When Novartis ($NVS) opened its developing world-focused vaccine unit, it gave the team a clear mission--take candidates to proof-of-concept, then license them to manufacturers where the virus is endemic.
Five years later, the unit has the first solid evidence the model can succeed.
Indian manufacturer Biological E has licensed two vaccines developed by the unit--the Novartis Vaccines Institute for Global Health (NVGH)--with outside funding at its lab in Siena, Italy. The most advanced candidate, a typhoid vaccine, has already reported Phase II results and NVGH is due to transfer the technology to Biological E imminently. NVGH has also out-licensed a vaccine for paratyphoid, but this is yet to enter clinical trials. Once NVGH has done early work, de-risking the program, the vaccine will pass to Biological E too.
The development path and out-licensing deal closely follow the model Novartis envisaged when it created the non-profit back in 2008. "It validates that the model can succeed," Novartis Institutes for BioMedical Research's (NIBR) Don Ganem told FierceVaccines. Ganem, who heads up the global infectious diseases team at NIBR, said the model allows NVGH to leverage Novartis' early development capabilities across multiple projects. Novartis' experience helps NVGH quickly push a vaccine through the early stages of development.
Once the vaccine reaches proof-of-concept, the risk-reward balance is favorable to a licensee. NVGH looks for manufacturers in areas where the disease is endemic; for typhoid, Biological E fits the bill. It knows the Indian vaccine market well, is an established supplier to the government and has a low-cost manufacturing base. This will allow Biological E to make the vaccine widely available in India and throughout the developing world at a low cost. And because NVGH handled early development, Biological E can turn a profit while keeping prices low. The agreement comes 6 months after Biological E inked a 50-50 joint venture with GlaxoSmithKline ($GSK).
Experts from Biological E are due to visit Siena to learn about the typhoid vaccine, and then take this understanding back to India. NVGH will support Biological E through the technology transfer, after which it will remain available in an advisory capacity. Biological E will then have operational and financial responsibility for manufacturing, further clinical trials, approval and distribution in the developing world. Novartis retains the rights in the developed world.
- here's the release
Editor's note: This story has been updated. The previous version incorrectly called NVGH a nonprofit.