SAN DIEGO--(BUSINESS WIRE)--Sept. 16, 2002-- Epicyte Pharmaceutical, Inc., a San Diego biopharmaceutical company focused on the discovery and development of human monoclonal antibodies, announced today that it has selected AAI International, a division of aaiPharma Inc. (Nasdaq:AAII - News), to develop the industry's first topical formulation of a monoclonal antibody. This program is expected to lead to a topical gel formulation of Epicyte's lead antibody compound, HX8, which has proved capable of complete viral neutralization of herpes simplex virus (HSV) in preclinical models.
Epicyte partnered with The Dow Chemical Company to produce HX8, a promising product for the prevention and treatment for HSV, an illness that affects 50 million people in the U.S. Today's announcement marks Epicyte's engagement of AAI International to develop a formulation to Epicyte's specifications and manufacture products for pharmacology/toxicology and clinical studies. The alliance strengthens Epicyte's capability in formulation and drug delivery and moves the company closer to expected Phase I clinical trials of HX8 in 2003.
"We chose AAI International because of its broad expertise in developing formulations and testing proteins. The company's collaborative approach complements our own," said Dr. Catherine Lee, Epicyte's director of formulation development. "The AAI International team is very enthusiastic about our project both because of the novel opportunity to formulate a monoclonal antibody into a topical treatment and its potential to benefit millions of people around the globe."
The companies' collaboration creates a formidable team for the development, manufacturing and testing of protein-based pharmaceuticals. The Epicyte team includes Dr. Kevin Whaley, an internationally renowned microbiocide expert. In 1998, Dr. Whaley co-founded the Alliance for Microbiocide Development, an organization that unites corporate, academic and advocacy institutions in the rapid development of vaginal microbiocides. While Epicyte has extensive experience with a range of human monoclonal antibodies, including capabilities for antibody discovery, analysis and characterization, AAI International has expertise in developing and manufacturing semi-solid gel formulations. Dr. Whaley's microbiocide expertise coupled with AAI International's technical depth will allow Epicyte to strengthen its leadership position in developing topical applications for antibodies to treat inflammatory and infectious diseases.
"AAI International is very pleased to be able to support Epicyte in developing the industry's first topical formulation of a monoclonal antibody," according to Vijay Aggarwal, Ph.D., President of AAI International and Executive Vice President of aaiPharma. "Through agreements like this, we see significant opportunities to grow our contract services business in the biotechnology arena due to the unique depth and breadth of our development work on novel proteins and large molecules as well as our technical experience with diverse formulations such as gels and semi-solids."
In July, Epicyte received broad and exclusive commercial rights to a U.S. patent claiming any transgenic plant that expresses any antibody, including human monoclonal antibodies. Epicyte is using this technology to produce its own antibody pipeline and to address capacity constraints in the antibody-based therapeutics market. In addition to partnering with Dow on its lead compound HX8, Epicyte also has partnered with Dow to produce R19, a treatment for respiratory syncytial virus (RSV). Epicyte's discovery and development efforts also focus on building a pipeline of monoclonal antibodies for the treatment of patients with other major healthcare problems, including Clostridium difficile, Alzheimer's disease and HIV.
Epicyte's current partners include The Dow Chemical Company; Medarex; Centocor, a wholly owned subsidiary of Johnson and Johnson; AAI International and the U.S. government.
About aaiPharma
aaiPharma Inc. is a fully integrated, science-based pharmaceutical company with more than 22 years of drug development experience. Focusing on targeted therapeutic areas, the Company markets a growing portfolio of established branded products and applies innovative technologies to increase the commercial potential of these products. At the same time, aaiPharma's research and development organization is developing an impressive pipeline of products to position the Company for near-term and long-term growth in its targeted therapeutic areas. In addition to developing and marketing its own line of proprietary pharmaceutical products, aaiPharma continues to be a world leader in providing contract pharmaceutical development services through its AAI International division. For more information on the Company, please visit the website at www.aaipharma.com.
About Epicyte
Epicyte Pharmaceutical, Inc. is a biopharmaceutical company focused on the discovery and development of therapeutics to treat inflammatory and infectious diseases. The company's proprietary technology for producing antibodies in plants allows Epicyte to address an unmet need -- making antibody treatments for common infectious diseases in large enough quantities for widespread use. High production costs associated with traditional methods for producing antibodies have limited their use as a disease treatment. Epicyte's technology for growing antibodies in plants is scalable and cost effective. For additional information, visit www.epicyte.com. |
