Biotech Values

[DewDiligence]

SCLN Zadaxin Fails Again in HCV

[For the second time, Zadaxin showed no statsig benefit vs placebo as an augment to peg-interferon. Although a third study, evaluating Zadaxin as an augment to peg-ifn+ribavirin, is still running, SCLN’s HCV program would appear to be dead for all practical purposes.]

http://biz.yahoo.com/iw/060525/0131333.html

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SciClone Reports Final Results From Second ZADAXIN U.S. Phase 3 Hepatitis C Trial

Thursday May 25, 6:30 am ET

SAN MATEO, CA--(MARKET WIRE)--May 25, 2006 -- SciClone Pharmaceuticals, Inc. (NasdaqNM: SCLN ) today reported final results from its second U.S. phase 3 hepatitis C virus (HCV) trial evaluating the benefit of adding ZADAXIN® to pegylated interferon alpha treatment for HCV patients with early cirrhosis of the liver who have failed prior therapy. Final results indicate that treatment with ZADAXIN plus pegylated interferon alpha did not demonstrate a statistically significant improvement compared with treatment with pegylated interferon alpha alone in sustained virologic response (SVR), the trial's primary endpoint. ZADAXIN was generally well tolerated with no treatment-related toxicities or side effects. In December 2005, SciClone reported final results from its first U.S. phase 3 HCV trial, which were consistent with these results and not statistically significant.

"Given these results, our ZADAXIN development efforts will be focused on advanced-staged malignant melanoma in conjunction with our European development and marketing partner, Sigma-Tau," commented Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Further development of ZADAXIN in HCV will be dependent on the results achieved from the ongoing triple therapy HCV trial being conducted by Sigma-Tau in Europe that are expected in 2008. In addition to developing ZADAXIN as a treatment for melanoma, our clinical development plans include our proprietary drug candidate SCV-07, which has demonstrated broad therapeutic applicability in a variety of viral and other infectious diseases. Currently, we are conducting an oral comparison study with SCV-07 to determine its availability when administered orally, and in the second half of this year we expect to initiate a proof-of-concept clinical trial to evaluate the potential benefit of SCV-07 in an influenza vaccine dose sparing setting. Our business strategy also includes the expansion of our operations and product portfolio in China, and we are focused on growing sales in this market by in-licensing or acquiring the rights to at least one new product for China this year."

HCV patients in this second U.S. phase 3 clinical trial received a 48-week course of therapy of either ZADAXIN (1.6 mg, twice a week) and pegylated interferon alpha (180 mcg, once a week) or placebo and pegylated interferon alpha followed by a 24-week observation period. The trial's primary endpoint was the achievement of SVR at week 72.

Sigma-Tau is conducting an HCV trial in Europe to evaluate the efficacy of a triple therapy combination of ZADAXIN, pegylated interferon alpha and ribavirin. Results from this trial are not expected until 2008. The Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) generally require two confirmatory phase 3 clinical trials to support a regulatory filing. Should the results of this European triple therapy trial be statistically significant, they will likely be insufficient for a regulatory filing, and statistically significant results from a second triple therapy trial would be needed.

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 late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products to market in this rapidly growing pharmaceutical market. SciClone's other drug development candidate is SCV-07, currently in early clinical development in the U.S. for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
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