XECHEM INTL Inc. (OTC:XKEM)
Industry: Healthcare

Listed 4 Consecutive Market Days. On List as of 03/06/2006 Through 03/10/2006

Xechem International, Inc. is a holding company that owns all of the capital stock of Xechem, Inc., a development stage biopharmaceutical company engaged in the research and technology development of generic and drugs from natural sources. Research and development efforts focus principally on antifungal, anticancer, antiviral (including anti-AIDS) and anti-inflammatory compounds, as well as anti-aging and memory enhancing compounds. Xechem is also focusing on phytopharmaceuticals and other technologies for orphan diseases. As of December 31, 2005, the Company's lead project involves the development of a phytopharmaceutical product, NICOSAN/HEMOXIN, which has received United States Food and Drug Administration (FDA)-designated orphan drug status as the first definitive therapy for sickle cell disease (SCD). The development and production of NICOSAN/HEMOXIN is being conducted through Xechem Pharmaceuticals Nigeria Limited (Xechem Nigeria). In 2002, Xechem acquired the exclusive worldwide rights to produce, market and sell the sickle cell drug formerly known as NIPRISAN under an exclusive licensing agreement with the Federal Republic of Nigeria's National Institute for Pharmaceutical Research & Development (NIPRD). The medicine, to be produced at a facility being constructed in Abuja, Nigeria by Xechem Nigeria, will be marketed and sold in Africa under the name NICOSAN. In the United States and the rest of the developed world, the product will be known as HEMOXIN. Xechem Nigeria plans to develop this facility into a self-sufficient four-building complex for the commercial production of NICOSAN/HEMOXIN. Xechem Nigeria has developed small-scale formulations, which have shown efficacy in the treatment of SCD, and must further refine and standardize this formulation for consistent production scale quantities. NIPRD conducted Phase I, IIa and IIb clinical trials in Nigeria using its staff as volunteers. The drug materials of the NICOSAN dosage had no adverse effect on the volunteers in the identified clinical parameters (blood chemistry, liver functional status and kidney functional status). Results from the clinical trials indicated that approximately 90% of the participants experienced no major SCD crises since entering the program. The approximately 10% who did experience one or more SCD crises report that the crises were both less frequent and less severe than those they had previously experienced. These figures vary slightly from the results of a Phase IIb trial of NICOSAN, conducted at an army base hospital in Yaba, Lagos, Nigeria between 1996 and 1997, wherein 73% of the 30 patients who participated in the study experienced no crisis during the 12-month trial period and the remaining 27% experienced less frequent and less severe crises. Certain patients also exhibited the benefits of positive weight gain, as well as, reduced or eliminated sickling tendencies with resulting healthy liver and kidney functioning. Two patients on NICOSAN developed non-itching macular rashes, three to four days after commencing treatment. These rashes disappeared two to five days later. Six patients experienced headaches. No other side effects were observed or reported during the trial period. The preliminary results indicate that NICOSAN/HEMOXIN appear to be safe and effective for prophylactic management of SCD. The Drug Master File (DMF) dossier for NICOSAN has been submitted for a registration approval to the National Agency for Food and Drug Administration and Control (NAFDAC) Abuja, Nigeria, which is Nigeria's regulatory agency. The Company is also preparing its Investigational New Drug (IND) application for the drug HEMOXIN to the FDA so that it may begin clinical trials in United States hospitals, for eventual sale of the drug in the United States. Xechem has obtained the orphan drug designation for HEMOXIN from the FDA, which is granted only for diseases that afflict less than 200,000 people in the United States. The orphan drug status brings many advantages that could assist the Company in obtaining FDA approval for the

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