A biosimilar version of etanercept , TuNEX® will be an affordable, high-quality alternative
20 October, 2009 TAIPEI, Taiwan – Protein drug development company Mycenax Biotech Inc. (GreTai, Taiwan: 4726) announced today that its rheumatoid arthritis and psoriasis drug TuNEX®, a biosimilar version of etanercept, has successfully completed a Phase I trial in South Korea and Phase I/II clinical trials in Taiwan is in the data analysis and report preparation stage, important clinical trial milestones towards the commercial release of the drug in both regional and global markets.
Mycenax also announced that TuNEX® would undergo a Phase III clinical trial soon, with plans to also undertake multinational, multicenter Phase Ⅲ studies in several countries such as Korea and India, using the clinical data obtained to apply to market the drug in other locations globally.
With the completion of the Phase I trial in Korea -- a 'biosimilar' as stipulated by Korean drug approval regulations, conducted on 24 healthy patients at National Seoul University -- TuNEX® becomes the first protein drug developed in Taiwan to pass such a milestone overseas.
The Taiwan clinical trial -- a 'new drug' as stipulated by Taiwan drug approval regulations -- was completed in September on 18 arthritis patients at the Taichung Veteran General Hospital, Kaohsiung Veteran General Hospital and Buddhist Tzu Chi General Hospital. The final report will be completed at the end of the year, reported Dr. Karen Wen, spokesperson and vice president at Mycenax.
Dr. Michael Hwang, Mycenax founder and president said, "With TuNEX® being an INN etanercept biosimilar to Enbrel®, the world's 1st largest biological pharmaceutical with over US$6 billion in sales, we expect that TuNEX® will become a successful, popular cost-effective alternative."
The development of Taiwan's first biosimilar is also welcome news for the country's fledgling biotech sector.
"With the drug ready to enter Phase III trials, it's indicative of the strength and potential of the biotechnology industry in Taiwan that a small company [50 employees] can produce and develop such an international class drug and compete on global markets," Hwang said.
TuNEX® is a dimeric fusion protein consisting of the extracellular domain of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The extracellular portion of TNFR was also discovered as soluble TNF-binding protein in urine and serum and plays a physiological role by inhibiting TNF activities. The Fc component of TuNEX® contains the CH2 domain, the CH3 domain and hinge region and it corresponds to the formation of TNFR:Fc dimmer.
TuNEX® is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory process of rheumatoid arthritis (RA) and the result of joint pathology. TuNEX® can bind specifically to tumor necrosis factor a (TNFa) and it blocks the interaction with cell surface TNF receptors, rendering TNF biologically inactivity.
TuNEX® is a similar biological medicinal product to Etanercept (Enbrel®, Amgen Inc.), a FDA-authorized biological medicine. The approval indications of Etanercept include 1) moderately to severely active rheumatoid arthritis, 2) moderately to severely active polyarticular-course juvenile rheumatoid arthritis patients who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs), 3) psoriatic arthritis, 4) active ankylosing spondylitis, and 5) chronic moderate to severe plaque psoriasis. The pharmaceutical form, strength and route of administration of TuNEX® will be the same as Etanercept.
The manufacturing of TuNEX® has been accredited a Type V Drug Master File (DMF) by the US FDA and cGMP by Department of Health in Taiwan. All process data and documentation is backed up with FDA master file registration and cGMP has complied with PIC/S regulation.
The market rights for TuNEX® in 31 countries including Korea and India have been licensed to BioTrion of Korea.
Enbrel® is a registered trademark of Amgen Inc. and/or Wyeth Pharmaceuticals.
Mycenax Biotech Inc. is a publicly-listed (GreTai, Taiwan: 4726) biopharmaceutical product development and manufacturing organization specializing in mammalian and microbial cell-derived biologics. Operating with full line of single-use and pipeless technology by a group of experts in technical and quality compliance, Mycenax is committed to the use of best-in-class technology and international control standards to translate research findings into therapeutic biologics in a timely and cost-effective manner. Three additional biosimilars are in Mycenax's pipeline, including biosimilar version of rh-GCSF, Herceptin, and Rituxan.
Mycenax utilizes "Single-use technology" throughout its biopharmaceutical production process from cell cultivation, scale production, harvest, purification and fill/finishing, including lyophilization. The scale is 12,000L per lot perfusion cultivation, 500gm down-stream, and up to 8,000 liquid fill units per day.
Mycenax's state-of-the-art facilities are located at the Jhunan Science Park, Taiwan, with a module-designed cGMP facility including associated supported laboratories. This world-class facility received USFDA DMF Type V certification in 2005, and meets the latest international regulatory standards.
Mycenax is currently searching for global marketing partners for its TuNEX® and GranNEX® products. Mycenax’s bio-drug development and manufacturing capabilities are also available for contract manufacturing, service and co-development opportunities to the global biopharmaceutical development community.
Mycenax Biotech Inc.
3F, No. 8 Kedung 3 Rd., Jhunan, Miaoli, Taiwan
Dr. Karen Wen
Vice President and Spokesperson
Mycenax Biotech Inc.