Source: Xechem International, Inc.
Demand for New Sickle Cell Drug NICOSAN(TM) Far Exceeds Supply
Wednesday July 26, 6:30 am ET
Xechem Nigeria Accelerates Construction of Commercial Scale Production Facility
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--July 26, 2006--Xechem International, Inc. (OTC BB: XKEM - News) announced today that response to the first limited sales and distribution of NICOSAN(TM), its new product for the prophylactic management of Sickle Cell Disease (SCD), by its subsidiary, Xechem Pharmaceuticals Nigeria, Ltd. (Xechem Nigeria), has been far greater than anticipated. Xechem Nigeria has broken ground for a new state-of-the-art commercial scale production facility and accelerated the facility\'s construction schedule. Xechem Nigeria, which received regulatory approval for NICOSAN(TM), its first major breakthrough "Natural Herbal Drug," on July 3rd, 2006 from the National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC), has been producing the drug in limited quantities at its pilot scale facility in Abuja, Nigeria.
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Xechem Nigeria\'s new commercial scale facility will have capacity to meet the demand of Nigeria and other African countries. Nigeria alone has 4 million sickle cell disease patients. The new facility will also be able to supply the drug for the clinical trials in the United States and the European Union.
NICOSAN(TM) was launched by the President of Nigeria, His Excellency Chief Olusegun Obasanjo on July 6th, 2006 at SHESTCO Complex. Immediately after the launch ceremony Xechem Nigeria has started direct sales of NICOSAN(TM) in Abuja, the Federal Capital Territory of Nigeria.
The drug is taken through one-a-day capsules which, once started, must be taken daily by the patient. The current price for a months supply for Adults is established at N 3,000 Naira (approx. US $23) and for Pediatrics at N 2,400 Naira (approx. US $18), respectively. Xechem is also accepting mail orders for the drug from other States within Nigeria.
The financing for this first phase of construction was supplied by Nigerian Export-Import (NEXIM) Bank, which loaned Xechem Nigeria N150 Million Naira (US$1.2 million) in June of this year. Xechem estimates that the expanded facility will be fully operational within 9 months.
Dr. Ramesh Pandey, Chairman and CEO of the Xechem Companies said, "This is a very exciting time for Xechem and one that has been more than four years in the making. Getting NICOSAN(TM) approved for the prophylactic management of Sickle Cell Disease (SCD) was a major milestone which changes Xechem from a research and development company to a full scale business venture with NICOSAN(TM) to market.
"This also required the construction of a full scale production facility, on which we have now broken ground This plant will meet all the current Good Manufacturing Practices (cGMP) guidelines, the first facility in Nigeria to do so. We are grateful to NEXIM Bank for the loan and their early support for this project. This will help ensure the completion of our expanded facility in the shortest possible timeframe. Xechem is very proud to be the leader in bringing NICOSAN(TM) for Sickle Cell sufferers first in Nigerian market which will be followed throughout the African continent and the world."
About NICOSAN(TM)
NICOSAN(TM) is an anti-sickling, phyto-pharmaceutical (Natural Herbal Drug) for the prophylactic management of Sickle Cell Disease (SCD). It was 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. Preliminary studies carried out at the National Heart, Lung and Blood Institute Sickle Cell Disease Reference Laboratory (NHLBI-SCDRL), NIH, at the Children\'s Hospital of Philadelphia (CHOP) and Xechem Research Laboratory in New Brunswick, NJ have confirmed some of the Nigerian studies.
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 is a development stage biopharmaceutical company working on anticancer, antiviral (including AIDS), antifungal, antimalarial and antibacterial products from natural sources, including microbial and marine organisms. 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. Xechem\'s mission is to bring relief to the millions of people who suffer from these diseases. Its recent focus and resources have been directed primarily toward the development and launch of NICOSAN(TM) (to be marketed as HEMOXIN(TM) in the US and Europe). With the Nigerian regulatory approval now in hand, Xechem has turned to the commercialization of the drug in Nigeria and plans also to pursue US FDA and European regulatory approval. In addition to NICOSAN(TM), Xechem is also working on another sickle cell compound, 5-HMF, which it has licensed from Virginia Commonwealth University.
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.
Contact:
Xechem International, Inc.
Stephen Burg, 707-425-8855
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Source: Xechem International, Inc.
http://biz.yahoo.com/bw/060726/20060726005261.html?.v=1
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