Xechem Files for FDA Orphan Drug Status for the Treatment of Muscular Dystrophy with MYODUR; MYODUR Recently Acquired Through Ceptor Merger.

Business Editors/Health/Medical Writers

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Feb. 3, 2004

Xechem International (OTC BB: XKEM) today announced that it has applied for Orphan Drug status for MYODUR(TM).

Developed by Ceptor, a wholly owned subsidiary of Xechem, MYODUR, Ceptor's lead product, has successfully demonstrated, in animal trials, safety and efficacy in Muscular Dystrophy. MYODUR includes carnitine, a membrane transport carrier molecule that targets skeletal muscle, and its passenger molecule, leupeptin, a known calpain inhibitor. Calpain is the primary protease that degrades skeletal muscle. Because calpain is up regulated in muscular dystrophy, the Company believes the inhibiting effect of leupeptin along with the efficient targeting effect of carnitine makes MYODUR an ideal candidate for this orphan disease.

The Company estimates that muscular dystrophy represents a $1 billion+ market opportunity. Ceptor has previously received Orphan Drug Status from the FDA for the use of leupeptin, as a therapeutic treatment for nerve injuries. Because both carnatine and leupeptin are known compounds to the FDA, and because much larger doses of leupeptin alone have been studied in humans, Xechem believes this is not a high risk development program.

Under the Orphan Drug Act, companies that develop drugs that meet Orphan Drug status have certain benefits that are not available otherwise, including:

-- Market Exclusivity - Government legislation protects and

rewards companies for the development of orphan drugs by

providing for seven years of market exclusivity in the U.S.

and 10 years in the EU, creating a competition free

environment with that technology.

-- Regulatory - Also, because of the Orphan Drug Legislation, the

regulatory challenges for product approval may be less

daunting. This means fewer total patient exposures, possibly,

a fewer number of clinical trials and acceptance of surrogate

markers along with clinical outcomes. Also, the FDA is

mandated to review an orphan drug approval application (NDA or

BLA) in six months (fast track), instead of a year or two. To

be adept at thoroughly understanding the orphan legislation

and designing clinical trials for orphan drugs provides

efficiencies across many different diseases.

Dr. Alfred Stracher, Distinguished Professor and Chairman of Biochemistry at Downstate Medical Center in Brooklyn, New York, and head of Ceptor commented, "We are pleased that our expectations that we would be filing for Orphan Drug Status for MYODUR in 2004 have been met so early in the year. Ceptor's platform technology allows specific membrane transporters and their molecular passengers, at very low doses, to be deposited specifically and effectively within skeletal and cardiac muscle cells in the case of MYODUR. Due to a genetic defect, muscular dystrophy patients produce insufficient dystrophin, which normally provides skeletal cell membrane integrity. With the lack of this cell membrane integrity, calcium ions seep into the cells and up regulate calpain, leading to the degradation of muscle. Ceptor is working on other cell targeting molecules that appear to be equally as efficacious. We are pleased that Xechem has taken the key first steps to commercializing our technology and expect that our association as a wholly-owned subsidiary of Xechem will result in the rapid development of our basic technology."

William Pursley, Vice-Chairman and President of Xechem, noted, "This is just the first of many benefits that we expect will accrue from our acquisition of Ceptor. Muscular dystrophy patients suffer from an over abundance of calpain and this devastating disease usually ends in death in adolescence. The Company believes that these patients can be managed definitively with the proper, targeted inhibition of calpain using MYODUR."

Mr. Pursley concluded, "Unfortunately, many deadly diseases, taken individually, impact a relatively small number of people and, therefore, are not given the research attention that they deserve. Xechem's focus is centered on implementing an orphan disease strategy that can efficiently develop and commercialize drugs that can address both the patients suffering from these diseases and establish Xechem as a leader in this marketplace. Applying for orphan drug status for MYODUR is another step in achieving these goals."

Xechem International, Inc. is a fully integrated biopharmaceutical company focusing on proprietary technologies for orphan diseases. Its mission is to increase the quality and quantity of life of the people who suffer from these diseases.

This news 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 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.