[2010/02/06] InnoPharmax Submits NDA for Innomustine® for the Treatment of Patients with Indolent NHL, CLL and MM
InnoPharmax Submits New Drug Application for Innomustine® for the Treatment of Patients with Indolent Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) and Multiple Myeloma (MM)

TAIPEI, Taiwan, R.O.C.—February 6, 2010 -- InnoPharmax announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for the approval of Innomustine® (bendamustine HCl). The drug is intended to treat patients with indolent non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and multiple myeloma (MM).
 

“The filing of an NDA in Taiwan for NHL,CLL, and MM represents an important step to achieve our goal of delivering Innomustine® to patients who need more options for the treatment of hematological cancers,” said CS Hsu, Ph.D., President of InnoPharmax Inc..
 

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 HCl was approved for the treatment of CLL by Swiss health authority. In March 23, 2008, InnoPharmax had signed the license agreement with SymBio Pharmaceuticals Ltd. for the sublicense rights to bendamustine hydrochloride in Taiwan.
 

About SymBio
SymBio Pharmaceuticals Ltd. was established in March 2005 and SymBio’s main focus lies in the development of drugs within three therapeutic areas: oncology, hematology and autoimmune disease. Through its proprietary in-house search and evaluation process and experienced management team having strong development expertise in biopharmaceuticals, SymBio is able to adopt unique strategies in the development of drug candidates in order to bring much-needed therapies to market as nimbly as possible.
 

About InnoPharmax
InnoPharmax was established in 2005 and the Company’s Research and Development group is working on novel delivery vehicles with the aim of improving drug in-vivo performance, and is fully dedicated to conducting clinical research for new drugs in oncology and immunology in bringing clinical benefits to patients suffering from unmet medical needs.

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