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Feb
16
Sandeep Singh Dhillon
CCM Duopharma seeks to commercialise erythopoietin for kidney failure treatment – Edge Malaysia
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KUALA LUMPUR (Feb 15): CCM Duopharma Biotech Bhd will begin the registration for commercialisation of its erythopoietin (EPO) biosimilar, which will be beneficial in the treatment of anaemia in end-stage kidney failure patients.

This follows the completion of a two-year clinical trial totalling RM17.5 million in investment cost by its wholly-owned subsidiary Duopharma (M) Sdn Bhd (DMSB) with South Korea-listed PanGen Biotech Inc. CCM Duopharma’s parent Chemical Co of Malaysia Bhd (CCM) has a 9.34% stake in PanGen.

Through its investment in the trial, CCM Duopharma said it obtained commercialisation rights for product marketing and distribution of the EPO biosimilar in Malaysia, Singapore and Brunei.

“The product is expected to be launched once marketing authorisation has been received from the National Pharmaceutical Regulatory Agency,” it said in a statement today.

CCM Duopharma noted that it will be the first Malaysian company to co-develop a biotherapeutic product and the second epoetin-alfa biosimilar to be developed globally.
 
According to the group, the clinical trial involving 228 patients in Malaysia and 70 patients in South Korea, was a multi-centre, multi-national, double-blind, randomised, active-controlled parallel-group clinical study to assess the safety and efficacy of PanGen’s EPO product (codenamed PDA10) in patients with anaemia arising from chronic renal failure.

“PDA10 showed similar efficacy and safety to the innovator drug demonstrating equivalence in terms of pharmacokinetics, pharmacodynamics and toxicity,” said CCM Duopharma.

PDA10, PanGen’s first commercial biosimilar finished product is an erythropoietin produced in cell culture using recombinant DNA technology and is responsible for the production of human red blood cells.

“The completion of the Phase III trials is a significant milestone for us as we expand our focus on biosimilars while indirectly assisting in the development of the Malaysian biopharmaceutical industry. It will also enable us to offer more affordable treatment options for patients without compromising their safety and efficacy,” said CCM group managing director and CCM Duopharma chief executive officer Leonard Ariff Abdul Shatar.
 
“Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry of the innovator product,” said CCM Duopharma.
 
“The biosimilars business, which is dominated by global pharmaceutical players, is expected to expand at a compounded average growth rate of 12% in Asia to an estimated RM8 billion in Southeast Asia by 2020,” it added.

CCM Duopharma shares closed down two sen or 0.92% at RM2.16 today, bringing a market capitalisation of RM602.55 million. PanGen’s stock also closed 1,350 won or 7.54% lower to 16,550 won, with a market cap of 149.75 billion won.



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