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Week Ending: July 23rd, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Hepatitis C Breakthrough May Save Lives
• Xtlbio Gets FDA Fast Track Designation for Hepatitis C Therapy
• Harney Apologises to Blood-Product Victim
• Judge To Rule by August Whether Doctor to Face Trial on Tainted Blood Charges
• Council Rejects Needle Exchange
• Gilead Sciences Announces Initiation of Phase III Clinical Program Evaluating Tenofovir Disoproxil Fumarate for the Treatment of Chronic Hepatitis B Virus
• Health Centers Mobilize Against a 'Silent Killer'
• InterMune and Array BioPharma Expand Hepatitis C Drug Discovery Collaboration
• Editorial: Hepatitis C Funds Not Reaching Target
• Insulin Pulses Keep the Liver Lean
• Denial of Hepatitis Treatment 'Cruel and Unusual,' Court Says
• Valeant Reports Positive Test Results
• Hepatitis C Caring Ambassadors Program Dismayed by Oregon Governor Ted Kulongoski's Veto of Hepatitis C Legislation
• Fury at Hepatitis C Decision
• Low Accelerating Dose Regimen Benefits Patients with Hep C
• Cirrhosis in Hep C Predicted with Standard Lab Tests
• Newcastle Researchers Join Search for Hep C Cure
• Abbott and Celera Diagnostics Announce CE Marking for HCV Real-Time PCR Viral Load Test
July 18th, 2005
Hepatitis C Breakthrough May Save Lives
SourceURL:http://www.hindustantimes.com
Scientists have for the first time produced an infectious form of the hepatitis C virus in the laboratory that is expected to lead to more effective treatments that could save millions of lives.
Hepatitis C, which like HIV is spread by blood and body fluids, can lead to chronic liver disease, cancer and death. But it can take many years to develop, and 80 per cent of infected people show no symptoms.
An estimated 170 million people around the world are affected by the disease.
Professor Charles Rice, from Rockefeller University in New York, who led the new research published today in the journal Science, said: "The inability to reproduce aspects of the hepatitis C virus life cycle in cell culture has slowed research progress on this important human pathogen."
Like all viruses, hepatitis C (HCV) cannot replicate by itself. Instead it takes over the machinery of a host cell to make copies of itself. But much about the life cycle of HCV remains poorly understood because scientists have been unable to reproduce an infectious form of the virus they can observe in cell cultures.
The virus enters liver cells before unloading genetic material and proteins.
HCV carries its genetic information in Ribonucleic acid (RNA) and not Deoxyribonucleic acid (DNA). This information is separated from the protein, copied, and joined with new protein components before being released to infect other cells.
The scientists named their infectious cell culture virus HCVcc.
Already, it is yielding new knowledge about the hepatitis C virus. In separate experiments, the researchers used HCVcc to confirm that a molecule that sits on the surface of human cells plays a crucial role in allowing the virus in.
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Xtlbio Gets FDA Fast Track Designation for Hepatitis C Therapy
SourceURL:http://www.globes.co.il
XTL Biopharmaceuticals' new drug would prevent hepatitis C re-infection following liver transplants.
XTL Biopharmaceuticals (LSE: XTL) today announced that it has received "fast track" designation from the US Food and Drug Administration for XTL-6865 (formerly known as HepeX-C).
Fast track designation is granted to facilitate the development and expedite the regulatory review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs.
XTL-6865 is being developed to prevent hepatitis C (HCV) re-infection following a liver transplant and for the treatment of chronic HCV disease.
The fast track designation was limited by the FDA to the post-transplant indication.
XTL Biopharmaceuticals interim non-executive chairman Michael Weiss said, “The designation of XTL-6865 as a fast track program recognizes the need for new forms of treatment for patients with recurrent HCV following a liver transplant.”
XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus E2 envelope protein. A single antibody version of this product was tested in a pilot clinical program that included both Phase I and Phase II clinical trials. In April 2005, XTL Biopharmaceuticals submitted a US investigational new drug application (IND) to the FDA in order to commence a Phase Ia/Ib clinical trial later this year for XTL-6865, the dual-monoclonal antibodies (mAb) product.
A biologics license application (BLA) is submitted before a drug is approved for marketing by the FDA. XTL Biopharmaceuticals noted that fast track designation gives it the opportunity to submit a BLA for XTL-6865 in sequential sections, and to have these sections reviewed as they are submitted. Fast track designation also opens the possibility for receiving a priority review or accelerated approval of the BLA where the review time at the FDA would be six months, further reducing the time to market.
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Harney Apologises to Blood-Product Victim
SourceURL:http://www.rte.ie/
An apology was read before the High Court today on behalf of Tánaiste and Minister for Health, Mary Harney, to a woman who contracted Hepatitis C from infected blood products.
Unknown to the woman, her blood was then used to make the Anti-D blood product.
Ms Harney said she was deeply sorry that failures in the health services should have had such terrible consequences and described what had happened to the woman and others as a 'major catastrophe'.
The apology was read in court following settlement of the woman's action for compensation.
No details of that settlement were disclosed. The woman was referred to as Patient X during hearings before the Finlay Tribunal into the Hepatitis C scandal.
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July 19th, 2005
Judge To Rule by August Whether Doctor to Face Trial on Tainted Blood Charges
SourceURL:http://news.yahoo.com
TARA BRAUTIGAM
TORONTO (CP) - A judge will rule by next month whether the doctor at the centre of the tainted blood scandal will face a year-long trial on negligence charges for his alleged role in what's considered to be the country's worst public health disaster in the last century.
Insinuations that Dr. Roger Perrault is using his ailing health as an excuse to try to avoid justice are erroneous, defence lawyer Eddie Greenspan argued Tuesday.
