Established in 1982, Genius is arguably the oldest health care biotechnology company in South Africa, if not the African continent, with a track record of investing in research and development work that led to successfully commercialising South Africa’s first biosimilar product, Repotin, a recombinant human hormone known as erythropoietin (EPO).
Genius focuses on health care applications and more specifically on the production of biopharmaceutical products. Biopharmaceutical products include such therapeutics as hormones, protein-based drugs and antibodies.
Genius is a research and development biopharmaceutical group of companies which includes the following operational business units:
- Immunotherapy dendritic cell vaccine technology (DCV)
- Erythropoietin production, registered as Repotin
- Granulocyte-colony stimulating factor (G-CSF) product development
- Integrated Bioworks (IBW) reagents
2017 OPERATIONAL PERFORMANCE
The divisions are engaged in product development which are at different stages and the progress is as follows:
- Regulatory preparation and process validation phase for the production of EPO, a biosimilar drug used to treat anaemia caused by kidney disease
- Developmental work on DCV for cancer immunotherapy and non-communicable diseases such as extreme drug-resistant tuberculosis
- Further developmental activities at the Ribotech facility for a second biosimilar drug called Recogen, a G-CSF used for the treatment of neutropenia
- Production of protein-based reagents used mainly in research laboratories and industrial applications.
VISION 2020 VISION – GENIUS’ CONTRIBUTION
The outlook for Genius and their value proposition is based on a long-term vision and value-add that is linked to defined milestones.
Unlike other typical investments in other sectors, Genius works to achieving milestones in their developmental stage, hence a five-year strategic plan to the year 2020 was implemented with clear deliverables and strategic actions for each strategic lever as well as detailed clear time frames.
- The cell culture division is currently manufacturing EPO and is undergoing regulatory preparation with “mock-runs”
- The DCV project is preparing for phase 1 human clinical trial in breast cancer patients and performing pre-clinical trials on X‑DR tuberculosis
- Further development work for the production of a second biotech drug for humans
PROSPECTS AND FUTURE OUTLOOK
The following prospects have been identified:
- For Repotin production, processes, updates and regulatory framework are to be completed by 2018
- Secure funds to complete final filling solutions for recombinant products for both Repotin and Recogen
- Further research and development work in order to continue to production phase
- Begin the phase 1 human clinical trial in breast cancer patients and pre-clinical work on other diseases
- Integrated Bioworks to generate revenue from the sale of laboratory reagents and increase its product offering
- Based on the phase 1 trial results – accelerate the listing of Genius to obtain the necessary capital to complete phase 2 and 3 trials
MEDIUM- TO LONG-TERM:
- Optimise and increase the production output of Repotin so that it is able to meet market demand by 2020 and introduce additional formulation strengths to enter the oncology market
- Introduce an additional range of recombinant and biologically derived products through a licensing agreement with an international partner
- Partner with a South African multinational pharmaceutical company to secure a sales and marketing channel for local and international biological markets
- Plan and prepare to list Genius on a foreign stock exchange
The Genius Group has two state-of-the-art medium-sized biopharmaceutical laboratory facilities, one in Cape Town and the other in Centurion, Pretoria.
Detailed information about Genius’ business model, stakeholders, risks and governance is available on the website at www.aeei.co.za.