering-Plough announced today that they had
reached an agreement improving access to prescription drugs.
Schering-Plough made two major commitments as part of the
dialogue with
faith-based investors. They are:
• Creating a pilot education program
in one neighborhood of a major metropolitan area for helping
diagnose hepatitis C in low-income patients. The program will
include counseling to assist those diagnosed to qualify for
the financial assistance needed to pay for their treatment,
through third party programs or Schering-Plough's own patient
assistance programs, including Schering-Plough's Commitment
to Care program. If successful, it may be expanded over time.
• Adding a component to the sales representative training
program designed to increase sensitivity to the perspective
of clinics and other service providers who serve low-income
patients as customers.
The investors, led by Trinity Health System,
agreed to withdraw their shareholder proposal entitled "Payments
and Rebate Policies and Access to Schering-Plough Products"
from Schering-Plough's 2004 proxy ballot.
The agreement follows a series of dialogues
including a meeting with Schering-Plough Chairman & CEO
Fred Hassan and senior members of the Schering-Plough executive
team. "We appreciated the candid and results-oriented
nature of the dialogue," said Hassan. "As Schering-Plough
moves forward with its new vision -- to earn trust every day
-- we look forward to maintaining a transparent relationship
with shareholders concerned about access to medicines."
"The crisis of millions of people
lacking access to health care – and especially to prescription
drugs -- continues," said Catherine Rowan, a consultant
who represented Trinity Health in the negotiations with Schering-Plough.
"The pharmaceutical industry must respond, to protect
both patients and shareholders. We hope the tangible steps
we've agreed to can begin to alleviate part of that crisis."
"Schering-Plough believes that the pharmaceutical industry
needs to address the challenges facing low-income, chronically
ill, underinsured and/or uninsured people who cannot access
the prescription medicines they need to improve their health,"
said Schering-Plough CEO Fred Hassan. "We support efforts
to increase access and are committed to assisting patients
in need obtain treatment. We continuously evaluate our patient
assistance programs for their ability to do the most good
for the most people. We intend to maintain and, to the extent
financially prudent, expand our programs."
"Schering-Plough has agreed to specific,
tangible steps to improve access to prescription drugs,"
said Margaret Weber, the chair of ICCR's Access to Health
Care Working Group. "As the company turns around, we
hope they make access to medicines a core value of the new
Schering-Plough."
Investors will make a statement at the
Schering-Plough annual meeting on April 27 on the issue of
access to medicines and how the research-based pharmaceutical
industry in general, and Schering-Plough in particular, can
improve their response to the crisis. The company and shareholders
also plan a series of dialogues over the next year implementing
the agreement.
Fourteen faith-based institutional investors
affiliated with the Interfaith Center on Corporate Responsibility
(ICCR), including healthcare providers Catholic Healthcare
West, Catholic Health Initiatives, and Christus Health, joined
Trinity Health in filing the resolution.
ICCR is a thirty-year-old international
coalition of 275 faith-based institutional investors including
denominations, religious communities, pension funds, healthcare
corporations, foundations and dioceses with combined portfolios
worth an estimated $100 billion. ICCR members utilize religious
investments and other resources to change unjust or harmful
corporate policies, working for peace, economic justice and
stewardship of the Earth.
Back to top
Growing
Number of Patients With Advanced Liver Disease Will Take the
Hepatitis C Virus Drug Market to $10 Billion In 2013
Source: PRNewswire
Experts Disagree About Which Patients
Are Best Suited For Treatment, According
to a New Study from Decision Resources
WALTHAM, Mass.-- Decision Resources, Inc.,
one of the world's leading research and advisory firms focusing
on pharmaceutical and health care issues, finds that the growing
number of patients with advanced liver disease will fuel a
rise of the hepatitis C virus (HCV) market to $10 billion
in 2013. HCV disease burden is expected to rise during the
next ten years because of a maturing HCV population that has
been infected for more than 20 years, the amount of time it
takes for morbidity from HCV to emerge.
The new Pharmacor study entitled Hepatitis
C Virus also finds that experts disagree about which patients
are best suited for treatment given that HCV does not place
all infected persons at risk of significant morbidity or mortality.
"Some experts contend that the goal
of anti-HCV therapy is to prevent cirrhosis and hepatocellular
carcinoma," says Jason LaBonte, Ph.D., analyst at Decision
Resources. "Based on these criteria, patients with normal
serum ALT levels and who therefore are not at risk of advanced
liver disease do not require treatment. These experts also
maintain that the safety and efficacy of current therapies
is not sufficient to warrant treatment in this patient group.
