This award application is not only about a company, Digestive Care, Inc. (DCI), but about its founder, Dr. Tibor Sipos, renowned researcher, entrepreneur, and philanthropist, who has devoted his life to the advancement of science.
In 1990, Dr. Sipos founded Digestive Care, Inc. (DCI), a company dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. Funding received through the federal Small Business Innovation Research (SBIR) Program in 1992, and additional early stage funding from the state Ben Franklin Technology Partners (BFTP) of Northeastern Pennsylvania Program was instrumental in fueling the growth of DCI.
Dr. Sipos invented a microencapsulated digestive enzyme preparation that improved the quality of life and added ten years to the life expectancy of children afflicted with cystic fibrosis (CF). He also developed a patented formulation of enteric-coated buffered pancrelipase microspheres, for which he filed an Investigational New Drug Application (IND) with the FDA under the original name of Digestizyme™. DCI later introduced this product onto the US market in 1995 as a physician prescribed pancreatic enzyme replacement therapy (PERT), under the tradename PANCRECARB®.
DCI continued to grow and in 2000 Dr. Sipos moved the company from the BFTP Center on the Lehigh University mountaintop campus to a new manufacturing facility located in south Bethlehem, PA, an area left economically underserved since the demise of the Bethlehem Steel industry. In 2002, Sipos was honored with the Ben Franklin Innovator Award for his achievement as an entrepreneur. Due to changes in the way FDA regulated the pancreatic enzyme products, DCI completed additional work to support the submission of a New Drug Application (NDA) for its PERT. In May 2012, the FDA approved the NDA for DCI’s flagship product named PERTZYE® (pancrelipase) Delayed-Release Capsules. PERTZYE® is a unique bicarbonate-buffered formulation of enteric-coated pancreatic enzyme microspheres, protected by several U.S. and international patents, manufactured at DCI’s FDA approved facility located in Bethlehem, PA.
Dr. Sipos and DCI emulate the goals of the SBIR program, having taken an invention from concept through to a successful business, navigating challenges along the way. Dr. Sipos also continues to serve as a mentor in the Lehigh University Chemistry Department, and DCI has been a generous supporter of scientific advancements through research grants and patient educational programs.