Drug repurposing venture Novalead Pharma expects to tie-up with a pharmaceutical company and launch its novel diabetes foot ulcer (DFU) gel next month, company executives said.
The 15-year-old venture had recently received the Indian drug regulator’s greenlight for its novel topical gel formulation of an existing drug - Esmolol hydrochloride (from Baxter), that is presently approved in several countries for cardiac conditions given through an intravenous injection.
The “repurposed” drug is not a “line extension” of an existing product, but an entirely novel, “non-obvious” use of an existing drug (from a different company), in a different format, said Atul Aslekar, Novalead Co-founder and Chief Operating Officer.
Novalead Founder and Chief Executive Officer Supreet Deshpande told businessline, they expected to launch in August and were in advanced discussions with a pharmaceutical company to take it to a wider audience.
Pune-based Novalead had undertaken Phase I and II trials overseas and India through contract research organisations, while the advanced stage Phase III trials on the product were done in India, said Deshpande. It has made submissions to the United States Food and Drug Administration and would need to undertake Phase III trials in that geography, he added..
With about $10 -12 million invested in researching the drug, another $ 65 million was required to take it to Europe and the United States, he said, adding that these discussions were also in the works. Till date, funds for the research have been pumped in from high net worth individuals, family trusts, private equity and founders themselves, he said. Its development was also part funded by BIRAC, the company said. (BIRAC - Biotechnology Industry Research Assistance Council, is a public sector enterprise under the central government’s Department of Biotechnlogy.)
While the founders do not have a background in pharmaceuticals, Deshpande said, they found “drug discovery was the most inefficient research in the world”. The founders are mechanical engineers.
This product involves “indigenous development from scratch”, he said, adding that their success involved screening several drugs with the right algorithms and scientific acumen.
“Although it is a repurposed drug, we developed it as a new drug with comprehensive preclinical and clinical investigations, keeping patient safety at the forefront. Its approval is based on statistically significant positive results over standard of care treatment in a randomised, double blind Phase 3 clinical trial.” said Dr Sudhir Kulkarni, Novalead’s Vice President (Discovery).
DFU
The diabetic condition is a prevalent complication caused by chronic diabetes, the venture said, and over 15 -25 percent of people with diabetes suffer from it at least once in their lifetime, it added. “DFU is the leading cause for lower limb amputations globally, with about 100,000 annual incidences in India alone,” a note from Novalead added.