MORRISVILLE, N.C.--(BUSINESS WIRE)--June 9, 2006--BioDelivery Sciences International, Inc. (NASDAQ: BDSI - News), a specialty biopharmaceutical company, announced that representatives of the company met with the U.S. Food and Drug Administration’s (FDA) Division of Gastroenterology Products on May 17, 2006 to discuss the FDA’s February 2006 decision and action letter regarding BDSI’s new drug application (NDA) for the Emezine® (prochlorperazine maleate) buccal tablets for the treatment of nausea and vomiting. At such meeting, BDSI and the FDA agreed in principle on an approach for BDSI to potentially achieve regulatory approval of Emezine®. In light of the promising results of this meeting, which were confirmed in formal meeting minutes recently received by BDSI, BDSI is currently reevaluating its Emezine® strategy.
The meeting was held in an effort to gain better clarity of the non-approval notification and to determine the most appropriate pathway forward with Emezine® in light of the issues raised by the FDA in February. As previously announced, the NDA submission on Emezine® was under the FDA’s 505(b)(2) approval process whereby BDSI was permitted by the FDA to conduct a limited number of pharmacokinetic (PK) studies to support the approval of Emezine® and was not required to conduct a clinical efficacy and safety program. A key element of the meeting was to determine what additional studies were needed by the FDA. In a promising development, BDSI believes that it will be allowed to proceed with a pathway forward that would allow the company to manage the FDA’s remaining questions through the conduct of two small PK studies and, in doing so, avoid the necessity of having to conduct a major efficacy and safety trial in patients.
Dr. Mark Sirgo, BDSI’s President and CEO, said, “The meeting was a frank and open discussion of the FDA’s review of the Emezine® NDA. While we were and remain disappointed that the data submitted in the NDA raised several additional questions from the FDA resulting in the need for the collection of additional information, we now have a clear understanding of the type of additional data that will be required for product approval. More importantly, the FDA has reaffirmed that a pharmacokinetic pathway to approval under the 505(b)(2) regulations is still a viable way forward for Emezine®. This pathway avoids the need to conduct a clinical efficacy and safety study.”
The PK studies required as part of the original NDA compared Emezine® to two reference listed drugs that included both the 5mg oral swallow tablet and the intravenous formulations of prochlorperazine (Emezine’s® active ingredient). The overall objective of these studies was to demonstrate that the plasma concentration time course (amount of drug in the blood as measured over time) of the buccal (in between the cheek and gum) delivery of Emezine® was within the plasma concentration and time course of the two reference standards for the active ingredient prochlorperazine and metabolites. These studies were conducted in normal volunteers.
The results of these studies by BDSI demonstrated that Emezine® had significantly greater absorption (more drug reaching the blood stream) over the oral swallow tablet and considerably less absorption compared to the intravenous formulation. These were both anticipated outcomes. These studies also demonstrated that Emezine® had a slightly slower absorption pattern over the first 1-2 hours compared to the oral swallow tablet. This was one of the main areas of focus in the non-approval notification letter from FDA as it relates to the potential onset of activity of the product. Emezine® also demonstrated a higher peak plasma concentration (maximum achieved concentration of drug in the blood) compared to the 5mg oral swallow tablet although well below that seen with the intravenous injection. The FDA indicated that this higher peak concentration compared to the oral swallow tablet could potentially lead to a more pronounced effect in older patients and therefore requested that BDSI consider collecting additional information in this population. Among other observations, the FDA also recommended that any additional pharmacokinetic studies performed include the collection of metabolic profile data (breakdown products) as well as the tolerance of the Emezine® tablet in the oral cavity.
Dr. Sirgo further stated, “We are pleased that we met our previously announced objectives regarding this meeting. The meeting was extremely positive from the standpoint of providing clarity on the FDA’s concerns as well as to identify a reasonable approach to potentially resolving them in an efficient and timely manner. Although our contention was that the FDA’s remaining issues with our data could be managed with product labeling, we believe we have come to an agreement over a pathway forward that is achievable. The details of the studies will of course need to be confirmed with the FDA, after which we will determine the costs of the studies and the time to complete them. It will be at that this point when we can fully consider our options as it relates to proceeding forward.”
Thomas Shumaker, Director of Regulatory Affairs at BDSI added, “The FDA indicated that they would consider the additional information being requested under the context of a special protocol assessment (SPA). This means that protocol design, endpoints, and expected regulatory results would be evaluated by the FDA and agreed with us as to whether they are sufficient to meet regulatory expectations for approval, prior to commencing the studies. At this point, we are in the process of developing the pharmacokinetic protocols that we will present to the FDA under the SPA. Once we have their agreement on the protocols through the SPA process, we will have a better idea of the cost and timing for completing these studies. Based on our experience, we believe that once the new information is obtained and submitted to FDA, it will be reviewed within 6 months.”
Emezine® is an oral transmucosal (drug absorbed directly through the mucosa of the mouth) medication for the treatment of nausea and vomiting. The current alternatives to oral tablets are injections and suppositories. BDSI licenses Emezine® on an exclusive basis in the U.S. from Reckitt Benckiser Healthcare (UK) Limited. The Emezine® tablets are proposed to be manufactured for BDSI by Reckitt Benckiser, which currently distributes a similar product in the United Kingdom.
BDSI is also working on BEMA(TM) Fentanyl, a treatment for “breakthrough” cancer pain, and expects to complete its Phase III BEMA Fentanyl trials during the second half of 2006. BEMA(TM) Fentanyl is an oral adhesive disc formulation of the narcotic analgesic fentanyl. BEMA(TM) is a separate delivery system from that used in Emezine® with a development pathway that is different as well in that pivotal efficacy and safety trials will augment BEMA(TM) Fentanyl, as agreed with the FDA. Additionally, BDSI is currently conducting Phase I trials with BEMA(TM) LA, its second analgesic utilizing the BEMA(TM) technology and plans to announce its intentions to initiate Phase III trials in the second half of 2006 with this product. Though Emezine® does represent a projected $30 million revenue opportunity; it is significantly lower in comparison to the pain franchise opportunity with BEMA(TM) Fentanyl and BEMA LA, with projected $250 million and $500 million in revenue potential, respectively.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at “acute” treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company’s drug delivery technologies include: (i) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology and (ii) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications. 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
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Source: BioDelivery Sciences International, Inc.
