| Back
to News Review
Alan Franciscus
Editor-in-Chief
To download pdf version click here
In This Issue:
Chisholm Misled MSPs Over
Hepatitis, Claim Campaigners
Hepatitis C Treatment Rules Continue to Draw
Criticism
Quebec Calls 1,200 People for HIV Tests
Schering-Plough: $1.6M Was Paid to Ex-Chairman
Benefit to Help Hepatitis C Victim
Screening for Hepatitis C Virus Infection in
Adults
Liver Regeneration Slower in Donors Than Recipients
Laboratory Corporation of America® Holdings
(LH) Announces U.S. Launch Of Exclusive Liver Fibrosis Assay
HCV FibroSURE
Valentis Earns Milestone Payment from Genencor
Hemispherx Biopharma (HEB) Completes Acquisition
For Worldwide Rights To Alferon N
Area Health Care Workers Learn How To Combat
Hepatitis C
Ex-lab Worker Says Faulty Results From HIV Tests
Could Affect Thousands
March 14th, 2004
Chisholm
Misled MSPs Over Hepatitis, Claim Campaigners
Liam McDougall, Health Correspondent
Sunday Herald
Health Minister Malcolm Chisholm was last
night under mounting pressure to answer claims he had misled
the Scottish parliament over the hepatitis C medical scandal.
Campaigners and opposition MSPs launched a furious attack
on him after it emerged that documents from the Irish government
and a Dublin law firm appeared to contradict statements he
made last year.
Their anger centres around his decision
to give ex-gratia payments of around £20,000 to haemophiliacs
who contracted hepatitis C through NHS blood products. In
Ireland, the average payout was £300,000.
Last year the minister told the health
committee : “In Ireland, the government and everyone
else have agreed that wrongful practices were used. The payments
in Ireland were compensation.
“We are making an ex-gratia payment”.
This weekend, the Scottish Executive also
described the Irish scheme as “compensation, following
evidence of negligence”.
But a letter from the Irish government’s
Blood Policy Division shows that payments were made “as
an ex-gratia scheme”. Ann McGrane, the division’s
assistant principal officer, writes: “Compensation for
persons with haemophilia were made on compassionate grounds,
without legal liability on the part of the state.
“The legal advice to the government
was that the state was not liable.”
“It was announced [in 1995] the compensation
scheme was to be extended to cover all those who had contracted
hepatitis C from a blood transfusion or blood product administered
within the state. Also … the scheme of compensation
was a no-fault scheme.”
Another letter, from legal firm Malcolmson
Law, which represented more than 90% of Ireland’s hepatitis
C sufferers, said: “It is patently incorrect for it
to be indicated that the Irish compensation schemes were as
a consequence of any public tribunal of inquiry investigation.”
The revelations have prompted angry claims
by campaigners that Chisholm may have misled parliament to
keep payments down.
David Davidson, the Conservative’s
health spokesman, called on Chisholm to be recalled to the
health committee. “The minister must explain the phrasing
he used,” he said. Last night, a Scottish Executive
statement insisted: “The two situations are completely
different.”
Back to top
March 15th, 2004
Hepatitis C Treatment Rules Continue
to Draw Criticism
Joel Stashenko
Associated Press Writer
ALBANY, N.Y.--The state's refusal to treat
short-term prison inmates infected with hepatitis C does not
jeopardize their ultimate chances of beating the disease,
the state prison system's top doctor told skeptical state
Assembly committee chairmen Tuesday.
"We just don't feel it's wise to start
something we can't finish," said Dr. Lester Wright, chief
medical officer for the state Department of Correctional Services.
"You really mean to say that it doesn't
make a difference if you start treatment today or a year or
two from now?" asked Richard Gottfried, a Manhattan Democrat
who chairs the Assembly's health committee.
Wright said hepatitis C is not like other
diseases in state prisons, such as the HIV virus or tuberculosis,
which usually compel immediate treatment when detected.
“Hepatitis C is a disease of decades,”
he said. “The fact that somebody doesn't start (with
treatment) this week or next doesn't make a difference.”
Gottfried and Jeffrion Aubry, a Queens Democrat and chairman
of the Assembly's corrections committee, continued their criticism
of the prison's policy of only treating hepatitis C-infected
inmates if they will be incarcerated for the year it takes
to complete the drug regimen. The state also refuses treatment
to inmates with alcohol or drug problems who fail to complete
treatment for substance abuse.
Consequently, only a few hundred of the
estimated 9,200 inmates who show some signs of hepatitis C
infection are being treated while behind bars. It may take
decades for the disease to advance to its liver-damaging stage,
experts said.
