Kirin Brewery Co. Ltd. is paying Dendreon Corp. $20 million for certain patent rights related to HLA-DR antibodies, as well as returning Asian rights to Dendreon for the prostate cancer candidate, Provenge.
Seattle-based Dendreon is happy on both accounts as it settles an emerging dispute over the HLA-DR antibodies and regains rights to Provenge, giving it clearance to complete ongoing discussions for a global sales and marketing partner.
Under the HLA-DR section of the deal, Dendreon retains rights to DN1921 and DN1924, two monoclonal antibodies in preclinical studies, and to others not currently being developed by Tokyo-based Kirin.
Mitchell Gold, Dendreon's CEO, told BioWorld Today that DN1921 might be used in diseases like rheumatoid arthritis or multiple sclerosis, while DN1924 is showing activity in larger cancer markets, including non-Hodgkin's and Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia
Overall, Dendreon believes the worldwide market for anti-HLA-DR antibodies is in excess of about $6 billion. Gold said Kirin's desire to strike a deal speaks volumes to Dendreon's strong intellectual property in the HLA-DR arena.
The agreement prevents Kirin from developing identical compounds to DN1921 and DN1924, and equally, prevents Dendreon from duplicating compounds arising from Kirin's licensed properties.
"But anything that is not in one of those two classes is open to both parties," Gold said.
As for Provenge, Gold said Kirin has been a great collaborator, but Dendreon wanted rights returned so it could pursue a global partner in preparation of filing a biologics license application in 2005.
Provenge, an immunotherapy for prostate cancer, is the subject of a pivotal, double-blind, placebo-controlled Phase III (D9902B) in men with androgen-independent prostate cancer. The trial is designed to confirm results of an earlier Phase III showing that the product might delay progression of disease and development of disease-related pain. (See BioWorld Today, Jan. 14, 2002; June 16, 2003; and July 16, 2003.)
Dendreon has received fast-track designation for Provenge in addition to a positive assessment under the Special Protocol Assessment provision indicating that the D9902B trial may serve as the basis for the BLA.
The Provenge agreement between Kirin and Dendreon was signed in 1998 and expanded in 2001. (See BioWorld Today, Aug. 13, 2001.)
For the period ended Sept. 30, Dendreon reported a net loss of $13.9 million, or 35 cents per share, compared to a net loss of $5.2 million, or 20 cents per share, for the same quarter in 2002. Revenues were $1.8 million in the third quarter, compared to $5 million in 2002's third quarter.
Cash, cash equivalents, and short-term and long-term investments at the end of the third quarter totaled $123.1 million, compared to $60.8 million as of Sept. 30, 2002.
Dendreon's stock (NASDAQ:DNDN) rose 33 cents Friday to close at $7.75.