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We would like to highlight BioDelivery Sciences International Inc. (NASDAQ: BDSI). The company is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI’s pain franchise currently consists of two products in development utilizing the company’s patented BEMA™ oral adhesive film technology.
In the company’s news yesterday,
BioDelivery announced 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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Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.
