YM BioSciences Inc. is receiving at least $30 million as part of an overseas licensing deal for a cancer drug.
The Mississauga, Ontario-based company transferred European development and marketing rights to TheraCIM hR3, an EGF receptor antibody therapeutic, to Oncoscience AG. The agreement covers more than 40 countries, including the European community and neighboring territories.
"We have done this in order to expand the clinical indications we are aiming at," YM Chairman and CEO David Allan told BioWorld Today. "And it also targets a rapid entry to market, which makes a lot of sense to us."
Wedel, Germany-based Oncoscience will assume responsibility in Europe and the other designated territories for all further development expenses, including clinical trials and regulatory procedures. The company has identified three undisclosed indications in which to use the antibody to enhance the effectiveness of conventional radiation therapy and plans to start trials in the second quarter of next year. Oncoscience said it is optimistic about the possibility of achieving regulatory approval in 2006, as it expects its potential indications to receive orphan drug status.
YM's TheraCIM program focuses on head and neck cancer, and the company plans to move it into a randomized Phase II trial early next year. It originally licensed the compound from the University of Havana in Cuba, and retains rights in North America, Japan and Australasia.
CIMYM, a joint venture between YM and CIMAB SA, will receive a minimum of $30 million as a share of any sublicensing fees and as a premium royalty on initial product sales. CIMYM, which is 80 percent owned by YM, eventually will receive an escalating royalty on all product sales.
Allan said the terms provide for the subsidiary to receive 50 percent of all licensing amounts up to $30 million, followed by a standard royalty that will range between 15 percent and 25 percent.
"We think this is going to end up being a very big story," Allan said.
Havana-based CIMAB, the commercial arm of the University of Havana's Center for Molecular Immunology, will manufacture the product at its GMP manufacturing plant in Havana or other plants with equal capabilities. The manufacturing facility already has produced the drug for clinical trial material that has been used in Canada and Europe to date.
Oncoscience may decide, in consultation with YM, to name sublicensees or distributors for countries in which it does not plan to immediately establish its own sales force. Should Oncoscience not decide to sublicense the product, Allan said YM would receive a super-royalty until reaching a $30 million ceiling, followed by the 15 percent to 25 percent royalty range.
Bioscience Managers Ltd., of London, aided in the transaction's completion.
Beyond TheraCIM, YM's pipeline includes a Phase III product called tesmilifene for metastatic breast cancer. Licensed from the University of Manitoba, the small molecule was shown to improve survival as a secondary endpoint in a completed Phase III study, and the company last week received FDA clearance to begin a pivotal trial in metastatic breast cancer patients with survival as the primary endpoint. In the spring, the FDA approved the study under its special protocol assessment program. (See BioWorld Today, March 5, 2003).
Allan said the 520-patient trial could be of a shorter duration than normal because of its sequential analysis design, which allows for a monitoring board to review data at any point without penalty. Such a review could come after 400 patients have been enrolled.
"As a result, we anticipate that if we get the results that we expect from the first Phase III trial," he added, "then we'll be finishing the trial in two-and-a-half years."
Another candidate, Norelin, is in a Phase II program to evaluate its use as a biological castration product for hormone-dependent prostate cancer. Allan said the product, which is licensed from the University of Saskatchewan, could be partnered next year.
A fourth clinical candidate, RadioTheraCIM, is a radiolabeled version of TheraCIM and has been tested in 75 glioma patients in Italy. Preclinical development of two other cancer products also continues at YM.
The company's stock (TSE:YM) lost C5 cents Wednesday to close at C$1.55 (US$1.19).