Video Q&A: Mark A. Sirgo, President and CEO of BioDelivery Sciences Print E-mail
By Staff and Wire Reports   
Wednesday, 28 March 2012 02:33
After spending more than 20 years in the pharmaceutical industry with companies like GlaxoSmithKline and others, Mark A. Sirgo joined BioDelivery Sciences (Nasdaq:BDSI) in August 2004 as Senior Vice President of Commercialization and Corporate Development upon the acquisition of Arius Pharmaceuticals-- a company which he co-founded. 

Today, in an exclusive, video interview with BioMedReports, Sirgo answers questions about BioDelivery’s platform, partners and unique pipeline products. In addition, he tells investors about some of the key characteristics which set BDSI apart in the market.

“The two products in our pipeline have much greater value than our first product, “explains Dr. Sirgo. “We’ve demonstrated the ability to move products through the regulatory hurdles. Investors need to take a closer look at our pipeline and the value that we plan to create there.”

“We have one marketed product that uses the same technology that products in our pipeline are using. It’s approved. It’s been through the FDA and it serves as a great proof-of-concept for our ability to not only take our product through the regulatory pathway, but also partner and get through commercialization."

BioDelivery Sciences utilizes patented and proprietary drug delivery technologies to create products and formulations that meet important patient and healthcare provider needs. Its drug delivery technologies include: Bioral® and Bema®. The company's Bema® drug delivery technology consists of a small bioerodible polymer film for application to mucosal membranes (inner lining of cheek) for delivering a dose of drug across the mucous membranes for time sensitive conditions or to facilitate administration of drugs with poor oral (pill) absorption. Its Bioral® drug delivery technology encapsulates and protects the drug without chemically bonding to it and may facilitate oral dosing of drugs that typically need to be given by intravenous administration.

Our BioMedReports FDA Calendar and Clinical Trials Tracker shows that BDSI plans to initiate their BEMA Buprenorphine/Naloxone pivotal pharmacokinetic study and the safety study by mid-2012. Results of the pivotal pharmacokinetic study are anticipated to be available within three months of initiation and the safety study by early 2013 and that this will allow for an anticipated NDA filing in the first half of 2013. In addition, there are other key milestones which investors should be looking for involving the initiation of two Phase III studies in the third quarter of 2012.

BioDelivery Sciences' products include: Onsolis® indicated for the treatment of breakthrough cancer pain; Bema® Buprenorphine indicated for the treatment of moderate to severe chronic pain; Bema® Triptan indicated for the treatment of migraine; Bema® Buprenorphine/Naloxone indicated for the treatment of opioid dependence; Bema® Granisetron indicated for the prevention of nausea and vomiting associated with cancer therapies, etc.

The past fifteen months have been very exciting for BDSI as they have made significant progress in prudently deploying their resources and moving their company forward. Share are currently trading at a discount; -42.47 % from their 52-Wk High ($4.05) and there is very small short interest in the stock.



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