"It would be dead wrong to suggest that he is somehow trying to escape (a trial)," Greenspan said, adding that Perrault appreciates the enormity of the tragedy and if he were healthy would face the charges "in a New York minute."
Perrault, former national medical director of the Canadian Red Cross, is charged with four counts of criminal negligence causing bodily harm and one count of common nuisance endangering the public.
He is seeking to stay the charges - a process that would effectively withdraw them without presenting evidence - on the basis that stress arising from the rigours of trial could kill him.
The proceeding is expected to last 13 months and involve more than one million pages of documents.
"I am greatly concerned of my physical abilities . . . to participate in my defence," Greenspan quoted from Perrault's affidavit.
The 68-year-old suffered his first heart attack in 1980, and from there underwent a series of operations including angioplasty to unblock a coronary artery, bypass surgery, and emergency surgery for an aneurysm.
Perrault, who was not present at the hearing, has since changed his lifestyle to include daily afternoon naps and a reduced workload and travel schedule, Greenspan said.
But victims of the tainted blood tragedy, which left thousands infected with HIV and hepatitis C in the 1980s and early '90s, said it's bitterly ironic Perrault is arguing he is too ill to face court.
"His health situation pales in comparison to what the victims of this tragedy go through on a day-to-day basis," said John Plater, who contracted HIV and hemophilia from contaminated blood.
"The irony is overwhelming here."
James Kreppner, 43, echoed Plater's feelings.
"I've got a friend who died last year who was 25 years old," said Kreppner, who was infected with HIV and hepatitis C after a blood transfusion about 20 years ago.
"He'll never have a life, yet we got a doctor . . . saying, 'I shouldn't face the consequences.' "
Justice Mary Lou Benotto said Tuesday she would render her decision by early August.
More than 1,000 Canadians became infected with blood-borne HIV and up to 20,000 others contracted hepatitis C after receiving tainted blood products.
It's not clear how many people have lost their lives to tainted blood, but the death toll was 3,000 as of 1997.
Perrault, three other doctors and New Jersey-based Armour Pharmaceutical Co. are accused of allegedly allowing an HIV-infected blood-clotting product to be given to hemophilia patients.
It's alleged that Perrault and other officials with the Red Cross and Health Canada failed to screen blood products and take adequate measures to prevent people infected with HIV-AIDS from donating blood.
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Council Rejects Needle Exchange
The Republican (Springfield, Mass.)
Mike Plaisance
On Monday, the Springfield City Council rejected a plan to set up a needle-exchange program by a 5-4 vote. Needle exchange advocates framed the vote as a public health issue but concerns about the city condoning illegal drug use prevailed. In a nonbinding referendum in 1998, more than 60 percent of voters rejected a plan to create a needle exchange. Councilor Rosemarie Mazza Moriarty, who had raised proponents' hopes by saying Sunday that she was leaning toward voting yes on public health grounds, ultimately voted no. "I have not been able to convince myself that a city can support an illegal action," said Mazza Moriarty.
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Gilead Sciences Announces Initiation of Phase III Clinical Program Evaluating Tenofovir Disoproxil Fumarate for the Treatment of Chronic Hepatitis B Virus
SourceURL:http://biz.yahoo.com
FOSTER CITY, Calif.--(BUSINESS WIRE)--July 19, 2005--Gilead Sciences, Inc. (Nasdaq: GILD - News) today announced that it has begun enrolling patients in its Phase III clinical program evaluating the oral antiviral drug tenofovir disoproxil fumarate (tenofovir DF) for the treatment of chronic hepatitis B. Two Phase III clinical trials (Studies 102 and 103) will evaluate tenofovir DF among patients with either hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B or HBeAg-negative/anti-hepatitis B "e" positive (anti-HBe positive) chronic hepatitis B.
"Gilead has already brought to market Hepsera, an important antiviral for the treatment of chronic hepatitis B," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development, Gilead Sciences. "We are pleased to now initiate our second clinical program in this therapeutic area, underscoring our dedication to and investment in exploring new treatment options for hepatitis B."
Study Design
Studies 102 and 103 are randomized, double-blind trials that will compare the efficacy, safety and tolerability of tenofovir DF versus Gilead's Hepsera® (adefovir dipivoxil) over a 48-week period at more than 100 centers in 14 countries.
Study 102 will enroll approximately 300 patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B, with 200 patients receiving tenofovir DF (300 mg once daily) and 100 patients receiving Hepsera (10 mg once daily). Study 103 is designed to enroll approximately 240 patients with HBeAg-positive chronic hepatitis B, with 160 patients receiving tenofovir DF (300 mg once daily) and 80 patients receiving Hepsera (10 mg once daily).
The primary endpoint of both trials is the proportion of patients with a complete response at week 48, defined as a serum HBV DNA level below 400 copies/mL, and improvement in liver histology scores, which is defined as at least a two-point reduction in the Knodell necroinflammatory score without worsening in fibrosis.
About Tenofovir DF
Tenofovir DF is an oral, once-daily nucleotide analogue approved by the U.S. Food and Drug Administration in October 2001 for use in combination with other antiretroviral agents for the treatment of HIV infection, and is currently in development as a treatment for chronic hepatitis B. Tenofovir DF is believed to work by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.
The parent compound of tenofovir DF, tenofovir, was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium. The inventors have agreed to waive their right to a royalty on sales of products containing tenofovir in the Gilead Access Program countries to ensure the product can be offered at a no-profit price in parts of the world where the AIDS epidemic has hit the hardest.
About Hepsera
Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.
In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks up to a maximum of 109 weeks. Changes in serum creatinine were observed very commonly in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2004 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
Hepsera is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
Contact:
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Edgley, 650-522-5635 (Media)
Source: Gilead Sciences, Inc.