Wright said inmates do not have particularly
good histories of going to doctors and sticking to health
care routines on the outside. He also said prison officials
have had a difficult time lining up hepatitis C treatment
programs outside of prisons for inmates released unexpectedly,
before their treatments had concluded.
"Treatment ends up with large gaps
in it, which is not good health care," Wright said.
"Better than no health care?"
countered Gottfried.
Wright said discontinuing the treatment
schedule could make later attempts to treat hepatitis C impossible.
According to Gottfried, treatment is often
delayed for inmates because they cannot become immediately
eligible for Medicaid upon their release. He urged that a
system be worked out where the paperwork for Medicaid could
be started well in advance of the end of inmates' sentences.
Dr. Guthrie Birkhead, director of the state's
AIDS Institute, said social services officials in New York
City and counties outside the city are now reluctant to accept
Medicaid applications for people who do not apply in person
and who are not already living in the local district.
About two dozen members of the Legislative
Action Coalition on Prison Health held up signs reading "Health
Care Out of Reach for NYS Inmates" at the hearing and
shouted out derisively at some statements made by Wright and
Glenn Goord, state corrections commissioner.
One aim of the coalition is to pass a Gottfried-Aubry
bill giving the state Health Department oversight over prison
health programs. Goord reiterated his opposition to the measure
Monday and the director of the Health Department's Office
of Health Systems Management, Wayne Osten, did the same.
"Our focus is on hospitals, nursing
homes ... Corrections health is a whole different issue and
we simply don't have the expertise," Osten said.
Back to top
Quebec Calls
1,200 People for HIV Tests
Source: Associated Press
TORONTO-- The Quebec government is asking
1,200 people to undergo a blood test for HIV and hepatitis
after needles were used more than once at a Montreal acupuncture
clinic.
Health officials told a news conference Monday the risks of
infection were "minimal." The patients who may have
been affected went to the clinic between 1979 and January.
It was the second patient "recall"
in Montreal this year because of the risk of HIV infection.
The Ste-Justine Children's Hospital was
deluged with thousands of calls in January after it asked
2,614 patients to be tested for the virus that causes AIDS.
An HIV-infected surgeon, Maria Di Lorenzo,
performed operations on thousands of children at the hospital
between 1990 and 2003. Staff emphasized the chances of a patient
becoming infected were extremely slim.
Di Lorenzo, 48, died last year while on
medical leave. The hospital's administration wasn't aware
the doctor was HIV-positive until January, although her supervisor
and a committee of doctors knew in 1991.
Back to top
March 16th, 2004
Schering-Plough:
$1.6M Was Paid to Ex-Chairman
David Schwab
Star-Ledger Staff
The cost of cleaning house at Schering-Plough
keeps mounting.
The drug maker said yesterday it paid $1.6
million in total compensation last year to Richard Kogan,
the former chairman and chief executive. That was more than
Schering-Plough paid in base salary to Kogan's successor,
Fred Hassan.
The payment to Kogan -- who was replaced
after presiding over more than two years of setbacks -- includes
$203,135 for an office and secretary outside of Schering-Plough's
facilities, according to documents the company filed yesterday
with the Securities and Exchange Commission.
It also includes $670,813 for unused vacation
time Kogan accumulated during his 20-year career, according
to Rosemarie Yancosek, a company spokesman.
"I have never heard of it that high,"
Paul Hodgson, a senior research associate at The Corporate
Library, a corporate watchdog group, said of the vacation
payout. "Normally it's in the tens of thousands of dollars,
not the hundreds of thousands. Most employees can't carry
holiday unused over that length of a time."
Kogan could not be reached for comment.
This latest payment to Kogan comes on top
of the $50 million severance package he received that raised
eyebrows among investors and executive compensation experts
when the company disclosed it last year.
Hassan, who replaced Kogan last April,
earned $1 million in salary and turned down a bonus, though
it was guaranteed in his employment contract.
He also received restricted stock valued at $3.5 million and
900,000 stock options. The options, which expire in 2013,
were valued at $6 million.
The former Pharmacia CEO has been trying
to engineer a turnaround at Kenilworth-based Schering-Plough,
which has been hurt by manufacturing problems and declining
sales. That has prompted the company to cut jobs, eliminate
bonuses and impose a hiring freeze.
Meanwhile, two senior executives who recently
announced plans to leave also received lucrative payouts,
according to the SEC filing.
