Drugs in the Pipeline

Pfizer has received an approvable letter from the Food and Drug Administration (FDA) for oral and intramuscular (IM) formulations of its atypical antipsychotic, ziprasidone (Zeldox), for the treatment of schizophrenia. The product is already launched in Sweden, in both oral and IM formulations. This represents the first IM formulation of an atypical antipsychotic.

Novartis says it does not expect any delay in the approval of its new monoclonal antibody asthma therapy, omalizumab (Xolair, E25), despite problems in animal trials with E26, a second-generation, more potent version of omalizumab. Omalizumab is the first in a new class of therapies for asthma that target immunoglobulin E, the antibody trigger of allergic reactions. Although some predict blockbuster status for the product, there are concerns about where exactly it will fit into asthma therapy and about its anticipated high cost.

Merck & Co.’s investigational drug etoricoxib (also referred to as MK-663) appears to relieve moderate to severe pain associated with tooth extraction to a greater degree and in shorter time than placebo. Results from a dose-ranging study of etoricoxib, ibuprofen, and placebo show that the overall analgesic effect of etoricoxib is not significantly different from that of ibuprofen. Etoricoxib is designed as a cyclooxygenase-2 (COX-2) enzyme inhibitor.

Biomira announces that an independent data safety monitoring board (DSMB) has completed a second review of safety data from an ongoing phase III pivotal trial of 600 patients. The DSMB has recommended the trial continue without modifications. The trial is designed to study Biomira’s Theratope vaccine for metastatic breast cancer. The goal for enrollment is 900 patients.

Baxter Healthcare Corp. announces initiation of a phase III clinical trial of its recombinant Factor VIII therapy for the treatment of hemophilia A. By eliminating the use of human- or animal-derived materials in producing the agent, the final product should be free from the risk of transmission of related infectious disease.

Aviron and American Home Products Corp. announce that a Biologics License Application for FluMist has been submitted to the FDA. FluMist is an investigational intranasal influenza vaccine for use in preventing influenza in children and adults.

IDEC Pharmaceuticals Corp. announces the submission of a BLA to the FDA for ibritumomab tiuxetan (Zevalin). Ibritumomab tiuxetan is submitted as a radioimmunotherapy for the treatment of low-grade or follicular, relapsed or refractory, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) and Rituximab-refractory follicular NHL. The FDA has designated the agent for fast-track review.

Genmab announces positive results from a phase I/II clinical trial of HuMax-CD4, a human antibody used to treat patients with rheumatoid arthritis. The study shows a high level of safety and activity in severely diseased patients.

United Therapeutics announces that its New Drug Application for UT-15 has been accepted by the FDA for filing. UT-15 is a prostacyclin analog being developed for subcutaneous treatment for pulmonary arterial hypertension.