Other experts believe that patients with mild disease are
more likey to respond to current therapies, and they say that
the prevention of HCV transmission, improvement in quality
of life, and improvement of symptoms are important considerations
when determining whether or not to treat patients with normal
serum ALT levels."
About Pharmacor from Decision Resources
Pharmacor is a unique family of studies that assesses a host
of market- impacting factors and analyzes the commercial outlook
for drugs in research and development.
About Decision Resources
Decision Resources, Inc., is a world leader in research publications,
advisory services, and consulting designed to help clients
shape strategy, allocate resources, and master their chosen
markets.
All company, brand, or product names contained in this document
may be trademarks or registered trademarks of their respective
holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
SOURCE Decision Resources, Inc.
CONTACT: Elizabeth Marshall of Decision Resources, Inc., +1-781-296-2563,
emarshall@dresources.com
/
Web site: http://www.decisionresources.com/
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April
21st, 2004
Changing
Compliance to the ACG Guidelines for Variceal Hemorrhage
Source: www.gastrohep.com
Significantly more gastroenterologists
screened for varices to prevent initial variceal hemorrhage
following the publication of guidelines, find investigators
in the April issue of the American Journal of Gastroenterology.
In mid-1997 the American College of Gastroenterology
(ACG) published guidelines for the management of varices.
In this study, investigators from Portland,
Oregon, assessed the change in regional practice patterns
between early 1997 (pre-guidelines) and 2000 (post-guidelines).
The team sent gastroenterologists in Oregon
and Southwestern Washington a self-reporting questionnaire
regarding the management of varices in 1997 and 2000.
Overall, 76% of the surveys were completed
in 1997 and 74% in 2000. More respondents followed the guidelines
to prevent initial variceal hemorrhage in 2000.
The team found that 50 to 60% of the respondents
saw between 3 and 5 cirrhotic patients per month.
They determined that more respondents followed
the guidelines to screen and treat large varices to prevent
initial variceal hemorrhage in 2000 than in 1997 (54% versus
18%).
Of the respondents who performed screening
of EGDs, the majority treated large varices with beta-blocker
therapy (93% in 1997 and 97% in 2000).
All respondents used early endoscopy to
treat variceal bleeding.
More respondents began pharmacologic therapy
prior to endoscopy if active variceal hemorrhage was suspected
in 2000 than in 1997 (83% versus 56%).
Dr Atif Zaman and colleagues concluded,
"After the publication of the ACG guidelines, significantly
more gastroenterologists screened for varices to prevent initial
variceal hemorrhage and significantly more used pharmacologic
therapy prior to endoscopic treatment for variceal hemorrhage".
Am J Gastroenterol 2004; 99(4): 645-9
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Donor
Livers Not Consistently Allocated According to Medical Need
Source: www.gastrohep.com
Donor livers are not always distributed
according to a patient's need, but may be retained by some
organ procurement organizations with smaller waiting lists,
find researchers in the latest issue of the Journal of
the American Medical Association.
The Model for Endstage Liver Disease (MELD)
score was implemented in February 2002 to serve as the basis
for the liver allocation system used by the United Network
for Organ Sharing.
The MELD score is an objective scoring
system of medical characteristics predictive of prognosis,
with minimal emphasis on waiting time as a priority for transplantation.
However, recommendations to increase and
standardize the size of the area of organ allocation have
not been implemented.
The distribution of patients' MELD scores
listed for transplantation was the same.
Consequently, there is great disparity
in the patient populations served by organ procurement organizations
(OPOs) across the United States.
In some regions of the United States, an
OPO may serve as few as 1.2 million people, whereas in other
areas, the population covered by the OPO is nearly 18 million.
The smallest OPO has fewer than 10 patients
listed for liver transplantation, whereas the largest has
more than 2000.
Dr James Trotter and Michael Osgood of
the University of Colorado Health Sciences Center, Denver,
conducted a study to determine whether there is a difference
in MELD scores for liver transplant recipients receiving transplants
in small versus large OPOs.
The researchers reviewed data from the
US Scientific Registry of Transplant Recipients between 2002
and 2003.
Overall, 4798 transplant recipients had
end-stage liver disease and received deceased-donor (DD) livers.
