Good News for Non-Responders to HCV Combination Therapy
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SciClone and Sigma-Tau Provide Update on Phase 3 Hepatitis C Study
June 26, 2008
http://money.cnn.com/news/newsfeeds/articles/marketwire/0410557.htm
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A. today announced that all 553 enrolled patients successfully completed a Phase 3 trial. After 48 weeks of therapy, all patients responding to treatment have now completed their 24-week follow-up. The unblinded data from the trial are expected to be available in the fourth quarter of 2008. The Phase 3 trial is evaluating ZADAXIN® (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin. In February 2008, SciClone and Sigma-Tau S.p.A. announced promising blinded interim data from this trial.
“The completion of the study is an important step toward unblinding the data. Previously reported data from this Phase 3 hepatitis C trial have been promising,” said Mario Rizzetto, M.D., Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. “The standard data review and analysis is underway with an unblinding of the data expected in late 2008.”
“We continue to believe that thymalfasin could represent an important advance in the treatment of non-responder hepatitis C patients and address a growing and acute need,” said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc.
The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the United States and Europe until 2021. Details of the thymalfasin triple therapy for HCV, the hepatitis C virus, and thymalfasin may be found in the press release from SciClone Pharmaceuticals dated February 11, 2008, at www.sciclone.com.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone’s lead product ZADAXIN® is currently being evaluated in a late-stage clinical trial for the treatment of hepatitis C, and successfully completed a phase 2 clinical trial in malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone’s strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead(TM). For the U.S. market, SciClone’s other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit www.sciclone.com.
About sigma-tau Group
Sigma-tau Group is a leading research-based Italian pharmaceutical company with a consolidated 2007 turnover of approximately EUR 665 million (US$ 920 million) and over 2500 employees worldwide. The therapeutic areas in which sigma-tau Group focuses its Research and Development include cardiovascular disease, metabolism, neurology, oncology and immunology, totalling 48 projects. Over 30 indications are explored in clinical trials with 24 molecules of which 17 are proprietary and the majority of them (14) are NCEs. Sigma-tau Group has operating subsidiaries throughout Europe and the U.S. and is active in every major pharmaceutical market. For additional information about sigma-tau Group, please visit www.sigma-tau.it.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding future sales and financial results for 2008, and progress, timing and results of our clinical trials. Words such as “expects,” “plans,” “believe,” “may,” “will,” “anticipated,” “intended” and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including changes in demand for ZADAXIN, the progress or failure of clinical trials, our actual experience in executing on our objectives, the performance of our partners, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, the performance and future actions of our strategic partners, unexpected delays in clinical trial enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission. Further, although our financial guidance is based on our current estimates, factors such as the actual timeline and design of the phase 3 melanoma clinical trial and final decisions regarding expense sharing arrangements for the trial could alter the estimates of our research and development expenses, net loss and year-end cash balance for 2008.
Corporate Contact:
Ana Kapor
SciClone Pharmaceuticals, Inc.
650.358.3437
