AVANIR's Docosanol 10% Cream Approved for Marketing in Korea
"We continue to make important advances in our strategy to increase our revenue base by expanding the docosanol franchise through license agreements and regulatory filings," said Gerald J. Yakatan, Ph.D., President and CEO of AVANIR Pharmaceuticals. "Earlier this week, we announced that docosanol 10% cream was approved for marketing by our Canadian licensee, GlaxoSmithKline, as an OTC product in Canada. And earlier this month, we submitted a new drug application to Swedish regulatory authorities seeking marketing approval of the drug in Sweden, which we intend to be the lead country in the mutual recognition process in Europe."
Sold in the U.S. consumer market by GlaxoSmithKline as Abreva(TM), docosanol 10% cream leads its product category in sales, having captured over 38% of the OTC lip remedies market in U.S. retail sales since its launch in late 2000. Abreva is the only cold sore product approved by the U.S. Food and Drug Administration for the over-the-counter market. Abreva was recently recognized as the number one pharmacist recommended cold sore treatment in the OTC market.
AVANIR has docosanol license agreements in place in the United States, Canada, Korea, Israel, and selected Middle-Eastern countries. AVANIR also has a research and development agreement with Shanghai New Asiatic Pharmaceutical Company, Ltd., a division of the largest state-owned pharmaceutical conglomerate in the People's Republic of China, for the purpose of exploring the commercialization opportunities for docosanol 10% cream as a treatment for cold sores in the People's Republic of China. Additional indications for docosanol 10% cream including genital herpes and herpes zoster, also known as shingles, may also be explored under the Shanghai company research agreement.
To further develop its docosanol franchise, AVANIR is evaluating in pre-clinical studies the efficacy and safety of new topical formulations of docosanol that could be used to treat genital herpes. AVANIR was recently awarded $1.2 million in grants from the National Institutes of Health and from the California Trade, Technology and Commerce Agency for development of a potential genital herpes product.
Boryung was founded in 1963 as a pharmaceutical company based on its successes in the drugstore and wholesale businesses. Boryung has grown into a broader corporation with over $200 million in annual sales through six affiliated companies -- Boryung Pharm, Boryung Medience, Boryung Biopharma, Boryung Industrial, Kim's Communications and BR Netcomm. Boryung is recognized in Korea as one of the preeminent competitors in its space, with continuous development of new drugs to service a nationwide market.
AVANIR Pharmaceuticals, based in San Diego, is a biopharmaceutical drug discovery and development company. AVANIR is engaged in research, discovery, development and licensing of innovative drug products and, through its subsidiary Xenerex Biosciences, antibody generation services. The Company's next potential product, Neurodex, 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 product launch will be timely for docosanol 10% cream. Further, market acceptance for docosanol and other drug products is unpredictable and substantially outside of the influence and/or control of the Company.
For further information, please contact: Gregg Sloate, General Information, +1-310-407-6547, firstname.lastname@example.org, or Tricia Ross, Analyst/Investor, +1-310-407-6540, email@example.com, or Tim Grace, Media, +1-312-640-6667, firstname.lastname@example.org, all of FRB|Weber Shandwick for AVANIR Pharmaceuticals; or Patrice Saxon, Investor Relations of AVANIR Pharmaceuticals, +1-858-622-5202, psaxon@AVANIR.com.
SOURCE AVANIR Pharmaceuticals
Gregg Sloate, General Information, +1-310-407-6547,
email@example.com, or Tricia Ross, Analyst/Investor, +1-310-407-6540,
firstname.lastname@example.org, or Tim Grace, Media, +1-312-640-6667,
email@example.com, all of FRB|Weber Shandwick for AVANIR
Pharmaceuticals; or Patrice Saxon, Investor Relations of AVANIR
Pharmaceuticals, +1-858-622-5202, psaxon@AVANIR.com
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