When discussing nations’ scientific discoveries and contributions to medical science not much can be said about Nigeria. Research funding and output in Nigeria is low and the few tangible discoveries or prototypes from the country’s research institutes and centres in the country are hardly developed beyond the labs. However, the story of the development of a sickle-cell drug by research scientists from the country’s pharmaceutical research institute, the National Institute for Pharmaceutical Research and Development (NIPRD) is leading a change of this narrative.
Nigeria has helped develop one of the world’s foremost anti-sickle-cell disease medication – Niprisan™ which was an important development due to the fact that since the anti-cancer drug Hydroxyurea was introduced more than 30 years ago, and later approved as a treatment for sickle-cell anaemia, there was no other known drug for treating the symptoms of sickle cell disease, until Niprisan came to being.
The story of Niprisan started in 1992 when Rev. P. O. Ogunyale, a traditional health practitioner was discovered by researchers in NIPRD to treat sickle-cell disease patients effectively with indigenous herbal medicine. The herbal medicine has been used among the Yoruba people to manage the sickle-cell disease for many years. Contacted by Professor Charles Wambebe, who was the then Chief Executive Officer of the NIPRD, Rev. Ogunyale who had an M.Sc. degree in psychology released his recipe, as a sacred trust, for further development into an effective medicine for the benefit of sickle-cell disease patients globally.
NIPRD scientists and Rev. Ogunyale formulated the multiple herbal anti-sickle cell disease medication that was patented in the United State in September 1998 by NIPRID. NIPRISAN was patented first in Nigeria and later in the USA and 46 other countries. Seven NIPRD researchers and Rev. Ogunyale were credited as the inventors of the new drug. The drug, a phytochemical formulated from parts of four different indigenous plants is not a cure to the disease which is a genetic disorder, but it is very effective in controlling the symptoms associated with the disease.
Clinical trials showed that Niprisan significantly reduced the frequency of sickle-cell disease crises associated with severe pain during a six-month period without causing acute hepatic or renal toxicity and has no serious adverse events on patients. Lab test shows the drug works by reversing sickled red blood cells and protected them from being sickled when exposed to low oxygen tension.
In 2002, a Nigerian subsidiary of the American company Xechem International acquired the rights to Niprisan and after Phase I and Phase II clinical trials, Niprisan was granted orphan drug status by the United States Food and Drug Administration (2004) and the European Medicine Evaluation Agency (2005) i.e. a drug used to treat rare diseases and whose development may not offer the pharmaceutical industry a return on the research investment. This status in Europe and the United State is due to fact that Sickle-cell disease is particularly common in western Africa and people of western African ancestry.
In 2006, the drug was launched in Nigeria after it had been registered by the National Agency for Food and Drug Administration and Control (NAFDAC). It was then sold by Xechem under the trade name, Nicosan™ in the United States of America and in Nigeria. Despite early trials showing a benefit, a Cochrane Collaborations review on the phytochemicals for the disease noted that though Nicosan appeared to be safe and effective in reducing crises associated with severe pain over a six-month follow-up period of this trial, further trials are required to assess its role in the management of people with sickle-cell disease.
Nicosan was produced and marketed in Nigeria and becoming popular as users found it effective and useful but, before the Xechem could develop the drugs further, it went bankrupt in 2008. Around the same time, in Nigeria, the bank foreclosed on the facilities that produced Nicosan. All those with sickle-cell that were taking Nicosan could no longer get their treatment. In 2009, NIPRD withdrew the license and took over the production of the drug. The phase III clinical trials with Niprisan, funded by NIPRD was concluded as “inconclusive”. Though financial constraints hindered NIPRD from doing more phase III trials of the drug, Niprisan was seen as a success being the first herbal medicinal product in Nigeria to have successfully gone through the full phase I, IIa and IIb of clinical studies.
When the patent of the drug expired in 2015 the Nigerian Government stopped the commercialization of the drug. The Nigerian government in an effort to restart commercial production of the drug, in June 2018, through NIPRD signed an MOU with May and Baker (M&B) Plc to begin the production of the drug in commercial-scale. Several generic brands based on the original Niprisan are now being developed globally. For instance, the United States pharmaceutical company, Xickle already sells their own improved Niprisan drug brand.