Immunex to file Novantrone NDA for hormone refractory prostate cancer in first half of 1996.

IMMUNEX TO FILE NOVANTRONE NDA FOR HORMONE REFRACTORY PROSTATE CANCER in the first half of 1996, Immunex CEO Edward Fritzky forecast Jan. 9 at the Hambrecht & Quist annual health care conference in San Francisco. Novantrone (mitoxantrone) currently is indicated for initial therapy of acute nonlymphocytic leukemia in adults. "In December, we had a favorable discussion with the FDA about our filing plan, and if all goes well with our final data analysis, we plan to file for Novantrone's use in hormone refractory prostate cancer in the first half of this year," Fritzky said.

"Novantrone has the potential to be the first approved in an untapped market that is valued at approximately $100 mil. per year," Fritzky declared. The company completed a Phase III trial in 1995 in hormone refractory prostate cancer that showed a positive outcome, he said.

Immunex became cash-flow positive in 1995, Fritzky reported. "We are financing our business with our own cash flow and have accumulated now $20 mil. in cash, and today we have no debt," he said. In addition, the company expects to receive a $45 mil. payment from its majority owner American Home Products in the first quarter.

"In addition to product sales, our total revenue growth has been fueled by new contract development and manufacturing projects," Fritzky stated. Revenues from these projects were approximately $6 mil. in 1995. Overall 1995 revenues were up 11% to approximately $170 mil.

Although Immunex rejected a $14.50 per share buyout offer from AHP in November because Immunex believed the offer did not appropriately value the company, "our collaborations continue with American Home Products and, in fact, have expanded since the offer," Fritzky commented.

Immunex has signed an agreement with AHP's Wyeth-Ayerst division to collaborate on using the tumor necrosis factor alpha-converting enzyme to discover small molecule therapies for inflammatory diseases. Immunex scientists discovered TACE in 1995, and the collaboration will use TACE to screen potential inhibitors of TNF. Wyeth-Ayerst will make milestone payments and provide research fees of approximately $35 mil. over the course of the agreement. In addition, Immunex will receive royalties on the sales of any products that result from the collaboration.

Immunex also is examining its TNF receptor in rheumatoid arthritis. Phase II results in 180 patients who were refractory to available therapies had joint pain, total pain and swelling count scores improve "dramatically" when compared to placebo, Fritzky maintained. "With these textbook- like results, we expect to size our pivotal studies with hundreds of patients rather than thousands and expedite the time line to one or two years," he said. Phase III trials likely will begin early in 1996.

Immunex continues to seek further label expansion for Leukine (sargramostim, GM-CSF), particularly in the infectious disease realm. Results from a cohort of a Phase III neonatal sepsis study showed that 14% of premature babies who received Leukine had confirmed nosocomial infections as opposed to 35% in the placebo group (p=.043). "This was a remarkably strong early result" for a study that was "originally sized to reach significance at 250 babies, and instead it reached significance [at] only 60," Fritzky asserted. The full trial from which the cohort was drawn will be completed in 1996.

Leukine is being examined also in a 750-patient Phase III trial for prevention of infection after surgery by administering Leukine as prophylaxis. Patient enrollment is halfway completed, and Immunex expects the trial to be finished by the first half of 1997. While the trial is being conducted in cancer patients undergoing surgery, the results can be extrapolated to other high-risk surgeries such as gunshot wounds, trauma and abdominal surgery, Fritzky maintained.

Immunex expects to bring three additional compounds into clinical trials in 1996: FLT3 ligand as a progenitor cell and dendritic cell growth factor; CD40 ligand for treatment of B-cell lymphoma; and interleukin-15 as treatment for gastrointestinal tract mucositis.