* Topline phase III results expected in 3Q
Pain, which is difficult to describe, is an unpleasant sensory and emotional experience. There are two basic types of pain, namely, acute and chronic.
Opioid analgesics are used for the relief of severe or chronic pain. There has been a dramatic growth in the use of opioid to treat pain. According to market research firm Wolters Kluwer, opioid analgesics are generating sales in excess of $10 billion a year in the U.S. But these opioid analgesics, also known as narcotic analgesics, are at risk of being abused because they are highly addictive in nature.
Working on an effective opioid analgesic with a low propensity for abuse and addiction is a specialty pharmaceutical company BioDelivery Sciences International Inc. (BDSI), which is on track to report top-line results from a phase III study of its pain product in the third quarter.
The company's patented and proprietary drug delivery technologies are BEMA (BioErodible MucoAdhesive) and Bioral.
The BEMA drug delivery technology consists of a small, bioerodible polymer film which aids in applying the active drug to the mucosal membranes (inner lining of cheek). This technology facilitates transmucosal delivery of drugs with otherwise poor oral absorption. The Bioral delivery approach, which involves "encapsulating" or protecting a drug by alternate layers of lipids spiral, facilitates oral dosing of drugs otherwise given by intravenous administration.
The company's first product developed using the BEMA technology was Onsolis (fentanyl buccal soluble film). Onsolis was approved by the FDA in July 2009 to help manage breakthrough pain in certain cancer patients, and was launched in the U.S. in October of that year. The drug was approved in Canada last May and in Europe last October. In Canada, Onsolis is expected to be launched by the end of this quarter (2Q) while in Europe the drug, which will be marketed as Breakyl, is anticipated to be launched next quarter. (3Q).
BioDelivery has license, development and supply agreements with Meda AB, a Sweden-based specialty pharmaceutical company, to develop and commercialize Onsolis in the United States, Mexico and Canada and in certain countries in Europe. Product royalty revenue, which is based on net sales of Onsolis, was $1.9 million in 2010 compared to $2.8 million in 2009. In the first quarter ended March 31, 2011 product royalty revenue was $0.03 million, up from $0.01 million in the comparable year-ago quarter.
A modified REMS (Risk Evaluation and Mitigation Strategy) program for Onsolis was submitted to the FDA in early December 2010 and is under review. If approved, the REMS program, which among other changes, is expected to allow for dispensing of Onsolis from retail pharmacies. The company expects final approval of the modified REMS program sometime this summer.
In January of this year, drug delivery company MonoSol Rx, LLC filed an amended patent infringement and false marking lawsuit against BioDelivery, Meda and Aveva Drug Delivery Systems Inc. in the United States District Court for the District of New Jersey relating to the proprietary manufacturing process for Onsolis. However, the patent claim has been strongly refuted by BioDelivery.
The second drug being developed using the BEMA technology is BEMA Buprenorphine, which is under phase III testing, for the management of moderate to severe chronic pain. BioDelivery expects to report top-line results from the late-stage study in the third quarter. The company is also in partnership discussion for BEMA Buprenorphine and a commercial partnership is expected to be secured by the fourth quarter.
If the phase III results are positive, a New Drug Application for BEMA Buprenorphine could be filed in the first half of 2012, according to the company. The market potential for BEMA Buprenorphine in the U.S. is estimated to be in excess of $500 million annually.
Now about the other BEMA products under development...
- BEMA Buprenorphine/Naloxone for the treatment of opioid dependence. The "high dose" of Buprenorphine in the product works by preventing opioid withdrawal syndrome and craving while Naloxone works as an abuse deterrent, according to the company. A 505(b)(2) NDA pathway has been confirmed by the FDA for Buprenorphine/Naloxone. Under the 505(b)(2) NDA pathway, a company can submit a New Drug Application for review without the need for any phase II or phase III clinical trials.
The 505(b)(2) approach is an abbreviated pathway, which permits an applicant to rely for approval on information from published scientific literature or on the FDA's findings of safety and effectiveness for referenced approved drug to support approval of a proposed product.
The bio-equivalence study results comparing BEMA Buprenorphine/Naloxone to the marketed drug Suboxone, a combination of Buprenorphine and Naloxone, are anticipated by the end of this year.
According to Wolters Kluwer, sales of Buprenorphine products for the treatment of opioid dependence exceeded $1 billion in 2010. In its preliminary estimate, BioDelivery has pegged the sales of BEMA Buprenorphine/Naloxone at over $300 million.
- BEMA Granisetron for the prevention of nausea and vomiting associated with cancer therapies. This investigational product utilizes the BEMA drug delivery technology to administer the 5HT-3 antagonist Granisetron, which is currently marketed in oral and intravenous formulations as Kytril. The 5HT3 antagonists represent a $1.74 billion market.
BioDelivery filed an Investigational New Drug application for BEMA Granisetron in early 2011. BEMA Granisetron is also being developed under the 505(b)(2) NDA pathway. The company is expected to submit an NDA for BEMA Granisetron by late next year.
A quick peek at BioDelivery's balance sheet...
Since inception, the company has recorded accumulated losses totaling about $81 million. At March 31, 2011 the company had zero debt, and cash and cash equivalents of $26 million.
Shares of BioDelivery have thus far hit a 52-week low of $2.12 and a 52-week high of $4. The stock closed Tuesday's trading at $3.47.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.