Transforming the Treatment of Diabetes

Overview

Transforming the Treatment of Diabetes

Dance Biopharm is focused on the 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 we are dedicated to creating a new generation of products that make inhaled insulin more compelling than ever.

Introducing Dance-501

Dance-501 is an investigational drug-device combination under development for treatment of diabetes with the intent to eliminate the need for injections for mealtime insulin. Dance-501 includes a liquid formulation of natural human insulin and a small silent handheld electronic aerosol device, intended to deliver the patient’s individualized dose of insulin in 1-3 breaths at mealtime. dance-501 technology allows for efficient insulin delivery and the potential to make inhaled insulin easy and economical.

Dance-501 has completed Phase 2 clinical trials and is in preparation for pivotal development.

The Story of Inhaled Insulin

The Challenge

There is a global epidemic of diabetes. The estimated 382 million people with diabetes worldwide is expected to grow to 592 million in less than 25 years. Diabetes patients account for up to one third of healthcare costs in many regions the world over. A diagnosis of type 2 diabetes after the age of 40 leads to an average decrease in lifespan of 13-14 years, as well as deterioration in quality of life. But numerous studies have shown that better glucose control can extend life expectancy, improve quality of life, and reduce the costs of managing diabetes and its complications.

The long-term benefits of mealtime insulin therapy to control blood glucose for type 2 patients have been consistently demonstrated. Many clinical studies have shown that insulin is not only most effective in controlling blood glucose, but also preserves pancreatic beta-cell function (insulin production), and slows progression. 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% of diabetes). Typically, patients delay taking mealtime insulin for 5-10 years, in order to avoid multiple daily injections as long as possible. Delaying insulin treatment or refusing to take injections eventually results in significant health consequences for the patients and enormous costs to health care systems.

Now all of the major diabetes medical associations recommend the introduction of insulin much earlier in the treatment process for type 2 patients, and if glycosylated hemoglobin (HbA1c) is above 9% upon diagnosis and patients are symptomatic, insulin is recommended immediately.

In addition, around 3 million people living with type 1 diabetes in America depend on taking insulin daily via injections or infusion pumps to keep them alive. This daily process is cumbersome, uncomfortable, and expensive.”

The Idea

Many attempts have been made to develop new ways of delivering insulin without the use of injections. By far the most promising non-injection route of insulin delivery is via the deep lung, where insulin is readily absorbed. Over 20 years of research has demonstrated that inhaled insulin is a safe, effective, and reliable alternative to injections. There have been 118 human studies completed, including 48 large Phase 3 studies and 16,000 patient years of dosing, which overwhelmingly demonstrated clinical benefit. The most advanced of these products, Exubera®, was approved for use in adults with type 1 and type 2 diabetes in the US and EU in 2006. 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.”

Simply put, most patients loved it! However, the first generation products did not succeed due to high cost and cumbersome devices.

The Next Step

Dance-501 is a novel second-generation inhaled insulin product in development that could resolve the problems inherent in the first-generation products. Dance Biopharm’s inhaled insulin is a low-cost product that has the potential to be priced competitively. Dance’s inhaled insulin is designed to be small, discreet, and easy-to-use.

1. http://diabetes.niddk.nih.gov/dm/pubs/control/DCCT-EDIC.pdf http://www.bmj.com/content/320/7246/1373.full

2. American Association of Clinical Endocrinology (AACE) Comprehensive Diabetes Management Algorithm 2013, Endocrine Practice 19:327-336; Consensus statement of the American Diabetes Association (ADA) and the European
Association for the Study of Diabetes (EASD), Diabetes Care 2009 32:193-203)

More about Dance-501

Dance’s Dance-501 is an investigational pocket-sized inhaler device and insulin container that are designed to be used together to control prandial blood sugar in adults with diabetes without the need for injections. Dance-501 has completed Phase 2 clinical trials and is in preparation for pivotal development.

The insulin formulation is packaged separately in a special insulin container. A few drops of liquid can be accurately dispensed into the reservoir on top of the device for dosing at mealtime.

The Dance-501 insulin inhaler is based on vibrating mesh micropump technology developed and commercialized by Aerogen. Dance has chosen to develop a liquid formulation of insulin instead of a dry powder with the goals to lower manufacturing costs, eliminate cough, and facilitate ease-of-use.

A Patient-friendly Approach

Needle-free, pain-free insulin delivery system
Gentle, tasteless soft-mist
Dose-delivery in only a few breaths

Easy + Reliable Dosing

Dose-action profile mimics natural insulin response (fast onset with a tail)

Insulin container designed to dispense precise volumes of insulin that will be stable at room temperature during use for multiple weeks.

