Kastle closes transaction within 30 days to help keep a lifesaving medication on the market.

FDA was notified that Kynamro was at risk of going off the market unless a new partner was found.  The transfer of Kynamro ownership, involved a complex set of transactions between three separate entities, with the simultaneous cessation and initiation of commercial and operational activities on the closing date

As an alliance relationship was being terminated, an innovator biotechnology company needed to transition all commercial, manufacturing and regulatory responsibilities to a new partner in order to keep Kynamro on the market and available for patients living with homozygous familial hypercholesterolemia (HoFH).  The Innovator company needed to find a partner who was committed to further investments in Kynamro and the ability to assume complete commercial and regulatory responsibility on day one.  The new partner would also need to commit to establishing new manufacturing and supply chain capabilities for the product.  They were focused on preserving their relationships with physicians and health authorities around the world and placed great value on finding a partner that shared their commitment to the product and patients.

Working in collaboration with the innovator company, Kastle created a solution that met their unique goals.

  • Completed diligence and transitioned Kynamro to Kastle ownership within 35 days from initial meeting with the innovator company.
  • Immediately initiated technology transfer for drug product manufacturing and secondary packaging operations
  • Within 30 days of the close took over responsibility of current patients and prescribers currently on therapy, REMS Program management, HUB program, distribution to specialty pharmacies and Medical Information (including PV & AE reporting). Assumed responsibility for all post-marketing commitments

The Results:

Immediate transfer of target assets, manufacturing technology transfer, uninterrupted distribution and a commitment to a long-term investment in the product to maintain a continuous supply for all that benefit from Kynamro.