By Lisa Seachrist

Washington Editor

With an eye toward familiarizing urologists with the company name, Cell Pathways Inc. obtained rights from Aventis Pharmaceuticals Inc. to market the non-steroidal antiandrogen Nilandron as a treatment for prostate cancer.

With the marketing rights for Nilandron, Horsham, Pa.-based Cell Pathways will begin to establish a relationship with urologists. The relationship could prove useful when the company's lead oral cancer drug, Aptosyn (exisulind), enters the market. Aptosyn currently is under consideration for FDA approval for use in patients with familial adenomatous polyposis (FAP).

"This is a major opportunity for Cell Pathways," Robert Towarnicki, the company's CEO and president, said in a conference call. "It moves us one step closer to having a presence in oncology and moves us in the direction of becoming a revenue-producing and earnings-driven company."

In developing a sales force for Nilandron, Cell Pathways is relying on contract sales provider Innovex, of Research Triangle Park, N.C., to hire and train the 13 members of the team. The two companies already have signed a deal to create a contract sales force for Aptosyn as a treatment for patients with FAP. (See BioWorld Today, Jan. 27, 2000, p. 1.)

Nilandron (nilutamide) is a hormonal therapy that blocks the production of testosterone and is used to increase survival time and promote disease regression in men with advanced prostate cancer who have undergone surgical castration. Already an approved product, Nilandron's sales have ranged from approximately $6 million to $14 million per year under Parsippany, N.J.-based Aventis' watch.

Under the marketing rights agreement, Cell Pathways will receive somewhat more than two-thirds of the sales of the drug over $10 million. Heather Morris, an analyst with Janney Montgomery Scott LLC, estimated the revenues to Cell Pathways this year would be less than $1 million.

"This is really mostly a strategic move for them," Morris said. "You want to have a sales force to reach oncologists and urologists. This lets them get started."

The key issue in having a sales force for both oncology and urology comes from the fact that the company fully intends to develop Aptosyn for the treatment of prostate cancer. Currently under review for patients with FAP, Aptosyn is a selective apoptotic anti-neoplastic drug (SAAND). Aptosyn works by triggering apoptosis, also known as programmed cell death, an orderly sequence of biochemical or physical signals that eliminates defective or worn out cells with new, healthy cells. Cells that fail to respond to apoptotic signals continue to multiply and form tumors.

The FDA is scheduled to make a decision on Aptosyn sometime late this fall. Once the product is on the market, the company, under certain well-regulated circumstances, may provide peer-reviewed literature to physicians about other uses.

"That absolutely doesn't mean the company will promote off-label uses," Morris said. "They will provide whatever information FDA says they can provide and nothing more."

Towarnicki pointed out the access to urologists may serve Cell Pathways in another way by getting the urologists interested enough in the drug that they will enroll patients in prostate cancer clinical trials.

The 13-member sales force will begin hitting urologists' offices sometime in September. These sales representatives will be joined by another 31 once Aptosyn gains entry into the market. The full 41-member sales force will visit gastroenterologists' offices. The original 13 will continue to market Nilandron to urologists as well.

In addition to announcing the Aventis deal, Cell Pathways said its scientists published a paper in the July 1 issue of the journal Cancer Research describing the mechanism by which Aptosyn and other SAANDs trigger apoptosis. The researchers found these compounds inhibit specific cyclic GMP phosphodiesterases of the PDE5 and PDE2 gene families. Scientists previously demonstrated these cyclic GMP phosphodiesterases are overexpressed in precancerous and cancerous cells in the colon.

By inhibiting these proteins, SAANDs trigger apoptosis of the abnormal cells while preserving normal cells. The researchers also found SAANDs that are better inhibitors of PDE5 and PDE2 are better able to induce apoptosis and inhibit growth of cancer cells than Aptosyn.

Cell Pathways also is developing Aptosyn as a treatment for Barrett's esophagus, breast and lung cancer and sporadic colon polyps.

Cell Pathways stock (NASDAQ:CLPA) closed Wednesday at $24.687, up $1.312.

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