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CURRENT NEWS

12/16/2009
URL PHARMA ANNOUNCES FDA APPROVAL OF DONEPEZIL HYDROCHLORIDE (ARICEPT®) ORALLY DISINTEGRATING TABLETS FOR TREATMENT OF ALZHEIMER’S-RELATED DEMENTIA

PHILADELPHIA, December 16, 2009 – URL Pharma, Inc. today announced that its subsidiary, Mutual Pharmaceutical Company, Inc., received approval from the U.S. Food and Drug Administration (FDA) for donepezil hydrochloride orally disintegrating tablets (ODT) 5mg and 10mg. This product is bioequivalent and AB-Rated to Aricept® ODT, which is indicated to treat dementia related to Alzheimer’s disease.

 

Currently, URL Pharma plans to market donepezil after November 25, 2010, upon expiration of a key Aricept patent (#4,895,841).

 

Aricept, marketed by Eisai and Pfizer, had worldwide sales of $3.4 billion in 2008.

 

About URL Pharma

URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a profitable, technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. The Company’s profits are derived predominantly from its exclusive products and technologies. For more information, visit www.urlpharma.com.

 

For further information, please call 215-697-1900 or media@urlpharma.com.