Dance Biopharma Announces Encouraging Clinical Data for Adagio&#0153-- Inhalable Insulin Product Candidate for Diabetes

SAN FRANCISCO, Aug. 13, 2013 /PRNewswire/ -- Dance Biopharm Inc., a privately-held biotechnology company focused on the development of inhaled insulin products to treat diabetes, recently completed a key clinical study for Adagio, an investigational drug-device combination under development for the treatment of diabetes with the intent to eliminate the need for injections for mealtime insulin.

"Hundreds of my colleagues and I spent decades of our lives in the 90s and 00s showing that inhaled insulin is safe, reliable and effective. It is a damn shame that despite US and EU approval, inhaled insulin is still not available, but we learned so much from the first-generation products and now there are two improved second-generation products in development. Dance has carefully selected a delivery system that is small, patient friendly and efficient that addresses issues with the first-generation efforts," stated John Patton, Ph.D., chairman and chief executive officer of Dance Biopharm. "With Phase 2 trials under way and active discussions with the EMA and FDA, we believe we are on a clear path to delivering this product to the many patients around the world who are in great need of an alternative to injectable insulin."

In several multi-centered, comparative effectiveness clinical trials, Dr. Marcia Testa, Harvard School of Public Health and colleagues previously showed that Exubera® inhaled insulin was greatly preferred by persons with diabetes as compared to injectable insulin. Dr. Testa stated, "In over 30 years of studying quality of life and satisfaction in a broad array of new medical products for various diseases and conditions, the magnitude of the treatment differences favoring inhaled insulin compared to injectable insulin were the largest we have ever seen. Inhaled insulin resulted in decreased burden, life interference, hassle and pain, and increased, convenience, flexibility, and social acceptance."

Furthermore, Dr. Tim Heise of Profil Institute for Metabolic Research, Neuss, Germany, commented, "I believe that Profil has tested nearly all of the insulin inhalation devices, and Adagio is among the best we've ever seen in terms of ease of use and no coughing."

Initial Clinical Trial Demonstrates Safety and Reliability of Adagio
The trial recently completed (Samba 01) was a Phase 1/2 pharmacokinetic (PK) study in patients with Type 1 diabetes designed to determine the safety, efficiency, and dosing reliability of the Adagio device and formulation. This preliminary study indicated the product was safe and well tolerated with no coughing and importantly, delivered insulin consistently when patients received four doses over time, and showed reliability compared with insulin delivered by injection. While this initial trial enrolled Type 1 patients based on the ability to obtain a more precise measurement due to their lack of endogenous insulin, the initial target population for Adagio is patients with Type 2 diabetes, which the company is enrolling in its next PK and pharmacodynamics study, Samba 02. Samba 01 was a 12-patient, randomized, semi-blinded study conducted by Profil, a contract research organization based in Neuss, Germany, specializing in early-mid phase clinical trials in diabetes and metabolism.

Introducing Adagio, a Second-generation Inhaled Insulin Product
Dance Biopharm's Adagio is a novel second-generation inhaled insulin product in development that could resolve problems inherent in the first-generation inhaled insulin products, which were known to be safe and effective yet uneconomical and cumbersome. The liquid formulation of natural human insulin is dispensed through a small, silent, handheld electronic aerosol device, intended to deliver the patient's individualized dose of insulin in one to three breaths at mealtime. Dance has chosen to develop a liquid formulation of insulin instead of a dry powder with the goals of lowering manufacturing costs, eliminating cough, and facilitating ease-of-use. Adagio is a low-cost product that has the potential to be priced competitively to the leading injection pens.

Adagio is currently in clinical trials and is in preparation for pivotal development. The first clinical trial was completed in Germany, and the company has conducted an extensive scientific advice process in Europe, which has resulted in an abbreviated development plan there. The Company met with six EU National Authorities and then with the Committee for Medicinal Products for Human use (CHMP) at the European Medicines Agency (EMA) in preparation for a centralized filing. The company is actively engaged in discussions with the U.S. Food and Drug Administration (FDA) and is incorporating FDA input into clinical development plans for Adagio.

Diabetes, A Global Epidemic Affecting an Estimated 347 Million People Worldwide
There is a global epidemic of diabetes. The estimated 347 million people with diabetes worldwide is expected to grow to 439 million by 2030. For the majority of people with diabetes worldwide their disease is out of control and they will die prematurely. Metabolic disease may account for up to one third of healthcare costs in many regions of the world. Numerous studies have shown that better glucose control can extend life expectancy, improve quality of life, and markedly reduce the huge costs of managing diabetes and its complications.

The long-term benefits of mealtime insulin therapy to control blood glucose have been consistently demonstrated. It is important to remember that exogenous insulin itself addresses both of the defects in Type 2 diabetes by improving endogenous insulin secretion (corrects insulin deficiency) and decreasing glucotoxicity and therefore decreasing insulin resistance. Many clinical studies have demonstrated that insulin not only preserves but can also restore b-cell function to the point of clinical remission in newly diagnosed Type 2 diabetics (Ryan et al, 2004; Li et al, 2004; Ilkova et al 1997, Alvarsson et al. 2003). Although injected insulin is the gold standard for treatment, traditionally it has been the last drug taken by Type 2 patients (who make up about 90-95 percent of diabetics). The typical patient delays taking mealtime insulin for five to 10 years in order to avoid multiple daily injections. Delaying insulin treatment, or refusing to take injections, eventually results in miserable health consequences for the patients and enormous costs to health caresystems.

Now all of the major diabetes medical associations recommend the introduction of insulin earlier in the treatment process for Type 2 patients, and if glycosylated hemoglobin (HbA1c) is above nine percent upon diagnosis and patients are symptomatic, insulin is recommended immediately.

About Dance Biopharm Inc.
Dance Biopharm, a privately-held company based in San Francisco, is focused on the clinical development of inhaled insulin products to treat diabetes patients worldwide. The company began operations in 2010 led by Dr. John Patton, who has over 20 years of experience in the development of inhaled insulin. The Dance team consists of experts in all aspects of inhaled insulin development, and the company is dedicated to creating a new generation of products that make inhaled insulin more compelling than ever. Additional information about Dance Biopharm can be found at www.dancebiopharm.com.

FORWARD-LOOKING STATEMENTS
All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. We have based these forward-looking statements upon information available to management as of the date of this release and management's expectations and projections about certain future events. It is possible that the assumptions made by management for purposes of such statements may not materialize. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements may involve risks and uncertainties, including but not limited to those relating to our limited operating history, our recurring losses from operations, our ability to obtain additional capital on acceptable terms, our ability to successfully develop Adagio, the cost and uncertainty of obtaining regulatory approvals, our ability to protect our intellectual property, the loss of any executive officers or consultants, competition, and changes in the regulatory landscape.

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SOURCE Dance Biopharm