The licensing agreement is part of an overarching strategy to utilize recent genomics and chemistry advances made by researchers at DNAPrint to develop next-generation drugs that maximize efficacy and minimize side effects by tailoring medication for specific individuals and well-defined population sectors.
The royalty bearing licensing agreement creates an opportunity for DNAPrint genomics to develop and market an improved "Super"- EPO. EPO is currently commercialized by several pharmaceutical companies for a worldwide market that exceeds $10 billion, and the EPO market is growing at an average annual rate of 21%. Leading participants in the existing monomer EPO market include Amgen, Johnson & Johnson and Roche.
EPO is a glycoprotein naturally made by the body to stimulate red blood cell production; the marketed forms are manufactured by recombinant DNA technology and are used to treat anemia or low blood cell count that results from a variety of illnesses and conditions. PT-401, the improved version of EPO licensed by DNAPrint, is an Erythropoietin dimer, or a double form of the natural protein.
"With the first pharmaceutical in our nascent drug pipeline, our Company is evolving into a genomics-based pharmaceutical company that develops innovative 'theranostic' products, which blend genomics-based tests with drugs as products to target segments of the patient population for enhanced efficacy and reduced side effects," stated DNAPrint genomics Chief Executive Officer Richard Gabriel. "Everything we have done as a company up until this point -- aggressively introducing new tests, forging new markets, expanding the envelope of genomics expectations in the fields of forensics, consumer genomics and pharmacogenomics -- has made today's announcement possible."
"DNAPrint genomics has taken a major step forward in establishing a drug pipeline that has the potential to provide the Company a significant opportunity for growth," stated Tony Frudakis, Ph.D., Founder and Chief Scientific Officer. "We are pleased that a prestigious organization such as Beth Israel Deaconess is embracing our innovative technology in the development of our first drug candidate."
"Starting immediately, we intend to devote a very significant proportion of our resources to fund and execute the PT-401 development program. EPO exhibits an element of variable response that DNAPrint management believes Company technology can help address. PT-401 will be coupled with a genetic test for predicting response and individualizing dosage, thereby providing personalized treatment," said Hector J. Gomez, MD, Ph.D., DNAPrint's Chairman and Chief Medical Officer. "We believe we have made a wise choice in selecting PT-401 to apply our genomics expertise -- expertise which is not restricted to xenobiotic metabolism genetics but inclusive of far more complex gene-drug interactions."
"Our EPO technology has significant promise as a more powerful and commercially successful application of Erythropoietin," stated BIDMC's Dr. Arthur J. Sytkowski, who holds patents related to the new "Super"-EPO. "We are pleased that DNAPrint has made a commitment to work with BIDMC in expanding the potential for this drug."
The human gene that produces EPO was cloned in 1985, and, in 1989, scientists at Amgen introduced to market a recombinant form under the trade name EPOGEN®, a drug that many credit for the rise of Amgen in the 1990s as one of the world's most successful biotechnology companies ever.
Patients undergoing certain therapies or with certain conditions are often rendered anemic, meaning their red blood cell count drops dramatically. Without adequate amounts of erythropoietin in the blood, red blood cells are not regenerated efficiently, and there are too few red blood cells to deliver oxygen sufficiently throughout the body. Erythropoietin has been approved by the U.S. Food and Drug Administration as a treatment for anemia associated with renal failure, cancer chemotherapy, zidovudine-treated HIV-infected patients and to reduce blood transfusion in surgery patients. Anemia leaves patients tired, often impairing their ability to work or perform even routine tasks and over the last decade, EPO has proven to improve quality of life and overall fitness of those patients.
In 1995, Dr. Sytkowski, Director for the Laboratory for Cell and Molecular Biology, Division of Hematology and Oncology at Beth Israel Deaconess, was awarded the first in a string of eight patents covering methods of producing and using recombinant protein multimers with increased biological activity. In these patents, which are subject of the exclusive DNAPrint license announced today, Dr. Sytkowski described a new dimer (double) form of EPO -- "Super"-EPO, that elicited a heartier, more predictable hematocrit (red blood cell count) response, constituting a significant improvement over existing EPO technology.
About Harvard Medical School's Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu .
About DNAPrint genomics, Inc.
DNAPrint genomics, Inc. uses proprietary human genome research methods to develop genomic-based services and products. The Company's ANCESTRYby DNA(TM) is a consumer product for individuals interested in learning their family heritage. DNAWitness(TM) is a forensics market tool for analyzing DNA evidence recovered at a crime scene. DNAPrint is also developing products in the pharmacogenomic market including OVANOME(TM), a genomic-based diagnostic tool that matches ovarian cancer patients with the most suitable form and dose of chemotherapy, and STATINOME(TM), a test for the cardiac drug market to determine whether patients will be good or poor responders to statins, which are effective in cholesterol reduction. For more information about the company, please visit http://www.dnaprint.com.
Safe Harbor Provision
All statements in this press release that are not historical are forward- looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint genomics, Inc. expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward- looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Company Contact
Richard GabrielPresident and CEO941-366-3400
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