Tucson-created cancer drug advances: South Korea in licensing accord for still-in-trials Amplimexon

September 23, 2008

By hammersmith

[Source: Arizona Daily Star] – A local drug-development company with links to the University of Arizona got a boost from a drug-licensing deal with a South Korean company — even before the cancer drug is approved by U.S. regulators.

Tucson-based AmpliMed Corp. said Wednesday that it has entered into a license agreement with a leading South Korean-based pharmaceutical company for exclusive rights to its developmental cancer drug Amplimexon in the Asian nation.

Under terms of the agreement with Seoul-based Handok Pharmaceuticals, Handok will receive marketing and distribution rights for all cancer uses for Amplimexon in South Korea.

The company will pay AmpliMed an upfront fee, plus additional payments based on certain development and regulatory milestones. Additional financial terms of the deal were not disclosed.

AmpliMed CEO Robert Dorr said deals like these don’t usually happened until results from randomized trials are returned, but Handok came looking to make an investment in the drug.

“Handok was willing to make a substantial investment before the trials were over,” Dorr said. “It’s a real vote of confidence in the technology.”

A local biotech industry official said the deal is a big step for AmpliMed’s technology.
“The drug’s going to move forward through this relationship,” said Nina Ossanna, director of business development for the UA’s Bio5 Institute. Bio5 is the UA’s cross-campus genetics institute.

Ossanna, who also chairs the Bioindustry Organization of Southern Arizona, said such early licensing deals provide “third-party validation” of a drug’s potential.

Dorr said AmpliMed — founded in 1989 by UA cancer researchers — will retain the drug’s rights in the United States but may look to sell similar rights to its drug in the European Union and Japan.
So far, the company said it has raised $29.3 million since 2004 to help fund its research.

The drug has undergone rigorous trials and is making progress toward approval by the U.S. Food and Drug Administration, said Dorr, who is a UA professor of pharmacology and toxicology and director of pharmacology for the Arizona Cancer Center.

Amplimexon, a spinoff from UA research, has shown results in fighting melanoma, breast, lung, prostate and pancreatic cancer, the company said.

Representatives from Handok noted the drug’s potential in the fight against cancer.

“Amplimexon is poised to be a leading product in Handok’s cancer pipeline, and we anticipate this promising agent will improve the quality of life for cancer patients,” Handok CEO Young-jin Kim said in a press release.

Currently, Amplimexon is in Phase II clinical trials combined with gemcitabine to test for use against pancreatic cancer.

Dorr said that Phase II trials should be completed by the second quarter of 2010, with Phase III trials to wrap up by 2013.

Phase III trials are typically the last step before a drug is submitted for final approval.
The company also plans to start a Phase II trial of Amplimexon in combination with the chemotherapy drug taxotere in patients with non-small-cell lung cancer later this year.
More tests for other cancers, as well as potential further deals with Handok are in the works.
AmpliMed plans to hold trials of Amplimexon in South Korea to combat gastric cancer, Dorr said.

“I foresee further interaction with Handok in the future,” he said.