Xechem International and its lead product NICOSAN(TM)/HEMOXIN(TM). We are extremely excited about our strategic alliance with Alembic, a well-established pharmaceutical company in India. Alembic's financial, technical and distribution strength will accelerate our ability to successfully launch NICOSAN(TM)/HEMOXIN(TM) first in Nigeria and surrounding countries where such conditions are a national priority, followed by the USA, Europe, Latin America, and Asian countries. Alembic's faith in Xechem and its technology validates our excitement about the product, and our immediate opportunity in Africa. We believe this will accelerate our drive toward clinical trials of NICOSAN(TM)/HEMOXIN(TM) in the United States."
Food and Drug Administration (FDA) in the USA has granted the orphan drug status to HEMOXIN(TM), and when appropriate FDA regulatory approval is attained, after the US clinical trials, the sales will start immediately. Xechem has agreed to use its best efforts to provide a board seat to designee from Alembic, subject to Alembic's fulfillment of its obligations.
The European Medicine Evaluation Agency has approved orphan drug status for the phytomedicine niprisan in the treatment of sickle cell disease; Germany's Federal Institute for Drugs and Devices has approved modafinil tablets for the treatment of moderate to severe chronic shift work sleep disorder; and Costa Rica's Ministry of Health has approved a hyaluronic acid–based gel for the management of exuding or debrided wounds.
Orphan Drug Niprisan (Nicosan/Hemoxin) for Sickle Cell Disease in EU
The European Medicine Evaluation Agency (EMEA) approved orphan drug status for the phytomedicine niprisan (Nicosan/Hemoxin, made by Xechem International, Inc.) for the treatment of sickle cell disease (SCD).
Niprisan is an ethanol/water extract of Piper guineenses seeds, Pterocapus osum stem, Eugenia caryophyllum fruit, and Sorghum bicolor leaves.
The approval was based in part on data from a phase 2b, placebo-controlled, double-blind crossover study in 82 Nigerian patients. The data showed that treatment with niprisan significantly reduced the frequency of SCD crises associated with severe pain during a six-month period (P < .01). Moreover, 73% of patients achieved complete remission.
Niprisan did not appear to cause acute hepatic toxicity, as assessed by liver enzyme activity; evaluation of serum creatinine and blood urea nitrogen levels suggested that renal function also remained normal. No serious adverse events were reported.
Niprisan (Hemoxin) was previously granted orphan drug status for this indication by the U.S. Food and Drug Administration in March 2006.
Modafinil (Vigil) to Treat Chronic Shift Work Sleep Disorder in Germany
The Germany's Federal Institute for Drugs and Devices approved modafinil (Vigil tablets, made by Cephalon, Inc.) for the treatment of moderate to severe chronic shift work sleep disorder with excessive sleepiness in patients working night shifts who have not responded adequately to sleep hygiene measures.
The approval was based on data from a double-blind, 12-week study in 209 patients showing that nightly treatment with 200 mg of modafinil increased sleep latency from baseline (1.7 ± 0.4 vs 0.3 ± 0.3 minutes; P = .002) and improved clinical symptoms in a greater proportion of patients (74% vs 36%; P < .001) compared with placebo.
Modafinil-treated patients also experienced a decrease from baseline in the frequency and duration of attention lapses during nighttime testing, contrasting with the increase observed among those receiving placebo (Psychomotor Vigilance Test score, –2.6 vs 3.8; P < .001).
In addition, patients receiving modafinil therapy reported fewer accidents or near misses while driving home from work compared with those receiving placebo (29% vs 54%; P < .001).
The most commonly reported adverse events associated with modafinil therapy were headache (25%) and nausea (9%). Treatment did not adversely affect daytime sleep compared with placebo.
Although 200 mg of modafinil reduced the extreme sleepiness of chronic shift work sleep disorder and resulted in small but significant improvements in performance compared with placebo, patients continued to have residual sleepiness and impaired performance at night. This finding suggests that the therapy is not completely effective and underscores the need for development of more effective interventions.
Modafinil tablets were previously approved for this indication by the U.K. Medicines and Healthcare Products Regulatory Agency and the U.S. Food and Drug Administration (FDA).
Other approved indications for modafinil in Germany include narcolepsy and moderately severe to severe obstructive sleep apnea with excessive daytime sleepiness despite nocturnal continuous positive airway pressure. Modafinil tablets are also approved by the FDA to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome.
Hyaluronic Acid Gel (IPM Wound Gel) for Healing Ulcers and Debrided Wounds in Costa Rica
The Republic of Costa Rica's Ministry of Health approved a hyaluronic acid (HA)–based gel (IPM Wound Gel, made by LAM Pharmaceutical Corp. and distributed by aQva Pharmaceuticals, Inc.) for the management of exuding (such as leg, pressure, and diabetic ulcers) and debrided wounds. The product is also available without a prescription for use on minor abrasions and cuts.
The clear and odorless aqueous gel is composed mainly of sodium hyaluronate, a purified derivative salt of HA obtained from avian sources. Unlike other glycosaminoglycans such as chondroitin or chondroitin sulfate, HA is not immunogenic.
According to a company news release, wounds containing high concentrations of HA heal rapidly with little scarring. The effect is thought to be due to the molecule's ability to serve as a transportation system between the epidermal and dermal skin layers, allowing increased efficiency in the process of wound healing (inflammatory cell migration, fibroblast cell migration, cytokine migration, and epithelial cell migration).
The approval was based on the results of a study in 27 patients with 53 nonhealing ulcers of at least one month's duration (mean, 25.34 weeks). In the study, treatment was well tolerated and 89% of ulcers were healed at four months.
The HA-based gel was approved by the U.S. Food and Drug Administration, the Ecuadorian Ministry of Health, and the Panamanian Ministry of Health in April 2002, March 2005, and September 2005, respectively |