Jack Wyszomierski , the former executive
vice president and chief financial officer, and Joseph Connors,
executive vice president and general counsel, worked at Schering-Plough
for more than 20 years.
Their payouts consist of triple their salary
plus bonus, the same formula used to compensate Kogan and
typically used for senior executives with employment contracts
who leave prematurely. Both earned $647,000 in salary last
year.
Wyszomierski got $3.3 million in severance
payments. Plus, Schering-Plough will pay him $5 million for
his pension, according to the company's annual proxy.
Connors will receive more than $1.9 million
in severance. His severance payments is not yet available
because he decided to leave earlier this month, too late to
be included in the shareholder proxy filed with the SEC, according
to Yancosek.
The executives' contracts called for the
triple payment in the event they were fired by Schering-Plough
or had good reason to leave.
Typically an executive has a good reason
to leave if his duties are changed, he is demoted or he is
forced to relocate, according to Hodgson of the Corporate
Library.
Yancosek, the Schering-Plough spokesman,
could not say why the two executives received the triple payment.
Back to top
Benefit to
Help Hepatitis C Victim
Money will go toward Nekoosa native's medical bills
Antoinette Rahn
Daily Tribune Staff
NEKOOSA - Friends and family of Laura Pickett
can't take away the symptoms of her hepatitis C, but they
hope to relieve some of the pain of her medical bills on Sunday.
Pickett, a 53-year-old Nekoosa native,
was diagnosed in 2000 with hepatitis C. Complications from
the disease, along with diabetes and chronic anemia, prompted
Pickett to retire from her job at Wal-Mart Supercenter in
Wisconsin Rapids in June.
Pickett's out-of-pocket expenses for three
weekly treatments and other medication continue to rise, prompting
her sister, brothers and mother to figure out a way to help.
"Laura is pretty quiet, but we were
all talking and we figured her medical and clinical bills
had to be getting up pretty high. That's when we thought maybe
we could do a little benefit or something," said Pickett's
sister, Rebecca Clasen of Grand Rapids.
To participate
A benefit for Laura Pickett of Nekoosa is set for Sunday.
The event is to help Pickett with medical expenses related
to complications of chronic hepatitis C, diabetes and chronic
anemia.
* Where: Good Time Charlie's Sports Bar,
111 E. Jackson St., Wisconsin Rapids.
* Time: Noon until evening.
* Activities: Live music provided by four south Wood County
and Wisconsin-based bands, food and raffle prizes.
The fund-raiser, co-sponsored by the Independent
Motorcycle Owners of Central Wisconsin, will include more
than 100 raffle prizes, food and performances by Northbound
Train, Spirit Plane, The Fire and Stone Float.
Pickett suffers severe fatigue, nausea,
abdominal pain and problems with her liver. She believes she
contracted the virus before the mid- 1980s when she was working
in Baltimore as a licensed practical nurse in public health.
She could have been infected through an accidental needle
stick or via blood transfusions she received during those
years for her anemia, she said.
That was nearly 20 years before she was
diagnosed, which is typical in most cases of hepatitis C,
said Dr. Christopher Rall, gastroenterologist and hepatologist
at Marshfield Clinic, where Pickett receives treatment.
"In many cases it takes 20 to 30 years
of infection before it shows up in blood tests," Rall
said. "Almost anyone with (hepatitis C) is chronic. Rarely
do we find someone with just acute symptoms." Pickett's
benefit already has drawn support from more than family and
friends.
"It's amazing. We haven't had too
many people who wouldn't give us something for the raffle,"
said Tom Clasen, Pickett's nephew and member of Northbound
Train. "We just thought this would be a good way to help
Laura and for people to have fun, too." Such generosity
helps Pickett personally, she said, and it helps her to educate
people about hepatitis C. "It sometimes feels like there's
no hope, but this benefit makes me feel good inside and out,"
Pickett said. "I think it's so important that people
understand that they can't catch hepatitis C by being near
me. And it's not just a drug users' disease, either. I don't
use drugs.
"But people have gotten it by needle
sticks working in public health, and before all the testing
they do now on blood donations, people got it from blood transfusions."
Before widespread efforts to test the nation's blood supply,
in the 1940s and 1950s the most prevalent form of contracting
the virus was through blood transfusions, Rall said. Today
the most prevalent cause is illegal injection drug use.
A common therapy for people with hepatitis
C is a combination of long-acting interferon and ribavirin.
The mix is effective in eliminating the virus in 60 percent
of people with hepatitis C.
