Guest guest Posted April 19, 2004 Report Share Posted April 19, 2004 Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine Phase 2 Clinical Trials - Data Shows a Sustained Reduction in Viral Titre for All Three Doses of Viramidine, Comparable to Ribavirin - COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing in oral form for the treatment of chronic hepatitis C (HCV) in conjunction with a pegylated interferon. Valeant presented its data at the European Association for the Study of the Liver (EASL) Conference in Berlin, Germany. The Viramidine Phase 2 study consists of 180 treatment-naive subjects with chronic HCV. The on-going study was an open-label, randomized, active control trial, being conducted at multiple centers in the United States and with patients stratified by genotype. The study consists of four demographically comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID, Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination with peginterferon alfa-2a. Treatment duration was based on genotype, with genotypes two and three receiving 24 weeks of treatment and genotype one receiving 48 weeks of treatment, each with a post-treatment follow-up period of 24 weeks. The interim 24-week data shows that Viramidine demonstrates antiviral activity comparable to that of ribavirin, when used in combination with peginterferon alfa-2a in treatment naive patients, but with a lower incidence of anemia. The data demonstrates a sustained reduction in HCV RNA of approximately two-and-a-half log10 for all three doses of Viramidine, comparable to the ribavirin group in the same study. The proportion of patients with greater than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83 percent for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The results also show the percent of patients with non-detectable HCV RNA at 12 weeks and 24 weeks were similar between all treatment groups. There were also fewer patients in the Viramidine groups with anemia (defined as hemoglobin < 10g/dL) when compared with the ribavirin arm (2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and 600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not occur, while there were only two occurrences of anemia in the 800 mg BID group. Other adverse events were similar among treatment groups. Data was presented by Gish, M.D., the lead investigator on the Viramidine Phase 2 study and Medical Director of the Liver Transplant Program at California Pacific Medical Center in San Francisco. A Phase 3 clinical trial of Viramidine compared to ribavirin in combination with pegylated interferon was initiated in the fourth quarter of 2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of Viramidine to ribavirin, each in conjunction with pegylated interferon alpha 2b. About Valeant Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials and expected research and development expenses. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, the company's success in identifying and enrolling patients in the clinical trials program, the absence of adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission. SOURCE Valeant Pharmaceuticals International Web Site: http://www.valeant.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 19, 2004 Report Share Posted April 19, 2004 Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine Phase 2 Clinical Trials - Data Shows a Sustained Reduction in Viral Titre for All Three Doses of Viramidine, Comparable to Ribavirin - COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing in oral form for the treatment of chronic hepatitis C (HCV) in conjunction with a pegylated interferon. Valeant presented its data at the European Association for the Study of the Liver (EASL) Conference in Berlin, Germany. The Viramidine Phase 2 study consists of 180 treatment-naive subjects with chronic HCV. The on-going study was an open-label, randomized, active control trial, being conducted at multiple centers in the United States and with patients stratified by genotype. The study consists of four demographically comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID, Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination with peginterferon alfa-2a. Treatment duration was based on genotype, with genotypes two and three receiving 24 weeks of treatment and genotype one receiving 48 weeks of treatment, each with a post-treatment follow-up period of 24 weeks. The interim 24-week data shows that Viramidine demonstrates antiviral activity comparable to that of ribavirin, when used in combination with peginterferon alfa-2a in treatment naive patients, but with a lower incidence of anemia. The data demonstrates a sustained reduction in HCV RNA of approximately two-and-a-half log10 for all three doses of Viramidine, comparable to the ribavirin group in the same study. The proportion of patients with greater than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83 percent for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The results also show the percent of patients with non-detectable HCV RNA at 12 weeks and 24 weeks were similar between all treatment groups. There were also fewer patients in the Viramidine groups with anemia (defined as hemoglobin < 10g/dL) when compared with the ribavirin arm (2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and 600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not occur, while there were only two occurrences of anemia in the 800 mg BID group. Other adverse events were similar among treatment groups. Data was presented by Gish, M.D., the lead investigator on the Viramidine Phase 2 study and Medical Director of the Liver Transplant Program at California Pacific Medical Center in San Francisco. A Phase 3 clinical trial of Viramidine compared to ribavirin in combination with pegylated interferon was initiated in the fourth quarter of 2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of Viramidine to ribavirin, each in conjunction with pegylated interferon alpha 2b. About Valeant Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials and expected research and development expenses. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, the company's success in identifying and enrolling patients in the clinical trials program, the absence of adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission. SOURCE Valeant Pharmaceuticals International Web Site: http://www.valeant.