BioDelivery, Meda Receive FDA Approval For Onsolis

BioDelivery (BDSI) and Meda have received FDA approval to market Onsolis (fentanyl buccal soluble film), formerly referred to as Bema Fentanyl. It is for the management of breakthrough pain (BTP) in patients with cancer (18 years of age and older), who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Onsolis is the first product to utilize the company’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek).

Under the terms of its commercialization agreement with Meda, BioDelivery will receive an aggregate of approximately $27 million in milestone payments. The first is based upon FDA approval of Onsolis, in the amount of approximately $12 million. Meda had already advanced the company $3 million in January 2009, against the $15 million milestone payment.

A second payment of $15 million will be received following the manufacture of launch stocks of Onsolis, a target the company has also achieved. In addition, BDSI will receive a double-digit royalty on net sales as well as the potential for up to another $30 million in milestone payments, upon the achievement of certain sales thresholds.

Mark Sirgo, president and CEO of BioDelivery, said: “The approval of Onsolis is a landmark and transformational event for BDSI and represents the culmination of an extraordinary and focused effort by a determined group of BDSI and Meda employees.”

All of us at BDSI, along with our partner Meda, are very pleased to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition,” he added.