Multiple dosage strengths

Durable Design

Each device will be intended for one year’s use

This picture shows a patient inhaling on Dance-501. In patient use, Dance-501 only produces mist when a patient breathes in.

Our People

Management
Transforming the Treatment of Diabetes

Founded by Dr. John Patton—who has spent more than two decades developing inhaled insulin—the Dance Biopharm team consists of a wide range of experts with deep experience in aerosol delivery, inhaled insulin product development, and diabetes therapy.

John Patton
John Patton, PhD – Chief Executive Officer and Chairman

Dr. John Patton began Dance Biopharm operations in 2010 with a carefully selected core team. Previously, he was the co-founder of Inhale Therapeutics (now Nektar), where he helped lead the development and FDA approval of the first inhaled insulin product. During his 18-year tenure at Inhale, Patton was a key driver for the company’s business development deals, participating in financings totaling more than $700M. Prior to founding Inhale, Patton led the drug delivery group at Genenlech from 1985-1990; before that time, he was a professor at the University of Georgia. In 1990, Dr. Patton was the founding investor in Halozyme Therapeutics, Inc. and currently serves as a member of its board of directors. From 1985 to 1990, Dr. Patton served as the head of the drug delivery group of Genentech, Inc., a biotechnology company. From 1979 to 1985, Dr. Patton served as a professor at the University of Georgia. Dr. Patton also serves as a member of the board of directors of Incarda Therapeutics, Inc., a product- focused cardiovascular company co-founded by Dr. Patton, since 2009. Dr. Patton previously served as a member of the board of directors of Actvaero GmbH, a drug delivery company, from 2007 until its acquisition by Vectura Group plc in March 2014. Dr. Patton also serves as a member of the advisory board of the College of Science at Pennsylvania State University and is a member of the Scripps Institution of Oceanography Advisory Counsel. Dr. Patton earned a B.S. in Zoology from Pennsylvania State University, an M.S. in Oceanography from the University of Rhode Island, and a Ph.D. in Marine Biology from the University of California, San Diego. Dr. Patton also has held post doctorate positions in Biomedicine at Harvard Medical School and the University of Lund in Sweden. He is author or co-author of more than 100 publications, and inventor or co-inventor of more than 37 patents.

Samantha Miller
Samantha Miller, MSc, MBA – Chief Business Officer and Director

Samantha has served as our Chief Business Officer and as a member of our board of directors since October 2010. From February 2009 to October 2010, Ms. Miller served, on a part time basis, as our senior consultant of business development. With more than two decades of corporate biotechnology and pharmaceutical development experience, Samantha Miller has negotiated, executed, and managed global and regional partnerships and licenses the world over. Miller’s partners have included a long roster of companies—Glaxo Smithkline, Eli Lilly, Johnson & Johnson, Astra Zeneca, Astellas, Asahi Kasei, Transgene, Lee’s, and many others. Miller has held senior positions in corporate development at Jennerex, Theravance, Inhale/Nektar, Scios, Onyx, and has been involved in numerous technology acquisitions, corporate financings, and other strategic transactions. Ms. Miller earned a B.S. in Biochemistry and Cell Biology from the University of California, San Diego, and an M.S. in Microbiology and Immunology and an M.B.A. from the University of Rochester.

Greg Zante
Greg Zante – Chief Financial Officer and VP Administration

A veteran life science finance executive with more than 20 years of experience in public and private life sciences companies, Greg Zante brings extensive financing transaction and senior management experience. Prior to joining Dance, Mr. Zante was Vice President, Finance and Administration at Sangamo BioSciences, Inc., a publicly traded clinical stage biopharmaceutical company, which he joined in 2003. From 2001 until 2003, he was Director, Finance and Administration at Calyx Therapeutics, Inc., a privately held pharmaceutical discovery and development company. From 1995 until 2001, Mr. Zante held senior financial managerial positions of increasing responsibility at several publicly traded companies including Matrix Pharmaceuticals, Inc., a clinical stage biopharmaceutical company. Previously, Mr. Zante served as a Senior Staff Accountant at Ernst & Young LLP, which he joined in 1993. Mr. Zante holds a B.A. in business economics and managerial accounting from the University of California, Los Angeles, and is a Certified Public Accountant in the state of California.

