Kinlytic deal coming in the near future The clot-busting drug has a storied history, first approved in 1978 as Abbott Laboratories' (NYSE:ABT) urokinase and becoming the market leader under the brand name Abbokinase with $300 million in revenue in 1998 before being removed from the market over safety concerns. The FDA was worried that manufacturing of Abbokinase was not adequately protecting against infections in the neonatal kidney cells being used in the therapy.
The concerns relate to contamination with micro-organisms such as neovirus and mycoplasma. While the company assured the FDA that none of these batches were distributed, the agency says that these findings and "Abbott's inability to locate the source of the problem" raised further concerns about the entire manufacturing process.
Urokinase was originally launched by Abbott Laboratories and was the leading thrombolytic drug in the market until a manufacturing disruption. Abbott then sold the NDA regulatory file and all assets to another party, from which Microbix later acquired them. Microbix has previously manufactured this natural human protein at commercial scale and performed numerous biochemical and functional analyses on the product that demonstrate its ability to undertake the reintroduction of this drug into the marketplace as competitor to tPA (tissue plaminogen activator), the only approved thromolytic drug available today. Microbix believes it's ready to re-launch its product under the Kinlytic brand name with the blessing of regulators into a U.S. thrombosis market exceeding $1 billion annually.
Urokinase was previously used in major worldwide health care markets, but there is now a monopoly. Currently only one thrombolytic drug (tissue plasminogen activator or "tPA") is available for dissolving blood clots in hospitals and clinics. Microbix believes that there is significant need for another therapeutic option, both to provide an alternative for care providers and patients and to mitigate the risk of supply disruptions.
This past webinar with Adelaide Capital Cameron said that a deal for a partnership was getting close. possibly by the end of this calendar year. That will be a big deal when that happens