Nicolaas Duneas knows that starting a biotechnology company is not for sissies. He's been working on bone morphogenetic proteins (BMPs), a protein naturally present in bone and responsible for regeneration and repair of bone, for more than a decade and has made some significant discoveries in that time.
Four years ago he launched AltisBiologics to commercialise his intellectual property.
However, despite a manufacturing facility that has a good manufacturing practice certification and a full pharmaceutical manufacturing licence, the company is still battling to get Medicines Control Council (MCC) approval to run phase 1 clinical trials on Altis OBM, Altis's first porcine- (pig) derived BMP product.
Altis's patented technology platform makes it commercially feasible to extract BMPs from natural bone, such as pig bone, which no-one else has achieved.
From this technology platform numerous products are possible that could be used to treat chronic fractures, osteoporosis or dental restructuring.
Altis Biologics has focused on producing products that deal with difficult human fractures and has licensed the technology to a Dutch company which will develop products for the osteoporosis market.
The technology offers the market a less-invasive alternative to traditional bone graft products which typically involve painful harvesting of bone from a patient's hip or using donor bone from bone tissue banks.
The first licensed product available on the SA market developed using the Altis technology platform is Endogen IVT, a human donor bone-derived BMP product, which is produced by the Centre for Tissue Engineering (CTE) at Tshwane University and marketed by Bone SA, a section 21 company.
The product is not a bone replacement, stresses business development CE Nuno Pires. "It is injected into the site and acts as a scaffold, stimulating the body's own tissue regeneration system."
Altis is also in discussions with the three largest bone tissue banks in the US regarding the licensing of this technology and has a partner in Japan which represents Altis in that country.
But in these markets Pires insists on co-branding in order to gain awareness in the world's largest market. "There is a severe shortage of human donor bone worldwide, so the cannibalisation risk for Altis OBM [the porcine product] is not significant, and at the same time we gain invaluable regulatory and marketing exposure, which will make it easier for us when we are ready to enter the US market with Altis OBM."
Endogen IVT was developed with similar expectations. "We did not expect large financial returns when we licensed our technology to Bone SA and CTE, which operate in a not-for-profit industry, but what we did gain was critical clinical data. Using this data we have successfully raised R15m from the Innovation Fund to finance the Altis OBM clinical trials," says Pires.
But this is where the company has been stalled for two years. "First we had to secure the good manufacturing practice (GMP) and pharmaceutical manufacturing licences," says Pires. "We did not expect to have to obtain full GMP certification for clinical trials."
Having obtained this certification, Altis still awaits MCC approval to commence with the trials.
"In the US, products that are the first of their kind in the world get orphan drug status. This means that the regulatory authorities work with you to ensure a quicker turnaround time. Here, if you are small and have no influence, the bureaucracy works against you."
However, undaunted, the Altis team is focusing its efforts on doing the right things to get its technology platform out into the international market. "We have solid technology platforms, with massive product pipeline potential, and despite the setbacks we have faced we will be an international player one day."