HEMOXIN™/NICOSAN™ (Sickle Cell Disease, SCD)
In July, 2002, Xechem acquired an exclusive, worldwide license to develop NICOSAN™ (HEMOXIN™ in the US) from the Nigerian government and, subsequently, received U.S. orphan drug status for HEMOXIN™ from the FDA in August, 2003. The product is made from four botanical species indigenous to Nigeria. NICOSAN™ is produced there today by Xechem. The Company expects to launch NICOSAN™ in Nigeria’s 4,000,000 SCD patient market, the world’s largest SCD market, in 2005. SCD, a devastating hereditary blood disorder characterized by acute painful crisis, organ damage, anemia and early death, affects over 80,000 African Americans in the U.S. alone. Based on published data and human experience, the Company believes the successful clinical development of HEMOXIN™ represents an unusually low risk. In phase II human studies in Nigeria, published in Phytomedecine, HEMOXIN™ was shown to be safe in all patients and effective in approximately 80% of patients. As published in the May 2003 issue of the British Journal of Hematology, Asakura and colleagues from Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania demonstrated the anti-sickling effects of HEMOXIN™ in transgenic mice. This lends significant credibility to the Nigerian human experience to initiate clinical trials in the U.S.
PAXETOL™ Brand of Paclitaxel
Currently, our PAXETOL™ brand of paclitaxel for injection is being prepared for marketing, via strategic manufacturing, distribution, sales and alliances in Domestic and International markets
On June 3, 1996, Xechem announced the findings of a comparison study between TAXOL™ (a registered trademark of Bristol-Myers Squibb) and PAXETOL™ for antitumor activity in vitro and in vivo.
Proprietary Drugs
Our expertise in drug development started with our first project: the successful launch of vancomycin in a remarkably short time - within 3 and 1/2 years, from culture in the test tube through final active drug substance to the finished dosage form marketed with FDA approval. This occurred when Xechem was affiliated with the LyphoMed Pharmaceutical Company.
An emphasis is now on our PAXETOL™ brand of paclitaxel for treating refractory ovarian and breast cancer.
Generic Drugs
The generic drugs produced include:
Vancomycin
Paclitaxel (PAXETOL™)
Bleomycin |
