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Xechem Receives Approval For Sale Of NICOSAN(TM) From Nigerian Regulatory Authorities -- NAFDAC
Jul 5, 2006 2:26:00 PM
Copyright Business Wire 2006
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--July 5, 2006--
Xechem International, Inc. (OTC BB: XKEM). Xechem International announced today that its subsidiary, Xechem Pharmaceuticals Nigeria, has received approval on July 3rd, 2006 from Nigeria\\'s drug regulatory authority, the National Agency for Food and Drug Administration and Control (NAFDAC), for the marketing and sale of NICOSAN(TM), for the prophylactic management of Sickle Cell Disease (SCD). The approval is for an initial term of two years, which will allow Xechem to complete confirmatory Phase III clinical trials in Nigeria. The company faces no restrictions on its ability to market and sell the drug in Nigeria.
President Obasanjo To Launch NICOSAN(TM) at Xechem Nigeria\\'s Corporate Headquarters
His Excellency, President Olusegun Obasanjo, the President and Commander in Chief of the Federal Republic of Nigeria, is expected to officially launch NICOSAN(TM) at a ceremony to be held on July 6th, 2006 at the headquarters of Xechem Pharmaceuticals Nigeria. A number of other dignitaries, business leaders and governmental officials are also scheduled to attend the launch.
According to Dr. Ramesh Pandey, the Chairman and CEO of both Companies, NAFDAC\\'s approval of NICOSAN(TM) represents a monumental and historical achievement for Xechem and the great people of Nigeria. Xechem is grateful to the many people whose tireless efforts have made this day possible. Sickle Cell Disease is a devastating and debilitating disease for which there has never been an effective treatment on the market. Finally, we can say categorically that is no longer the case. To bring this drug to market first in Nigeria, a country with by far the largest sickle cell population in the world and whose scientists originally developed the medicine, from historical herbal remedies, is particularly gratifying. For sickle cell sufferers in Nigeria, the wait is over. Soon, we hope that will be the case for other countries of the world."
About NICOSAN(TM)
NICOSAN(TM) is an anti-sickling "Natural Herbal Drug" developed by Nigerian scientists at the National Institute for Pharmaceutical Research and Development (NIPRD). In clinical studies conducted under NIPRD\\'s auspices, the drug has shown to substantially reduce the degree of sickling of the red blood cells of those afflicted with the disease. While not a cure, the clinical trials have confirmed that the large majority of patients taking NICOSAN(TM) no longer experience sickle cell "crises" while on the medication, and even among those whose crises are not eliminated, the number and severity of the crises are substantially reduced.
About Sickle Cell Disease
Sickle Cell disease (SCD) is an inherited blood disorder caused by an abnormality in the hemoglobin molecule. Patients with the disease often produce stiff, abnormally shaped red blood cells that often do not flow freely through the blood vessels. This can create clogs in the vessels, which in turn cut off the flow of normal hemoglobin and oxygen to parts of the body, and can cause severe painful attacks or "crises", damage to various organs and shortened life spans. People with SCD often suffer unpredictable painful crises several times a year lasting from a few hours to a week or more. In the US, there are approximately 80,000 patients with SCD. In Nigeria, that number is believed to be approximately 4 million, and worldwide at least 12 million individuals are afflicted with SCD.
About Xechem
Xechem International, Inc. is a development stage biopharmaceutical company whose focus and resources are currently being primarily directed toward the development and commercial launch of NICOSAN(TM) (to be marketed as HEMOXIN(TM) in the United States and Europe), which has shown efficacy in the prophylaxis management of Sickle Cell Disease (SCD). In addition to NICOSAN(TM) and 5-HMF, Xechem is also working on anticancer, antiviral (including AIDS), antifungal, antimalarial and antibacterial products from natural sources, including microbial and marine organisms. Xechem\\'s mission is to bring relief to the millions of people who suffer from these diseases. Its focus is on the development of phyto-pharmaceuticals (Natural Herbal Drugs) and other proprietary technologies, including those used in the treatment of orphan diseases.
Forward Looking Statements
This press release contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and section 21E of the Securities and Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created hereby. Such forward looking statements involve known and unknown risks and uncertainties.
