Last $11.97 USD
Change Today -0.68 / -5.38%
Volume 1.0M
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As of 8:10 PM 12/26/14 All times are local (Market data is delayed by at least 15 minutes).

biodelivery sciences intl (BDSI) Snapshot

Open
$12.65
Previous Close
$12.65
Day High
$12.71
Day Low
$11.86
52 Week High
09/12/14 - $18.48
52 Week Low
01/8/14 - $5.65
Market Cap
613.9M
Average Volume 10 Days
1.3M
EPS TTM
$-1.04
Shares Outstanding
51.3M
EX-Date
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P/E TM
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Dividend
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Dividend Yield
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Current Stock Chart for BIODELIVERY SCIENCES INTL (BDSI)

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biodelivery sciences intl (BDSI) Details

BioDelivery Sciences International, Inc., a specialty pharmaceutical company, develops and commercializes therapeutics in the areas of pain management and oncology supportive care. The company provides its products based on its patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, bi-layered erodible polymer film for application to the buccal mucosa. Its products include ONSOLIS, a fentanyl buccal soluble film for the management of breakthrough pain in patients with cancer; and BEMA Buprenorphine that is in Phase III trial for the treatment of chronic pain in a mixed opioid naïve and opioid experienced population. The company is also involved in the development of BUNAVAIL for the maintenance treatment of opioid dependence; and Clonidine Topical Gel for the treatment of painful diabetic neuropathy. It has a licensing and development agreement with Endo Pharmaceuticals, Inc. to develop and commercialize BEMA Buprenorphine; and license agreement with Arcion Therapeutics. The company was founded in 1997 and is headquartered in Raleigh, North Carolina.

24 Employees
Last Reported Date: 03/14/14
Founded in 1997

biodelivery sciences intl (BDSI) Top Compensated Officers

Chief Executive Officer, President, Chief Sci...
Total Annual Compensation: $739.3K
Executive Chairman and Member of Executive Su...
Total Annual Compensation: $368.7K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $61.2K
Executive Vice President of Product Developme...
Total Annual Compensation: $438.2K
Compensation as of Fiscal Year 2013.

biodelivery sciences intl (BDSI) Key Developments

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced that they have submitted a New Drug Application (NDA) for Buprenorphine HCl Buccal Film to the U.S. Food and Drug Administration (FDA). Buprenorphine HCl Buccal Film is under development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug uses BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology to efficiently and conveniently deliver buprenorphine across the buccal mucosa (inside lining of the cheek). Buprenorphine, a Schedule III controlled substance, is a partial opioid agonist and a potent analgesic with a relatively long duration of action. Buprenorphine HCl Buccal Film is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI. The two pivotal phase 3 studies for demonstration of safety and efficacy were double-blind randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. One study (BUP-307) was conducted in opioid experienced subjects, and the second study (BUP-308) was conducted in subjects naïve to opioid therapy. Both studies met the primary efficacy endpoint of change from baseline to week 12 of mean daily pain intensity score from placebo (BUP- 307; p <0.00001; BUP 308; p= 0.001). Buprenorphine HCl Buccal Film was generally well tolerated demonstrating a low incidence of typical opioid like side effects.

BioDelivery Sciences Announces Completion of Randomization in Phase 3 Trial of Clonidine Topical Gel for the Treatment of Painful Diabetic Neuropathy

BioDelivery Sciences International, Inc. announced that it has completed the randomization of all patients in BDSI's ongoing initial pivotal Phase 3 clinical trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). BDSI anticipates that topline results of the study will be available by the end of March 2015. The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN. In the trial, known as the RHAPSODY Study, subjects were randomized to receive either Clonidine Topical Gel or a placebo gel. Two hundred and sixty three adult subjects were randomized into the 12 week double-blind treatment phase of the study. This is the first of two pivotal trials that would be required for submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition. BDSI plans to begin the second Phase 3 study during the first quarter of 2015.

BioDelivery Sciences International, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 10:30 AM

BioDelivery Sciences International, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 10:30 AM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Mark A. Sirgo, Chief Executive Officer, President, Chief Scientific Officer, Executive Director and Member of Executive Subcommittee.

 

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Valuation BDSI Industry Range
Price/Earnings NM Not Meaningful
Price/Sales 14.7x
Price/Book 11.2x
Price/Cash Flow NM Not Meaningful
TEV/Sales 12.7x
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