By Chris Delporte
Staff Writer
Dendreon Corp. expanded its drug development and licensing collaboration with the pharmaceutical division of Kirin Brewery Co. Ltd.
Dendreon, of Seattle, will provide Tokyo-based Kirin with extensive clinical development and regulatory support aimed at seeking marketing approval in Asia of Dendreons leading cancer vaccine candidates, Provenge and Mylovenge. The pharmaceutical division of Kirin focuses on new product development, including cancer and hematopoietic disease.
As part of the expanded agreement, Dendreon received a $10 million payment from Kirin. As Dendreons marketing and development partner in Asia, Kirin has obtained all options and rights to the Asian marketplace, and is involved in clinical trials in Asia for the products. In addition, Kirin secured a supply of key components of Provenge and Mylovenge and has an option to license Dendreons manufacturing technology for Provenge. Dendreon retains all rights for Provenge and Mylovenge in North America and Europe. Financial terms of the original agreements are unaffected, the company said.
The relationship weve had with Kirin has been a positive one for the company, David Urdal, Dendreons president and chief scientific officer, told BioWorld Today. Being able to develop product for the Asian market is difficult, even for companies much larger than we are, so this is a good strategic move for us.
The original deal, which began in December 1998, was a collaborative license agreement and was followed with a research and development agreement in May 1999. Kirin provided support for research efforts, and retained rights in Asia to any products developed as part of the partnership. Dendreon retained rights for the rest of the world. Kirin, at the time, paid a $5 million up-front licensing fee and $2.3 million in research funding. If any products are developed jointly, Dendreon will pay Kirin royalties on North American sales and European sales would be shared equally.
Also as part of the original agreement, Kirin, which will develop Provenge on its own in Japan, agreed to pay Dendreon $5 million in fees and milestone payments, in addition to royalties on potential sales. Kirin also will pay $5 million in fees and milestones, as well as royalties for Mylovenge, if the drug is approved.
Urdal also said the research agreement with Kirin focuses on antigen targets that are of more interest in Asia than in Western countries. Gastric cancer and liver cancer are more prevalent in Japan, for example, Urdal said.
Dendreon currently has three therapeutic cancer vaccine candidates in clinical trials. Provenge is involved in three Phase III trials in the U.S. The first two identical trials are 120-patient, multicenter, double-blind, placebo-controlled trials for hormone-refractory prostate cancer. The company expects to complete enrollment this year. The third Phase III, which began enrollment in June, is examining Provenges effect on earlier-stage prostate cancer.
Mylovenge, for the treatment of multiple myeloma, is in three Phase II trials. The milestone for this year is to discuss the design of a Phase III trial with the FDA, Urdal said. Dendreon hopes to initiate a Phase III trial by early next year.
The third drug in clinical trials is APC8024, which currently is in a Phase I trial. APC8024 is a vaccine designed to trigger T-cell immunity of the antigen Her2-neu for women with breast cancer. A second Phase I trial at the Mayo Clinic in Rochester, Minn., is scheduled to start enrolling patients later this year.
Dendreons stock (NASDAQ:DNDN) gained $1.79, or 16 percent, Friday to close at $12.95.