You can reach Antoinette Rahn at 422-6726
or arahn@wisconsinrapidstribune.com.
http://www.wisinfo.com/dailytribune
/wrdtlocal/280051936257269.shtml
Back to top
March 17th, 2004
Screening
for Hepatitis C Virus Infection in Adults
Individuals who are not at high risk for hepatitis C infection
do not need to be screened for the disease, according to a
new recommendation from the US Preventive Services Task Force.
The US Preventive Services Task Force (USPSTF) has issued
recommendations on screening for hepatitis C virus (HCV) infection
in asymptomatic individuals.
USPSTF has based their recommendations
on evidence presented by Dr Roger Chou and colleagues from
Portland, Oregon.
HCV is the most common bloodborne pathogen
in the United States. It is an important cause of patient
morbidity and mortality.
Dr Chou's team synthesized the evidence
on risks and benefits of screening for HCV infection.
The team searched for controlled studies
of screening and antiviral therapy, as well as observational
studies on other interventions. They also evaluated risk factors,
accuracy of antibody testing, work-up, harms of biopsy, and
long-term outcomes.
The researchers found that there were no
published trials of screening for HCV infection.
They determined that approximately 2% of
US adults have HCV antibodies. The majority of these people
have chronic infection.
The team that risk factor assessment identifies
adults at substantially higher risk of infection.
However, while antiviral treatment can
result in a sustained virologic response rate of 54% to 56%,
no trials have been done in asymptomatic patients likely to
be identified by screening.
Furthermore, data are insufficient to determine
whether treatment improves long-term outcomes.
Also, there are no data to estimate the
benefit from counseling or immunizations.
The researchers also found that while risks
of biopsy and treatment appear minimal or self-limited, data
on other adverse effects of screening are sparse.
Dr Chou's team concluded, "Antiviral
treatment can successfully eradicate HCV, but data on long-term
outcomes in populations likely to be identified by screening
are lacking".
"Although the yield from targeted
screening…would be substantially higher than in the
general population, data are inadequate to accurately weigh
the overall benefits and risks of screening in otherwise healthy
asymptomatic adults".
Ann Intern Med 2004; 140(6): 465-79
Back to top
Liver Regeneration
Slower in Donors Than Recipients
Source: Reuters Health
NEW YORK (Reuters Health) - Living people
can donate a part of their liver for transplantation because
near-complete regeneration occurs within weeks in the transplanted
organ as well as in the donor's remaining liver.
Now, researchers have discovered that liver
regeneration is slower in the donors than in the recipients.
At the University of Minnesota in Minneapolis,
Minnesota, Dr. Abhinav Humar and colleagues used CT scans
to analyze liver regeneration in donors and recipients. Their
findings are published in the medical journal Liver Transplantation.
At 3 months, donors had attained an average
of 78 percent of their ideal liver size, compared with more
than 100 percent for recipients.
The researchers admit that the reasons
for their findings remain unclear. They point out, however,
that while the donors' livers appeared to regenerate "at
a less vigorous pace," this may not have great clinical
significance. The liver's functional ability "was usually
completely normal in living donors by 1 week" after their
surgery, according to the paper.
"Patients who undergo a partial-liver
transplant or a partial hepatectomy offer ideal clinical models
for the study of liver regeneration," the investigators
comment. "Studies such as this are important to help
solve the mystery of liver regeneration and to ultimately
make partial-liver transplants safer for donors and more effective
for recipients."
SOURCE: Liver Transplantation, March
2004.
Back to top
Laboratory
Corporation of America® Holdings (LH) Announces U.S. Launch
Of Exclusive Liver Fibrosis Assay HCV FibroSURE
Source: PRNewswire
BURLINGTON, N.C. -- Laboratory Corporation
of America(R) Holdings (LabCorp(R)) today announced the availability
of HCV FibroSURE(TM), a noninvasive blood test for assessing
liver status in hepatitis C virus (HCV) patients. Developed
by leading hepatologists at the Pitie-Salpetriere Hospital
and BioPredictive in France, HCV FibroSURE(TM) is only available
in the United States through LabCorp.
HCV FibroSURE(TM) provides an easily accessible
alternative to liver biopsy, which physicians use to assess
liver fibrosis and necroinflammatory activity in HCV patients.
While liver biopsy has long been considered the gold standard
to monitor the status of HCV and determine therapy options,
it is an invasive procedure that carries a risk of serious
complications. HCV FibroSURE(TM) uses a combination of six
serum biochemical markers plus age and gender in a patented
algorithm to determine the degree of liver fibrosis and the
level of ongoing necroinflammatory activity. The test, which
has been clinically available in Europe for the past two years,
has been shown in several studies to enable quantitative,
reproducible assessment of fibrogenic and necrotic activity
in the liver of HCV patients.