The authors examined MELD score distribution,
graft survival, and patient survival for liver transplant
recipients in small (less than 100) and large (100 or greater
on the waiting list) OPOs.
The researchers found that the distribution
of patients' MELD scores listed for transplantation was the
same in large and small OPOs: 92% had a MELD score of 18 or
less, 7% had a MELD score between 19 and 24, and only 2% of
listed patients had a MELD score higher than 24.
They found that the proportion of patients
receiving transplants in small OPOs and with a MELD score
higher than 24 was significantly lower than that in large
OPOs (19% versus 49%).
Patient survival rates at 1 year after
transplantation for small OPOs (86%) and large OPOs (87%)
were not statistically different, and neither were graft survival
rates in small OPOs (80%) and large OPOs (81%).
"In summary, we report that a significantly
smaller proportion of adult DD liver transplant recipients
in OPOs with small waiting lists receive transplants and have
a MELD score higher than 24 compared with recipients in large
OPOs.
"The most likely explanation for this
disparity is that DD livers are preferentially retained for
transplantation in the local OPO, where the number of patients
with high MELD scores is numerically smaller than that in
large OPOs.
"Although this disparity does not
reflect the mandate of the final rule, there may be advantages
for selected patients.
"Transplant professionals should be
aware of this disparity and its implications as they continue
to amend regulations for organ allocation," the authors
conclude.
JAMA 2004; 291: 1871-4
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Roche
Q1 Sales Beat Forecasts as Pegasys Flies
Jon Cox and Ben Hirschler
Source: Reuters
ZURICH/LONDON-- Roche Holding AG's (ROG.VX:
Quote, Profile, Research) first-quarter core sales rose a
consensus-beating 14 percent to 7.6 billion Swiss francs ($5.8
billion), led by its pre-eminent stable of cancer drugs, it
said on Wednesday.
The biggest star, however, was hepatitis
C treatment Pegasys, which was launched in the United States
only last year and is already racking up annualised sales
of more than one billion francs.
In an upbeat statement, Roche forecast
a "substantial increase" in net income this year
-- helped by gains from a debt restructuring -- and reiterated
guidance that its core drugs and diagnostics divisions would
outgrow the overall market in 2004.
Roche certificates, its most widely traded
form of equity, opened higher as brokerage Vontobel upgraded
the stock to "sector outperform". But by 0825 GMT
they had slipped 0.9 percent to 132.50 Swiss francs, following
a 10-franc advance this month, compared with a 0.45 percent
decline in the overall Swiss market.
Once the sick man of Europe's drug industry,
Roche has rebounded thanks to the successful launch of new
products. Its shares have outstripped the European drug sector
by some three percent this year, rising more than seven percent.
Sales at the Swiss company's flagship pharmaceuticals
division rose 16 percent to 5.65 billion francs, against nine
percent growth for the overall market, while diagnostics rose
11 percent to 1.91 billion francs, twice as fast as the market.
Analysts had expected sales from continuing
operations to rise to around 7.3 billion francs, with estimates
varying between 7.1 billion and 7.7 billion, according to
a Reuters poll.
Sales of its keenly watched blockbuster
hepatitis C drug, Pegasys/Copegus, came in at 391 million
francs, far ahead of most forecasts from analysts of 300-350
million.
"Sales outside the United States were
stronger than I had been looking for, and my guess is people
will be looking to push their profit forecasts up," said
analyst Paul Diggle at Code Securities in London.
OTC DECISION
Roche has a two-pillar strategy that seeks synergies between
pharmaceuticals and diagnostics. It expects the two will increasingly
go hand in hand in determining the administration of drugs
to different patients to get optimum results.
Including its majority stake in separately
listed U.S. biotech group Genentech (DNA.N: Quote, Profile,
Research) , Roche is now the world leader in cancer drugs
and the biggest diagnostics group.
Roche and Genentech together have one of
the most promising new cancer drugs of recent years in Avastin,
a new kind of therapy that works by starving tumours of blood
supply and which was launched in the United States earlier
this year.
The product is on track for approval in
Europe by the end of this year or early next year, according
to Roche.
Roche has been paring its operations to
focus on core businesses, and Chairman and CEO Franz Humer
said he would decide on the future of the non-core over-the-counter
drugs business during the second half of 2004.
Roche has said all options -- including
disposal -- are open for the unit, which includes Rennie indigestion
tablets.
