(Taiwan) Medigen signs alliance and licensing agreement with Japan's Oncolys for its new cancer drug candidate :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast staff)

13 March, 2008
Japanese firm Oncolys BioPharma, Inc. and Taiwan's Medigen Biotechnology Corp. announced last week the signing of a strategic alliance and license agreement to develop Oncolys' oncology drug candidate Telomelysin (otherwise known as OBP-301), currently undergoing Phase I clinical trials in the US.

According to a joint statement by the two companies, the agreement gives Taipei-headquartered Medigen the rights to develop OBP-301 for liver cancers or an alternative indication. Upon completion of Phase II studies, Medigen will have the option to acquire regional rights for Asian countries for the drug for all indications under this strategic alliance. Further, the agreement states that Oncolys will develop esophageal cancers, head and neck cancers or alternative indications, until the completion of Phase II studies, with the option to continue development through commercialization.

The two companies will also seek be seeking a Big Pharma partner to maximize the value of OBP-301.

For this agreement with Medigen, Oncolys will receive an up-front payment and potential future milestones. Total financial terms for this agreement, including up-front and milestones, may reach a total of US$198.9 million for combined strategic alliance and regional license for Asia and Japan region.

"We are delighted and happy about forming this strategic alliance with Medigen, a leading Biotechnology company in Taiwan. Medigen has a proven track record and expertise in the field of liver diseases, and we strongly believe in Medigen to add-value and speed up the development of Telomelysin. In addition, we believe in Medigen's future potential as a commercial partner in Taiwan, China and Asian markets" reported Yasuo Urata, president and CEO of Oncolys.

Dr. Stanley Chang, chairman of Medigen added "With our prior experience and track records in successfully conducting liver cancer trials under the auspice of the US FDA, we believe the collaboration between Medigen and Oncolys on OBP-301 is truly synergistic and value-added. Other than being a strategic collaborator in drug development, Medigen looks forward to a further partnership in licensing the Asian rights to bring Oncolys and its OBP-301 product into China and other Asian countries where Medigen has already had its business connections."

OBP-301 is derived from adenovirus, generated by replacing the normal transcriptional regulatory element of the E1A gene in the human adenovirus type 5 with the human telomerase reverse transcriptase (hTERT) promoter. The drug candidate is currently undergoing Phase I clinical trials in the US, targeting solid tumors, with completion expected in the first half of 2008.

Telomerase is an enzyme expressed in approximately 90% of all types of cancer cells. The hTERT promoter is the key for the expression of telomerase, as well as for the complete replication of chromosomal ends. Telomelysin® is able to achieve a high replication rate, due to the internal ribosome entry site (IRES) gene inserted between the E1A and E1B genes. Telomelysin® is currently in phase-I clinical development in the US targeting solid tumors and is expected to complete in the 1st half of 2008.

Publicly-listed Medigen Biotechnology Corp. was founded in 1999, and is focused on the development of biopharmaceuticals for liver diseases and cancers. Medigen's record in drug development includes completing Phase II trials for PI-88 for liver cancer in collaboration with Progen Pharmaceuticals of Australia. The company also produces a series of HLA typing kits as well as high-sensitive pathogen detection products.

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