Key Developments For Sciclone Pharmaceuticals Inc
Sciclone Pharmaceuticals Inc (SCLN.O) (Consolidated Issue listed on NASDAQ Global Market)
SciClone Pharmaceuticals Announces Commencement Of Clinical Study Examining ZADAXIN's Ability
SciClone Pharmaceuticals announced that Rome-based development partner Sigma-Tau, S.p.A., has initiated a pilot study in Italy to evaluate ZADAXIN's ability to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis. The study, being conducted in hemodialysis patients, is now completely enrolled, having reached full enrollment after two days. Top-line clinical results are expected by late 2009 or early 2010.
SciClone Pharmaceuticals Raises FY 2009 Guidance-Conference Call
SciClone Pharmaceuticals updated fiscal 2009 guidance and expects revenue to be in the range of $70-$72 million and earnings per share (EPS) be in the range of $0.18-$0.22. According to Reuters Estimates, analysts on an average were expecting the Company to report revenue of $72 million and EPS of $0.17 for the same period.
SciClone Pharmaceuticals Announces Workforce Reduction
SciClone Pharmaceuticals announced a corporate restructuring that will reduce its United States based workforce by approximately 17%, primarily in research and development. This restructuring follows the discontinuation of SciClone Pharmaceuticals' RP101 phase II clinical trial announced on October 2, 2009. As a result of the restructuring, SciClone Pharmaceuticals anticipates incurring a one-time severance-related charge of approximately $0.3 million, which includes severance and other expenses associated with the workforce reduction plan. SciClone Pharmaceuticals expects to complete the restructuring in the fourth quarter of 2009.
SciClone Pharmaceuticals Announces Enrollment Of First Patient In Its Phase 2 Trial Of SCV-07 In Hepatitis C
SciClone Pharmaceuticals announced the enrollment of its first patient at the Atlanta Gastroenterology Associates in Atlanta, GA, in a phase 2 trial of SCV-07 for the treatment of hepatitis C (also known as HCV). This multicenter, multidose, open-label study is designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy or in combination with ribavirin in non-cirrhotic patients with genotype 1 chronic HCV who have relapsed after at least 44 weeks of treatment with pegylated interferon and ribavirin. The study, which will monitor biomarkers of immune activation and HCV viral load dynamics, will include two treatment cohorts of 20 patients each, who will receive SCV-07 at a dose of either 0.1 mg/kg or 1.0 mg/kg. The treatment period will be approximately eight weeks long, including four weeks of SCV-07 monotherapy followed by four weeks of SCV-07 in combination with ribavirin. In addition, there will be three follow-up visits within seven weeks after the completion of treatment.
SciClone Pharmaceuticals Discontinues Phase 2 Trial of RP101 in Late-Stage Pancreatic Cancer
SciClone Pharmaceuticals announced the discontinuation of the investigational treatments under its randomized, placebo-controlled, double-blind Phase 2 trial that is evaluating RP101 - a nucleoside analog known as BvdU - for the treatment of late-stage pancreatic cancer. This decision followed the recommendation of the Data Safety Monitoring Committee (DSMC) with oversight responsibility for this clinical trial that was based upon the data reviewed at the DSMC meeting. Further details will be reported when these data have been unblinded and reviewed by SciClone. SciClone has notified the study investigators and appropriate regulatory authorities of the decision to discontinue the study. The Company expects to conduct a detailed safety and efficacy analysis once the data are unblinded and will then evaluate what effect these data will have on any future RP101 development potential. At this time, SciClone anticipates that all remaining significant clinical trial expenses for this phase 2 trial will be incurred during fiscal 2009 and that this discontinuation will not adversely impact its previously provided financial guidance.
