AVANIR Pharmaceuticals Files for Marketing Approval Of Docosanol 10% Cream in Europe
"AVANIR chose to make its submission to the Swedish MPA because it is held in high regard by regulatory agencies in other European countries," said James E. Berg, Vice President of Clinical and Regulatory Affairs for AVANIR Pharmaceuticals. "If docosanol 10% cream is approved for marketing in Sweden, we intend to ask the MPA to prepare a marketing approval package for consideration by regulatory agencies in other European countries, seeking mutual recognition."
AVANIR estimates that annual sales of cold sore products in Europe are over $90 million, consisting of over 22 million units, including prescription and OTC products. The retail prices of the products vary by product and by country, but average about $9.00 per unit (U.S. dollars). In the United States, Europe, and in most other countries in the world, it is estimated that eighty percent of adults are carriers of the virus that causes cold sores. Each year, twenty to forty percent of these adults develop symptomatic episodes, characterized by the formation of a blister on the upper or lower lip.
Docosanol 10% cream was approved by the U.S. Food and Drug Administration (FDA) for the treatment of cold sores in July 2000. Marketed in United States by GlaxoSmithKline as Abreva(TM), it is the only cold sore product approved by the FDA for the over-the-counter (OTC) market. Abreva leads the category in sales and was recently recognized as the number one pharmacist recommended cold sore treatment in the OTC market. AVANIR has already received over $28 million in licensing fees and royalties for Abreva from GlaxoSmithKline and expects to earn royalties on Abreva sales until at least 2014.
AVANIR has expanded its docosanol franchise through license agreements, regulatory filings and research agreements throughout the world. In addition to the United States and Canada, AVANIR has license agreements in place in Korea, Israel, and selected Middle-Eastern countries. AVANIR is awaiting decisions by regulatory agencies in each of the licensed territories outside the United States in order for its licensees to begin selling the product in those countries. AVANIR intends to seek one or more licensees in Europe following the outcome of the regulatory filing in Sweden.
In pursuit of additional uses for docosanol 10% cream and to further develop its docosanol franchise, AVANIR is currently evaluating the efficacy and safety in animal models of new topical formulations of docosanol that could be used to treat genital herpes. The Company has been awarded $1.2 million in outside funding for development of a potential genital herpes product from grants awarded by the National Institutes of Health's Small Business Innovation Research program and by the California Trade, Technology and Commerce Agency.
AVANIR and Shanghai New Asiatic Pharmaceutical Company, Ltd., a division of the largest state-owned pharmaceutical conglomerate in the People's Republic of China, have entered into a research and development agreement to explore other uses for AVANIR's docosanol 10% cream beyond cold sores. These additional uses could include genital herpes and herpes zoster, also known as shingles.
Through license fees and royalties being earned under existing license agreements with GlaxoSmithKline and other companies in the rest of the world, AVANIR expects that docosanol 10% cream should provide an important source of funds for AVANIR to continue developing other drugs currently in the product development pipeline.
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 such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "intend," "plan" or "expect." Preliminary research findings are not always supportable by the scale-up of commercial operations, and many known and unknown risks and uncertainties could cause actual results to differ materially from those indicated in these forward-looking statements. The company can give no assurance that the New Drug Submission will be approved by the Swedish Medical Products Agency on a timely basis or at all. Further, market acceptance for docosanol 10% cream and other drug products is unpredictable and substantially outside of the influence and/or control of the company.
For further information, please contact: General Information, Kristen McNally, +1-310-407-6548, email@example.com, or Analyst/Investors, Tricia Ross, +1-310-407-6540, firstname.lastname@example.org, or Media, Tim Grace, +1-312-640-6667, email@example.com, all of FRB|Weber Shandwick, for AVANIR Pharmaceuticals; or Investor Relations, Patrice Saxon of AVANIR Pharmaceuticals, +1-858-622-5202, firstname.lastname@example.org.
SOURCE AVANIR Pharmaceuticals
General Information, Kristen McNally, +1-310-407-6548,
email@example.com, or Analyst/Investors, Tricia Ross,
+1-310-407-6540, firstname.lastname@example.org, or Media, Tim Grace,
+1-312-640-6667, email@example.com, all of FRB|Weber Shandwick, for
AVANIR Pharmaceuticals; or Investor Relations, Patrice Saxon of AVANIR
Pharmaceuticals, +1-858-622-5202, firstname.lastname@example.org
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