Lisa Porter
Lisa Porter, MD — Chief Medical Officer

With more than 15 years of experience in developing medicines for diabetes and metabolic diseases with a singular focus on bringing innovative therapies to patients with high unmet need. From 2004 to 2013, Dr. Porter served as Vice President, Medical Development for Amylin Pharmaceuticals where she led the R&D efforts for the Amylin-Lilly Alliance culminating in the approval of the GLP-1 agonist Bydureon, the 1st once weekly treatment for Type 2 diabetes. From 1999 to 2004, Dr. Porter held progressively increasing leadership positions at GlaxoSmithKline Pharmaceuticals with responsibilities for the clinical strategy for Avandia diabetes treatment and early obesity compounds. Prior to joining GlaxoSmithKline, she served as Associate Medical Director for Zeneca Pharmaceuticals from 1997 to 1999. Dr. Porter earned a BS in Biology from the College of William & Mary, an MD from Duke University and completed fellowship training in Endocrinology and Hypertension at Brigham and Women’s Hospital/Harvard Medical School.

Truc Le
Truc Le — SVP Operations and Quality

In addition to his role at Dance Biopharm, Truc Le is also head of operations for a cell therapy company and a drug/device company. He is responsible to build Best-in Class Operation and Quality organizations for these companies. Truc was the COO for Avid Bioservices, a leading CMO that specializes in clinical trials and commercial distribution of monoclonal antibodies and recombinant proteins. Truc was also SVP of Operations and Quality for Nektar Therapeutics, a biopharmaceutical company; his responsibility included all manufacturing, supply chain, material, purchasing, facility, ERP implementation, quality management, and compliance. There he led the CMC quality approval of the first inhaled insulin product, Exubera. Truc has over 30 years of experience in worldwide operations, quality systems management, and business effectiveness. Mr. Le has assisted numerous companies in developing their operations and regulatory affairs to meet USFDA and International Standards, including achievements of ISO registration and CE mark approval for European Union. Mr. Le has also assisted multiple companies in Business Excellence, utilizing 6-Sigma program to help companies improve their efficiency and effectiveness. As a due diligence assessor, he is actively involved in International Supplier/OEM compliance program. Previously, Mr. Le was employed for a division of Johnson & Johnson as the Worldwide Vice-President of Regulatory Compliance and Quality Systems. Mr. Le has BS in mechanical engineering, MBA in Management, and completed numerous executive leadership training programs, including World Class Manufacturing at Duke University, Executive Management at Harvard University, and a QSR trainer at AAMI/FDA.

Sue Wilson
Sue Wilson, PhD – Vice President Program and Alliance Management

A seasoned leader, Susan Wilson brings to Dance more than 20 years experience in broad-based biopharmaceutical product development and cross-functional R&D program leadership (encompassing biologics, vaccines and small molecules). As Vice President of Project Management at KAI Pharmaceuticals, Wilson was the Project Team Leader and Alliance Lead for KAI-4169 (velcalcetide) from IND until end-of-Phase 2 (and subsequent acquisition by Amgen). Dr. Wilson has also served as Vice President of Product Development at Osprey Pharmaceuticals, Senior Program Director for the Diarrheal Disease Program at OneWorld Health, Project Leader on a small molecule project at Theravance, and Associate Director of Protein Therapeutics at Chiron (now Novartis). A board member for the National Kidney Foundation, Wilson holds a Ph.D. in Medical Microbiology, M.Sc. in Immunology from the University of London, and a B.Sc in Pharmacology from the University of Leeds.

Mei-chang Kuo
Mei-chang Kuo, PhD – Vice President Pharmaceutics

With a long track record in pharmaceutical R&D, Mei-Chang Kuo has seen several new and life-cycle-management products through different phases of research and development at a several start-up and mid-size life science companies. At Immulogic, Kuo developed two AllerVax products for cat and ragweed allergies to Phase 3. In the last 15 years, at Inhale/Nektar, Dr. Kuo formulated dry powder insulin for Exubera® and was responsible for the second and third generation of insulin formulation development. Kuo earned a Ph.D. in Biochemistry from the University of Wisconsin, Madison, and completed an Arthritic Postdoctoral Fellowship at National Institute of Health (NIH).

Yu-Ping Yen
Yu-Ping Yen, PhD — Vice President Clinical Operations

After 25 years of hands-on experience in clinical operations and development for therapeutics and diagnostics programs, Yu-Ping is well equipped to lead a global Phase 3 trial. Dr. Yen was directly responsible for clinical operations and active participant in clinical development and regulatory submissions for several approved therapeutic products including Dendreon’s Provenage™, a new drug entity to treat hormonal insensitive prostate cancer, Transcept Intermezzo™, a 505(b)(2) product to treat middle of the night insomnia, and several PMA and 510(k) products including Baxer’s PMA product ChemResponse™ Assay, a predictive test for cancer chemotherapeutics, and diaDexus’s PLAC test™, an IVD prognostic indicator for the development of cardiovascular disease. Dr. Yen also led clinical operations for Aerovance’ large global Phase 2b program for a novel IL4/IL13 inhibitor pitrakinra, formulated as dry-powder inhaler for treating uncontrolled moderate to severe asthmatics. Dr. Yen obtained her PhD from Rutgers University and Post-doctoral Fellowship from University of Washington, Department of Health Science in hematology/oncology.

