Xechem International Inc. (fka XKEM)

[lsd673]

Nigeria to re-launch indigenous sickle cell drug
Stories by Onche Odeh Head Education & Science


For the over four million people in Nigeria with sickle cell disorders, this might be cheery news. That the government of Nigeria is fine-tuning plans to begin the commercialisation of Nicosan, a herbal based sickle cell medicine made by home-grown scientists with input from the Nigerian Institute for Pharmaceutical Research (NIPR).

The research institute is also developing an immune stimulant that could be a major boost to HIV/AIDS treatment in the country, the Director General of NIPR, Prof. Karniyus Gamaliel, has revealed.

Gamaliel who spoke told Daily Independent in Abuja disclosed that, an end to the troubles that truncated the commercialisation of the medicine is in sight, as the government of Nigeria is currently holding on to the licence for the production of the medicine until it finds a credible firm that would be handed the rights to produce the medicine for commercialisation.

The medicine, hitherto named Niprisan was made from the extracts of West African plants known to a Nigerian family. The licence for its production was subsequently given to American firm, Xechem until the Nigerian government withdrew it in 2009 as a measure to save Nicosan from the internal squabbles that engulfed the company.

“The drug was produced in Nigeria between 2002 and 2006, after which time there was a change in management of the company that caused inner wrangling among the company that led to a comatose. What we did then was to withdraw the licence for Nicosan from the company pending when we find a credible company,” Gamaliel said.

Developed at NIPR under the U.S. Patent number 5,800,819-September 1, 1998. It was found after Phase I, Phase IIa, IIb and subsequent clinical trials conducted by NIPRD in Nigeria to be highly efficacious in reducing crisis among sickle cell sufferers.

A chronology of progress made towards the commercialisation of Nicosn shows that Xechem International, an American company, acquired the exclusive world-wide rights to it in August 2002. It was officially launched in Nigeria on July 6, 2006, during which period Gamaliel said the drug was being produced in Nigeria.

A Phase IIb trial of Nicosan was conducted at an army base hospital in Yaba, Lagos, Nigeria between 1996 and 1997. The company had reported that 73 per cent of the 30 patients who participated in the study experienced no crisis during the 12 month trial period and that the remaining 27 per cent experienced less frequent and less severe crises.

At that point, the government of Nigeria took over the company, which was then liquidated. There have since been several efforts by both Xechem and fresh investors to take over the company and recommence production.

A court dismissed a US$25 million suit against the Nigerian government for withdrawing its licence.

Gamaniel was quoted by Scidev.Net as saying that a committee to resolve all the issues concerning Nicosan has been constituted.

According to Scidev.net, the committee is to look into all the court suits and counter suits and ensure it is all resolved and a competent company appointed to manage the production.

Established drug, hydroxyurea, acts in SCD as an antisickling agent, however not all patients respond to this drug and some experience adverse effects, including myelosuppression. But Nicosan, with possibly less adverse effects also appears to work through a strong antisickling effect, according to the makers.

http://www.independentngonline.com/DailyIndependent/Article.aspx?id=20875


.