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Health Centers Mobilize Against a 'Silent Killer'
SourceURL:http://biz.yahoo.com
New National Initiative Targets Hepatitis C (HCV) Infection
WASHINGTON, July 19 /PRNewswire/ -- The National Association of Community Health Centers (NACHC), has launched a new initiative against the "silent killer" Hepatitis C (HCV), concentrating efforts through local health care centers and seeking to treat patients before they develop potentially life- threatening symptoms. Among the chronically infected, nearly 70% of patients will develop chronic liver disease, with Hepatitis C being the leading cause of liver transplants in the United States. Kicked off this week in Denver, Colorado, with a national HCV Educational Symposium for project participants, sponsored by The National Association of Community Health Centers (NACHC), the program is rolling out nationally to pilot programs in six U.S. cities.
HCV is described as a "silent epidemic" because most people who are infected will carry the virus for years without knowing it. The disease is responsible for an estimated 10,000 US deaths a year - a number that the Centers for Disease Control and Prevention (CDC) projects will double or triple as people infected decades ago develop more debilitating symptoms.
The Denver symposium lays the groundwork for select health centers throughout the country to develop aggressive clinical strategies against the disease. Working in conjunction with the Denver-based Liver Research Institute (LRI), NACHC will conduct pilot programs in six U.S. cities. After completing the program, health center clinical providers will have the capacity to treat HCV on-site at the patients' medical home. NACHC expects the on-site treatment will lead to improved adherence to the rigorous treatment protocol and enable more health center HCV patients to receive care.
"It is appropriate that the health centers are a staging area for the battle against HCV," stated Tom Curtin, MD, the Vice President for Clinical Affairs at NACHC. "Health centers have compiled an impressive record of success in the prevention and early detection of diseases over the last 40 years. They are uniquely designed for this intervention effort because they are community-based; they understand their patient population and, more importantly, the foundation necessary to conduct outreach and early intervention is already in place."
The Liver Research Institute (LRI) is committed to understanding the natural history of liver disease and the development and evaluation of new therapies. LRI is involved in educational activities to increase awareness and improve outcomes.
"We are excited to be working with NACHC to bring together both clinical expertise and practical tools for health centers in the fight against Hepatitis C," said Stephen Steinberg, MD, Medical Director of the Liver Research Institute.
The second phase of the project includes a three day training program guided by local HCV experts. The national HCV initiative provides select health centers with the state-of-the-art tools and clinical training to expand HCV early intervention and treatment. Each health center will receive clinical education and training, as well as resources to help integrate a treatment strategy in their existing clinical setting. Clinical teams from participating health centers include those from Miami, FL, Houston, TX, New York City, NY, Baltimore, MD, Los Angeles, CA, and Denver/Fort Lupton, CO.
The launch of the initiative comes as the CDC estimates that nearly four million Americans are infected by HCV, with new infections expected to grow at a rate of 30,000 a year. HCV sufferers can develop liver diseases that impair function, such as liver cancer or cirrhosis -- conditions that are ultimately fatal.
Health centers are the medical home to nearly 15 million Americans, many of whom are low-income and/or uninsured and at high risk for HCV infection. For more information about health centers or NACHC, visit http://www.nachc.com.
Established in 1971, NACHC is a non-profit organization whose mission is (1) to represent the interests of federally supported and other federally qualified health centers and (2) to serve as an information source concerning issues of health care for poor and medically underserved populations in the United States.
Source: National Association of Community Health Centers, Inc.
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InterMune and Array BioPharma Expand Hepatitis C Drug Discovery Collaboration
SourceURL:http://biz.yahoo.com/
BRISBANE, Calif. and BOULDER, Colo., July 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) and Array BioPharma Inc. (Nasdaq: ARRY - News) announced the extension and expansion of their current collaboration to discover and develop novel small molecule inhibitors of the Hepatitis C Virus (HCV) NS3/4 protease.
The program, which began in 2002, has produced several promising candidates that InterMune is advancing toward IND-enabling studies. In addition to extending the current agreement, the program has been expanded to allow Array and InterMune to enhance their combined discovery efforts. Array will continue to conduct process research and cGMP scale-up of drug candidates to support clinical development.
Under the terms of the agreement, InterMune will fund drug discovery, preclinical and process development at Array. InterMune maintains responsibility for clinical development and commercialization of the resulting products. Array will be entitled to receive milestone payments based on the selection and progress of clinical drug candidates, as well as royalties on net sales of products derived from the collaboration. In June 2004, Array received a milestone payment from InterMune for creating the first lead compound for this program. Other terms were not disclosed.
"We are pleased with the progress of our collaboration with Array," said Dan Welch, Chief Executive Officer and President of InterMune. "To date, this program has resulted in drug candidates which we believe have the potential to provide superior treatment for HCV patients. We have expanded the collaboration to accelerate the development of this important class of novel HCV inhibitors. In addition to our protease inhibitor program, we are advancing our late stage HCV pipeline in PEG-nonresponders and growing our marketed brand, Infergen® (interferon alfacon-1) for the retreatment of chronic HCV."
"We are excited to be working with InterMune on developing this important new class of therapeutics to treat HCV patients," said Robert E. Conway, Chief Executive Officer of Array. "In less than three years, our collaboration with InterMune, combining InterMune's therapeutic knowledge and Array's drug discovery expertise, has resulted in several novel therapeutic candidates."
According to the Centers for Disease Control an estimated 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. Protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4 protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.
