AVANIR Signs Agreement With ACO HUD To Market Docosanol 10% Cream in Scandanavia
SAN DIEGO--(BUSINESS WIRE)--Oct. 5, 2004--AVANIR Pharmaceuticals (AMEX: AVN) announced today that it has signed an exclusive agreement with ACO HUD to manufacture and market AVANIR's docosanol 10% cream as a treatment for cold sores in Sweden, Norway, Denmark and Finland. Stockholm-based ACO HUD is the Scandinavian market leader in sales of cosmetic and medicinal skincare products. ACO HUD plans to launch the product in 2005.
"ACO HUD's expertise in promoting products in the prescription and over-the-counter (OTC) pharmacy skincare market was a major factor in selecting them as our partner for docosanol 10% cream," said J. David Hansen, AVANIR's Senior Vice President of Corporate Development. "AVANIR received marketing approval of docosanol 10% cream in Sweden in November 2003. We look forward to the launch of our product and to a long and productive partnership with ACO HUD."
Under terms of the agreement, ACO HUD will be responsible for all sales and marketing activities, as well as manufacturing and distribution of the product. The terms of the agreement provide for AVANIR to receive a license fee, royalties on product sales and milestones related to product approval in Norway, Denmark and Finland. ACO HUD will be responsible for filing for marketing approval using the mutual recognition process initiated by AVANIR that resulted in direct to OTC approval of docosanol in Sweden.
Sold in the U.S. consumer market as Abreva(R) by AVANIR's licensee, GlaxoSmithKline Consumer Healthcare, docosanol 10% cream is the only cold sore product approved by the U.S. Food and Drug Administration (FDA) available without a prescription. 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 inhibits fusion between the plasma membrane and the herpes simplex virus (HSV) envelope, thereby preventing viral entry into cells and subsequent viral replication.
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.
ACO HUD is the Scandinavian market leader in cosmetic and medicinal skincare products. The brand ACO was established in 1939 and the products are sold exclusively in pharmacies.
Omega Pharma acquired 100% of ACO HUD in September 2004. Omega Pharma manages a portfolio of OTC medicines and distributes non-prescription drugs and other medical products to pharmacies across Europe. Omega has expanded this year through acquisition of two companies, ACO HUD and Medestea, and the purchase of 60 non-prescription brands from Pfizer.
AVANIR Pharmaceuticals is a drug discovery and development company focused on the development of treatments for chronic diseases. The Company's lead product candidate, Neurodex(TM), recently completed a second pivotal Phase III trial for the treatment of pseudobulbar affect. Neurodex(TM) is also in Phase III clinical development for the treatment of neuropathic pain. A potential treatment for allergy and asthma, AVP 13358, is in Phase I clinical development. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
Except for the historical information presented in this press release, matters discussed herein contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "anticipate," "believe," "plan" or "expect" or similar statements are forward-looking statements. There can be no assurance that regulatory approval efforts will succeed, that docosanol 10% cream will receive required regulatory clearance, or that even if such regulatory clearance is received, that such products would ultimately achieve commercial success. Risks and uncertainties for AVANIR Pharmaceuticals also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and from time-to-time in other publicly available information regarding the Company. Copies of such information are available from AVANIR upon request. The company disclaims any intent or obligations to update these forward-looking statements.
CONTACT: AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 firstname.lastname@example.org SOURCE: AVANIR Pharmaceuticals