BioDelivery Sciences International, Inc and Meda AB announced approval from the US Food and Drug Administration (FDA) to market Onsolis (fentanyl buccal soluble film), formerly referred to as Bema Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen 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).
"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," said Dr Mark A Sirgo, president and chief executive officer of BioDelivery Sciences. "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."
"Importantly, with the approval of Onsolis, we have validated the utility of the Bema drug delivery technology and demonstrated our ability to move a product through clinical development and the regulatory requirements set by FDA," said Dr Andrew Finn, executive vice president of Product Development. "We now look forward to replicating our performance and regulatory achievements as we progress our pipeline."
"Having worked on the clinical development of Onsolis, it is exciting to see it reach approval," said Dr Richard L Rauck, executive director of the Carolinas Pain Institute and for the Center for Clinical Research, a site that participated in the phase-3 trials for Onsolis. "Many patients with cancer suffer from these sharp spikes in pain referred to as breakthrough pain. These patients can benefit from a product like Onsolis with its onset of action and oral tolerability profile. We look forward to having this important option available for our patients with cancer breakthrough pain."
Onsolis is anticipated to be available in the fourth quarter of 2009 and will be commercialized in the US by Meda Pharmaceuticals, the US subsidiary of Meda AB. Meda is the company's commercialization partner for the product worldwide, with the exception of Taiwan and South Korea, the rights to which remain with BDSI. "We are very excited to launch Onsolis in the USand make this product available to patients and healthcare providers," said Anders Lonner, chief executive officer of Meda AB. "The introduction of Onsolis has high priority for us, and we are well positioned to be successful."
Under the terms of its commercialization agreement with Meda, BioDelivery Sciences will receive an aggregate of approximately $27 million in milestone payments. The first is based upon FDA approval of Onsolis which is 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.
"We are also announcing launch of the Focus (Full Ongoing Commitment to User Safety) Programme for Onsolis, the first opioid Risk Management and Evaluation Strategy (REMS)," said Dr David Wright, director of Regulatory Affairs at BDSI. "The goal of the Focus Programme for Onsolis is to mitigate the risk of Onsolis overdose, abuse, addiction, and serious complications due to medication errors. The programme was created in accordance with the FDA's requirements to help ensure that the benefits outweigh the risks of Onsolis. The programme will facilitate appropriate use of Onsolis and provide healthcare practitioners, patients, and caregivers support through training and education."
Onsolis consists of a small, dissolvable, polymer film, formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek).
BioDelivery Sciences International, Inc is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain.
Meda AB (publ) is a leading international specialty pharma company. The company specializes in marketing and pharmaceutical development in late clinical stage.