Today, Valeant (NYSE: VRX, formerly ICN Pharmaceuticals) announced that it would increase resource allocation for the research and development of Viramidine, pursuing “an accelerated schedule….” The first of two global, 1,000-patient, phase III Viramidine investigations, VISER1 (Viramidine’s Safety and Efficacy vs. Ribavirin), is expected to complete enrollment this year. VISER2 is slated for a mid-2004 initiation. Both ambitious programs compare Viramidine to ribavirin, each in conjunction with a pegylated interferon – Schering Plough’s (NYSE: SGP) Peg-Intron in VISER1 and Roche’s (Swiss: ROG) Pegasys in VISER2. Enrollees will be treated for either 24 or 48 weeks, depending on viral genotypes, and will be further evaluated after being off therapy for an additional 24 weeks. At that time, the proportions of patients with undetectable virus in their blood will be determined, as will be the incidence of anemia during the course of the study period.

Viramidine’s phase II program is ongoing. 24-week data will be presented at the 39th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin in April. Additional data will be presented at Digestive Disease Week (DDW) in New Orleans in May. Interim data from the ongoing, 180-patient, phase II investigation has revealed Viramidine’s therapeutic effect, in combination with pegylated interferon, after at least 12 weeks (160 patients) in terms of viral load reduction without as much hemolytic anemia-associated adversity as seen with ribavirin. The full study includes treatment for 48 weeks, followed by 24 weeks off treatment. The study also included an interim analysis performed on the first 160 patients who received at least 12 weeks therapy.

Viramidine is a nucleoside (guanisine) analog prodrug of ribavirin. It is converted to ribavirin by the liver enzyme adenosine deaminase. Prodrugs, converted to active drugs once in the body, often have preferable pharmacokinetic and pharmacodynamic profiles compared to active drugs, which can lead to better activity and dosing schedules. Clinical trial data suggests that Viramidine has these favorable properties.

The standard of care for the management of people with chronic hepatitis C infection is pegylated interferon plus ribavirin. The combination is effective, but adherence is suboptimal due to numerous adverse effects. One of the most common adversities attributable to ribavirin is the development of hemolytic anemia. Patients experience symptoms such as fatigue, irritability, and angina (chest pain). Myocardial infarction (heart attack) can occur. After ribavirin is absorbed, it accumulates in red blood cells until some cells rupture. The resultant hemolytic anemia prompts ribavirin dose reduction or discontinuation in approximately 20-30% of ribavirin recipients.

Viramidine, on the other hand, is not able to penetrate red blood cells until it is converted to ribavirin. Equi-dosed Viramidine and standard ribavirin results in a 2.4 fold reduction of ribavirin accumulation in red blood cells. Viramidine is likely not only to reduce risk of hemolytic anemia, but also to allow greater serum ribavirin concentrations with fewer adversities. In turn, greater patient compliance, improved sustained viral response rates, and enhanced use offer significant commercial opportunity. Earlier safety and pharmacokinetic profiles of Viramidine in patients with hepatitis C have shown that Viramidine doses of up to 800mg twice daily for up to 4 weeks are safe and well tolerated. The overall Viramidine data set confirms that Viramidine-derived ribavirin yields a much lower hemolytic anemia rate compared with standard ribavirin. Pharmacokinetic effects of taking Viramidine with food or on an empty stomach did not appear to be clinically relevant. Ribapharma, acquired by Valeant in 2003, developed Viramidine.

It is not guaranteed as to completeness or accuracy by BioPortfolio, the BT publishers, or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. Opinions expressed are subject to change without notice. The Information and views provided by BT are prepared by BT employees and in no way reflect the views or efforts of BioPortfolio Limited., any of BioPortfolio's employees or officers. BioPortfolio, and BioPortfolio's employees and officers, as well as BT’s employees and officers, in no way accept responsibility for any of the BT content published on www.bioportfolio.com/. 

While all reasonable care has been taken to ensure that the Information contained herein is presented in good faith, and is not untrue or misleading at the time of publication, BioPortfolio, and BT make no representation as to its accuracy or completeness and it should not be relied upon as such. The Information is supplied on the condition that the reader or any other person receiving the Information will make his or her own determination as to its suitability for any purpose prior to any use of the Information. From time to time, BioPortfolio and any officers or employees of BioPortfolio, as well as BT, and any officers or employees of BT, may, to the extent permitted by law, have a position or otherwise be interested in any transactions, in any investments (including derivatives) directly or indirectly the subject of this report. Also BioPortfolio and BT may, from time to time solicit business from any company mentioned in this report. This report is provided solely for the information of viewers of BioPortfolio and/or viewers and subscribers of BT and BioPortfolio information services, who are expected to make their own investment decisions without reliance on this report. Neither BioPortfolio nor any officer or employee of BioPortfolio, nor BT, or any officer or employee of BT, accepts any liability whatsoever for any direct, indirect, special or consequential damages or loss arising from any use of this report or their contents. This report may not be reproduced, distributed or published by any recipient for any purpose without the prior express consent of the publishers. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark or copyright of BioPortfolio, BT or any third party. 

The value of the investment(s) to which this report relates and their income yield(s) may go up or down. The investment(s) referred to in this report may not be suitable for private investors: if you are in any doubt you should seek advice from your investment advisor. Changes in rates of currency exchange may have an adverse effect on the value, price or income of investments. Statements as to past performance of any investment are not a guide to future performance. The levels and bases of taxation can change, and if you are in doubt you should seek independent professional advice. In some cases it may be difficult for you to sell or realize your investment or to obtain reliable information about its value or the extent of the risks to which you are exposed. 

THIS INFORMATION IS PROVIDED "AS IS" AND NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED OF ACCURACY, MERCHANTIBILITY FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION.