SOURCE: SciClone Pharmaceuticals, Inc.

March 20, 2006 06:30 ET

SciClone's ZADAXIN Granted Orphan Drug Designation for Malignant Melanoma in United States

SAN MATEO, CA -- (MARKET WIRE) -- March 20, 2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that thymalfasin, the chemical composition of ZADAXIN®, has been granted Orphan Drug designation for the treatment of stage IIb through stage IV malignant melanoma by the U.S. Food and Drug Administration (FDA). Orphan Drug designation could provide SciClone with seven years of market exclusivity in the United States should ZADAXIN receive regulatory approval from the FDA for the treatment of malignant melanoma.

"We are extremely excited to receive this designation, which we believe emphasizes the pressing need for new therapeutic options that may improve the currently bleak prospects for patients with advanced stages of malignant melanoma," commented Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We reported encouraging interim tumor response data in December 2005 from the large, ongoing phase 2 stage IV malignant melanoma trial in Europe, and look forward to reporting additional tumor response data as well as preliminary survival information from this trial later in 2006. We and Sigma-Tau intend to approach the U.S. and European regulatory authorities to share these data and to discuss our plans to initiate phase 3 registration trials."

ZADAXIN currently is being investigated in combination with dacarbazine (DTIC) chemotherapy with and without low-dose interferon alpha in a large, multi-centered phase 2 stage IV malignant melanoma trial in Europe. This trial is being conducted by Sigma-Tau, SciClone's European development and marketing partner. In December 2005, SciClone and Sigma-Tau reported encouraging interim data on overall tumor response showing a distinct ZADAXIN dose-dependent response in combination with DTIC chemotherapy with and without low-dose interferon alpha.

About FDA Orphan Drug Designation

The U.S. FDA Orphan Drug designation is intended to provide incentives to drug and biologics suppliers to develop and supply drugs for the treatment of rare diseases, currently defined as diseases that affect fewer than 200,000 individuals in the United States. Under this designation, the holder of the first FDA approval of a designated orphan product will be granted a seven-year period of marketing exclusivity for that product for the orphan indication. The marketing exclusivity of an orphan drug would prevent other sponsors from obtaining approval of the same drug for the same indication without a showing of clinical superiority.

About ZADAXIN Phase 2 Malignant Melanoma Trial

In this trial, Sigma-Tau is evaluating different dose levels of ZADAXIN (1.6 mg, 3.2 mg and 6.4 mg) in combination with DTIC chemotherapy with and without low-dose interferon alpha as a first-line treatment for malignant melanoma. All of the more than 450 patients enrolled in this trial have stage IV, the most advanced form of malignant melanoma, meaning the cancer has spread beyond the skin to a distant site in the body. Most of these patients have visceral metastases, and the remaining patients have lung metastases and skin or lymph node metastases. Patients are receiving six cycles of therapy for 6 months and will be observed for a period of 12 months after the end of therapy. The trial's primary endpoint is overall tumor response. Secondary endpoints include overall survival, duration of response, time to disease progression and immunological response.

About Malignant Melanoma

The American Cancer Society estimates that in 2006, approximately 7,900 Americans will die from melanoma. Commonly used treatments for advanced staged malignant melanoma patients include chemotherapeutic agents, like dacarbazine (DTIC), and immunotherapeutics, including interferon alpha. Response to treatment can vary from patient to patient and is largely dependent on the stage of melanoma, disease site and the extent to which the cancer has spread. Unfortunately, none of the current therapies have proven to be very effective at extending overall survival for patients with advanced stages of the disease. For patients with stage IV malignant melanoma, the median survival is approximately six to nine months.

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.

The information in this press release contains forward-looking statements including our expectations and beliefs regarding progress 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, any 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, future actions of our strategic partners, unexpected delays in preparation for 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.

Contact Information

  • Corporate information contact:
    Becky Horner
    Investor Relations
    SciClone Pharmaceuticals, Inc.
    650-358-3437