West Coast Editor
Genmab A/S is paying Medarex Inc. $14.5 million in up-front money, license fees and potential milestone payments for the European and Asian rights to use the latter's UltiMAb for drugs using antibodies against the CD4 antigen.
That includes HuMax-CD4, a fully human antibody that the overseas firm is testing in Phase III trials against cutaneous T-cell lymphoma.
"I believe they licensed these rights to us because we can move forward on a rapid basis, using all the information we [already] have," said Lisa Drakeman, president and CEO of Copenhagen, Denmark-based Genmab, which already held the rights in North America, South America and a few other territories.
"It would have been expensive for them to start from the beginning" in Europe and Asia, she added, noting that the deal is "a really nice add-on in value." Genmab has been "saying publicly for quite a while that we were hoping to consolidate the rights," Drakeman said.
Medarex's stock (NASDAQ:MEDX) closed Thursday at $8.30, unchanged.
European and Asian rights had been licensed to Eisai Co. Ltd., of Tokyo, but Princeton, N.J.-based Medarex reacquired them. Genmab has no payment obligations to Eisai as a result of the latest move, and the deal leaves Genmab with worldwide rights to HuMax-CD4.
Of the cash, Genmab is paying $2 million up front, but other specifics were not disclosed. Drakeman said the Phase III trials now under way by Genmab are expected to end "about a year from now," with a regulatory filing to follow around the end of 2006. She said the market for a product in the U.S., assuming it would have some kind of orphan pricing and the drug could be used to treat cutaneous and non-cutaneous lymphoma, has been estimated in the "multi-$100 million" range. If the Phase III in cutaneous lymphoma is successful, the next step would be a pivotal study in non-cutaneous patients, she said.
The latest transaction represents another piece of the broad alliance between the firms that provides Genmab with access to many-partnered Medarex's arsenal, including the mouse technology UltiMAb. Donald Drakeman is the president and CEO of Medarex, which owns about 25 percent of Genmab. Lisa Drakeman is his wife.
Medarex got 7 percent of its revenue from Genmab during the three months ended March 31, as compared to 43 percent for the period last year. More came from two New York-based firms, Pfizer Inc. (25 percent) and Bristol-Myers Squibb Co. (31 percent), during the first quarter of 2005.
In November, Medarex signed a potential $530 million deal to partner its Phase III metastatic melanoma product, MDX-010, with Bristol-Myers, and the companies are investigating the product in other tumor types. The Pfizer deal, less than two months earlier, was valued at up to $510 million, and is focused on the discovery and development of up to 50 antibody products over 10 years. (See BioWorld Today, Sept. 21, 2004, and Nov. 9, 2004.)
Late last year, Genmab and Medarex reported positive data from another of their efforts. A Phase I/II trial using the antibody HuMax-Inflam/MDX-018 for patients suffering from an undisclosed autoimmune disease yielded a 57 percent success rate. Sixteen of 28 patients gained a 50 percent or more reduction compared with baseline in disease activity a week after final dosing.
Genmab is developing two more product candidates separately. In May, the firm reported positive data from the HuMax-EGFr Phase I/II study in refractory head and neck cancer at the 2005 American Society of Clinical Oncology annual meeting. In June, the firm said objective responses of up to 63 percent, according to Cheson criteria, were achieved at all dose levels with HuMax-CD20 in a Phase I/II study against relapsed or refractory follicular non-Hodgkin's lymphoma.
Genmab and Thousand Oaks, Calif.-based Amgen Inc. are developing AMG 714 in a Phase II trial for rheumatoid arthritis. In October, Genmab offered data regarding the first 110 patients, showing that at week 14, those taking the higher doses of AMG 714 had the greatest reduction in disease activity and the lowest frequency of disease flare up, while those on placebo often worsened. Although the data at week 14 were not statistically significant vs. placebo, they were part of an interim analysis of an ongoing pilot study that involves 180 patients. As part of its first-quarter report in April, Amgen said dosing in the trial was complete.