Boulder, Colorado - December 16, 2008 - Bolder BioTechnology, Inc. today announced that it has been awarded a $1.9 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH). The grant will be used to perform additional preclinical toxicology and pharmacology studies of the company’s proprietary long-acting growth hormone product, which is being developed as a potential treatment for growth hormone deficiency, short stature in children and HIV-associated adipose redistribution syndrome (HARS). Receipt of the entire grant award is contingent upon the achievement of certain research milestones.
George (Joe) Cox, Ph.D., Company President and Principal Investigator for the grant, stated “We are delighted to receive continued support from NIAID for our long-acting growth hormone program. Funding from a Phase I SBIR grant from NIAID allowed us to complete many of the studies required by the Food and Drug Administration for filing an Investigational New Drug application to begin testing our long-acting growth hormone analog in people. We obtained important proof-of-concept data demonstrating that our long-acting growth hormone analog can be administered less frequently, but with comparable efficacy, as a leading daily growth hormone therapy in a validated animal model of growth hormone deficiency. Recombinant human growth hormone products have annual worldwide sales of over $2 billion. However, these products are inconvenient to use because they must be injected daily, typically for many years. We expect our product will be a once weekly growth hormone therapy, providing patients with an easier to use and potentially more effective treatment for their disease.
The NIH SBIR program is a peer-reviewed grant program that provides research support to small businesses to discover and develop innovative biomedical products for the treatment of serious unmet medical needs.
Bolder BioTechnology, Inc. uses advanced protein engineering technologies to create proprietary human protein pharmaceuticals with enhanced therapeutic properties for the treatment of hematopoietic and endocrine disorders, cancer and infectious diseases. For additional information about Bolder BioTechnology, Inc., please visit our web site at www.bolderbio.com.
Statements contained herein that are not historical facts are forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company. These factors include, but are not limited to: (1) the Company’s ability to successfully complete product research and development, including pre-clinical and clinical studies, and commercialization; (2) the Company’s ability to obtain required government approvals; (3) the Company’s ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (4) the Company’s ability to develop and commercialize its products before its competitors.
Contact information: Joe Cox, Ph.D., President (303) 420-4420 (ext.202)