Blaine Bueche
Blaine Bueche, PhD — Director Pharmaceutics

With over 12 years of experience formulating and characterizing insulin, Dr. Bueche is a leader in the field. His involvement with the Exubera® product from Phase 1 through FDA approval has brought deep technical knowledge of insulin’s remarkable physico-chemical properties, as well as the ability to optimize the properties for analytics and formulation stability. Dr. Bueche began his career synthesizing and purifying custom DNA strands by ion exchange chromatography at Operon, Inc. Since then he has worked on many research projects and advanced several therapeutic development programs. His name appears on seven US patents. Dr. Bueche received his B.S. in Biochemistry from San Francisco State University and earned his PhD from the University of Bradford in Pharmaceutical Sciences.

Jim Fink
Jim Fink, PhD, RRT, FAARC, FCCP – Senior Fellow Clinical Aerosol Product Development

A highly trained clinician and researcher, Dr. Jim Fink has spent the past 25 years of his career focused on understanding the design of aerosol devices and how patients interface with them. In his capacity as Fellow of Aerosol Science at Aerogen (later Nektar), Fink developed efficient liquid aerosol delivery systems for adults, children, and infants, in critical care and ambulatory contexts, with multiple patents both in the US and abroad. Dr. Fink is a Registered Respiratory Therapist with a Ph.D. in Pharmaceutical Innovation from Bradford University, UK and a Fellow of both the American Association of Respiratory Care (FAARC) and the College of Chest Physicians (FCCP). An internationally recognized researcher and lecturer, Fink has authored 3 textbooks and more than 120 chapters and peer-reviewed papers. Dr. Fink serves on the editorial board for the Journal of Aerosol Medicine and is adjunct Professor for the Respiratory Therapy Program at Georgia State University in Atlanta GA, and faculty at Rush Medical School in Chicago.

Lisa Malloy
Lisa Molloy — Senior Director, Device Development

In a career that spans more than two decades, Lisa Molloy has spent the bulk of her professional life focused on drug delivery products. Molloy played a key role in the development of such products as Nektar’s inhalable insulin, Exubera®, Anesiva’s transdermal device, and MAP’s inhalable migraine medication—so she’s familiar with the complexities of combining drug delivery devices with specific formulations. Molloy came to the biotech field from the electronics industry, where she designed automated handling and test systems for high-frequency devices. She holds a bachelor’s degree in mechanical engineering from San Jose State University.

Board of Directors

John Patton (CEO and Chairman)
Samantha Miller MSc, MBA (CBO)
Don Huffman (independent, audit committee)

A senior financial and corporate development executive, Don Huffman has raised $700 million in equity and debt financing and assisted in structuring $650 million in merger, acquisition, and spinout transactions. Huffman has held the office of CFO at three companies with active programs in Diabetes: EndoSonics Corporation, a NASDAQ-listed manufacturer of medical devices (now the +$1 billion Volcano Corporation); Microcide Pharmaceuticals; and Celtrix Pharmaceuticals, where he assisted in successful merger outcomes for these NASDAQ-listed companies. Huffman also served as CFO and Principal of Sanderling Ventures, a $1.2 billion toptier biomedical venture capital firm, and participated in raising a $420 million fund. Huffman received his B.S. from Pennsylvania State University and an M.B.A. from the State University of New York at Buffalo. He completed the Financial Management Program at the Stanford University Graduate School of Business. He qualifies as an “audit committee financial expert” per SEC and SOX requirements.

Augustine Chow, PhD (independent, Asia advisor)

A highly accomplished Asia business and global investment professional, Dr. Chow has served as the CEO of Harmony Asset Limited since 1996, a publicly listed investment company specializing in China and Hong Kong. From 1990-1998, Dr. Chow was the CEO of Allied Group of Companies based in Hong Kong. Prior to this, Dr. Chow held increasingly senior positions with Brunswick Corporation and Outboard Marine Corporation. Dr. Chow has held numerous directorships of listed and non-listed companies, principally in Hong Kong, China and the UK. He currently serves as an independent director of Medifocus, Inc. He has also participated and managed over 50 direct investments in China. Dr. Chow holds a M.S. from London Business School, a Ph.D. in Transfer of Technology from the University of South Australia, a DBA in Internet Research from Southern Cross University, and an Engineering Doctorate in Commercialization of Radical Innovation from the City University of Hong Kong.

Jay Skyler, MD (Independent)

Jay S. Skyler, M D., MACP is a scholar and educator in the field of endocrinology has served as a member of our board of directors since November 2013, and as an advisor to us since 2011. Dr. Skyler has served as a Professor of Medicine, Pediatrics and Psychology and Deputy Director of the Diabetes Research Institute at the University of Miami, where he has been employed since 1976. Dr. Skyler also has served as Study Chairman for the National Institute of Diabetes & Digestive & Kidney Diseases Type 1 Diabetes TrialNet, a nationwide network conducting clinical trials. Dr. Skyler has served as a member of the board of directors of DexCom, Inc., a publicly held medical device company, since September 2002. Dr. Skyler served as a member of the board of directors of Amylin Pharmaceuticals, Inc., a biopharmaceutical company, from 1999 to 2012, when it was acquired by Bristol-Myers Squibb Company. Dr. Skyler earned a B.S. in from Pennsylvania State University and an M.D. from Jefferson Medical College.

Joseph Krivulka (Independent)

Joseph J. Krivulka has served as a member of our board of directors since March 2014. Since January 2008, Mr. Krivulka has served as Chairman of the Board of Akrimax Pharmaceuticals, LLC, a privately-held emerging brand pharmaceutical company founded by Mr. Krivulka. Since September 2008, Mr. Krivulka has served as Chairman of the Board of Rouses Point Pharmaceuticals, LLC, a privately-held generic pharmaceutical company with several skin care products founded by Mr. Krivulka. Since March 2005, Mr. Krivulka has served as a member of the board of directors of Nektar Therapeutics, a biopharmaceutical company. Mr. Krivulka served as a member of the board of directors of Aeolus Pharmaceuticals, a biopharmaceutical company from 2004 to May 2013. Mr. Krivulka served as Chief Executive Officer of Triax Pharmaceuticals, LLC from November 2004 to May 2011, a privately-held dermatology products company founded by Mr. Krivulka. From 1999 until 2004, Mr. Krivulka served as the President of Reliant Pharmaceuticals, LLC, a company co-founded by Mr. Krivulka, which successfully launched and marketed four cardiovascular products and was purchased by GlaxoSmithKline in December 2007. From 1990 to 1997, Mr. Krivulka served as Chief Executive Officer of Berktek, Inc., the branded pharmaceutical subsidiary of Mylan Laboratories Inc., and Corporate Vice President of Mylan Laboratories. Mr. Krivulka holds a B.S. from West Virginia Wesleyan College.

Other Key Personnel

Ben Stedman – Manufacturing
Yu-Ling Yan – Quality
Gary Miller – Quality
Louis Fries – Regulatory
Ryan Patton – Technical Support
Mona Luangvala – Laboratory and Quality Operations
Matthew Leyden – Project Management

Scientific Advisors

Joe Brain, PhD (Harvard) — Pulmonary safety expert
Carl Grunfeld, MD (UCSF VA) — Endocrinologist, diabetes opinion leader US
Ehud Iviri, PhD (Independent inventor) — Device innovator
Paul Norwood, MD — Endocrinologist, 100 patients on Exubera
Andreas Pfutzner, MD (IKFE) — Endocrinologist, opinion leader EU
Ron Wolff, PhD (Novartis, Nektar, Lilly) — Biophysicist, preclinical safety expert
Marcia Testa, PhD (Harvard) — Pharmaceutical patient preference expert
Lex Adjei PhD – Pioneer in inhaled insulin development
Peter Byron PhD (Virginia Commonwealth) – Leading academic inhaled medicines expert
Robert Gerety MD – Former FDA, regulatory affairs expert
Ralph Niven PhD – Pioneer in inhaled medicines development

Pipeline

Dance Biopharm plans to introduce a series of electronic inhaled insulin devices with continuous improvements in capability and features based on patient and prescriber preferences. Dance has an intellectual property portfolio to protect every key component of Dance-501 — and we will continue to evolve the device’s capabilities in line with patient feedback and high-tech innovations. Since Dance-501 is an electronic device, it offers flexibility to incorporate memory, data, and future technology features to integrate therapy and monitoring.

Contact Us

Dance Biopharm Inc.
150 North Hill Drive, Suite 24
Brisbane, California 94005

info@dancebiopharm.com
(415) 369-9415

Transforming the Treatment of Diabetes