Following a meeting with the FDA last month, Microbix Biosystems (TSX:MBX) is entertaining expressions of interest from potential partners to license or acquire its anti-clotting urokinase drug, which has been rebranded as Kinlytic, and also provide funding for its re-launch in the U.S. market.
“We believe the outcome of our consultation indicates the planned path to approval of our lead indication is worthwhile, information that will help us conclude a development agreement and re-launch Kinlytic," Vaughn Embro-Pantalony, CEO of Microbix, says in an interview with BioTuesdays.
“We plan to retain a significant interest in the economics of Kinlytic following an agreement with an investor to enable a re-launch program,” he adds.
He says the company received clarification from the FDA on several issues related to the fact that the previous product, Abbott Labs’ Abbokinase, has been off the market for several years.
Urokinase was originally launched by Abbott and was the leading anti-thrombolytic drug in the market, generating peak annual sales of more than $300-million, before Abbott discontinued sales due to manufacturing issues. The drug has been administered to more than four million patients.
After Abbott split into two publicly traded companies, it sold the NDA regulatory file and all of its urokinase assets to another party, from which Microbix later acquired them, making Microbix the only worldwide source of low-molecular-weight urokinase.
Microbix has manufactured urokinase at commercial scale and performed numerous biochemical and functional analyses on the product that demonstrate its ability to undertake its reintroduction into the marketplace, he adds.
According to Mr. Embro-Pantalony, the global use of thrombolytic drugs that dissolve blood clots has been increasing annually and now exceeds $1-billion in the U.S. alone.
Currently, only one thrombolytic drug, tissue plasminogen activator, or tPA, is available for dissolving blood clots in hospitals and clinics in the U.S. market.
“We believe there is significant need for another therapeutic option, both to provide an alternative choice for care providers and patients, and to mitigate the risk of supply disruptions,” he contends.
The company’s three-year program includes transferring the production process to a contract manufacturing organization, which should shorten the timeline to return urokinase to the market; producing new batches of urokinase according to the original NDA drug file, which Microbix owns; and complete comparability analysis and pivotal testing.
“We are finalizing the budget to re-launch Kinlytic within the next three years,” Mr. Embro-Pantalony says, adding that the company has already assembled many of the assets needed to return urokinase to the North American market.
“Following the positive outcome of our meeting with the FDA, our focus now shifts to attracting a development partner,” Mr. Embro-Pantalony says.