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 19, 2004 Report Share Posted April 19, 2004 Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine Phase 2 Clinical Trials - Data Shows a Sustained Reduction in Viral Titre for All Three Doses of Viramidine, Comparable to Ribavirin - COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing in oral form for the treatment of chronic hepatitis C (HCV) in conjunction with a pegylated interferon. Valeant presented its data at the European Association for the Study of the Liver (EASL) Conference in Berlin, Germany. The Viramidine Phase 2 study consists of 180 treatment-naive subjects with chronic HCV. The on-going study was an open-label, randomized, active control trial, being conducted at multiple centers in the United States and with patients stratified by genotype. The study consists of four demographically comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID, Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination with peginterferon alfa-2a. Treatment duration was based on genotype, with genotypes two and three receiving 24 weeks of treatment and genotype one receiving 48 weeks of treatment, each with a post-treatment follow-up period of 24 weeks. The interim 24-week data shows that Viramidine demonstrates antiviral activity comparable to that of ribavirin, when used in combination with peginterferon alfa-2a in treatment naive patients, but with a lower incidence of anemia. The data demonstrates a sustained reduction in HCV RNA of approximately two-and-a-half log10 for all three doses of Viramidine, comparable to the ribavirin group in the same study. The proportion of patients with greater than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83 percent for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The results also show the percent of patients with non-detectable HCV RNA at 12 weeks and 24 weeks were similar between all treatment groups. There were also fewer patients in the Viramidine groups with anemia (defined as hemoglobin < 10g/dL) when compared with the ribavirin arm (2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and 600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not occur, while there were only two occurrences of anemia in the 800 mg BID group. Other adverse events were similar among treatment groups. Data was presented by Gish, M.D., the lead investigator on the Viramidine Phase 2 study and Medical Director of the Liver Transplant Program at California Pacific Medical Center in San Francisco. A Phase 3 clinical trial of Viramidine compared to ribavirin in combination with pegylated interferon was initiated in the fourth quarter of 2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of Viramidine to ribavirin, each in conjunction with pegylated interferon alpha 2b. About Valeant Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials and expected research and development expenses. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, the company's success in identifying and enrolling patients in the clinical trials program, the absence of adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission. SOURCE Valeant Pharmaceuticals International Web Site: http://www.valeant.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 19, 2004 Report Share Posted April 19, 2004 Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine Phase 2 Clinical Trials - Data Shows a Sustained Reduction in Viral Titre for All Three Doses of Viramidine, Comparable to Ribavirin - COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing in oral form for the treatment of chronic hepatitis C (HCV) in conjunction with a pegylated interferon. Valeant presented its data at the European Association for the Study of the Liver (EASL) Conference in Berlin, Germany. The Viramidine Phase 2 study consists of 180 treatment-naive subjects with chronic HCV. The on-going study was an open-label, randomized, active control trial, being conducted at multiple centers in the United States and with patients stratified by genotype. The study consists of four demographically comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID, Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination with peginterferon alfa-2a. Treatment duration was based on genotype, with genotypes two and three receiving 24 weeks of treatment and genotype one receiving 48 weeks of treatment, each with a post-treatment follow-up period of 24 weeks. The interim 24-week data shows that Viramidine demonstrates antiviral activity comparable to that of ribavirin, when used in combination with peginterferon alfa-2a in treatment naive patients, but with a lower incidence of anemia. The data demonstrates a sustained reduction in HCV RNA of approximately two-and-a-half log10 for all three doses of Viramidine, comparable to the ribavirin group in the same study. The proportion of patients with greater than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83 percent for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The results also show the percent of patients with non-detectable HCV RNA at 12 weeks and 24 weeks were similar between all treatment groups. There were also fewer patients in the Viramidine groups with anemia (defined as hemoglobin < 10g/dL) when compared with the ribavirin arm (2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and 600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not occur, while there were only two occurrences of anemia in the 800 mg BID group. Other adverse events were similar among treatment groups. Data was presented by Gish, M.D., the lead investigator on the Viramidine Phase 2 study and Medical Director of the Liver Transplant Program at California Pacific Medical Center in San Francisco. A Phase 3 clinical trial of Viramidine compared to ribavirin in combination with pegylated interferon was initiated in the fourth quarter of 2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of Viramidine to ribavirin, each in conjunction with pegylated interferon alpha 2b. About Valeant Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials and expected research and development expenses. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, the company's success in identifying and enrolling patients in the clinical trials program, the absence of adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission. SOURCE Valeant Pharmaceuticals International Web Site: http://www.valeant.com Quote Link to comment Share on other sites More sharing options...
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