About InterMune
InterMune is a biopharmaceutical company focused on developing and commercializing innovative therapies in hepatology and pulmonology. In addition to the currently marketed product indicated for the treatment of chronic hepatitis C virus (HCV) infections, three-times-a-week Infergen® (interferon alfacon-1), InterMune has a broad and deep late-stage product portfolio addressing HCV infections, particularly nonresponders, or those patients who do not respond to first-line therapy, and idiopathic pulmonary fibrosis (IPF). Leading the hepatology portfolio is the DIRECT Trial, a Phase III study of daily Infergen plus ribavirin, and a Phase IIb trial of daily Infergen plus Actimmune® (interferon gamma-1b) with and without ribavirin for the treatment of HCV patients who do not respond to first-line therapy. In addition, InterMune has an early stage small molecule program targeted at the HCV protease. The pulmonology portfolio includes pirfenidone and Actimmune. Pirfenidone is being developed for the treatment of IPF. Actimmune is being evaluated in the INSPIRE Trial, a Phase III study in patients with IPF. For additional information about InterMune and its development pipeline, please visit www.intermune.com.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat life threatening and debilitating diseases. Array's proprietary drug development pipeline is focused on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important targets. In addition, leading pharmaceutical and biotechnology companies access Array's drug discovery technologies and expertise through collaborations to design, create, optimize and evaluate drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.com.
InterMune's Forward-Looking Statement
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to anticipated future financial results and product development. All forward- looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's Form 10-Q filed with the SEC on May 10, 2005 and other periodic reports filed with the SEC, including the following: (i) the risk that if physicians do not prescribe Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, or if patient referral rates continue to decline, InterMune's revenues will decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF; (iii) risks related to potential increases in Infergen sales; (iv) reimbursement risks associated with third-party payors; (v) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (vi) risks related to significant regulatory, supply and competitive barriers to entry; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (viii) risks related to achieving positive clinical trial results; (ix) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-Q report and InterMune's other periodic reports filed with the SEC.
Array BioPharma's Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties, including those discussed in our annual report filed on form 10-K for the year ended June 30, 2004, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties for their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet drug objectives, including clinical trials, tied to milestones and royalties, and our ability to attract and retain experienced scientists and management. We are providing this information as of July 19, 2005. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.
Source: InterMune, Inc.; Array BioPharma Inc.
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July 20th, 2005
Editorial: Hepatitis C Funds Not Reaching Target
SourceURL:http://www.thestar.com
When government ministers make commitments, during elections or otherwise, an increasingly cynical public usually waits for the other shoe to drop -- to learn, in fact, that the promise was only partially addressed or perhaps not addressed at all.
So Health Minister George Smitherman has some explaining to do about his promise almost a year ago that "every penny" of $132.6 million from the federal government would go to the care and treatment of those who contracted hepatitis C from tainted blood.
The federal government set up a $300 million fund in 1998 for hepatitis C victims who fell outside the 1986-1990 period, in which governmental liability was so clear it was barely contested.
While those in the 1986-1990 period received outright cash compensation, the $300 million fund was characterized as "care instead of cash." In other words, hepatitis C sufferers could expect some additional supports -- short of monetary -- to manage their health.
John Plater, chair of a task force set up by Smitherman, states plainly that none of the money -- Ontario's share is $132.3 million, with $66.3 million already received -- has directly benefited hepatitis C victims.
In fact, Plater believes Ontario and other provinces have simply ploughed the federal money into their existing health-care budgets.
"As far as I'm concerned, no one ever saw a dime anywhere in the country from the `care instead of cash' fund that they wouldn't have been ... entitled to as a citizen of this country," Plater said.
Smitherman has only bolstered Plater's claim in a recent statement, agreeing that "all provinces in Canada have treated those dollars in exactly the same way."
Plater also points out that Ontario's share of the $300 million is about the same amount the province contributed to the federal compensation program for tainted blood victims between 1986 and 1990. In other words, it is a fiscal wash.
The provincial health ministry released a report last fall noting it spent $82.5 million between January 2002 and January 2004 covering a range of medical services and treatments for those with hepatitis C. That may be true, but Plater's point is still valid: those afflicted received no more help than they would expect to receive as residents of Ontario.
So while ministry officials can make a case on technical grounds, they need to remember they are dealing with human beings living with a debilitating condition that will eventually rob many of them of their lives.
With his "every penny" boast exposed as a sham, Smitherman can still make amends. Plater notes that those with hepatitis C face long waits to see hematology specialists, that they pay for costly nutritional supplements out of their own pockets and that access to complementary therapies, like massage, could help improve the quality of their lives.
Minister Smitherman, it is time to start spending those pennies.
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Insulin Pulses Keep the Liver Lean
SourceURL:http://www.eurekalert.org/
Insulin, a hormone long recognized as a generator of fat, also keeps fat in the liver under control, according to a new study in the July issue of Cell Metabolism. The newly discovered role for insulin may explain how an organ frequently flooded with the fat-building hormone normally stays trim and also suggests new dietary strategies and treatments to avoid fatty liver, a growing healthcare epidemic, said the researchers.
Insulin produced by the pancreas allows cells to take up glucose from the bloodstream and burn it for energy. In the liver, insulin promotes the synthesis and storage of lipids and carbohydrates and blocks their breakdown and release into the bloodstream. A failure to make or respond to insulin in people with diabetes causes blood sugar levels to rise.
The current study uncovered a new mechanism whereby acute insulin pulses limit fat synthesis in the liver. This protective mechanism fails in obese mice and mice with persistently high levels of insulin, the researchers also found.
The findings suggest that periods of fasting between meals play a critical role in maintaining a lean and healthy liver by allowing insulin levels to rise and fall, said study lead author Sonia Najjar of the Medical University of Ohio.
Furthermore, she said, the results emphasize the central role of the liver in metabolic control. A liver overwhelmed with insulin--as can occur in those who overeat--may become resistant to the hormone, leading to greater fat production and visceral weight gain. Resulting hikes in blood sugar and fat can also spell diabetes and heart disease, Najjar added.
