Twenty five years after intensive research, the National Institute for Pharmaceutical Research and Development (NIPRD), a parastatal of the federal government, signed a licencing agreement for the commercialization of NIPRISAN- a Sickle Cell drug with May & Baker. HASSAN ZAGGI x-rays the history of the drug, the challenges confronted during the research and the impact it will make to Sickle Cell sufferer in Africa.
Last week, on Friday, June 8 to be precise, Nigeria made history. This is following the signing of a licencing agreement for the commercialization of NIPRISAN, a Sickle Cell drug. This is after 25 years of intensive research.
Nigeria is said to be home to the largest number of Sickle Cell suffers globally. An estimated 25 percent of Nigeria’s population is said to carry the sickle cell gene and over two million people have sickle cell anemia which is a combination of the two genes.
It would be recalled that the Federal Executive Council (FEC) in April this year gave approval to the NIPRD and May & Baker Plc to scale up the commercialisation and marketing of NIPRISAN, for the treatment of sickle cell patients.
FEC gave the approval for the licensing agreement to NIPRD and May and Baker Plc to produce the drug on a commercial scale in a bid to give succor through the management of suffers of the disease in Nigeria and indeed, other parts of Africa.
According to findings, the story of NIPRISAN started 25 years ago when the then Director General of NIPRD, Prof. C.O.N. Wambebe, in the course of his engagement and as a result of the good relationship that the Institute had cultivated with the Traditional Medicine Practitioners (TMPs) that he came across Rev. Paul Ogunyale who was then reputed for managing Sickle Cell Disease (SCD) patients in Oyo.
Rev. P. Ogunyale, findings further showed, was not the conventional TMP as he was a well-educated, urbane man of the cloth and a Pastor of the Baptist Church.
In this chance acquaintance between Prof. Wambebe and Rev. Ogunyale, their meeting was like a divine arrangement as “everything aligned for the project – the right man, the right disease, and a willing and prepared Institute.”
NIPRD then entered into a working relationship with Rev. Ogunyale, initially based on his trust of the Institute. The drug was then subjected to different stages and the processes and formulae were eventually patented by the Institute with Rev.Ogunyale as a Co-inventor.
According to findings, at some point after many years, NIPRD reached out to the Pharmaceutical industries in Nigeria for support, especially in terms of materials such as capsule shells and excipients in order to make dosage forms in readiness for clinical trials.
NIPRISAN is said to be the first medicinal preparation in Nigeria to go through the full process of clinical studies starting from Phase 1. It was also said to be the first attempt in the country to develop a phytomedicine into a drug by adapting the standard drug development pathway.
“The NIPRISAN project was actually the model (and served as incentive) for the development of regulatory guidelines for the assessment and registration of phytomedicines in the country. The Institute collaborated closely with NAFDAC as it developed these guidelines,” sources revealed.
Speaking during the signing of the MoU, the Minister of Health, Isaac Adewole, while commending the management of May &Baker for the partnership, also applauded the management of NIPRD, both past the present, for their resilience and determination over the years.
He disclosed that President Muhammadu Buhari played key role in ensuring that the signing of the MoU was possible.
“We must commend Mr President because in terms of discussion, this happened to be the fastest memo that was considered by the Federal Executive Council.
“There was no single dissent, everybody from Mr President supported it and Mr President said how he wished this was available many years back. This is a drug that people are waiting for,” Adewole said.
Speaking earlier, the Acting Director General of NIPRD, Prof. Olubayo Kunle, lamented that most pharmaceutical products in Nigeria are imported even though Nigeria is rich with pharmaceutical raw materials.
While describing the scenario as strange, Prof Kunle noted that “we have all the plant, the know-how and our people know what these things do and now we have the scientific expertise to make these things standardize. The final step is to have a proper manufacturing system and this agreement that has been signed today will be a giant step in that direction.”
He noted NIPRISAN is not a cure for sickle cell, but rather for the management of the ailment.
He, however, disclosed that: “We are still doing more work at the NIPRD to see how to improve on the product and we are working on other products that will do more than this.”
According to him, even though, NIPRD does not known how much the drug will cost after the production, he noted that, “but one thing our MoU puts into consideration is that the cost will be affordable. We know that the majority of sufferers of sickle cell will not able to afford anything expensive.”
Responding to a question on the length of time the research took to be completed, Prof. Kunle said: “It is has taken almost 25 years, but of course it can be done in a more shorter period but it was due to the challenge of funding.
“One of the things we hope is that the more we collaborate with the private sector in discoveries like this, the more resources will be available for us to speed up subsequent ones. If we had the resources, this product could have be been delivered in about three to four years.”
On his part, the Managing Director /CEO of May&Baker, Mr. Nnamdi Okafor, commended the Federal Ministry of Health for its strategy of partnering with the private sector to ensure that health care delivery in Nigeria gets to high heights.
He explained that May and Baker, “as most of you are aware, is the first pharma company in Nigeria. It is the first company to introduce western medicine to Nigerians.
“We are proud of that and we want to say that most of the medicines we have in the markets today are from the output of research done from abroad.
“We are delighted that we are today trying to take up a product that is from the research pipeline of a Nigerian agency. We think that time has come indeed for Nigerian pharma companies to begin to develop products that are researched from Nigeria.”
The May & Baker Chief Executive, however, assured NIPRD that with the agreement, it would soon reap the financial benefit of the research.
“We have discovered that NIPRD has not benefitted financially from the research. I want to promise you that with your cooperation, we will ensure that very soon you begin to benefit,” he reiterated.
A cross section of Nigerians interviewed by The AUTHORITY in Abuja, apart from being excited also expressed optimism that NIPRISAN has come at the time it is needed most.
Speaking to our Correspondent, a father of a sickle cell patient, Abdullahi, commended NIPRD for the efforts, insisting that it will bring succor to many sickle patients in the country.