BioDelivery Sciences International Inc. (Nasdaq: BDSI) is a specialty pharmaceutical company focused on the development of innovative products for pain management. The company has two products in development utilizing its patented BEMA oral adhesive film technology: ONSOLIS, for pain in opioid-tolerant patients with cancer, and BEMA Buprenorphine, for the treatment of moderate to severe pain.
BioDelivery today delivered news it has received a response letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for BEMA Fentanyl, which the company intends to market in the United States as ONSOLIS (fentanyl buccal soluble film).
The FDA has requested the company make modifications to the submitted risk management program. After a full review, no deficiencies were noted in chemistry, manufacturing and controls, or non-clinical/clinical efficacy or safety.
“We have been working over the last several months with Meda AB, our partner for the commercialization of ONSOLIS, to prepare for a potential REMS requirement. These activities have put us in a position to respond rapidly to FDA’s request. Depending on FDA review time, approval could occur as early as the first quarter or as late as second quarter of 2009,” Dr. Andrew Finn, executive vice president of Product Development stated in the press release.
Dr. Mark A. Sirgo, president and CEO of BioDelivery, said FDA approval of ONSOLIS will significantly boost the value of the company.
“We believe that FDA approval of ONSOLIS and its U.S. commercial launch should add considerable value to BDSI based on the aggregate $30 million in approval and launch milestone payments, sales-based milestone payments, and double-digit royalty on sales, which provide the means to accelerate development of our pipeline,” Dr. Sirgo stated. “In addition, the outcome of the ONSOLIS NDA review validates the BEMA drug delivery platform and should immediately enhance the value of other BEMA products in development, particularly BEMA Buprenorphine, our second pain product. We believe that the future of BDSI continues to be very promising.”
Dr. Sirgo continued that the company’s management of its cash throughout 2008 leaves it with a few months of cash in reserve.
“We have a financial plan that includes several choices to bridge the gap to approval and the receipt of milestone payments from Meda totaling $30 million. Importantly, we will seek to only raise the capital required to reach the anticipated approval, with little or no dilution to our stockholders. It should be noted that the costs associated with finalization and implementation of the REMS for ONSOLIS will be the responsibility of Meda,” Dr. Sirgo stated.
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