"When we eat, the pancreas produces insulin, which stimulates the absorption of sugar and fat by the liver," Najjar said. "But in today's Western society, large portions and frequent munching may lead insulin levels to remain high all the time. In that case, the liver no longer perceives pulses of the hormone and becomes resistant."
The researchers found that insulin pulses acutely reduce the activity of fat-building fatty acid synthase (FAS) in the liver by activating a second liver molecule, called CEACAM1. In mice lacking CEACAM1, insulin lost its ability to limit liver FAS activity. Obese mice and those with too much insulin also failed to exhibit a reduction in liver FAS activity following insulin delivery, suggesting that insulin's effects depend on prior levels of the hormone, the researchers reported.
"The current data demonstrate that CEACAM1 is at the intersection of the pathways regulating insulin and fat metabolism in liver," Najjar said.
"Although mutations in CEACAM1 have not been found in patients with diabetes or insulin resistance, it is tempting to speculate that CEACAM1-dependent inhibition of fatty acid synthesis might be compromised as a consequence or even a cause of the insulin-resistant state," wrote Alan Saltiel of the University of Michigan in an accompanying preview. In this case, he added, finding ways to mimic the effects of CEACAM1 might help to alleviate chronically elevated blood and liver lipids in patients with diabetes.
The researchers include Sonia M. Najjar, Yan Yang, Mats A. Fernström, Sang-Jun Lee, Anthony M. DeAngelis, George A. Abou- Rjaily, Qusai Y. Al-Share, Tong Dai, Tiffany A. Miller, Shobha Ratnam, Randall J. Ruch, and Ana Maria Oyarce of the Medical University of Ohio, Toledo, Ohio; Stuart Smith of Children's Hospital Oakland Research Institute, Oakland, California; Sue-Hwa Lin of the University of Texas M.D. Anderson Cancer Center, Houston, Texas; Nicole Beauchemin of the McGill Cancer Center, McGill University, Montreal, Quebec, Canada. This work was supported by ADA research award and NIH grants, and by the Canadian Institutes for Health Research.
Najjar et al.: "Insulin acutely decreases hepatic fatty acid synthase activity." Cell Metabolism, Vol. 2, July 2005, pages 43-53. DOI 10.1016/j.cmet.2005.06.001. www.cellmetabolism.org
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Denial of Hepatitis Treatment 'Cruel and Unusual,' Court Says
Journal News (Westchester County, N.Y.)
Bill Hughes
A recent ruling by a New York panel of judges said prison officials' denial of medical treatment for a Sing Sing inmate with hepatitis C amounted to "cruel and unusual punishment in violation of the Eighth Amendment." Four judges of the state Supreme Court's Appellate Division unanimously upheld a May 2003 order by state Supreme Court Justice Mary Smith directing prison officials to provide medication for the inmate, whose condition was diagnosed in February 2002.
The prisoner has been incarcerated since 1999, serving a 16-year maximum sentence for attempted murder. Prison officials directed the inmate to participate in an intensive six-month drug-treatment program in order to receive treatment for hepatitis. After two weeks, the prisoner dropped out of the program, saying he had not used drugs for 30 years, the program contained no useful information about his medical condition, and it disrupted his educational classes and work schedule. The prisoner filed an inmate grievance in May 2002 and a lawsuit on his own behalf after the grievance was denied.
Prison officials refused to provide the prisoner medication while Smith's ruling was appealed. James Flateau, a spokesperson for the state Department of Correctional Services, would not comment on the case while the department reviews whether to appeal the latest Court of Appeals ruling.
Correction officials said the prisoner's admission to prior use of drugs and alcohol and his refusal to stay in the drug-treatment program justified their withholding medication, despite a doctor having written the inmate a prescription for interferon in September 2002.
In her ruling, Smith wrote that while there were limitations to treatments available for hepatitis C, "this court finds no treatment at all to be repugnant to our standards of decency."
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Valeant Reports Positive Test Results
http://www.ocbj.com/
By Vita Reed
Orange County Business Journal Staff
Hepatitis B Candidate is Among Company's Late-State Drugs
Valeant Pharmaceuticals International of Costa Mesa said Tuesday a drug to treat hepatitis B showed positive results in the second-phase trials.
The company's pradefovir showed a significant decline in viral load, or the amount of the virus in a patient’s DNA, without evidence of kidney tissue damage, Valeant said.
The study involved 242 patients from the U.S. and three other countries, Valeant said, noting that around half the patients were previously treated ineffectively with other drugs.
“If the clinical results continue to be successful, pradefovir could provide physicians with a new treatment alternative that will significantly improve patient outcomes,” Chief Executive Timothy Tyson said.
If effective, Pradefovir could become a player in the worldwide hepatitis B market, which is estimated to reach $2.8 billion worldwide by 2012. Some 2 billion people have the potentially fatal liver disease. Of those, around 400 million are estimated to be chronically infected.
Pradefovir is one of Valeant’s late-stage drug candidates, which also include viramidine, a next-generation treatment for hepatitis C, and Zelapar, a drug for Parkinson’s disease, a nerve disorder.