"The launch of this important new
test once again validates LabCorp's strategy of creating a
world-class national laboratory with the best and broadest
array of diagnostic testing services," said Myla P. Lai-Goldman,
M.D., executive vice president, chief scientific officer and
medical director at LabCorp. "Our focus on bringing forth
innovative new technologies and tests, coupled with our scientific
expertise and national scope, helps us broadly deliver vital
new tools like BioPredictive's liver fibrosis assay to U.S.
physicians managing HCV patients."
BioPredictive is currently researching
clinical use of this test for other disease populations, including
hepatitis B, HIV-HCV, and alcoholic and non-alcoholic steato
hepatitis (NASH). "We anticipate that HCV FibroSURE(TM)
will prove to be just the first in a family of innovative,
noninvasive diagnostic testing products aimed at hepatitis
and non-hepatitis-related conditions," said Dr. Thierry
Poynard, a world-renowned hepatologist, head of Hepato-Gastrotroenterology
department in Pitie-Salpetriere Hospital in Paris, and researcher
and founder of BioPredictive. "We look forward to continuing
our relationship with LabCorp and building upon their expertise
in the world of hepatitis testing for future products."
HCV FibroSURE(TM) is recommended for use
to assess liver status following a diagnosis of HCV, as a
baseline determination of liver status before initiating HCV
therapy, as post-treatment assessment of liver status six
months after therapy completion, and for noninvasive assessment
of liver status in patients at risk of complications from
a liver biopsy. The blood sample for HCV FibroSURE(TM) can
be collected in minutes and results can be returned to the
physician within days. The test uses six biochemical markers
that are routine and considered standard of care in the United
States.
About BioPredictive
Founded at Paris University in 2002, BioPredictive is focused
on the study, design and development of medically important
biological tests. At the center of the company's scientific
efforts is the desire to improve disease management by replacing
invasive strategies with noninvasive alternatives. BioPredictive
has developed two noninvasive tests for chronic liver disease
- FibroTest and ActiTest. FibroTest is a biochemical marker
of liver fibrosis and ActiTest is a biochemical marker of
inflammation and necrosis of the liver. BioPredictive licenses
the FibroTest and ActiTest technology from Assistance Public-Hopitaux
de Paris (AP-HP). The company performs more than 2,000 tests
per month, and services 150 private and 12 public hospital
laboratories in France, Switzerland, Portugal, Morocco and
Mexico. To learn more about BioPredictive, visit the company
Web site at: http://www.biopredictive.com/.
FibroTest and ActiTest are available in
the U.S. exclusively through Laboratory Corporation of America(R)
Holdings (LabCorp) under the name HCV FibroSURE(TM).
About LabCorp
Laboratory Corporation of America(R) Holdings is a pioneer
in commercializing new diagnostic technologies and the first
in its industry to embrace genomic testing. With annual revenues
of $2.9 billion in 2003, approximately 23,000 employees nationwide,
and more than 220,000 clients, LabCorp offers over 4,400 clinical
assays ranging from blood analyses to HIV and genomic testing.
LabCorp combines its expertise in innovative clinical testing
technology with its Centers of Excellence: The Center for
Molecular Biology and Pathology, in Research Triangle Park,
NC; National Genetics Institute, Inc. in Los Angeles, CA;
ViroMed Laboratories, Inc. based in Minneapolis, MN; The Center
for Esoteric Testing in Burlington, NC; and DIANON Systems,
Inc. based in Stratford, CT. LabCorp clients include physicians,
government agencies, managed care organizations, hospitals,
clinical labs, and pharmaceutical companies. To learn more
about our growing organization, visit our Web site at: http://www.labcorp.com/.
Each of the above forward-looking statements
is subject to change based on various important factors, including
without limitation, competitive actions in the marketplace
and adverse actions of governmental and other third-party
payors. Actual results could differ materially from those
suggested by these forward-looking statements. Further information
on potential factors that could affect LabCorp's financial
results is included in the Company's Form 10- K for the year
ended December 31, 2003, and subsequent SEC filings.
