Bentley Pharmaceuticals Announces Completion of Treatment in Phase II India Clinical Study in Type 2 Diabetes and Preliminary Clinical ResultsEXETER, N.H.--(BUSINESS WIRE)--Feb 11, 2008 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced completion of treatment in an 80 patient multi-center open label, randomized, parallel group Phase II study in India to determine the safety and efficacy of add-on intranasal insulin spray (Nasulin(R)) in patients with type 2 diabetes mellitus on oral anti-diabetic therapy. The clinical study report is expected to be completed later this month, but preliminary clinical results are being released today.
The primary study endpoints were reduction of Post Prandial Blood Sugar (PPBS) by 20mg/dl from the baseline value and reduction of glycosylated hemoglobin (HbA1c) by 0.7% from the baseline value, both by the end of three months treatment with Nasulin. Tolerability of the study drug was a secondary study endpoint.
Although final analysis of the data has not yet been completed, it appears that patients on Nasulin reached their primary endpoint for PPBS after two months with an average decline of 49mg/dl, although PPBS values increased in month three, apparently to levels above the primary endpoint. It appears that HbA1c levels also reached their primary endpoint of an average decline of 0.7 or more after two months, although HbA1c levels also increased in month three, apparently to levels above the primary endpoint. The cause of the apparent increases between months two and three is not yet certain and is being further evaluated.
In addition, control group patients on oral antidiabetic agents showed similar declines. The reason for the similar declines in the control group may be a result of non-uniform dietary and exercise regimens between the control and Nasulin groups.
The India study demonstrated that Nasulin was well tolerated during the three months that it was used three times per day. In the 60 type 2 diabetics taking Nasulin over three months reported in the study, no patient dropped out because of nasal symptoms or other study drug related phenomena. In contrast to studies by others in which insulin was administered by injection, patients on Nasulin in this study showed no overall weight gain over the three month interval and no indication of severe hypoglycemia.
To date Bentley has carried out five Phase I trials in normal individuals, five Phase IIA trials (three in type 1 and two in type 2 diabetic patients) with two additional studies ongoing, one each in type 1 and type 2 diabetic patients. These trials have been conducted in the U.S., Ireland and India. Nasulin has consistently shown a rapid onset of action with peak insulin blood levels occurring at approximately 15 minutes and with elevated blood levels lasting for between 1-2 hours, which levels and duration coincide with the glycemic rise after a meal, and are similar to normal endogenous insulin. The glucodynamic effect maximizes at approximately 40 minutes. The relative bioavailability over 1 hour has been in the range of 15-20%.
All Nasulin trials are being led through the Company's newly formed subsidiary, CPEX Pharmaceuticals, which is in the process of being spun off from Bentley. Following completion of the spin-off, CPEX will oversee all of Bentley's drug delivery technologies, including Nasulin.
Said John Sedor, President of Bentley, "Our focus in 2008 will be to continue moving forward with additional Phase II studies of Nasulin in the United States for the treatment of type 1 and type 2 diabetes, and Phase III efficacy trials to support global registrations will be designed after completion and analysis of these trials. Our intention with these additional trials is to demonstrate that Nasulin results in better glycemic control than injectable insulin because of Nasulin's more rapid onset of action, which coincides with the expected blood glucose levels after meals. In addition, its shorter duration should result in a decreased tendency toward hypoglycemic episodes. That feature coupled with the intranasal route of administration should yield significant improvements in patient compliance while avoiding the potential pulmonary disadvantages of competitive drug candidates that use an inhalation route of administration."
"We are excited by the prospects for Nasulin. Looking farther ahead, we are committed to seeking a pharmaceutical partner to support Phase III clinical trials and commercialization of Nasulin upon regulatory approval. Our goal is to make this potentially important diabetes treatment commercially available to patients around the world," concluded Sedor.
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley plans to spin off its drug delivery business as an independent, publicly traded company. Its newly formed subsidiary, CPEX Pharmaceuticals, Inc., has filed an initial registration statement on Form 10 with the Securities and Exchange Commission (SEC) in furtherance of this plan. Completion of the proposed spin-off is subject to numerous conditions, including final approval by Bentley's Board of Directors and the effectiveness of the registration statement on Form 10, which is subject to review by the SEC. Bentley's generic pharmaceuticals business manufactures and markets a growing portfolio of generic and branded generic products in Europe for the treatment of cardiovascular, gastrointestinal, infectious and central nervous system diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.
Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley's website at www.bentleypharm.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains certain forward-looking statements about Bentley and its current businesses, which are based on management's good faith expectations and beliefs concerning future developments in Bentley and CPEX Pharmaceuticals. Forward-looking statements can be identified by the use of words such as "in the future," "will," "may," "believe," "expect," "plans," "strategy," "intends," and "estimate." Statements that refer to Bentley's or CPEX Pharmaceuticals' plans for executing the spin-off and future prospects of the companies as independent companies, and the like, are forward-looking statements that reflect Bentley's current analysis of existing trends, information and current plans. Actual results may differ from current expectations based on a number of factors affecting Bentley's and CPEX's businesses, including changing competitive, regulatory and market conditions; inherent uncertainty associated with financial projections, which cannot be predicted with certainty; unpredictability associated with the timing and the results of both the research and development and regulatory processes; technological advances and patents obtained by competitors; approval, introduction and consumer acceptance of new products and continuing acceptance of currently marketed products; timely and successful implementation of strategic alternatives; uncertainty associated with the identification of and successful execution of external corporate development transactions and strategic alliance partners; matters affecting the economy in general, such as changes in interest and currency exchange rates; the uncertainties associated with effecting a spin-off of a separate public company; the discretion of Bentley's Board of Directors to delay or cancel the spin-off prior to execution; and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K and its other subsequent periodic reports filed with the Securities and Exchange Commission, as well as the risks set forth in the "Risk Factors" section of the CPEX Form 10 registration statement. Bentley disclaims any intent or obligation to update these forward-looking statements.
Sharon Merrill Associates
Jim Buckley, 617-542-5300
Executive Vice President
Posted: February 2008