In the Pipeline
These drugs have not yet received final approval:
• Atrix Laboratories has seen promising preliminary results from its phase III trial with a new Atrigel formulation of leuprolide acetate for the treatment of advanced prostate cancer. The company plans to file a new drug application (NDA) next year.
• Coulter Pharmaceutical Inc. and SmithKline Beecham announced resubmission of the biologics license application for Bexxar for treatment of relapsed or refractory low-grade or transformed low-grade B-cell nonHodgkin's lymphoma. Bexxar has been designated a fast-track product by the FDA. If approved in the time anticipated, it will be the first radioimmunotherapy on the market. It involves an antibody conjugated to iodine-131 (I-131) that attaches to a protein found only on the surface of B cells, including nonHodgkin's lymphoma B cells. Properties of the I-131 radioisotope allow a patient-specific dose to be determined and administered.
• Eli Lilly and Co. has signed an agreement with Generex Biotechnology Corp. for the development of a buccal formulation of insulin administered as a fine spray using technology belonging to Generex. Lilly will conduct the clinical trials.
• Helsinn Health Care has announced that enrollment of patients for phase III clinical trials is progressing for study of patients treated with palonosetron, a new agent for prevention of chemotherapy-induced nausea and vomiting. It is hoped that palonosetron will provide extended antiemetic coverage over current 5HT3 receptor antagonists, thus reducing the need for multiple administrations for cancer patients.
• Immunomedics Inc. has begun a phase III pivotal trial to study the safety, tolerability, and efficacy of its humanized, anti-CD22 monoclonal antibody, epratuzumab (LymphoCide) in the treatment of patients with nonHodgkin's lymphoma (NHL) who have failed or are refractory to other forms of therapy, including a prior therapy with an antibody against the CD20 marker of NHL.
• Kos Pharmaceuticals Inc. and DuPont Pharmaceuticals Co. have announced the submission of an NDA for an extended-release niacin/lovastatin product. It has been submitted for use in patients suffering from high cholesterol levels and are in danger of developing serious heart disease. Kos is developing a new brand name for the combination drug. Earlier, the combination was known as Nicostatin. The new product could be available by the end of 2001, depending on timing of FDA approval.
• Maxim Pharmaceuticals has received word of FDA priority review of its histamine dihydrochloride (Maxamine) as an adjunct to interleuken-2 for the treatment of stage IV malignant melanoma.
• Merck's bisphosphonate, alendronate (Fosamax) is effective in the treatment of men with osteoporosis, according to results of a two-year study. Merck has filed for this new indication in the U.S. and Europe.
• SuperGen Inc. reports that data were presented at the Leukemia 2000 conference in Houston on the activity of its anticancer agent pentostatin (Nipent), marketed for treating hairy cell leukemia. The activity of pentostatin in graft-vs.-host disease (GVHD), hairy cell leukemia, chronic lymphocytic leukemia (CLL), and cutaneous T-cell lymphoma (CTCL) was discussed. Preliminary data suggest use of the drug in the post-transplantation setting in patients with steroid-refractory CVHD can contribute to control of GVHD without destroying new bone marrow.
• Titan Pharmaceuticals has revealed positive safety and efficacy data from a large-scale, controlled, phase III study of iloperidone (Zomaril) in development for the treatment of schizophrenia. The trial, run by Novartis, included more than 600 patients to assess the ability of iloperidone to control the positive and negative symptoms in schizophrenia patients. Results show that both doses used in the study achieved a highly statistically significant reduction in schizophrenia symptoms as assessed by the Brief Psychiatric Rating Scale.
• Triangle Pharmaceuticals Inc. has announced the one-year results from a pilot study of a once-a-day HAART (highly active antiretroviral therapy) regimen, combining emtricitabine (Coviracil), didanosine (ddI), and efavirenz, as a first-line therapy in treatment naive HIV-infected patients. Results showed the regimen was generally well-tolerated and demonstrated strong antiretroviral and immunologic effects lasting for the 48-week duration of the study, with 95% of patients maintaining plasma HIV RNA levels below 400 copies/mL through 48 weeks.