West Coast Editor

SAN FRANCISCO — Access Oncology Inc. said it will pay Gem Pharmaceuticals Inc. up to $33 million in a licensing agreement for GPX-100 and GPX-150, two novel, noncardiotoxic analogues of the chemotherapeutic agent doxorubicin.

GPX-100, the lead compound, “has completed its first Phase I/II testing, and we’re going to be exploring a series of Phase II studies, which might include a pivotal Phase II,” said Michael Weiss, chairman and CEO of New York-based Access, who spoke at a presentation during the JPMorgan H&Q Healthcare Conference here. The Phase II studies would begin in 2002, Weiss said.

The deal with Birmingham, Ala.-based Gem calls for Access to fund all future development, plus pay up-front payments and development milestones of up to $33 million followed by royalties on sales of approved products. Both firms are privately held.

Access Oncology gets exclusive licensing rights in all markets of the world with the exception of Asia, which has been retained by Gem.

“The issue with doxorubicin is cumulative toxicity — you run out of cardiac function before you run out of utility of the drug,” Weiss told BioWorld Today. “[Physicians] all know they can only go so far, and once they get to a certain point, they have to stop. If you’re making people better and they die of heart failure, you haven’t done much.”

Gem’s formulations of doxorubicin do away with the alcohol metabolite implicated in the heart damage known to be caused by traditional chemotherapy, Weiss said.

“It’s such an active drug in so many indications,” he said, indications such as breast cancer and leukemia. He added that avoiding problems caused by therapy has been the challenge for years.

“You don’t want to give children a drug [that means] later in life they’ll have to deal with heart disease,” he said.

Earlier this month, Access finalized its deal for the anticancer compound Anhydrovinblastine (AVLB) with Prescient NeuroPharma Inc., of Toronto, gaining exclusive rights to develop and market AVLB worldwide, except in Latin America and the Far East. Access agreed to make up-front and early milestone payments of $1.25 million and development milestone payments of up to $17.5 million, pay royalties on net sales and fund all further development of AVLB, including the completion of Phase II and Phase III trials. (See BioWorld Today, Nov. 29, 2001, and Jan. 9, 2002.)

Gem Pharmaceuticals, with development out of its hands now, can sit and eye milestones and royalties. The company is focused on developing improved anthracyclines for use in oncology, autoimmune disease and anti-infective therapy. Researchers long have been interested in anthracyclines in the last two categories, and the compounds’ effects on over-proliferating cells is widely acknowledged, the company noted, adding that the Access deal is “the key first step in our campaign to revitalize the role of anthracyclines in major disease therapy.”