By Karen Pihl-Carey

SuperGen Inc. signed a worldwide sales and marketing agreement for its cancer drug rubitecan in a deal with Abbott Laboratories that could mean $150 million for the San Ramon, Calif.-based company.

Abbott will make an up-front equity investment in SuperGen and will pay cash milestones.

"The initial up-front equity investment is anywhere between $25 million and $40 million, and the additional milestone payments, the whole package, could be worth $150 million," said Joseph Rubinfeld, chairman and CEO of SuperGen. "But that is exclusive of royalties and R&D payments."

The agreement gives Abbott, of Abbott Park, Ill., exclusive distribution and promotion rights for rubitecan outside the U.S. and co-promotion rights with SuperGen within the U.S. Under terms of the deal, Abbott also will become the exclusive U.S. distributor for Nipent, the already-approved product to treat hairy cell leukemia. SuperGen will retain its U.S. marketing rights for Nipent.

The two companies will share in U.S. profits, and overseas royalties will be in the "high teens" for SuperGen, Rubinfeld told BioWorld Today. Abbott also has options to purchase additional shares, aside from those purchased in the up-front equity investment, at prices two to four times the current market price.

"The initial stake will be in the 5 percent [range], but they can go up to 19 percent, or less than 20 percent," Rubinfeld said of Abbott. "Then, with option exercises, they can go much higher," but not to the point of taking control of the company, he said.

"It verifies our technology," Rubinfeld said. "They wouldn't put up this type of stake unless they believed in the compound."

SuperGen is responsible for funding the clinical development of rubitecan for pancreatic cancer. Rubitecan is an oral chemotherapy compound in the camptothecin class. It is in Phase III studies at more than 200 clinical sites to treat pancreatic cancer, which causes more than 75,000 deaths annually in the U.S. and Europe. It is the fourth leading cause of death by cancer in the U.S. and has an average survival rate of four to five months following diagnosis at an advanced stage.

In a Phase II study of rubitecan, the median survival among responders exceeded 18 months.

Rubinfeld said he expects the Phase III data will be available in the third quarter of 2000. Based on the results, SuperGen will file a new drug application in the last quarter of next year with the aim of an accelerated approval in the first quarter of 2001.

The company also is testing rubitecan in 11 other tumor types, and Rubinfeld said the compound could be an "across-the-board" therapy because it is an oral drug with low side effects. It is in clinical trials for treating ovarian, head and neck, colorectal, breast, lung, cervical, prostate and gastric cancers. It also has demonstrated some benefit in a Phase II study in patients with hematological diseases.

Nipent is a small-molecule purine analogue that acts by blocking the enzyme adenosine deaminase in cells, and doesn't require the presence of surface receptors. It posted 1998 sales of $3 million for hairy cell leukemia. In March, SuperGen filed a supplemental new drug application requesting approval of Nipent for treating mature T-cell lymphomas, primarily cutaneous T-cell lymphoma and peripheral T-Cell lymphoma.

SuperGen's stock (NASDAQ:SUPG) closed Wednesday at $29.375, down $3.125.