Laboratory Corporation of America Holdings
CONTACT: Pamela Sherry of Laboratory Corporation of America
Holdings,+1-336-436-4855, or Shareholder Direct, +1-800-LAB-0401
Web site:
http://www.labcorp.com/
http://www.biopredictive.com/
Back to top
Valentis
Earns Milestone Payment from Genencor
Source: PRNewswire
BURLINGAME, Calif.--Valentis Inc. today announced that it
has earned a milestone payment from Genencor International,
Inc., which resulted from Genencor's initiation of subject
dosing in a Phase I clinical trial of its DNA-based therapeutic
vaccine to treat Hepatitis B. A Valentis polymer delivery
system, DNAVAX(TM), was incorporated as a part of the Genencor
therapeutic vaccine.
The Genencor Hepatitis B product is the
second product to enter clinical testing that incorporates
Valentis' DNAVAX(TM) vaccine delivery technology.
The DNAVAX technology has also been employed
in an HIV product, which is currently in clinical development
by Epimmune.
In an agreement dated July 9, 2002, Genencor
licensed non-exclusively Valentis' DNAVAX(TM) delivery technology
and related intellectual property rights on a worldwide basis
for DNA-based vaccines to treat or prevent hepatitis B (HBV)
and human papilloma virus (HPV) infections.
About Valentis
Valentis is creating innovative cardiovascular therapeutics.
The company begins its product development at the stage of
a validated target and applies its expertise in formulation,
manufacturing, clinical development and regulatory affairs
to create products that fill unmet medical needs.
Additional information about Valentis can
be found at http://www.valentis.com/.
This press release contains forward-looking
statements regarding the Company's DNAVAX(TM) delivery technology.
These statements are not guarantees of future performance
and are subject to certain risks, uncertainties and assumptions
that are difficult to predict. Factors that could cause actual
results to differ include the early stage of DNAVAX(TM) development,
uncertainties related to the timing of completing clinical
trials, and whether clinical trial results will validate and
support the safety and efficacy of any DNAVAX(TM) product.
Further, there can be no assurance that the necessary regulatory
approvals will be obtained or that any Valentis' licensee
will be able to develop commercially viable gene-based vaccines.
Actual results may differ from those projected in forward-looking
statements due to risks and uncertainties that exist in the
Company's operations and business environments. These risks
and uncertainties are described more fully in the Valentis
Annual Report on Form 10-K for the period ended June 30, 2003
and Quarterly Report on Form 10-Q for the period ended December
31, 2003, as filed with the Securities and Exchange Commission.
Forward-looking statements contained in this announcement
are made as of this date and will not be updated.
CONTACT: Joe Markey of Valentis, Inc.,
+1-650-697-1900, ext. 369, or http://www.valentis.com/
Back to top
March 18, 2004
Hemispherx
Biopharma (HEB) Completes Acquisition For Worldwide Rights
To Alferon N
Source: Business Wire
PHILADELPHIA--Company Closes Final Agreement
on GMP Certified Manufacturing Facility; Expects International
Sales to Begin During the Second Quarter
Hemispherx Biopharma, Inc. (AMEX: HEB -
News) announced today that it has completed the second and
final agreement with Interferon Sciences (ISI), including
the acquisition of all the worldwide rights on Alferon N®
as well as an FDA approved biological production facility
of 44,000 square feet located in New Brunswick, New Jersey.
On March 11, 2003, Hemispherx Biopharma
executed two agreements with Interferon Sciences to purchase
certain assets of ISI and consummated the first agreement.
In the first transaction, the Company acquired the inventory
of Alferon N Injection® and a limited license for the
production, manufacture, use, marketing and sale of the product.
In the second agreement, the Company acquired
all intellectual, proprietary and commercial rights to Alferon
N® and other assets related to the product including,
but not limited to, all real estate and machinery.
"We are excited that we have successfully
completed the transaction, which gives us complete ownership
of the Alferon N® technology," said Dr. William A.
Carter, Hemispherx's CEO and President. "The closing
of the agreement allows us to expand the Alferon N® Program,
which consists of Alferon N Injection®, Alferon N LDO®
and Alferon N Gel®, outside of the United States. We expect
to start clinical trials and generate sales with Alferon N®
internationally in the second quarter of this year."
About Alferon N®
Alferon N® (Interferon alfa-n3, human leukocyte derived)
is a highly purified, natural source, glycosylated, multispecies
alpha interferon product, composed of eight forms of high
purified alpha interferon. It is the only natural-source,
multispecies alpha interferon currently sold in the U.S. for
the treatment of refractory papilloma infections (HPV) and
is also approved for sale by various regulatory agencies worldwide.
