Drug Criteria & Outcomes: In the Pipeline

• Protein Design Labs will start a Phase II clinical trial to evaluate its humanized antibody to interleukin-4 in asthma. The randomized, double-blind, placebo-controlled study will be conducted in the United States in 120 symptomatic asthma patients who are not being treated with controller medications, including inhaled steroids, leukotriene modifiers, or long-acting beta agonists. The primary goals of the study are to determine safety, tolerability, and preliminary efficacy.

• SkyePharma PLC and Sanofi-Synthelabo have announced that an "approvable letter" has been received from the Food and Drug Administration (FDA) for the once-daily formulation of alfuzosin (UroXatral) for the symptomatic treatment of benign prostatic hyperplasia. The formulation uses SkyePharma’s proprietary oral drug delivery technology, GEOMATRIX. The New Drug Application for UroXatral was submitted in December 2000 in the United States.

• Amylin Pharmaceuticals has announced that the FDA has completed its review of the New Drug Application for SYMLIN (pramlintide acetate) and has determined that SYMLIN is approvable for both Type 1 and insulin-using Type 2 diabetes. However, approval will require additional clinical work, the specific requirements of which will be determined following discussions with the FDA.

• Following an end-of-Phase II meeting with the FDA, Amylin Pharmaceuticals has reiterated its plans to initiate its Phase III program for synthetic exendin-4 (AC2993) before the end of 2001. AC2993 is a 39-amino acid peptide being studied for the treatment of Type 2 diabetes

• Atrix Laboratories has completed enrollment of its first Phase III study for dapsone topical gel in SMP technology (Atrisone), for the treatment of acne. The results of the trial are expected to be analyzed and available by April 2002.

• Transgene has initiated a Phase II clinical trial of its immunotherapeutic MVA-HPV-IL2 product candidate for the treatment of cervical cancer. The trial will be conducted in Mexico and will include up to 57 women with varying stages of HPV 16 cervical cancer, each of whose cancer either is resistant to radiotherapy or has recurred after radiotherapy.

• Genaissance Pharmaceuticals has initiated its second clinical study, STRENGTH II, to extend its efforts in developing new therapeutic approaches to lowering cholesterol, one of the country’s top public health issues. The STRENGTH (Statin Response Examined by Genetic HAP Markers) Studies are designed to link Genaissance’s proprietary markers of human gene variation, HAP Markers, to clinical response for the development of novel diagnostic and therapeutic products.

• Novartis has submitted a supplementary New Drug Application (sNDA) to the FDA, seeking marketing authorization for its drug imatinib mesylate (Gleevec) for the treatment of patients with unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors.

• Cell Genesys has initiated a Phase II clinical trial of GVAX vaccine in patients with pancreatic cancer who have undergone surgical resection of their tumors. This trial will evaluate the safety and efficacy of GVAX cancer vaccine used in combination with surgical resection of pancreatic cancer followed by standard adjuvant radiation and chemotherapy. The study is being conducted at the Johns Hopkins Oncology Center and will enroll up to 60 patients.

• SLIL Biomedical Corp. has announced that the FDA has completed its review of the Investigational New Drug application (IND) for SLIL’s candidate drug, SL11047. Phase I human clinical trials, aimed at AIDS-lymphoma patients, will be undertaken by Dr. Lawrence Kaplan at the University of California San Francisco.

• Novartis has announced that zoledronic acid for injection (ZOMETA) has been designated a priority review by the FDA in the treatment of bone complications (metastases) associated with a broad range of tumor types. These included patients with prostate cancer, lung cancer, and other tumor types for which no intravenous bisphosphonate therapy is currently approved for treatment, as well as patients with breast cancer and multiple myeloma.

• Immuno-Designed Molecules, S.A. (IDM), and its Canadian subsidiary, IDM-Biotech Ltd., has announced approval from the Canadian health authorities to begin Phase III clinical trials for the treatment of ovarian cancer using IDM’s Cell Drug known as IDM-1.

• Oculex Pharmaceuticals has begun to enroll patients suffering from persistent macular edema (PME) as part of its Phase II clinical trial for Posurdex. Posurdex, a biodegradable, micro-sized drug delivery system designed to provide continuous drug therapy for approximately one month inside the eye.