>>SAN MATEO, Calif., July 10 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) today announced that the Company's immune system enhancer, ZADAXIN® has received expanded indications in Mexico. ZADAXIN may now be marketed for the treatment of hepatitis C and hepatitis B as well as for use as an influenza vaccine adjuvant. The approval was based on existing clinical data from ZADAXIN marketing registrations around the world.
This marks the Company's first approval for hepatitis in North America. ZADAXIN currently is in a phase 3 U.S. clinical program for hepatitis C combining ZADAXIN with pegylated alpha interferon.
SciClone also said it has expanded its distribution relationship with Laboratorios Columbia, a leading specialty pharmaceutical company in Mexico, under an exclusive license agreement for Mexico. As licensee and exclusive distributor, Laboratorios Columbia will be responsible for in-country marketing and sales costs and has also agreed to pay for a new combination therapy clinical program designed to support ZADAXIN sales efforts in Mexico and to qualify ZADAXIN for inclusion in government and institutional formularies. As with its other licensing arrangements, SciClone will sell ZADAXIN as a finished product, avoiding any royalty related withholding taxes.
``The hepatitis C and hepatitis B ZADAXIN approvals in a neighboring country complements what we believe will be a growing awareness of our U.S. phase 3 hepatitis C clinical program,'' said Donald R. Sellers, SciClone's President and Chief Executive Officer. ``Importantly, our partner in Mexico will be funding the Mexican marketing and clinical programs for ZADAXIN while SciClone focuses its resources on the U.S. phase 3 program. With a dramatically expanded target patient population and related promotional opportunities, as well as exclusive licensee status, our distributor's incentives are now in alignment with the expectations and interests of SciClone and our shareholders. While sales growth may not be immediate, we fully expect Mexico to be one of our most significant ZADAXIN markets prior to the drug's approval in the U.S., Europe and Japan.''
ZADAXIN, a synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer (``ISE'') that helps stimulate, maintain and direct the body's antiviral or anticancer responses, has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 24 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. ZADAXIN is currently in a phase 3 program in the U.S. in combination with Pegasys®, pegylated interferon alfa-2a, for the treatment of hepatitis C, in a phase 2 program in combination with lamivudine for the treatment of hepatitis B and in two phase 2 trials for the treatment of liver cancer. In Europe, a phase 3 ZADAXIN program will be undertaken which would complement the Company's U.S. clinical program. ZADAXIN is also in clinical trials in Japan and Australia.<<
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