AVANIR Obtains First European Marketing Approval for Docosanol 10% Cream for Cold Sores; Sweden is Lead Country in European Mutual Recognition Process
SAN DIEGO, Nov 19, 2003 (BUSINESS WIRE) -- AVANIR Pharmaceuticals (AMEX:AVN) said the Swedish Medical Products Agency approved docosanol 10% cream (known in the U.S. as Abreva(R)) for marketing as a non-prescription, over-the-counter topical treatment for cold sore infections.
Sweden will act as AVANIR's Reference Member State for the mutual recognition process within Europe. AVANIR intends to license the product to partners for marketing in Europe and has already announced one such relationship for Italy.
Since licensing Abreva to GlaxoSmithKline in the U.S. in 2000, AVANIR has received over $55 million from milestones, fees, royalties and the sale of rights to future royalties for the product. Abreva became number one in sales after four months on the market and remains the U.S. sales leader in the lip care category.
"Docosanol 10% cream has a novel mechanism of action and is most effective early in the course of an outbreak. As a result, docosanol 10% cream reduces the length of time patients experience discomfort from cold sores," said Stephen Sacks, M.D., a leading clinician and scientist in the field of antiviral therapy and founder and president of Viridae Clinical Sciences Inc. "This product provides an important topical treatment option for cold sore sufferers."
Annual sales of cold sore products in Europe consist of over 23 million units, including prescription and non-prescription products. The prices vary by product and by country, but total sales are approximately $100 million annually. In the United States, Europe, and in most other countries in the world, it is estimated that 80 percent of adults are carriers of the virus that causes cold sores. Each year, 20 to 40 percent of these adults develop symptomatic episodes, characterized by the formation of a blister on the upper or lower lip.
"Unlike other cold sore products already sold in the European market, docosanol may address an important public health concern regarding the emergence of drug resistant viruses," said Gerald J. Yakatan, Ph.D., president and CEO of AVANIR. "We feel docosanol's unique mechanism of action will be especially appreciated by consumers in Europe, and look forward to receiving decisions from the other Member States in the European Union as the mutual recognition process moves forward."
About Docosanol (Abreva(R))
Docosanol inhibits fusion between the plasma membrane and the herpes simplex virus (HSV) envelope, thereby preventing viral entry into cells and subsequent viral replication. Since the compound does not act directly on the virus, it is unlikely that it will produce drug resistant mutants of HSV. Competitive products, such as nucleoside analogues, work by inhibition of viral DNA replication and, as such, carry the risk of mutating the virus.
A study published in the August 2001 issue of the Journal of the American Academy of Dermatology demonstrated that docosanol shortens healing time for cold sore sufferers. According to the study results, docosanol specifically reduces the most irritating and contagious stage of a cold sore. Normally, cold sores progress when the cold sore infection spreads from infected cells to healthy ones. Docosanol works by protecting healthy cells so the cold sore infection is less likely to spread to those cells. Docosanol also reduces the duration of the uncomfortable symptoms of cold sores, such as itching and burning sensations.
Abreva (docosanol 10%) cream) is the only product approved by the U.S. Food and Drug Administration (FDA) in its category for sale in the over-the-counter market. AVANIR licensed the product to GlaxoSmithKline in April 2000. The drug was approved by the FDA in July 2000 and ranked in the top ten of all new consumer healthcare products introduced in the 12-month period ended June 2001, according to AC Nielson data.
About the Company
AVANIR Pharmaceuticals is a drug discovery and development company focused on the development of treatments for central nervous system disorders and inflammatory diseases. The company's first commercialized FDA-approved product, Abreva(R), is marketed in North America by GlaxoSmithKline and is the leading over-the-counter product for the treatment of cold sores. The company's lead product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect and in Phase II clinical development for neuropathic pain. An internally developed small molecule, AVP 13358, is in a Phase I clinical trial for the treatment of allergy and asthma. Using its proprietary Xenerex(TM) technology, AVANIR also develops human monoclonal antibodies for infectious diseases and other therapeutic applications. Further information about AVANIR can be found at 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 European Union member countries 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.
SOURCE: AVANIR Pharmaceuticals
AVANIR Pharmaceuticals, San Diego
Patrice Saxon, 858-622-5202