"We are in preliminary discussions
with a number of potential partners. We have not made any
decision in what direction we will definitely go, because
we've not yet any firm numbers and proposals on the table,"
Humer told reporters.
Apart from a straight sale, Roche might
also keep a stake in an OTC spin-off or engage in some form
of drug swap, he said.
People familiar with the situation told
Reuters earlier this year that rivals interested in acquiring
the business included GlaxoSmithKline Plc (GSK.L: Quote, Profile,
Research) and Bayer AG (BAYG.DE: Quote, Profile, Research)
.
Sales of the unit rose seven percent to
429 million francs in the first quarter.
Roche made an after-tax gain of 613 million
francs when it completed the call of its Liquid Yield Option
Notes IV (LYONs IV) convertible notes in early April -- a
move which also cut its debt by 1.36 billion francs.
The notes were mainly exchanged for shares
of Genentech, reducing Roche's stake in the group by 2.5 percent
to 55.3 percent.
Back to top
April 22nd, 2004
Prison
Hepatitis C Infection Nears 14 Percent
Judy Putnam
Source: Lansing Bureau
LANSING -- Hepatitis C infection among
Michigan prisoners is less widespread than feared -- affecting
an estimated 13.8 percent of the population -- a new study
finds, but the state still needs millions to treat inmates
at risk of developing liver failure, corrections officials
say.
They are asking lawmakers for $2.3 million
next year to test and treat infected prisoners, and $11 million
the following year, at a time when the state is short of cash.
The blood-borne virus is a leading cause
of liver cancer and is common among inmates because of high-risk
lifestyles associated with drug abuse.
Gov. Jennifer Granholm had originally requested
$5.9 million for hepatitis C treatment, but the administration
reduced its request after survey results showed an infection
rate far lower than the 20 percent to 40 percent reported
in other states.
The state Senate last month voted to strip
the proposed spending for treatment entirely, saying there's
no money for new projects. A House panel is now considering
the administration's reduced request.
Female inmates in the study of 50 incoming
prisoners had an infection rate of 34 percent. By contrast,
only 12.1 percent of 600 incoming male prisoners were infected,
officials said Wednesday.
That means about 6,800, rather than nearly
20,000, of the 49,000 Michigan inmates may have the virus,
according to the study results.
But critics questioned the numbers.
"I am highly skeptical because it's
so out of whack with what other states have found, and there's
no good independent reason why Michigan should be any different
than any other state," said David Santacroce, an assistant
professor of law at the University of Michigan who has reviewed
200 records of infected inmates.
His clinical law class filed a class-action
suit in 2003 on behalf of infected inmates, charging the department
had failed to treat them. The suit was dismissed by a federal
judge.
Richard Russell, administrator of the Department
of Corrections Bureau of Health Care Services, said experts
are trying to determine why male rates are so low. Michigan's
HIV rates are lower than those of other big states, and the
hepatitis C infection may be following the same trend, he
said.
Russell said the department ran the male
study twice. The first batch of 600 tested were volunteers
among about 1,800 incoming inmates.
When the results came in much lower than
those for females, about 11 percent, the department decided
to test another 600 inmates because officials theorized males
may be more fearful of having their drug abuse history exposed.
The second test was mandatory, but came
out with similar results at 12.1 percent.
Hepatitis C is spread through sex, shared
needles or other exposure to blood, and can lay dormant for
years. Some with the virus may never develop symptoms and
don't require treatment, but for others it is fatal.
The virus is a leading cause of liver cancer.
Treatment is expensive, about $25,000 for a course of interferon,
and has severe side effects, such as depression.
While only an estimated 1 percent to 2
percent of the general population has the virus, it's much
greater in high-risk prison populations. A 1994 study in California
pegged infection among incoming inmates at 40 percent.
Santacroce and other critics charge that
Michigan corrections officials and a private company the state
uses for medical care, Correctional Medical Services based
in St. Louis, Missouri, are not treating inmates properly.
"There are hundreds, if not thousands,
of people dying of this disease because the Michigan Department
of Corrections and their primary health provider, CMS, does
not want to spend the money," Santacroce said.
But Russell said Michigan has followed
proper medical procedure by treating inmates who have shown
elevated liver enzymes in their blood or have symptoms of
liver problems. About 50 to 60 inmates at any one time are
in treatment, he said.
"All these claims that we're not treating
people with hepatitis C are not true," Russell said.
