Biology Reference
In-Depth Information
cheaply (Hassan
2009
). However, the factory closed in late 2009. By mid-2010
supplies were exhausted, and at the end of the year it was reported that 'despite
promises by the Nigerian government that it would restart production, the drug is
currently unavailable', and the NIPRD's research into the development of other
drug candidates from traditional remedies had ceased (Ndhlovu
2010
).
In March 2012 however, after much negotiation, the Nigerian Federal Ministry
of Information announced that NIPRD was about to resume commercial pro-
duction of Niprisan in Nigeria once a Memorandum of Understanding had been
signed between the various interested parties.
The Director-General of NIPRD, Professor Karniyus Gamaniel, stated that the
'most critical challenge facing the institute today is funding' (Federal Ministry of
Information
2012
). Nevertheless, the most enduring component of this programme
remains the strengthening of research capacity in Nigeria (Tables
4.3
,
4.4
).
Table 4.3
Time
Line and Details of Niprisan/Nicosan Case
Date
Details
1992
Research project commences based on MOU with traditional health practitioner
1994
Phase I clinical trials conducted at NIPRD in Abuja with healthy volunteers
(Wambebe
2008
)
1996
Phase II clinical trials commence in patients with sickle-cell disease at Army
Base Hospital, Yaba, Lagos, Nigeria
1997
Phase IIb clinical trials commence in patients with sickle-cell disease at NIPRD
Clinic, Abuja, Nigeria
1998 to 2000
Through grant from United Nations Development Programme, Niprisan patented
in Nigeria, USA, England, India and 42 other countries in Europe, Africa,
West Indies and Americas (Wambebe
2008
)
2002
Licence granted to Xechem for exclusive global manufacture and marketing of
Niprisan
2002
Rev. Ogunyale dies
2005
Both US Food and Drug Administration and European Medicines Evaluation
Agency give treatment 'orphan drug' status, qualifying it for financial incen-
tives to produce drugs considered too expensive or unprofitable to develop
(Hassan and Scott
2008
)
2006
Nicosan receives approval from Nigerian National Agency for Food and Drug
Administration and Control in March 2006 and, according to Xechem, is first
produced two months later (6 July 2006) 'on a limited basis' (Hassan and
Scott
2008
)
2006
Manufacturing plant at Abuja commissioned by US-based firm
2008
Xechem International files for bankruptcy protection in the United States
(Hassan
2008
)
2009
Nigerian government withdraws Xechem's licence and announces that NIPRD
will take over production in Nigeria (Hassan
2009
). Xechem liquidated.
Factory subsequently closes (Abutu
2010
)
2010
Supplies are exhausted and drug becomes unavailable (Abutu
2010
)
2010
Research and development of Niprisan at NIPRD cease (Ndhlovu
2010
)
2012
Resumption of commercial production announced (Nigerian Federal Ministry of
Information)
