Xechem Intl. (fka ZKEM)

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http://biz.yahoo.com/bw/030307/75079_1.html

Xechem Files Orphan Drug Application for HEMOXIN a Potential Treatment for Sickle Cell
Disease 'SCD'
Friday March 7, 8:07 am ET


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").
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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®, GinsengOnce®, GarlicOnce®, 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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Contact:
Xechem International
Ramesh C. Pandey, 732/247-3300



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Source: Xechem International, Inc.