By Biola Lawal
FLOWERBUDNEWS: Liddie Bioequivalence (Liddie BE) Ltd (https://www.liddie.org/), an emerging world class Clinical Research Organization (CRO), is now set for a major boost of Nigeria’s health sector with local production of genetic drugs.
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Flowerbudnews reports that the establishment of Liddie BE Limited, a consortium of pharmaceutical and drug research professionals and experts, is expected to make available high quality and safe generic drugs at significantly reduced costs to the government and patients in Nigeria and Sub-Saharan Africa.
(Chief (Dr.) Dele Fajemirokun, a Nigerian businessman, entrepreneur, investor, venture capitalist, and philanthropist)
The company is already investing heavily in a Bioequivalence/Clinical Trial Centre for a tremendous impact on the nation’s healthcare delivery.
The groundbreaking ceremony for Liddie BE’s state-of-the-art facility in Ibadan, Nigeria, which includes a dedicated 24-bed clinical trial unit and a bioanalytical laboratory (positioned for ISO 17025 certification), will take place by Q2 2025 and will be commissioned in Q3 2026, Flowerbudnews learnt.
The Nigeria-based Clinical Research Organization (CRO), is the first of its kind in sub-Saharan Africa and in collaborative operation with the prestigious Obafemi Awolowo University (OAU), Ile Ife, Nigeria. The CRO is being supported by funders, led by Chief (Dr.) Dele Fajemirokun, a Nigerian businessman, entrepreneur, investor, venture capitalist, and philanthropist, Flowerbudnews reports.
Flowerbudnews learnt that Liddie BE, which is already registered with the Corporate Affairs Commission (RC 1575041) has a Corporate Social Responsibility (CSR) commitment to strengthen the pharmaceutical industry in Nigeria in the assessment of the bioequivalence of generic medicines (drugs).
For effective operations, Liddie BE has signed a comprehensive memorandum of understanding (MOU) with the Obafemi Awolowo University (OAU), which covers collaboration in the design and conduct of bioequivalence and clinical research projects for the pharmaceutical industry and building capacity of academic staff and young scientists, Flowerbudnews reports.
A statement on the unique pharmaceutical project made available to Flowerbudnews disclosed that
currently, Liddie BE Ltd bioanalytical laboratory (Bioequivalence and Biopharmaceutics Laboratory, Faculty of Pharmacy, OAU) under the leadership of Prof. Oluseye Bolaji, is equipped with state-of-the-art analytical equipment (including LC-MS and HPLC) that are currently domiciled at OAU.
A clinical site is also now located at the newly built Jennifer Etuh Medical Center, Ifewara, Osun State (with in-house modern laboratories), a few kilometers from OAU, Flowerbudnews reports.
”The Centre will obtain WHO prequalification/FDA certification by Q4 2026 and will work closely with the National Agency for Food and Drug Administration and Control (NAFDAC) to ensure that all the expected clinical and laboratory operations compliances are met and consistent with international best practices,” the statement stressed
The statement further disclosed that ”the Liddie BE company is driven by a strong management team of US-based Nigerian pharmaceutical scientists in partnership with Nigeria-based pharmaceutical and clinical professionals (https://www.liddie.org/team/).
”The company is being built on a quality-driven foundation, staffed with a competent diaspora-sourced clinical pharmacologist with over 30 years combined US FDA/pharmaceutical industry regulatory work experience.”
Flowerbudnews learnt that the ”in-country scientists are composed of university professors with greater than 90 years of combined clinical/pharmaceutical research experience, and regulators with over 60 years of NAFDAC regulatory careers.”
The brief on LIDDIE BE also disclosed that the CRO’s top pharmaceutical scientists and administrators are operating with strategic direction, under a seasoned advisory board to provide oversight. It also has Dr Olawale Salami, an international clinical trials expert, as an advisor, who supports the company with his expertise in the design and management of Phase 1 to 4 clinical trials.
”Dr. Salami has overseen over 40 clinical trials, including complex trials, across several therapeutic areas (oncology, infectious diseases, cardiovascular and gynecological diseases),” the brief stated.
It disclosed further:
One component of healthcare that can be reduced substantially is the cost of medicines and this can be achieved by using cheaper, locally produced, and quality generic substitutes of the often more expensive innovator (or brand-named) medicines.
To serve as substitutes, generic products should be bioequivalent or therapeutically equivalent to the commercially available brand (innovator, originator, comparator) product.
The US FDA defines a generic drug as a “medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.”
Flowerbudnews learnt that the African market is dominated by the presence of generic drugs (>80%). Nigeria also controls more than 60% of pharmaceutical manufacturing in the ECOWAS sub-region, serving 300 million people.
Yet, a vast majority of the generic drugs in the Nigerian market do not have BE data. From Nigeria’s NAFDAC sources, at least 50% of drug products registered that are supposed to have BE data do not come with such data.
Specifically, 80% of antivirals, 75% antibiotics and 96% antimalarials are registered without BE data.
Flowerbudnews also learnt that, with the Maturity Level 3 status of NAFDAC and the goal for Maturity Level 4, the Director General had given a directive that BE data has become mandatory for the registration of products that need such data.
The establishment of Liddie BE Limited will play a significant role in achieving the laudable NAFDAC goal and will make available, high quality and safe generic drugs at significantly reduced costs to the government and patients in Nigeria and Sub-Saharan Africa, the statement assured.
It is noteworthy that Liddie BE recently initiated the first bioequivalence study from a local manufacturer sponsor and a Principal Investigator who is a professor of medicine at OAU, Ile Ife.(Flowerbudnews)