The additional money will allow the department
to test all inmates in Michigan prisons identified as high-risk,
and treat more of them.
Department of Corrections spokesman Leo
Lalonde said department plans call for treating 465 inmates
next year and 3,720 in 2006.
Contact Judy Putnam at (517) 487-8888 or
e-mail her at putnam@boothnewspapers.com.
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Bioartificial
Liver Reduces Mortality by 44% in Acute Liver-failure Patients
Source: Newswise
In a major study conducted at 20 centers
in the United States and Europe, a bioartificial liver developed
by researchers at Cedars-Sinai Medical Center reduced mortality
significantly among patients suffering from acute liver failure,
the dramatic loss of liver function that can cause death in
days or even hours.
This is the first large-scale, prospective,
randomized, multi-center trial examining the effectiveness
of any artificial liver support. Currently, standard treatment
consists of intensive, supportive care intended to keep patients
alive long enough that the liver might recover spontaneously
or a donor organ will become available for transplantation.
Acute liver failure is diagnosed when a
massive loss of hepatic cells causes severe liver dysfunction
and life-threatening complications within six months of the
onset of symptoms. When this dysfunction occurs within the
first eight weeks after onset, liver failure is termed “fulminant.”
When it occurs in the period between eight weeks and six months,
it is “subfulminant” (or late-onset). In either
case, few patients survive the resulting fluid buildup in
the brain, catastrophic bacterial infections, multi-organ
failure, blood-clotting abnormalities, respiratory problems,
kidney failure or other potential complications. It is estimated,
in fact, that up to 80 percent of patients will die unless
they receive a liver transplant.
In the United States, the causes of many
cases of acute liver failure are never identified, although
precipitating factors can include toxic poisoning, medication
interactions or overdoses, metabolic disorders, and some types
of viral hepatitis.
Achilles A. Demetriou, MD, PhD, Chairman
of Surgery at Cedars-Sinai and the study’s principal
investigator, has been pursuing treatments for acute liver
diseases since 1976 when he began studying liver cells at
the National Institutes of Health. He continued his research
at Vanderbilt University, coming to Cedars-Sinai in 1992 to
launch the country’s first unit devoted to managing
massive acute liver failure.
The study included 147 patients who suffered
from fulminant/subfulminant hepatic failure and 24 patients
whose livers had failed after transplantation. Of the 171
total patients, 85 received BAL treatment, while 86 received
standard supportive care.
For the entire patient population, survival
at 30 days was 71 percent among the BAL group, compared with
62 percent for those receiving traditional care. Analyzing
results among only the 147 patients with fulminant/subfulminant
hepatic failure, the researchers found that the BAL provided
a 44 percent reduction in mortality.
During a treatment, blood is drawn from
a vein through a catheter. Blood plasma is separated from
the serum and pumped through a charcoal column and an oxygenator
before it reaches the bioreactor – a tube-shaped device
containing a fiber membrane and 7 billion liver cells from
pigs. These cells are isolated, cryopreserved (frozen) and
thawed according to techniques originally developed by the
Cedars-Sinai researchers.
“The blood is removed at a fixed
rate, detoxified and treated in the various components of
the bioartificial liver, reconstituted, and returned to the
patient at the same rate at which it is being removed,”
said Dr. Demetriou. “Just before the patient is treated,
the pig liver cells are thawed, reactivated and attached to
small beads that serve as a scaffold for the cells. We put
the cells and beads into the cartridge, and when the patient’s
plasma flows through the fibers, the pig liver cells detoxify
it and replace missing nutrients.”
Each treatment is completed in about six
hours, and the benefits last about 24 hours. In most cases
of acute liver failure, a series of treatments may need to
continue for only a few days or several weeks. “Typically,
within that time the patient’s condition is going to
improve because his or her own liver kicks in or a liver will
be available for transplantation,” Dr. Demetriou said.
The study was funded by Circe Biomedical
Inc.
Cedars-Sinai is one of the largest nonprofit
academic medical centers in the Western United States. For
the fifth straight two-year period, it has been named Southern
California's gold standard in health care in an independent
survey. Cedars-Sinai is internationally renowned for its diagnostic
and treatment capabilities and its broad spectrum of programs
and services, as well as breakthroughs in biomedical research
and superlative medical education. The Medical Center ranks
among the top 10 non-university hospitals in the nation for
its research activities.
