Endo International plc – Ordinary Shares (NASDAQ:ENDP) reported the completion of the previously reported sale of Grupo Farmacéutico SOMAR to Advent International in a deal valued at around $124 million, after making estimated cash, net working capital and debt purchase price adjustments.
Paul Campanelli, the CEO and President of Endo, expressed that he would like to thank their SOMAR colleagues for their contributions to their firm and wish them all success with Advent International. With the divestiture of SOMAR done, they look forward to a sustained focus on their core strengths and execution against their strategic priorities as an extremely focused generics and specialty branded pharma firm.
In unrelated news, Endo International reported that its subsidiaries, Endo Par Innovation Company, LLC and Par Sterile Products, LLC, filed suit in the U.S. District Court against the U.S. FDA seeking a declaration that the USFDA’s current framework enabling for the bulk compounding of several products is unlawful under the DQSA amendments to the FDCA.
The lawsuit seeks the immediate removal of vasopressin from the USFDA’s Category I nominations list to guarantee that non-sterile-to-sterile outsourcing services cannot involve in bulk compounding of vasopressin. Endo International filed the suit grounded on legislative provisions mentioned in the DQSA amendments needing FDA to implement a regulatory framework pertaining bulk compounding that serves to safeguard the public health.
Matthew J. Maletta, the Chief Legal Officer and EVP of Endo, expressed that they welcome FDA Commissioner Gottlieb’s press statement given in September that FDA is focusing on a new compounding policy which they expect will include the legally needed changes to FDA’s regulatory framework.
Nevertheless, because they consider the status quo is illegitimate and because they have no assurance about FDA’s plans, they feel bound to bring this action in an attempt to safeguard the public health and safety, and company’s investments in product development as well as the integrity of the new drug approval procedure set by the Hatch-Waxman adjustments to the FDCA.