GENAERA CORP (OTC:GENR)
Industry: Healthcare
Genaera Corporation, incorporated in 1987, is a biopharmaceutical company committed to developing medicines to address substantial unmet medical needs in major pharmaceutical markets. The Company's research and development efforts are focused on anti-angiogenesis and respiratory diseases. EVIZON (squalamine lactate), Genaera's lead product candidate, is being developed to treat ophthalmic indications, specifically the wet form of age-related macular degeneration (AMD). Squalamine lactate is also being developed as the Company's second product candidate for the treatment of cancerous solid tumors. Its third product candidate, LOMUCIN (talniflumate), is being developed to treat the overproduction of mucus secretions involved in chronic respiratory disease. The fourth product candidate, interleukin-9 (IL9) antibody, is a respiratory treatment based on the discovery of a genetic cause of asthma. Additionally, Genaera has a number of discovery research programs focused on the treatment of obesity, infectious diseases and inflammatory disorders. As of December 31, 2005, Genaera has no products available for sale. EVIZON (squalamine lactate) EVIZON is being studied for the treatment of the wet form of age-related macular degeneration. EVIZON has been granted Fast Track designation by the United States Food and Drug Administration (FDA) and has been selected for participation in the FDA's Continuous Marketing Application (CMA) Pilot 2 program. In 2004, Genaera initiated three Phase II clinical trials following the FDA clearance of the investigational new drug (IND) application to conduct clinical trials of EVIZON in ophthalmic indications including the treatment of wet AMD. In 2005, Genaera completed enrollment in two of its three Phase II clinical trials of EVZON for the treatment of wet AMD. The Company's third and ongoing Phase II study, MSI-1256F-209, is designed to evaluate the safety and efficacy of EVIZON as first-line therapy in 100 patients with wet AMD over a two-year period. In addition to the Phase II clinical trials, Genaera is conducting the first of two planned global Phase III clinical trials (MSI-1256F-301) of EVIZON. Both MSI-1256F-301 and MSI-1256F-302 are multi-center, randomized, double-masked, controlled trials designed to evaluate two systemically administered doses of EVIZON (40 mg and 20 mg) versus placebo. The primary objectives of these studies are to demonstrate safety and significant clinical benefit of EVIZON therapy on visual acuity in the study eye at one year. Squalamine Lactate in Cancer Genaera has conducted Phase II clinical trials of squalamine for the treatment of solid tumors. As of December 31, 2005, the Company has an ongoing Phase II clinical study of squalamine for the treatment of prostate cancer. This cancer study will evaluate intravenously administered squalamine in combination with chemotherapeutics or accepted interventions in this indication. IL9 Antibody Therapeutics The Company's first genomics-based program is focused on the development of a blocking antibody to interleukin-9 (IL9) to treat a root cause of asthma. Functional genomic studies have demonstrated the role of IL9 as an etiologic agent in asthma. The IL9 gene varies in structure and function and as a result may have an important role in a genetic predisposition to asthma and allergic reactions. In April 2001, Genaera entered into a collaborative agreement with MedImmune, Inc. to develop and commercialize therapies related to the IL9 program. By the end of the two-year period, licensed technology had been transferred to MedImmune, which assumed responsibility for development and commercialization efforts on the IL9 program. In addition to the research and development funding, MedImmune agreed to reimburse Genaera for certain external costs the Company incur in connection with the IL9 program. The Company is also entitled to royalties on sales of commercial products resulting from the collaboration. LOMUCIN (talniflumate) LOMUCIN (talniflumate) is an orally available, small molecule inhib
As Of: 10/07 00:00 ET
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