Biodelivery Sciences International

BDSI's lead BEMA™ product under development is BEMA™ Fentanyl, which is being developed for breakthrough pain in opioid tolerant patients with cancer. In 2006, BDSI licensed the European rights for BEMA™ Fentanyl to Meda AB. In September 2007, BDSI and Meda expanded the BEMA™ Fentanyl collaboration to include the United States, Canada and Mexico. The company is currently evaluating partnership opportunities in other territories. BDSI recently submitted an NDA for BEMA™ Fentanyl to the US Food and Drug Administration.

BEMA™ Fentanyl is currently not approved for use. BEMA™ Fentanyl is under FDA review only for the management of breakthrough pain in opioid tolerant patients with cancer. BEMA™ Fentanyl must only be used in opioid tolerant patients because life-threatening respiratory depression could occur at any dose in patients not taking chronic opiates. BEMA™ Fentanyl is contraindicated in the management of migraine, acute (including emergency room), postoperative, or dental pain. Patients and their caregivers must be instructed that BEMA™ Fentanyl contains a medicine in an amount which can be fatal to a child. All BEMA™ Fentanyl units must be kept out of the reach of children.

The second pain product in the BEMA™ delivery system is BEMA™ Buprenorphine. This is a BEMA™ formulation that will be developed to target a broader range of pain conditions including postoperative and chronic pain due to osteoarthritis and lower back disorders. BDSI submitted an IND on BEMA™ Buprenorphine in December 2005 and has completed the initial Phase I clinical trial which demonstrated target plasma concentrations of the active ingredient.

A third product being considered for development, BEMA™ Zolpidem, is a BEMA™ formulation of the most widely prescribed drug for the treatment of insomnia.

BDSI's lead Bioral® formulation is an encochleated version of Amphotericin B, an anti-fungal treatment for treating systemic fungal infections. A Bioral® formulation of Amphotericin B provides the potential for oral delivery of a drug that is currently only given by intravenous injection. BDSI submitted an IND for Bioral Amphotericin B in late 2006 and is progressing to clinical studies in 2008. A second formulation for intranasal administration Amphotericin B to treat chronic rhinosinusitis is now in development. This product is licensed to Accentia Biopharmaceuticals for the use in the treatment of CRS and asthma.

BDSI has also exclusively licensed Emezine®, a formulation of prochlorperazine, a treatment for nausea and vomiting. In February 2005, BDSI announced that it completed the clinical studies and an NDA was subsequently submitted to the FDA. However, BDSI received a non approvable letter from the FDA relating to Emezine® in early 2006.

In addition to the proprietary pipeline, BDSI has conducted significant research utilizing the Bioral® system to deliver nucleic acids for which we are seeking potential partners to create new therapeutics.

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