About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical
company engaged in the manufacture and clinical development
of new drug entities for treatment of viral and immune-based
chronic disorders. Its flagship products include Alferon N®
and the experimental immunotherapeutics/antivirals Ampligen®
and Oragens(TM). These novel proteins, approved for a category
of STD infection, and experimental nucleic acids are being
developed for globally important chronic viral diseases and
disorders of the immune system including HPV, HIV, CFS and
Hepatitis. Its platform technology includes large and small
agent components for potential treatment of various chronic
viral infections. Hemispherx has approximately 400 patents
comprising its core intellectual property estate, a fully
commercialized product (Alferon N®) and GMP certified
manufacturing facilities for its novel pharma products. For
more information please visit www.hemispherx.net
Information contained in this news release
other than historical information, should be considered forward-looking
and is subject to various risk factors and uncertainties.
For instance, the strategies and operations of Hemispherx
involve risk of competition, changing market conditions, change
in laws and regulations affecting these industries and numerous
other factors discussed in this release and in the Company's
filings with the Securities and Exchange Commission. Any specifically
referenced investigational drugs and associated technologies
of the company (including Ampligen® and Oragens(TM)) are
experimental in nature and as such are not designated safe
and effective by a regulatory authority for general use and
are legally available only through clinical trials with the
referenced disorders. The forward-looking statements represent
the Company's judgment as of the date of this release. The
Company disclaims, however, any intent or obligation to update
these forward-looking statements. Only Clinical Studies under
well-controlled conditions can establish efficacy and safety
of any product. Clinical trials for other potential indications
of the approved biologic Alferon® do not imply that the
product will ever be specifically approved commercially for
these other treatment indications including SARS. The Alferon®
asset for overseas sales for a category of STD is currently
being acquired by the Company as part of a multi-step purchase
contract of inventory, intellectual property, commercial licenses
and GMP approved facilities, which house the biological operations.
Contact:
Hemispherx Biopharma, Inc. Investor Relations:
Dianne Will, 518-398-6222 ir@hemispherx.net
www.hemispherx.net
or CEOcast Cormac Glynn, 212-732-4300 cglynn@ceocast.com
Source: Hemispherx Biopharma, Inc.
Back to top
March 19th, 2004
Area Health
Care Workers Learn How To Combat Hepatitis C
New Orleans Site of First “Train
the Trainers” Event in the Southeast
NEW ORLEANS — With hepatitis C a
continuing health threat in the area, local health care professionals
and educators gathered Thursday and Friday for a comprehensive
training session designed to help them better combat this
potentially fatal disease.
Out of an estimated 4 million Americans infected with hepatitis
C, 80,000 live in Louisiana. Sixty-eight thousand state residents
will develop chronic hepatitis C. New Orleans has one of the
highest rates of the disease in Louisiana, which itself has
a higher rate than the national average.
“There are a lot of people in Louisiana
who are at high risk to contract hepatitis C, or who have
it and don’t know yet,” said Yolanda Criss with
Volunteers of America in Baton Rogue. “We’re working
to educate our community about hepatitis C and the importance
of being tested. This training helps me and my clients stay
up-to-date on the latest prevention techniques and treatment
options.”
“As a nurse practitioner, this gives
me more resources and information that I can share with my
patients. It’s also building relationships between individuals
who also have a passion for helping hepatitis C patients,”
said Renee Strickland, FNP, of the New Orleans HOPE-C Project.
The hepatitis C virus (HCV) is most often
spread by direct blood-to-blood contact, though transmission
from mother to child and between sexual partners is possible.
At higher risk are intravenous drug users who share needles,
persons who receive tattoos or piercings with unsterilized
equipment, and health care workers who come in contact with
HCV infected blood.
“Education is the key, both to treating
hepatitis C and to preventing infection in the first place.
We’re learning new things every day about how hepatitis
C spreads and how it can be treated, possibly even cured.
This training is designed to share that information with the
people who work directly with patients and those at risk of
infection,” said Alan Franciscus, executive director
of the Hepatitis C Support Project.
This is the first “Train the Trainers”
event in the Southeast United States. The national program
was created by the Hepatitis C Support Project based in San
Francisco and is supported by an unrestricted educational
grant from Roche Pharmaceuticals.
The training is being held at the No/AIDS
Task Force. Other local co-sponsors include the Louisiana
Office of Public Health Infectious Disease Epidemiology Program
and Siren to Wail.
Facts About Hepatitis C
• An estimated four million people
— 1.8 percent of all Americans — are infected
with hepatitis C virus (HCV). Eighty thousand of those live
in Louisiana.
• Seventy-one percent of individuals in Louisiana infected
with HCV are men.
