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R&D Enterprises Files First IND for Biogeneric Insulin


3/8/2010 2:37:27 PM

(Greenwood, Ind. – March 4, 2010) – R&D Enterprises, LLC, a subsidiary of Elona Biotechnologies, Inc., announced today that it has filed an IND with the FDA for a biogeneric form of insulin which, if approved, is expected to significantly reduce the cost of insulin for diabetic patients in the U.S. and eventually around the world.

“We have developed a unique, proprietary and iterative system that utilizes improved cell banking and protein expression technology which has significantly enhanced purification yields,” said Ron Zimmerman Sr., President of Elona. “If approved, this product will offer a high quality, low cost option to patients who otherwise cannot afford insulin,” he said. Compared to industry standards, Zimmerman stated that company scientists have reduced the number of production steps which lowers manufacturing costs.

“With this filing, we have proven that by assembling the right group of scientists, superior technology can trump low cost labor,” said Zimmerman. This IND is expected to be the first of many biogeneric products from R&D Enterprises. The company expects clinical trials to begin in third quarter of 2010.

Generic insulin represents a one billion dollar market opportunity, according to Jeffrey Evans, Ph.D., Managing Partner of Rondaxe Enterprises. “R&D Enterprises is in a leadership position as this filing is believed to be the first generic insulin filing in the U.S.,” said Evans.

Dr. Alexander Fleming, current president and CEO of Kinexum and former Supervisory Medical Officer for the Division of Metabolism and Endocrine Drug Products for the FDA said, “Medical breakthroughs as well as common disease management will more and more depend on protein drugs. But, these products are complex and currently very expensive to manufacture. The R&D Enterprises technology raises the prospects for affordable protein drug products, which will substantially benefit patients and healthcare budgets.”

(Greenwood, Ind. – March 4, 2010) – R&D Enterprises, LLC, a subsidiary of Elona Biotechnologies, Inc., announced today that it has filed an IND with the FDA for a biogeneric form of insulin which, if approved, is expected to significantly reduce the cost of insulin for diabetic patients in the U.S. and eventually around the world.

“We have developed a unique, proprietary and iterative system that utilizes improved cell banking and protein expression technology which has significantly enhanced purification yields,” said Ron Zimmerman Sr., President of Elona. “If approved, this product will offer a high quality, low cost option to patients who otherwise cannot afford insulin,” he said. Compared to industry standards, Zimmerman stated that company scientists have reduced the number of production steps which lowers manufacturing costs.

“With this filing, we have proven that by assembling the right group of scientists, superior technology can trump low cost labor,” said Zimmerman. This IND is expected to be the first of many biogeneric products from R&D Enterprises. The company expects clinical trials to begin in third quarter of 2010.

Generic insulin represents a one billion dollar market opportunity, according to Jeffrey Evans, Ph.D., Managing Partner of Rondaxe Enterprises. “R&D Enterprises is in a leadership position as this filing is believed to be the first generic insulin filing in the U.S.,” said Evans.

Dr. Alexander Fleming, current president and CEO of Kinexum and former Supervisory Medical Officer for the Division of Metabolism and Endocrine Drug Products for the FDA said, “Medical breakthroughs as well as common disease management will more and more depend on protein drugs. But, these products are complex and currently very expensive to manufacture. The R&D Enterprises technology raises the prospects for affordable protein drug products, which will substantially benefit patients and healthcare budgets.”

The global market for insulin and analogs exceeded $12 billion in 2009 and had double digit growth (IMS Health).

Elona Biotechnologies, Inc.

ELONA Biotechnologies, Inc., located in Greenwood Ind., is a technology leader in proteomics, process development, characterization and production of therapeutic proteins. The company, and its subsidiary R&D Enterprises LLC, develops and produces clinical trial materials such as human insulin, insulin analogs, human growth hormone and other generic proteins which treat chronic diseases.

http://www.elonabiotech.com/

Rondaxe Enterprises, LLC.

Rondaxe Enterprises, LLC, located in Syracuse, N.Y., is a unique company providing a suite of services that combines expert drug development consulting, in-depth project management leadership, software applications and virtual business development designed specifically for emerging pharmaceutical and biotech companies.

http://www.rondaxe.com/


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