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Latest News March 2002
America's Blood Centers Supports FDA Approval Of Nucleic Acid Testing
Thu Feb 28, 6:55 PM ET
WASHINGTON, Feb. 28 /U.S. Newswire/ -- America's Blood Centers, an international network of community blood centers that collect nearly half of the U.S. blood supply and a quarter of the Canadian blood supply, applauds today's announcement from the U.S. Food and Drug Administration (news - web sites) approving the licensure of NAT testing, a new gene-based, blood testing system which has been used in an FDA-approved study over the last three years to add an extra layer of safety when screening the blood supply for HIV (news - web sites) and Hepatitis C.
America's Blood Centers' members began using NAT testing in 1999, when the FDA allowed its use under a research study called an Investigational New Drug protocol. The goal of this study has been to determine the effectiveness of NAT testing for wide scale use by the entire blood banking community. To date, seven HIV and 88 HCV positive blood samples have been detected using the new screening system.
"NAT testing has truly been a breakthrough for the blood banking community," said Celso Bianco, M.D., executive vice president and medical director of America's Blood Centers. "This is an important milestone because it now means this powerful research tool is officially recognized as improving blood safety. This is especially important for the 4.5 million Americans who receive life-saving blood transfusions every year. We are pleased that the FDA has licensed the test."
NAT testing has reduced the window period, or number of days between the time that a person contracts HIV or HCV and when the viruses can be detected using current FDA-approved antibody and antigen tests, called serological tests. Using serological tests, the window period for HIV is 16 days. With NAT, it is now 12 days. The window period for HCV using serological testing was about 72-82 days, but it is down to 25 days with NAT testing.
Members of America's Blood Centers have screened more than 30 million donations using NAT testing, which is conducted at 16 laboratories geographically dispersed nationwide. Approximately 35 percent of the blood collected by members of America's Blood Centers is screened by the Chiron Corporation test that today received FDA approval. The remainder is screened by Roche Diagnostics test under an FDA approved research protocol. The largest providers of blood products and services, America's Blood Centers' members are located in 45 states and Canada, serving more than 125 million people at 450 blood donation sites. For 40 years, America's Blood Centers' members have been committed to serving the needs of their local communities by saving lives through volunteer blood donation. Our members were also the first to respond to national tragedies like Oklahoma City, Columbine and September 11th.
For more information on America's Blood Centers or NAT testing, please call America's Blood Centers toll-free at 1-888-USBLOOD or visit our Web site at www.americasblood.org.
ICN Pharmaceuticals Defends Ribavirin Patent
COSTA MESA, Calif., March 1 /PRNewswire-FirstCall/ -- ICN Pharmaceuticals, Inc. (NYSE: ICN - news) today released the following response regarding potential infringement on its ribavirin patent:
There have been questions raised in recent days about our patent position with respect to the use of ribavirin in combination with interferon alpha or pegylated interferon for use in the treatment of hepatitis C.
Last year three companies filed Abbreviated New Drug Applications challenging ribavirin patents. Other challenges could come forward. Lawsuits have been filed against two of the companies that will not come to trial for thirty months from filing at the earliest. If other challenges come forward, similar lawsuits will be filed.
ICN holds a very strong intellectual property position. There is no NDA for ribavirin alone. There are broad method of use and related patents held by ICN, and for combination therapy with interferon, by Schering-Plough, that extend to 2015-17. (In the EU and Japan, ICN has applied for extensions for important patents to about 2010.) In our license agreement with Schering- Plough, they are prohibited from licensing ribavirin to other companies either for mono or combination therapy.
ICN has licensed ribavirin to no other company, nor are we obliged to do so, for use in combination therapy with interferon. Any such use would be deemed a patent infringement and would be treated as such and responded to vigorously.
ICN's legal position is formidable, and we will vigorously resist attempts to weaken our market position by anyone claiming otherwise.
ICN is an innovative, research-based global pharmaceutical company that manufactures, markets and distributes a broad range of prescription and non- prescription pharmaceuticals under the ICN brand name. Its therapeutic focus is on anti-infectives, including anti-virals, dermatology and oncology.
Additional information is also available on the Company's website at http://www.icnpharm.com .
THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. This press release contains forward-looking statements that involve risks and uncertainties, including but not limited to, projections of future sales, operating income, returns on invested assets, regulatory approval processes, and other risks detailed from time to time in the Company's Securities and Exchange Commission filings.
For further information please contact: Investors, Joe Schepers, +1-212-754-4422, or Media, Peter Murphy, +1-714-545-0100 ext. 3213, both of ICN Pharmaceuticals, Inc.
SOURCE: ICN Pharmaceuticals, Inc.
Maxim says drug can stop liver damage from alcohol
STOCKHOLM, March 4 (Reuters) - U.S.-Swedish biotech Maxim Pharmaceuticals (NasdaqNM:MAXM - news) said on Monday an animal study showed that its drug Ceplene could completely reverse damage to the liver caused by alcohol.
Pre-clinical testing showed that rats injected with ethanol and the company's drug Ceplene sustained no liver damage, while rats given only ethanol developed symptoms related to alcohol abuse, the company said.
``We've shown we could completely reverse the damage made by the alcohol,'' Maxim Chief Scientific Officer Kurt Gehlsen told analysts at a meeting in Stockholm.
Maxim expects clinical testing of Ceplene against alcoholic liver disease and non-alcoholic steatohepatitis to start this year. Any drug must go through three different phases of clinical trials, which typically take several years, before being approved for sale to the public.
In the United States one out of 10 people suffer from chronic liver diseases such as cirrhosis and fatty liver, Maxim said.
Ceplene, with the scientific name histamine dihydrochloride, is also in clinical trials for use against hepatitis C and different forms of cancer.
``Hepatitis C is a two billion dollar market, but this is way bigger ... I have to say we are pretty enthusiastic for the prospects of Ceplene against chronic liver diseases,'' Maxim Chief Executive Larry Stambaugh said.
The company's shares rose 3.7 percent to $5.94 in early U.S. trading, while they gained 3.3 percent to 62.50 Swedish crowns ($5.99) in Stockholm on Monday.
The company would not disclose any further details of the animal study, which will be presented at the EASL conference for liver studies in Madrid starting April 18.
In late 2000, the U.S. Food and Drug Administration rejected Maxim's application to market Ceplene, then called Maxamine, for treatment of skin cancer.
The company's shares then plunged 92 percent from levels above $60 in late 2000 to a low of $5.
http://www.gastrohep.com/news/news.asp?id=1164
Flumazenil improves hepatic encephalopathy in patients with cirrhosis Flumazenil induces clinical and electroencephalographic improvement of hepatic encephalopathy in patients with cirrhosis, finds a study reported in March's Alimentary Pharmacology and Therapeutics. Researchers from France conducted a meta-analysis to compare flumazenil and placebo in hepatic encephalopathy in patients with cirrhosis. For each end-point, both heterogeneity and treatment efficacy were assessed by Peto and Der Simonian methods. As most trials were crossover in nature, a sensitivity analysis was performed including the 2 treatment periods. Six double-blind randomized controlled trials, including 641 patients (326 treated with flumazenil and 315 with placebo), were identified. The treatment duration ranged from 5 minutes to 3 days. Patients with clinical improvement: Flumazenil: 27% Placebo: 3% Alimentary Pharmacology & Therapeutics Heterogeneity tests between control groups were not significant. The mean percentages of patients with clinical improvement (5 trials) were 27% in treated groups and 3% in placebo groups. This difference was significant by both methods (Peto: odds ratio = 6.2; Der Simonian: mean rate difference, 29%). The team found that the mean percentages of patients with electroencephalographic improvement were 19% in treated groups and 2% in placebo groups. This difference was significant only with the Peto method (odds ratio = 5.8). The sensitivity analysis showed similar results. Author C. Goulenok, of the Pitié Salpêtrière Hospital, Paris, concluded on behalf of colleagues, "This meta-analysis shows that flumazenil induces clinical and electroencephalographic improvement of hepatic encephalopathy in patients with cirrhosis." Aliment Pharm Thera 2002; 16 (3): 361-72 06 March 2002
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Rivarin-High Dose Interferon Combination
Improves Responses In Hepatitis C A DGReview
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