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Hepatitis C Caring Ambassadors Program Dismayed by Oregon Governor Ted Kulongoski's Veto of Hepatitis C Legislation
SourceURL:http://home.businesswire.com/
OREGON CITY, Ore.--(BUSINESS WIRE)--July 20, 2005--The Hepatitis C Caring Ambassadors Program (HCCAP) announced that they had received notification on July 19th from the office of Oregon Governor Ted Kulongoski that he had vetoed hepatitis C legislation overwhelmingly passed by both the Oregon House and Senate. The legislation, HB 2480, would have prevented the Oregon Department of Human Services from restricting the drugs available to patients with hepatitis C covered by the Oregon Health Plan's fee-for service program. The bill was introduced in February 2005 at the request of the Hepatitis C Caring Ambassadors Program, a national nonprofit hepatitis C education and advocacy organization based in Oregon City, Oregon. Existing statutory limitations are already in place to prevent the Oregon Department of Human Services from restricting patient access to potentially life-saving drugs used to treat other life-threatening diseases including cancer, HIV/AIDS, and mental illnesses. Governor Kulongoski's veto of HB 2480 is particularly remarkable given the overwhelming support for the bill in the Oregon legislature. HB 2480 was approved with 41 ayes to 15 nays in the House, and 27 ayes to 1 nay in the Senate, demonstrating the strong bipartisan support for the bill. Governor Kulongoski reportedly began talk of vetoing HB 2480 in early February 2005, long before the bill reached the floor of the House or the Senate.
Hepatitis C is the most common chronic, blood-borne viral infection in the United States. Hepatitis C is the leading cause of chronic liver disease in the U.S., which now ranks among the top ten killers of adults over the age of 25 years. An estimated 3.9 to 4.5 million Americans have been infected with the hepatitis C virus including at least 64,000 Oregonians. The current methamphetamine crisis is likely to fuel an expanding hepatitis C epidemic in Oregon, a startling backdrop to Governor Kulongoski's veto of HB 2480.
Hepatitis C Caring Ambassadors Program Manager Lorren Sandt stated, "We are deeply distressed by Governor Kulongoski's use of his executive power to exercise his minority opposition to HB 2480. Like cancer and HIV/AIDS, chronic hepatitis C is a life-threatening illness. Medical treatment decisions to optimize care for illnesses that threaten both individual lives and the overall health and safety of the public should be made on a case-by-case basis by treating physicians, not a political bureaucracy. The Governor's veto of HB 2480 has dealt a blow to all Oregonians, not just those currently infected with hepatitis C. All people with hepatitis C should have access to the drugs that are most likely to be effective, regardless of the source of payment. But with the Governor's veto of HB 2480, hepatitis C patients receiving care under the Oregon Health Plan's fee-for-service program are now in a position to have to take whatever drugs the state deems they can have access to."
The Hepatitis C Caring Ambassadors Program will continue efforts to inform state and national policy-makers about the urgent personal and public health threats posed by the hepatitis C epidemic. Hepatitis C Caring Ambassadors Program Medical Director, Dr. Tina M. St. John, stated, "While we must respectfully agree to disagree with Governor Kulongoski on his veto of HB 2480, we will continue to work with the governor, the state legislature, and the Oregon Department of Human Service to ensure optimized care for all Oregonians with chronic hepatitis C, and to fully implement effective hepatitis C control and prevention."
For additional information about the Hepatitis C Caring Ambassadors Program (HCCAP), contact Lorren Sandt at 1-877-737-4372 or lorren@hepcchallenge.org, or visit HCCAP online at www.hepcchallenge.org.
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Fury at Hepatitis C Decision
SourceURL:http://www.eveningnews24.co.uk
Hepatitis C sufferers are furious that the introduction of a Government-backed action plan to help victims of the disease and prevent more infections has been halted.
Norwich Primary Care Trust has revealed it does not plan to implement the Hepatitis C Action Plan for England in the city because it does not have the cash.
The move has left city sufferers such as Anne Walker and Michael Colyer extremely concerned about the pending explosion in Hepatitis C and angry their efforts to roll out the plan have been wasted.
The action plan would have involved more publicity about the risks and symptoms of the disease, more screening and easier access to treatment.
But Alastair Roy, chief executive of Norwich Primary Care Trust, wrote in a letter to Norwich South MP Charles Clark in June: "I am sorry to say that I am still unable to give you a firm commitment to the action plan at this time. If the situation changes in the near future I will contact you again."
Mr Colyer, of Colman Road, who spearheaded the campaign to get the Department of Health-backed campaign rolled out, said: "I am appalled by this. We had created a second draft of the action plan and now it's stymied."
The 54-year-old haemophiliac was infected with Hepatitis C after receiving contaminated blood products through the NHS in the 1960s or 1970s.
He organised a meeting in November with Norwich Primary Care Trust, the other primary care trusts in Norfolk and organisations to get the project off the ground.
He said: "The action plan would have meant we would have been able to kick start the process of gathering data on people in Norfolk which no-one has done yet."
He said it would also have led to more screenings of possible carriers of the disease.
He said he was amazed the virus was 16 years old and still nothing was done when it was suspected there were 5,000 people in Norwich with the illness.
"The message is not getting through. Ninety per cent of those infected have used drugs in the past such as cocaine or drugs injected through needles." He said others at risk were nurses and healthcare workers who had needle stick injuries and people with tattoos, pierced ears and those like him who had had blood transfusions prior to 1991.
"This is a time bomb already going off because of the lack of action. The implications are awful because of the effect it is going to have on the lives of people who fall ill and it's going to be an enormous drain on the NHS. The Government can either pay out now to prevent it or they can pay for treatment."
Co-founder of the Norwich C Hepatitis Group, Ms Walker, 50, said: "I can't believe after all the efforts the professionals have put into it that it's not being put into action. It seems as though the liver is always put at the bottom of the list. I can't understand it because in 10 years' time there is going to be a huge demand for livers when people realise they have got Hepatitis C. We are so sick of nothing happening."
Ms Walker was infected with Hepatitis C in 1974 when she had a routine NHS blood transfusion.
Alastair Roy, chief executive of Norwich Primary Care Trust, said: "We recognise this as an important element in disease prevention along with a range of other initiatives.
"This financial year we are concentrating on avoiding hospital acquired infections and full implementation of the Norfolk wide Hepatitis C policy will be considered with other initiatives for the next financial year."