• The rate of hepatitis C among African-Americans is
double the infection rate for Caucasians: 3.2 percent of African-Americans
have HCV, compared to only 1.5 percent of Caucasians. Among
African-American men age 40 to 49, the infection rate is 9.8
percent.
• Hepatitis C causes inflammation of the liver, with
damage building up over time. Hepatitis C can cause cirrhosis
of the liver and, if not treated, can be fatal.
• The most common symptoms of HCV infection include
feeling tired or fatigued and having flu-like symptoms, including
stomach problems.
• The hepatitis C virus (HCV) is most often spread by
direct blood-to-blood contact, though transmission from mother
to child and between sexual partners is possible.
• At higher risk are intravenous drug users who share
needles, persons who receive tattoos or piercings with unsterilized
needles and equipment, and health care workers who come in
contact with blood from an HCV infected person.
Tips for Preventing HCV Infection
• Don’t share needles or other
works for prescription or recreational drugs.
• Practice safer sex by using latex condoms.
• Don’t share personal items such as razors, nail
clippers, toothbrushes, or pierced earrings.
• Make sure tattoo or body piercing equipment is sterilized.
• Cover open sores or wounds.
If you think you have been exposed to hepatitis
C, talk to your doctor about getting tested.
Call the Louisiana Office of Public Health
Infectious Disease Epidemiology Program at (800) 256-2748
or Siren to Wail at (866) 891-4164 to learn more about local
HCV resources.
More information about preventing and treating
hepatitis C is available at www.hcvadvocate.org
MEDIA CONTACTS:
Alan Franciscus
Hepatitis C Support Project
(415) 286-0993 - mobile
Jack Martin
McNeely Pigott & Fox
(785) 550-3182 - mobile
Back to top
March 20th, 2004
Ex-Lab
Worker Says Faulty Results From HIV Tests Could Affect Thousands
Foster Klug
Source: Associated Press
Thousands of patients could have received
questionable HIV test results -- not just hundreds, as hospital
officials have suggested, according to a former lab worker
who says she believes she was infected in an accident involving
a faulty blood analyzer.
"Every single test that came off that
machine should be in question, from its first day in use,"
said Kristin Turner, a former lab worker at Maryland General
Hospital who is suing the hospital and the maker of the analyzer
for $30 million.
Turner said Friday she blames the machine
for an accident in 2003 that left her infected her with HIV
and hepatitis C.
Turner estimated that the machine conducted
an average of 150 tests weekly for HIV and hepatitis C and
B over 14 months -- about 8,400 tests.
The hospital has said 460 patients were affected, but on Thursday
announced plans to expand "outreach and retesting efforts."
Maryland General said it would also report the analyzer to
the Food and Drug Administration.
Turner said she sent a letter to city officials
after the accident, which led to a state investigation that
found 10 to 15 percent of the tests performed from June 2002
to August 2003 might have been inaccurate.
According to the state inspection report,
lab personnel manipulated and eliminated readings showing
completed blood tests might be inaccurate. The report said
workers at all levels allowed results to be reported even
when instrumentation and quality-control materials were used
improperly.
But Turner said the machine itself was
a problem. Technicians from Adaltis U.S. Inc., which made
the Labotech blood analyzer, were either contacted or sent
to the hospital several times a week because of malfunctions,
she said.
Within a week of being trained on the device,
in October 2002, Turner said her warnings and complaints were
ignored.
On the day Turner believes she was infected,
she said the analyzer issued one of its frequent error readings.
When she opened the machine, a loose part crashed onto a plate
carrying blood samples from about 30 patients, including some
with HIV and hepatitis C.
A large splash of blood hit her face, running
down under the top edge of her protective goggles into her
eyes, she said. It also dripped behind her protective mask,
into her nose and mouth.
Turner washed the blood out and rushed
to the emergency room, where she tested negative for HIV and
hepatitis C. She said she came down with a fever in June and
tested positive for both.
Last week, Turner, 32, filed a lawsuit
against Maryland General and Adaltis, seeking $30 million
in damages.
A spokesman for the FDA, Jason Brodsky,
declined to confirm that the department had received a report
from the hospital, but said such reports are investigated
thoroughly. He did not know if the FDA had received previous
complaints about the Labotech blood analyzer.
Representatives for the hospital and Adaltis
did not return telephone calls Friday from The Associated
Press.
Adaltis has installed more than 2,500 of
the Labotech machines, which can perform up to eight blood
tests simultaneously, according to the company's Web site.
On the Net:
Maryland General Hospital: www.marylandgeneral.org
Back to top
Back to News
Review |
