TAIPEI, Taiwan, R.O.C.—Oct. 24, 2011 -- InnoPharmax Inc. announced that the Taiwan Food and Drug Administration (TFDA) approved the New Drug Application (NDA) for its Innomustine® Injection (bendamustine hydrochloride) for the treatment of Binet stage B and C chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin’s lymphoma (NHL) as monotherapy in patients, who have been treated with at least one chemotherapy and progressed within 6 months following treatment with rituximab.
Bendamustine hydrochloride is a unique drug with a nitrogen mustard group and a purine-like benzimidazole ring. Astellas Deutschland GmbH (“ADE”) originally owns the right to the bendamustine. SymBio has acquired an exclusive and sub-licensable development and marketing right from ADE for several territories in the Asia Pacific region, including Taiwan. In March 23, 2008, InnoPharmax had signed the license agreement with SymBio Pharmaceuticals Ltd. for the sublicense rights to bendamustine hydrochloride in Taiwan.
Bendamustine is currently marketed and sold by Mundipharma GmbH in Germany and Switzerland under the trade name "Ribomustin®" and in the rest of European countries under the trade name “Levact®”. In the United States of America, it is marketed and sold by Cephalon, Inc. under the trade name “Treanda®”. In Japan, SymBio received market approval in 2010 under the trade name of Treakisym®.
Innomustine® is the first in-licensed product and also the first approved oncologic product of InnoPharmax. “This is a great achievement of InnoPharmax” said Dr. CS Hsu, President of InnoPharmax. “Innomustine® is an important new treatment for patients with chronic lymphocytic leukemia and indolent NHL for patients in need of new options.”
About Bendamustine HCl
Bendamustine has been widely used in various oncology indications in Germany for years and it has been re-approved by the German health authority, BfArM, for the treatment of patients with NHL, CLL, or MM in July 2005. Bendamustine has been also approved with the indications of CLL and NHL in the United States (US), Hong Kong and Singapore in 2008, 2009 and 2010, respectively. In March 2009, bendamustine was approved for the treatment of CLL by Swiss health authority. Bendamustine was filed a marketing application, via the decentralized procedure, in EMEA and approved for indications of CLL, NHL, and multiple myeloma in July, 2010. In Japan, bendamustine was approved in October, 2010 for the treatment of patients with refractory/relapsed low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma low-grade NHL and mantle cell lymphoma.
About InnoPharmax
InnoPharmax is a specialty pharmaceutical company focused in the development and commercialization of products for the treatment of infectious diseases, immunology and oncology. It develops and acquires potential drug candidates for further development as well as commercialization, and uses internally developed drug delivery technology platforms for improving the safety and effectiveness of currently available drugs to provide better medical choices in these specific disease categories.