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Sustained
Virological Response in Transplant Recipients with Recurrent
Hepatitis C
Source: www.gastrohep.com
Direct detection of HCV RNA by RT-PCR of
liver tissue effectively predicts a sustained virological
response in liver recipients, find researchers in the latest
issue of Liver Transplantation.
The optimal duration of therapy for pegylated
interferon combined with ribavirin in recurrent hepatitis
C virus (HCV) following liver transplantation is not known.
In this study, researchers from Miami,
Florida, compared reverse transcriptase PCR (RT-PCR) in the
liver tissue with serum HCV RNA detection, for prediction
of sustained virological response (SVR).
All patients had nondetectable HCV RNA
by PCR serum testing.
All patients received combination pegylated
alpha-2b interferon (1.5 mcg per kg) and ribavirin (200 to
600mg per d) therapy for at least 48 weeks. These patients
were found to have nondetectable HCV RNA by PCR serum testing
at the end of therapy.
The team defined SVR as nondetectable serum
HCV RNA at 6 months post treatment withdrawal.
There were 10 liver transplant recipients
were included in the study. The team found that in 7 patients
HCV RNA in the liver tissue was found to be positive by RT-PCR,
while 3 patients had nondetectable HCV RNA in their liver.
The researchers determined that SVR was attained in all 3
patients who were hepatic tissue HCV PCR negative after 12
months of combination therapy.
Dr Guy Neff and colleagues concluded, "Direct
detection of HCV RNA by RT-PCR of liver tissue appears to
more effectively predict SVR following pegylated interferon
and ribavirin therapy than the conventional use of serum".
Liver Transpl 2004; 10: 595-8
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Schering-Plough
Posts Loss, Sales Fall 6 Pct
Ransdell Pierson
Source: Reuters
NEW YORK- Schering-Plough Corp. (SGP.N:
Quote, Profile, Research) on Thursday posted a first-quarter
loss as competition from cheaper medicines badly hurt sales
of its allergy and hepatitis drugs and it made sizable severance
payments to cut jobs.
The Kenilworth, New Jersey-based drugmaker
reported a loss of $73 million, or 5 cents per share, compared
with a profit of $173 million, or 12 cents per share, a year
earlier.
The loss included charges of $70 million,
or 4 cents per share, for the job cuts and research-related
costs.
Excluding items, analysts, on average,
had forecast a profit of 1 cent per share, according to a
poll by Reuters Research, a unit of Reuters Group Plc.
Sales fell 6 percent, to $2 billion, but
would have fallen 12 percent if not for the weak dollar, which
boosts the value of products sold overseas when converted
into dollars.
Global sales of prescription drugs, the
company's main business, fell 10 percent to $1.5 billion.
Quarterly sales of the company's Claritin
line of allergy medicines have fallen by almost 90 percent
since they lost their U.S. marketing exclusivity in late 2002
and became available without a prescription at a fraction
of their previous price.
Moreover, its almost identical allergy
pill still sold by prescription, Clarinex, saw quarterly sales
fall 25 percent to $130 million, despite earlier company hopes
that it could continue to grow despite the availability to
consumers of far cheaper Claritin.
Schering-Plough's two drugs against hepatitis
C that are taken together -- an injectable interferon called
Peg-Intron and the antiviral pill ribavirin, were mauled by
a similar dual therapy launched over a year ago by Swiss drugmaker
Roche Holding AG (ROG.VX: Quote, Profile, Research) .
Peg-Intron sales fell 33 percent to $148
million, while ribavirin tumbled 55 percent to $99 million
amid availability of Roche's far less-expensive version.
The company warned that ribavirin sales
will "sharply" decline in the future because other
drugmakers, including Schering-Plough itself, launched cheaper
generic forms of the medicine in the United States earlier
this month.
Another negative trend was the company's
profit margin, which shrank by 6 percentage points to 62.3
percent, in part because of continuing quality-control lapses
at its plants that have disrupted production of some products.
But the company did report some positive
trends, including a 45 percent jump in sales of arthritis
drug Remicade, to $165 million. And sales of the new cholesterol
fighter Zetia, which it co-markets with Merck and Co. (MRK.N:
Quote, Profile, Research), hit $189 million in the quarter.
Schering-Plough's consumer health
products held their own, rising 7 percent to $312 million,
although the gains were largely due to the weak dollar. (Additional
reporting by Jed Seltzer)
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