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Low Accelerating Dose Regimen Benefits Patients with Hep C
SourceURL:http://www.gastrohep.com
In a sizeable proportion of patients with advanced hepatitis C, low accelerating dose regimen may render blood free of hepatitis C RNA, stabilize clinical course, and prevent posttransplantation recurrence, finds the latest issue of Hepatology.
Patients with advanced hepatitis C virus are at risk of death and are candidates for liver transplantation.
After transplantation, hepatitis C recurs and may rapidly progress to cirrhosis and graft loss.
Treatment is needed to prevent progression of disease and minimize recurrence after liver transplantation.
Dr Everson and colleagues from Denver of antiviral therapy in the treatment of patients with advanced hepatits C.
The researchers evaluated the effectiveness, tolerability, and outcome of a low accelerating dose regimen.
The research team treated 124 patients, of which 81 were male between the ages of 37 and 71 years, with low accelerating dose regimen.
Sustained virological response was 13% in patients infected with genotype 1 hepatitis C – Hepatology
The team reported that 63% had clinical complications of cirrhosis including ascites, spontaneous bacterial peritonitis, varices, variceal hemorrhage, and encephalopathy.
The mean Child-Turcotte-Pugh score was 7, and the mean MELD score was 11.
The team noted that 56 patients were Child-Turcotte-Pugh class A, 45 were class B, and 23 were class C.
The researchers observed that 46% were hepatitis C RNA-negative at end of treatment, and 24% were hepatitis C RNA-negative at last follow-up.
Sustained virological response occurred in 13% of patients infected with genotype 1 hepatitis C and 50% in patients infected with non-1 genotypes.
The researchers noted that with non-1 genotype, Child-Turcotte-Pugh class A, and ability to tolerate full dose and duration of treatment were predictors of sustained virological response.
In addition, the team found that 12 of 15 patients who were hepatitis C RNA-negative before transplantation remained hepatitis C RNA-negative 6 months or more after transplantation.
Dr Everson's team concludes, “In a sizeable proportion of patients with advanced hepatitis C, low accelerating dose regimen may render blood free of hepatitis C RNA, stabilize clinical course, and prevent posttransplantation recurrence.”
Hepatology 2005: 42(2): 255-62
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July 21st, 2005
Cirrhosis in Hep C Predicted with Standard Lab Tests
SourceURL:http://www.gastrohep.com
Research in the latest Hepatology shows that a model based on standard laboratory test results can be used to predict histological cirrhosis with a high degree of accuracy in 50% of patients with chronic Hepatitis C.
Knowledge of the presence of cirrhosis is important for the management of patients with chronic Hepatitis C.
Most models for predicting cirrhosis were derived from small numbers of patients and included subjective variables or laboratory tests that are not readily available.
Dr Anna Lok and colleagues developed a predictive model of cirrhosis in patients with chronic Hepatitis C based on standard laboratory tests.
The investigative team analyzed data from 1141 chronic Hepatitis C patients including 429 with cirrhosis.
All biopsies were read by a panel of pathologists, who were blinded to clinical features, and fibrosis stage was determined by consensus.
A cutoff greater than 0.5 to confirm cirrhosis will misclassify 15% of patients without cirrhosis – Hepatology
The team divided the cohort into a training set including 783 patients and a validation set, which included 358 patients.
Variables that were significantly different between patients with and without cirrhosis in univariate analysis were entered into logistic regression models.
The investigative team compared the performance of each model.
The final model comprised of platelet count, the alanine aminotranferease/aspartate aminotransferase ratio, and the international normalized ratio for blood coagulation.
The investigators found that the area under the receiver-operating characteristic curve of the final model in the training set was 0.78 vs 0.81 in the validation set.
The team noted that a cutoff of less than 0.2 to exclude cirrhosis would misclassify only 8% of patients with cirrhosis.
However, a cutoff of greater than 0.5 to confirm cirrhosis would misclassify 15% of patients without cirrhosis.
The investigators observed that the model performed equally well in fragmented and nonfragmented biopsies and in biopsies of varying lengths.
The team noted that use of this model might obviate the requirement for a liver biopsy in 50% of patients with chronic Hepatitis C.
Dr Lok's team concludes, “A model based on standard laboratory test results can be used to predict histological cirrhosis with a high degree of accuracy in 50% of patients with chronic Hepatitis C.”
Hepatol 2005: 42(2): 282-92
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Newcastle Researchers Join Search for Hep C Cure
SourceURL:http://www.abc.net.au
Researchers at Newcastle's John Hunter Hospital are involved in a new nationwide clinical trial examining ways to boost the cure rates for people with hepatitis C.
The study, which involves 33 hospitals across Australia, is based on the introduction of a new drug dosing regime to attack a particularly resistant strain of the virus in the early stages of treatment.
So far around 12 Newcastle patients have been recruited for the project.
Hunter-New England Health's area director of drug and alcohol clinical services, Doctor Robert Batey, says the incidence of hepatitis C could be significantly reduced if the trial is successful.
"With genotype 1 you only get around a 50 per cent success rate," Dr Batey said.
"With our current approach and if you could get the success rate higher more people might come forward for treatment and that would therefore decrease the pool of infected people and risks to others for further spread of the disease."
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July 22nd, 2005
Abbott and Celera Diagnostics Announce CE Marking for HCV Real-Time PCR Viral Load Test
SourceURL:http://biz.yahoo.com/
- Highly Sensitive Molecular Test Provides Valuable Tool for Measuring HCV in Serum and Plasma, Helping Physicians to Effectively Manage Patient Therapy -
DELKENHEIM, Germany, July 22 /PRNewswire-FirstCall/ -- Abbott and Celera Diagnostics, a joint venture between the Applied Biosystems Group and Celera Genomics Group of Applera Corporation, today announced that Abbott has received CE Mark certification for a real-time PCR (polymerase chain reaction) test for monitoring hepatitis C (HCV) viral load in patients, allowing the test to be marketed in the European Union. This test is not available or approved for use in the United States.
