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BEMA(TM) LA Achieves Therapeutic Plasma Concentrations in Phase I Trial: Complementary Pain Therapy to Phase III BEMA(TM) Fentanyl Product

17 Aug 2006

Reports positive proof of concept pharmacokinetic study conducted in normal volunteers with the company’s BEMATM Long Acting Analgesic product (known as BEMATM LA).

MORRISVILLE, NC, USA | Aug 16, 2006 | BioDelivery Sciences International, Inc. (NASDAQ:BDSI) reports positive proof of concept

pharmacokinetic study conducted in normal volunteers with the company’s BEMATM Long Acting Analgesic product (known as BEMATM LA). The active ingredient contained within BEMATM LA met the company’s expectations in terms of the amount absorbed into the bloodstream. Plasma concentrations (amount of active ingredient in the blood) were well within the levels associated with analgesic activity. Accordingly, BDSI now intends to actively explore the scale-up of manufacturing of the product for clinical efficacy and safety studies in patients with acute and chronic pain. Given these promising results, and the competitive nature of the pain field, BDSI has, as previously reported, elected to not disclose the active ingredient in BEMA™ LA at this time.

Dr. Andrew L. Finn, Executive Vice President of Clinical Development and Regulatory Affairs for BDSI stated, “We are extremely pleased with the results of this positive proof of concept pharmacokinetic study in normal volunteers. To our knowledge, BEMA™ LA would be the first long-acting opioid to be delivered by the buccal route, extending the potential of our BEMA™ technology to another class of pain compounds. The 24-hour plasma concentrations seen in this study are highly encouraging and support the potential of once-daily dosing with BEMA™ LA.”

Dr. Mark A. Sirgo, President and CEO of BDSI, added, “With these results in hand, we have met our primary formulation development objective for BEMA™ LA by demonstrating the ability to deliver a therapeutic plasma concentration, and have thereby achieved another one of our key corporate objectives for this year.”

“BEMA™ LA represents a second pain product for BDSI for which, at our November 2005 meeting with the FDA, we were given clearance to use the more time and cost efficient 505(b)(2) regulatory approval process,” continued Dr. Sirgo. “We view BEMA™ LA and our Phase III pain product, BEMA™ Fentanyl, as complementary agents in the pain management area. These two products form the core of our pain franchise. Given the ease of use and efficiency of the BEMA disc delivery system, they both have the potential to assist doctors and patients in pain management, both in the U.S. and abroad.”

BDSI believes that BEMATM LA represents a substantial opportunity to capture market share in a pain market that reported 2004 sales of $21 billion, and is estimated to grow to $29.8 billion by 2008. Due to the potential for BEMA™ LA to be used to treat a variety of pain conditions, BDSI believes that the product could potentially generate peak sales of $500 million.

In addition, the company believes that BEMA™ Fentanyl maintains a strong potential of securing a significant share of the breakthrough cancer pain market in the U.S. BDSI estimates that BEMA™ Fentanyl will generate minimum annual peak sales of $250 million.

About BioDelivery Sciences International
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop and commercialize, clinically-significant new products using proven therapeutics. BDSI’s pain franchise currently consists of two products in development utilizing the company’s patented BEMA™ oral adhesive disc technology: BEMATM Fentanyl, a treatment for “breakthrough” cancer pain which is expected to complete its Phase III BEMA™ Fentanyl trials during the second half of 2006, and BEMATM LA, a second analgesic with a target indication of the treatment of moderate to severe pain, which is currently in Phase I trials and on which the company intends to initiate Phase III trials in the second half of 2006. The company is also working with both its BEMATM technology and its patented Bioral® nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting and infections. More recently the company has reported the ability to deliver through its Bioral technology certain specific siRNA therapeutics successful in certain animal models. The company’s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements
Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the results of scheduled or additional clinical trials and FDA review of the Company's formulations and products, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak sales estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.
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SOURCE: BioDelivery Sciences International, Inc

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