Source: Xechem International, Inc.
Jul 5, 2006 2:26:00 PM
Copyright Business Wire 2006
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--July 5, 2006--
Xechem International, Inc. (OTC BB: XKEM). Xechem International announced today that its subsidiary, Xechem Pharmaceuticals Nigeria, has received approval on July 3rd, 2006 from Nigeria\\'s drug regulatory authority, the National Agency for Food and Drug Administration and Control (NAFDAC), for the marketing and sale of NICOSAN(TM), for the prophylactic management of Sickle Cell Disease (SCD). The approval is for an initial term of two years, which will allow Xechem to complete confirmatory Phase III clinical trials in Nigeria. The company faces no restrictions on its ability to market and sell the drug in Nigeria.
President Obasanjo To Launch NICOSAN(TM) at Xechem Nigeria\\'s Corporate Headquarters
His Excellency, President Olusegun Obasanjo, the President and Commander in Chief of the Federal Republic of Nigeria, is expected to officially launch NICOSAN(TM) at a ceremony to be held on July 6th, 2006 at the headquarters of Xechem Pharmaceuticals Nigeria. A number of other dignitaries, business leaders and governmental officials are also scheduled to attend the launch.
According to Dr. Ramesh Pandey, the Chairman and CEO of both Companies, NAFDAC\\'s approval of NICOSAN(TM) represents a monumental and historical achievement for Xechem and the great people of Nigeria. Xechem is grateful to the many people whose tireless efforts have made this day possible. Sickle Cell Disease is a devastating and debilitating disease for which there has never been an effective treatment on the market. Finally, we can say categorically that is no longer the case. To bring this drug to market first in Nigeria, a country with by far the largest sickle cell population in the world and whose scientists originally developed the medicine, from historical herbal remedies, is particularly gratifying. For sickle cell sufferers in Nigeria, the wait is over. Soon, we hope that will be the case for other countries of the world."
About NICOSAN(TM)
NICOSAN(TM) is an anti-sickling "Natural Herbal Drug" developed by Nigerian scientists at the National Institute for Pharmaceutical Research and Development (NIPRD). In clinical studies conducted under NIPRD\\'s auspices, the drug has shown to substantially reduce the degree of sickling of the red blood cells of those afflicted with the disease. While not a cure, the clinical trials have confirmed that the large majority of patients taking NICOSAN(TM) no longer experience sickle cell "crises" while on the medication, and even among those whose crises are not eliminated, the number and severity of the crises are substantially reduced.
About Sickle Cell Disease
Sickle Cell disease (SCD) is an inherited blood disorder caused by an abnormality in the hemoglobin molecule. Patients with the disease often produce stiff, abnormally shaped red blood cells that often do not flow freely through the blood vessels. This can create clogs in the vessels, which in turn cut off the flow of normal hemoglobin and oxygen to parts of the body, and can cause severe painful attacks or "crises", damage to various organs and shortened life spans. People with SCD often suffer unpredictable painful crises several times a year lasting from a few hours to a week or more. In the US, there are approximately 80,000 patients with SCD. In Nigeria, that number is believed to be approximately 4 million, and worldwide at least 12 million individuals are afflicted with SCD.
About Xechem
Xechem International, Inc. is a development stage biopharmaceutical company whose focus and resources are currently being primarily directed toward the development and commercial launch of NICOSAN(TM) (to be marketed as HEMOXIN(TM) in the United States and Europe), which has shown efficacy in the prophylaxis management of Sickle Cell Disease (SCD). In addition to NICOSAN(TM) and 5-HMF, Xechem is also working on anticancer, antiviral (including AIDS), antifungal, antimalarial and antibacterial products from natural sources, including microbial and marine organisms. Xechem\\'s mission is to bring relief to the millions of people who suffer from these diseases. Its focus is on the development of phyto-pharmaceuticals (Natural Herbal Drugs) and other proprietary technologies, including those used in the treatment of orphan diseases.
Forward Looking Statements
This press release contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and section 21E of the Securities and Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created hereby. Such forward looking statements involve known and unknown risks and uncertainties.
Source: Xechem International, Inc.
