Microbix Expands Kinlytic Urokinase Reach with CDMO Agreement

• Microbix Biosystems and its partner, Sequel Pharma, have signed an agreement with an international CDMO for the production of Kinlytic urokinase.

• Sequel Pharma has committed to finance the return of Kinlytic to global markets, starting with the $350-million U.S. market for dissolving clots in indwelling venous catheters.

Microbix Biosystems, a Canadian biotech company, has announced a significant step forward in the production of Kinlytic urokinase, a biologic drug used for dissolving blood clots. The company’s financing and commercialisation partner, Sequel Pharma LLC, has executed an agreement with an international contract development and manufacturing organisation (CDMO) for the production of the active ingredient of Kinlytic.

Sequel Pharma, a U.S.-based specialty pharma company with expertise in developing and commercialising niche drugs, has committed to provide all financing needed to return Kinlytic to global markets. The initial focus will be on the $350-million U.S. market for dissolving clots in indwelling venous catheters.

Kinlytic is an enzyme derived from human cell cultures that dissolves the material of a blood clot. It is already approved for clinical use in the United States. The current work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics licensing application (sBLA).

The CDMO has undertaken to complete this work over a time frame specified by Sequel and in line with Microbix’s disclosed project objectives. The work of the CDMO will be overseen by Sequel, with scientific and technical assistance from Microbix.

Cameron Groome, chief executive officer and president of Microbix, commented: “We’re very pleased that a detailed agreement has been executed with a very well-qualified CDMO for the production of new Kinlytic drug substance. All parties will now move ahead at full speed to revalidate and restart manufacturing using state-of-the-art methods and best practices.”

Dr. Ken Hughes, chief operating officer of Microbix, also commented: “It is a pleasure to be working with Sequel, in this instance to identify and brief well-qualified CDMOs about Kinlytic and to solicit and receive well-reasoned proposals from several such parties. We thank each of the CDMOs that participated in this drug substance contracting process and hope to have the opportunity to work with them on other aspects of this program or in our future endeavours.”