Plethora Solutions, a developer of drugs and medical devices for the diagnosis, treatment and management of urological disorders, has reported that, following a recent meeting with the FDA regarding PSD502 for the treatment of premature ejaculation, it has amended its US licensing agreement for PSD502 with Sciele Pharma, a Shionogi company.
Under the terms of this amendment, Sciele has made additional license payments totaling $13.7 million to Plethora and its debt providers, with the company retaining $7 million. Sciele will now assume all future development and regulatory costs related to PSD502 in the US and will own the new drug application for the US market.
Plethora will not receive any further payments and royalties from Sciele with respect to US rights. To date, including these most recent license payments, Plethora has received more than $21.5 million from Sciele via license payments, share purchase and development contributions for the US rights to PSD502 since the original licensing agreement was signed in May 2007.
According to Plethora, PSD502 is a patient-friendly proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation.