Transforming the Treatment of Diabetes
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.
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
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.”
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
Each device will be intended for one year’s use
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 Genentech from 1985-1990; before that time, he was a tenured professor at the University of Georgia. Dr. Patton was the founding investor in Halozyme Therapeutics in 1998 and a co-founder in 2009 of Incarda Therapeutics, Inc., a product-focused cardiovascular company. 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.
Greg Zante, CPA – 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, 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 — EVP 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.
Mei-chang Kuo, PhD – SVP 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).
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.
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.
Samantha Miller, MSc, MBA – Strategic Consultant
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.
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.
Board of Directors
John Patton, PhD (CEO and Chairman)
Don Huffman (independent lead director, 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.
Adam Stern (Financing advisor)
Adam K. Stern has served as a member of our board of directors since December 2014. Adam is CEO of SternAegis Ventures and Head of Private Equity Banking at Aegis Capital since 2012. Previously he was Senior Managing Director, Head of Structured Finance at Spencer Trask Ventures, where he worked from 1997 to 2012 and was at Josephthal & Co., from 1989 to 1997 as Head of Private Equity Marketing. Mr. Stern has over 25 years of venture capital and investment banking experience focusing primarily on the life science and technology sectors of the capital markets. Mr. Stern has completed hundreds of transactions throughout his career, including private placements, public offerings and mergers and acquisitions. Mr. Stern also currently serves as a Director of Matinas BioPharma Holdings, Inc. (MTNB). He is a former Director of InVivo Therapeutics Holdings Corp. (NVIV), Organovo Holdings, Inc. (ONVO), Prolor Biotech (PBTH). In 2013, Prolor was acquired by OPKO Health, Inc. (NYSE: OPK).
Other Key Personnel
Ben Stedman – VP Manufacturing
Yu-Ling Yan – Quality
Gary Miller – Quality
Ryan Patton – Technical Support
Jay Skyler, MD (Diabetes Research Institute) – Endocrinologist, Diabetes opinion leader
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
February 18, 2015
Dance Biopharm Completes $9.5 Million Private Financing