BDSI - BioDelivery Sciences Intl, Inc (NASDAQ Stock)

[lovemoney]

Broke the trend line last week. Indicators are turned up. Looks like it's setting up.

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BioDelivery Sciences Announces New Drug Submission in Canada for BEMA Fentanyl

Presents Opportunity to Be the First Oral Transmucosal Fentanyl Product Approved in Canada



Press Release
Source: BioDelivery Sciences International, Inc.
On Friday October 2, 2009, 8:30 am EDT

Companies: BioDelivery Sciences International Inc.
RALEIGH, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) today announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined.

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BEMA Fentanyl was submitted to Health Canada by Meda Valeant Pharma Canada Inc. BDSI’s global commercial partner for BEMA Fentanyl, Meda AB, is engaged in a joint venture with Valeant Canada Limited to commercialize BEMA Fentanyl for the management of breakthrough cancer pain in opioid-tolerant patients.

“We are very pleased with the progress that Meda is making in expanding the availability of BEMA Fentanyl,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “We believe Meda’s global presence and commitment to the product are playing an important role in growing the opportunity for BEMA Fentanyl.”

In addition to approval from the U.S. FDA on July 16, 2009, BEMA Fentanyl is currently under regulatory review in the European Union with approval expected in 2010.

Under agreements with BDSI, Meda AB has the worldwide rights to commercialize and market BEMA Fentanyl, except in South Korea and Taiwan, the rights to which remain with BDSI.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News) 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 utilizing the Company’s patented BEMA buccal soluble film technology: ONSOLIS (fentanyl buccal soluble film) which was approved by FDA on July 16, 2009, for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain, and BEMA Buprenorphine, an analgesic in Phase 2 clinical development with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA technology and its patented Bioral cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company’s headquarters is located in Raleigh, North Carolina. For more information please visit BioDelivery Sciences International.

BDSI®, BEMA® and Bioral® are registered trademarks, and ONSOLISTM is a trademark of BioDelivery Sciences International, Inc.

[lovemoney]

Traded above the 10 and 50 dma's today and pushing the upper boli. Got a golden cross happening with the 10 about to cross above the 50 at a fairly sharp angle. The 9 day MACD crossing over the 0 line. And the RSI riding above the 50 and pointed up. Looking positive.

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Latest news....

Thursday, October 8, 2009, 10:26am EDT | Modified: Thursday, October 8, 2009, 10:45am
BDSI to begin sales of pain drug for cancer patients
Triangle Business Journal - by James Gallagher Triangle Business Journal


BioDelivery Sciences International Inc. will begin selling its Onsolis pain management therapy next week through its commercial partner Meda Pharmaceuticals.

Raleigh-based BioDelivery (NASDAQ: BDSI) received FDA approval in July for the drug, fentanyl buccal soluble film. The drug manages pain in cancer patients 18 years of age or older who are opioid tolerant.

Meda has initiated a national sales campaign targeting pain management physicians, oncologists and other health-care professionals who treat cancer pain.

BDSI will receive double-digit royalties on sales of Onsolis and is eligible for milestone payments of up to $30 million for reaching certain sales thresholds.

“Today is a banner day for BDSI and serves as validation of our business model and ability to bring important new therapeutics to market,” said Dr. Mark A. Sirgo, BDSI’s president and CEO.

Onsolis is the first product to use BDSI’s BioErodible MucoAdhesive drug delivery technology, which delivers medication through a dissolvable film that is applied to the inside of the cheek.

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** Also 2 new products are in the pipeline. BEMA® Buprenorphine (for chronic pain) is in phase II testing currently and should be ready by end of year. And BIORAL® Amphotericin is in phase I testing.

[lovemoney]

Nice move today. Hopefully more to come.

[lovemoney]

Getting ready.

[greencat]

MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.

WARREN, N.J., Jan. 18, 2011 /PRNewswire/ -- MonoSol Rx, LLC ("MonoSol Rx"), the developer of PharmFilm® drug delivery technology, filed an amended patent infringement and false marking lawsuit today against BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News), MEDA Pharmaceuticals Inc. ("MEDA"), and Aveva Drug Delivery Systems, Inc. ("Aveva") in the United States District Court for the District of New Jersey.

MonoSol Rx's complaint asserts that BDSI, MEDA, and Aveva's manufacture, marketing, and sale of the Onsolis™ film products infringe MonoSol Rx's United States Patent No. 7,824,588 related to methods of making drug-containing films. As one of the leaders in the development and commercialization of film pharmaceutical and over-the-counter drug products, MonoSol Rx has an extensive technology patent portfolio.

MonoSol Rx filed its patent infringement claim against these defendants initially in November, 2010. Today's amended complaint adds an additional false marking claim with respect to U.S. Patent No. 5,800,832.

MonoSol Rx is represented in the action by Howrey LLP.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence.

MonoSol Rx's commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. For press releases and other company information visit MonoSol Rx

MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc. - Yahoo! Finance