AVANIR Pharmaceuticals Receives CalTIP Grant to Develop a Docosanol-Based Genital Herpes Treatment
Total Federal and State Grants Awarded for Docosanol-Based Genital Herpes Treatment Reaches $1.2 MillionAVANIR Pharmaceuticals (Amex: AVN) announced today that it has received notification from the California Trade, Technology and Commerce Agency that a California Technology Investment Partnership (CalTIP) grant to be used in the development of a topical treatment for genital herpes has been funded. In 2001, the San Diego Regional Technology Alliance announced that AVANIR was eligible to receive the CalTIP award of $150,000 as a matching funds grant that could be used only in conjunction with a federally funded grant. Complementing the CalTIP award is a $1 million Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health that AVANIR received earlier this year.
AVANIR Pharmaceuticals and the California Trade, Technology and Commerce Agency have agreed that the CalTIP funds will be used for defining and assessing the market for a genital herpes (HSV-2) product using docosanol 10% cream, AVANIR's lead product that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of cold sores. The market analysis is intended to include assessment of competitive landscape, product opportunities, brand identification and possible brand names for a potential product. The SBIR grant is being used to fund the pre-clinical research.
AVANIR's SBIR grant, together with the CalTIP grant, brings total funds awarded to AVANIR for further research and development of a potential new treatment of genital herpes to $1,159,000. The SBIR grant represents a two-year period of funding of approximately $500,000 each year for the Company's research project.
"Our CalTIP and SBIR grants for genital herpes research will serve as important catalysts for our objective of expanding our docosanol franchise," said Gerald J. Yakatan, Ph.D., President and Chief Executive Officer of AVANIR Pharmaceuticals. "We have successfully completed studies showing the effectiveness of a docosanol-based product in an animal model of herpes simplex infections, and are pleased that these additional grants have been executed in response to our research efforts."
AVANIR previously entered into a collaborative research and development agreement with Shanghai New Asiatic Pharmaceutical Company, Ltd., a division of Shanghai Pharmaceutical Co., Ltd., the largest state-owned pharmaceutical conglomerate in the People's Republic of China. Under the collaborative research and development agreement, Shanghai New Asiatic Pharmaceutical Company will be exploring other indications or uses for AVANIR's docosanol 10% cream beyond cold sores. These additional indications include genital herpes and herpes zoster, also known as shingles. Terms of the agreement provide for Shanghai New Asiatic to conduct and finance all aspects of product development deemed necessary for regulatory approvals in the People's Republic of China for all three indications.
AVANIR Pharmaceuticals, based in San Diego, is a biopharmaceutical drug discovery and development company with an FDA-approved product. AVANIR is engaged in research, discovery, development and licensing of innovative drug products and, through its subsidiary Xenerex Biosciences, antibody generation services and antibody product development. The Company's next potential product, Neurodex, for the treatment of central nervous system disorders is currently in a Phase II/III clinical trial. The Company's website is http://www.avanir.com .
The information contained in this press release, including any forward looking statements contained herein, should be reviewed in conjunction with the Company's most recent Annual Report on Form 10-K and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and such statements, including risks and uncertainties related to drug development and clinical trials. The Company's receipt of a Phase II grant award intended to fund development of potential therapies for herpes should not imply that the Company's research will be successful or that a commercial product will be the result. Phase II grant award covers a span of two years and is funded in annual increments. The first year increment is $501,000 and the NIH's recommended funding for the second year is $507,000, subject to the availability of funds and satisfactory progress of the project. There can be no assurance that government funds will be available for the second year or that satisfactory progress will have been made at the end of one year. Final review decisions made by the NIH, FDA and other regulatory agencies concerning our research and government funding are unpredictable and outside of the influence and/or control of the Company.
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