3M Sees Delay In Approval Of Aldara For Skin Cancer
ST. PAUL, Minn.--(BUSINESS WIRE)--April 14, 2004--3M has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) in response to its supplemental new drug application on Aldara (imiquimod) Cream, 5% for the treatment of superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin cancer.
The FDA noted no major deficiencies in the application and requested 3M provide additional safety data as a condition of approval. 3M plans to submit such additional data from completed clinical studies shortly. Given that FDA review of the additional data will take up to six months, 3M now expects potential approval in the second half of 2004.
Last month, the FDA approved Aldara cream as a treatment option for certain patients with actinic keratosis (AK), a pre-cancerous skin disease caused by cumulative sun exposure. The response from dermatologists since 3M launched Aldara cream as an AK treatment option has been favorable.
Aldara cream is the first and only patient-applied immune response modifier and is available by prescription only. Full prescribing information is available at www.3M.com/Aldara.
This press release contains forward-looking statements about the potential of imiquimod for the treatment of superficial basal cell carcinoma that reflect the current beliefs of 3M. However, as with any pharmaceutical under development, there are substantial risks and uncertainties in the process of development and regulatory review. There are no guarantees that the product will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see 3M's filings with the United States Securities and Exchange Commission. 3M undertakes no duty to update forward-looking statements.
3M Pharmaceuticals - Part of the 3M Health Care Family
3M Health Care, the largest of seven major 3M businesses, is dedicated to improving the practice, delivery and outcome of care in medical, dental, pharmaceutical, health information and personal care markets. 3M Pharmaceuticals, part of the 3M Health Care family, develops, manufactures and sells branded prescription drug products for dermatology, women's health, sexual health, cardiology and respiratory medicine. Additional information is available at www.3M.com/pharma.
About 3M - A Global, Diversified Technology Company
Every day, 3M people find new ways to make amazing things happen. Wherever they are, whatever they do, the company's customers know they can rely on 3M to help make their lives better. 3M's brands include icons such as Scotch, Post-it, Scotchgard, Thinsulate, Scotch-Brite, Filtrete, Command and Dyneon. Serving customers in more than 200 countries around the world, the company's 67,000 people use their expertise, technologies and global strength to lead in major markets including consumer and office; display and graphics; electronics and telecommunications; safety, security and protection services; health care; industrial and transportation. For more information, including the latest product and technology news, visit www.3M.com.
Aldara, Scotch, Post-it, Scotchgard, Thinsulate, Scotch-Brite, Filtrete, Command and Dyneon are trademarks of 3M.
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Media Contact: John Cornwell, 651-733-7698