Quantitative measurements of HCV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of HCV infected individuals. An initial measurement of HCV viral load can guide a decision to begin antiviral therapy, while monitoring HCV RNA levels during therapy can influence its duration.
The Abbott RealTime(TM) HCV assay has been developed for use on the Abbott m2000(TM) system, an automated instrument using real-time PCR technology provided by Applied Biosystems.
"One of the key impediments of molecular testing we've addressed with the Abbott m2000 system is the complex and heavily manual procedures required, from the preparation of patient samples to the analysis of data," said Edward Michael, president, Abbott Molecular. "By taking automation to another level, we're helping molecular laboratories deliver patients' test results faster, easier and more accurately."
The Abbott m2000 system purifies the nucleic acid (RNA) from the specimen and automatically combines this with the assay reagents. The system's software has been specifically designed to be user-friendly and data are automatically calculated to provide highly reliable patient results for HCV viral load testing. In real-time PCR, the amplified DNA sequences are detected throughout the PCR process, instead of at the end of the amplification process. The instrument and reagents allow laboratories to provide highly accurate test results more quickly, increase productivity and help reduce human error, resulting in consistent and reproducible results.
"The Abbott RealTime HCV assay builds upon Abbott's 34 years of experience in hepatitis diagnostics and provides another level of confidence in testing for laboratories, physicians and patients," said John Robinson, Ph.D., director of research and development, Abbott Molecular. "It is among the most sensitive viral load tests available today, with a broad dynamic range, capable of detecting HCV RNA in plasma down to as few as 12 IU (international units) of HCV RNA per milliliter. With a broad dynamic range that quantitates (precisely measures HCV levels) specimens as high as 100 million IU of RNA per milliliter, the need for sample dilutions and additional testing is virtually eliminated."
"Given the reproducibility and precision of this test to quantitate HCV RNA levels across a broad dynamic range, physicians can be confident about assessing viral levels in their patients and determining the most appropriate course of therapy," said Carsten Tiemann, Ph.D., director, molecular diagnostics, Laboratory Dr. Krone & Partner, Germany.
In June, Abbott and Celera Diagnostics announced CE Mark certification of the Abbott RealTime HIV-1 assay for the Abbott m2000 system. Additional tests are in development for the system, including methods for detecting hepatitis B, chlamydia and gonorrhea.
"The CE certification of both our HIV-1 and HCV real-time assays represents an important step in our commitment to enhancing molecular testing through a growing portfolio of automated assays," said Kathy Ordonez, president, Celera Diagnostics. "Reliable and accurate quantitation of HIV-1 and HCV are an integral part of the disease management process. We believe that our exclusive partnership with Abbott in molecular diagnostics continues to deliver products that improve the capacity and sensitivity in clinical testing, enabling medical practitioners to make better choices in therapeutic selection that improve outcomes for patients."
Hepatitis C is a bloodborne pathogen and a frequent cause of chronic viral hepatitis in the world. The World Health Organization estimates that more than 170 million people worldwide are infected with hepatitis C. Often called the "silent epidemic," many individuals infected with the virus have no signs or symptoms of the disease until chronic infection or chronic liver disease has developed. Additionally, there is no vaccine to prevent HCV.
About Real-Time PCR
Real-time PCR is a modification of standard PCR, which is often compared to the photocopying of nucleic acid (DNA or RNA). The process involves the alternate heating and cooling of a small sample containing a segment of nucleic acid molecules dozens of times over several hours. Throughout this process, copies of these DNA molecules are "amplified" or exponentially increased so that the nucleic acid can be more readily analyzed. The method is called "real-time PCR" because the amplified DNA can be detected during the PCR process, in real time, rather than at the end of the process. This ensures more accurate and precise quantification of nucleic acid. The real-time PCR reaction proceeds automatically with no user intervention, providing increased productivity and reduced opportunity for human error, resulting in consistent and reproducible results.
About the Abbott/Celera Diagnostics Alliance
In 2002, Abbott and Celera Diagnostics, a joint venture between the Applied Biosystems Group and the Celera Genomics Group of Applera Corporation, entered into a long-term strategic alliance to develop, manufacture and market a broad range of in vitro molecular diagnostic products for disease detection, disease progression monitoring and therapy selection. The alliance develops and commercializes molecular diagnostic products to detect and manage infectious diseases and chronic conditions including autoimmune and cardiovascular diseases, central nervous system disorders and cancer. Celera Diagnostics' focus is primarily on assay development and genetic marker discovery and validation. Abbott's focus is on product development and sales and marketing, serving as the worldwide distributor for most products developed by the alliance.
About Celera Diagnostics and Applera Corporation
Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2004. The Celera Genomics Group is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com , or by telephoning 800.762.6923. Information about Celera Diagnostics is available at http://www.celeradiagnostics.com .
About Abbott
Abbott (NYSE: ABT - News) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available at the company's web site at http://www.abbott.com.
Applera Corporation's Forward-Looking Statement
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward- looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) uncertainty that the Abbott RealTime(TM) HIV-1 assay or the m2000 system will be accepted by the market, including the risk that these products will not be competitive with products offered by other companies; and (2) other factors that might be described from time to time in Applera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Abbott's Forward-Looking Statements
Private Securities Litigation Reform Act of 1995 -
A Caution Concerning Forward-Looking Statements
Comments will be made that are forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Exhibit 99.1 of our Securities and Exchange Commission Form 10-Q for the period ended March 31, 2005, and are incorporated by reference. We undertake no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
Source: Abbott
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