Xechem Files Orphan Drug Application for HEMOXIN a Potential Treatment for Sickle Cell Disease 'SCD'.
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--March 7, 2003
Xechem International, Inc. (OTC BB: ZKEM) has filed its Orphan Drug Application with the United States Food and Drug Administration ("FDA") seeking Orphan Drug status for its Phyto-Pharmaceutical product, HEMOXIN(TM), which is a strong candidate as a treatment for patients suffering with Sickle Cell Disease ("SCD").
Xechem signed an exclusive worldwide license on July 18, 2002 for the manufacturing, marketing, distribution and sales of HEMOXIN(TM) (NIPRISAN(TM)) with the National Institute of Pharmaceutical Research and Development ("NIPRD"), Abuja, Government of Nigeria. The license agreement between Xechem and NIPRD is supported by patents recently issued to NIPRD in various countries including the USA. Xechem is also preparing to file an Investigational New Drug ("IND") Application for HEMOXIN(TM) with the United States Food and Drug Administration ("FDA"). To date, there has been no successful non-toxic drug developed for the treatment of SCD. HEMOXIN(TM) is a non-toxic, Phyto-Pharmaceutical medicament.
SICKLE CELL DISEASE IN THE UNITED STATES
In 1972, the 92nd US Congress passed the National Sickle Cell Anemia Control Act, which called for grant support for screening programs. In 1975, the first US State began a newborn screening program for SCD. However, there has been only one drug, Hydroxyurea (HU), which has come to the marketplace since that time, out of approximately 2,000 screened candidates with over $1 billion in research funding.
According to a study published by Allison Ashley-Koch, Quanhe Yang, and Richard S. Olney of the Centers for Disease Control and Prevention ("CDC"), SCD is a major public health concern (Ashley-Koch, A. et al, Am. J. Epidemiol 151, 839, 2000). Each year in the US, an average of 75,000 hospitalizations are due to SCD, costing approximately $475 million. The average length of per hospital visit was 6.1 days and adults tended to have longer stays than children and adolescents. SCD is also associated with significant mortality. Among children, the primary causes of mortality are bacterial infections and stroke. This genetic disorder has great impact on both the individual and society.
ORPHAN DRUG STATUS
There are two significant advantages in obtaining Orphan Drug status for HEMOXIN(TM).
The first is FDA's recognition of exclusive approval. Orphan Drug Regulations underlying the Orphan Drug Act, provide under Section 316.34 (a) FDA will send the sponsor (or, the permanent resident agent, if applicable) timely written notice recognizing exclusive approval once the marketing application for a designated orphan drug product has been approved. The written notice will inform the sponsor of the requirements for maintaining orphan drug exclusive approval for the full 7 year term of exclusive approval; and (b) When a marketing application is approved for a designated orphan drug that qualifies for exclusive approval, FDA will also publish it in the "Approved Drug Products with Therapeutic Equivalence Evaluations" information identifying the sponsor, the drug, and the date of termination of the orphan drug exclusive approval.
Given the virtual lack of commercially viable treatments for SCD in the United States, the protective aspect of a 7-year exclusive term of protection for HEMOXIN(TM) could give Xechem a significant revenue opportunity.
The second advantage is the availability of tax credits. Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.
More information regarding investment tax credits under the Orphan Drug Act can be found at the following internet link: http://www.fda.gov/orphan/taxcred.htm
Xechem International, Inc., headquartered in New Brunswick, N.J., with subsidiary companies in the USA, India, Nigeria and joint venture partners in both Hong Kong and the Peoples Republic of China, is a biopharmaceutical company engaged in the research, development and production of generic and proprietary drugs from natural sources. The Company specializes in the development of niche-generic, difficult to replicate, anti-cancer, antiviral compounds, including Human Immuno-deficiency Virus ("HIV") and anti-fungal compounds. Xechem is also engaged in the research and development of several novel anti-infectives showing strong and selective efficacy against an array of antibiotic resistant bacterias, including Helicobacter pylori (H. pylori), Vancomycin resistant Enterococcus faecalis (VREF), Methicillin resistant Staphylococcus aureus (MRSA), and other antibiotic resistant Staphylococcus aureus and Candida albicans. The Company also screens extracts and pure compounds from various parts of the world for their therapeutic use.
XetaPharm (another U.S. subsidiary) develops quality controlled nutritional products such as GinkgoOnce(R), GinsengOnce(R), GarlicOnce(R), Gugulon(TM), VIDA PRAS(TM) and numerous other nutraceutical products, which are under development.
This and past press releases of Xechem International, Inc. are available at Xechem's web site at www.xechem.com.
This news release may contain certain forward-looking statements relating to Xechem's future business performance within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities 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, uncertainties, including the ability of the Companies to successfully develop and commercialize their technologies, and other factors that may cause the actual results, performance or achievements of the Companies to be materially different from any future results, performance or achievements of the Companies expressed or implied by such forward-looking statements.
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|Date:||Mar 7, 2003|
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