According to an article published in the British Journal of Haematology, in July 2002, an investigative study of NIPRISAN (HEMOXIN(TM)) has revealed this phyto-pharmaceutical compound has a strong anti-sickling effect.

Orphan Drug status entitles a company to various incentives including the waiver of Regulatory Filing fees, access to potential grant funding for non-clinical and clinical research to generate required data for marketing approval, and seven years of marketing exclusivity for a designated drug once approved by the FDA.

Xechem International, Inc. (the "Company") owns the exclusive rights to the NIPRISAN (HEMOXIN(TM)), a drug cocktail, which is a phyto-pharmaceutical composition of four traditional plants extracted in a proprietary process. The licensor of the technology is the National Institute for Pharmaceutical Research and Development (NIPRD) in Abuja, Nigeria. Nigeria has the highest sickle cell disease population in the world estimated at between four and six million sufferers, roughly three to five percent of the country's population. NIPRD has already conducted Phase I, Phase IIa and IIb clinical trials and is currently conducting Phase III clinical trials in Nigeria. The results of the Phase IIa and IIb trials while limited to a patient pool of 82 patients nonetheless resulted in a complete remission of SCD crisis in 73% of the patients taking the drug and a substantial reduction in crisis for the remaining patients in the study. The Nigerian human clinical trials were performed using a double-blind crossover study at six months using a placebo.

In the United States, there are approximately 80,000 patients suffering with SCD who have, on average, three to five crises per year. The estimated annual insurance costs for hospitalization associated with SCD crises is approximately $475 million.

According to Xechem's founder and President, Dr. Ramesh C. Pandey:

"We are pleased to hear this good news from the FDA. Receiving an Orphan Drug status for this phyto-pharmaceutical from the FDA's Office of Orphan Drug Products Development helps Xechem come a step closer to bringing its product to the patients who suffer from SCD. Having been granted Orphan Drug status for NIPRISAN (HEMOXIN(TM)) brings credibility to the value of phyto-pharmaceutical medicaments and also provides our investors with a better understanding of the Company's core competency. The granting of Orphan Drug status for NIPRISAN (HEMOXIN(TM)) marks a significant milestone in our Company's history."

Xechem International, Inc. is headquartered in New Brunswick, NJ, with subsidiary companies in the United States, India, and Nigeria with joint ventures located in the Peoples Republic of China, and Hong Kong. The Company is engaged in the research, development, and production of generic and proprietary drugs from natural sources, as well as specializing in the development of niche-generic, difficult to replicate anticancer (including generic Taxol(R)), antiviral (including HIV/AIDS) and antibiotic resistant bacterias such as Helicobacter Pylori (H. Pylori), Vancomycin resistant Enterococcus Faecalis (VREF), Methicillin resistant Staphylococcus Aureus (MRSA) and Candida Albicans. The Company's management and scientific team are also considered world wide as experts in the field of nutraceuticals and screening of extracts and pure compounds from various parts of the world for their therapeutic use.

Xechem Pharmaceuticals Nigeria Limited's current involvement with NIPRD and Sheda Science and Technology Complex (SHESTCO) through its operations in Nigeria will also give the Company a first hand view and potential collaboration in other important pharmaceutical developments in HIV/AIDS and Malaria currently being funded by the Nigerian government. Nigeria has the largest population of any country in Africa and one of the target focal points for the United Nations Development Program, Millenium Goals and other foundations such as USAID and the Bill and Melinda Gates Foundation. These groups are actively engaged in funding the research and development of new pharmaceuticals for the entire continent of Africa.