Schering-Plough's Leucomax (molgramostim, GM-CSF) could be approved for use with Syntex' Cytovene (ganciclovir) in the treatment of AIDS-related cytomegalovirus retinitis before the end of the year, the company indicated during a May 4 meeting with securities analysts in Kenilworth, N.J. "We do expect rapid review in the U.S. of our submission" for the combination use of granulocyte-macrophage colony stimulating factor, Schering-Plough Senior VP-Research Operations Frank Bullock said. "This use is the most probable first approval [of Leucomax] in the U.S." The PLA includes data from two studies of the indication, one conducted by the NIAID AIDS Clinical Trials Group and one conducted by Schering-Plough, Bullock said. Both studies "are likely to be published this year." Schering-Plough also has filed for approval of Leucomax for concomitant use in cancer chemotherapy and as an adjuvant for use in bone marrow transplant patients, Bullock said. Immunex' Leukine brand GM-CSF has been approved for the latter indication since February 1991. "FDA approval of our cancer chemotherapy submissions [for Leucomax] we think is unlikely in 1993," Bullock acknowledged. Leucomax, licensed from Genetics Institute and Sandoz, has been approved in 20 countries overseas and has received CPMP approval in Europe. The cytokine was highlighted by Schering- Plough as one of its "high potential products." Sales in 1992 were "not material," Chairman Bob Luciano said, noting that there are "still...some accounting issues" being ironed out among the partners for the product. Schering-Plough's once-a-day theophylline formulation Uni-Dur may be nearing the end of a prolonged review. "All our outstanding commitments to FDA have been submitted," Bullock said. "No additional studies have been requested. We believe we have mutual agreement on labeling, but we have no specific commitment on an approval timetable." FDA has requested more data on the cephalosporin antibiotic Cedax (ceftibuten), Bullock said. "A number of clinical trials are already in progress and significant additional data will be submitted later this year," Bullock said. "We do not forecast a U.S. approval before mid-1994." Schering-Plough is seeking approval for a 400 mg once-daily Cedax capsule and a pediatric suspension. "We're seeking labeling for...lower respiratory and urinary tract infections and otitis media in children," Bullock said. Cedax has shown "fewer gastrointestinal side effects...against a variety of comparator agents," he maintained. International launches began in Italy in March. FDA review of Schering-Plough's NDA for the once-a-day angina treatment Imdur (isosorbide-5-mononitrate) "has gone well," Bullock said. "No issues have surfaced, which suggests no obstacle to approval." Wyeth-Ayerst markets a twice-a-day isosorbide- mononitrate under the brandname Ismo. NDAs for Imdur and Cedax were filed in late 1991 ("The Pink Sheet" Nov. 11, 1991, p. 7). Schering-Plough is bringing three new compounds into the clinic in coming weeks: a cholesterol absorption inhibitor (SCH48461), an anticancer agent (temozolomide), and interleukin- 10. SCH48461 is a "biologically unique" compound that acts to block the absorption of cholesterol in the intestine, Bullock said. An IND was submitted in April and "we expect to have some early Phase II efficacy information this year" with a once-a-day oral dose. Temozolomide, an oral alkylating agent licensed from the Cancer Research Campaign Technology in the U.K., has shown "preliminary but nevertheless striking clinical efficacy" in "several patients with malignant glioma," Bullock said. The National Cancer Institute is "opening an IND on this compound soon," he added, and a company-sponsored IND will follow. The NCI IND will allow the company to explore additional indications, Bullock said. Phase I clinical trials of IL-10 will start "next month," Bullock said, with indications for efficacy studies likely to include organ transplantation and autoimmune diseases. Animal data showing "unusual cardiac lesions" have slowed Schering-Plough's development of IL-4, Bullock told the analysts. FDA has allowed Phase II anticancer studies to continue but with "extensive" cardiac monitoring that has hampered enrollment, he said. "With more extensive favorable clinical experience and favorable results from additional animal studies we now have ongoing we would expect that this extensive monitoring could eventually be eliminated," Bullock added. Other compounds in development include: the corticosteroid mometasone (Elocon), which is entering Phase III for seasonal rhinitis in a nasal spray formulation and is completing Phase II studies for asthma in an inhaler form; and SCH40120, a topical leukotriene antagonist for treatment of psoriasis, which is in Phase II. Noting that safety problems have been seen with other leukotrienes, Bullock said SCH40120 will only advance to full- scale development if comparative studies with the corticosteroid Valisone show an advantage for the new compound.
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