3M today announced positive clinical results in pivotal Phase III studies of Aldara (imiquimod) Cream, 5%, an immune response modifier (IRM), for multiple actinic keratoses (AK) and superficial basal cell carcinoma (sBCC). These potentially serious skin conditions are a direct result of cumulative sun exposure.
In the AK trials, the median percent reduction in the number of AK lesions counted at baseline was 83 percent in the Aldara treatment group versus 0 percent in the placebo group. The complete clearance rate in Aldara treated patients was 45 percent versus only 3 percent in patients treated with placebo. The sBCC studies showed a histological clearance rate of 82 percent. In all trials, less than 2 percent of patients treated with Aldara discontinued treatment due to local skin or application site reactions.
"Completion of these clinical trials marks a significant milestone in the development of our IRM portfolio," said Barry Labinger, division vice president, 3M Pharmaceuticals Division. "AK and BCC affect over 10 million people in the United States, and millions more in other parts of the world. We believe new advances in treatment will be well received." With these Phase III results, Labinger stated, 3M Pharmaceuticals is on schedule for mid-year FDA submissions of the supplemental new drug applications.
3M Pharmaceuticals launched Aldara in 1997 for the treatment of external genital and perianal warts. Aldara is 3M's first IRM and works by stimulating the immune system to recognize and respond to virus infections and tumors in the skin. 3M continues to build a pipeline of new IRM molecules for a broad range of indications.
Additional clinical trial data on Aldara will be presented at the 61st Annual American Academy of Dermatology Meeting in San Francisco, March 20-26, 2003.
Clinical Studies
Actinic Keratosis
In two double-blind, randomized, vehicle-controlled clinical trials, 436 patients with multiple AKs were treated with Aldara or vehicle cream two times per week for 16 weeks. At the 8-week post treatment visit, the median percent reduction in the number of AK lesions counted at baseline was 83 percent for the Aldara group and 0 percent for the placebo group. This means that half of the patients in the Aldara group had at least 83 percent reduction in the number of AK lesions counted at baseline. Complete clearance of AKs was seen in 45 percent of patients treated with Aldara, compared to 3 percent in the placebo group.
Superficial Basal Cell Carcinoma
In two double-blind, randomized, placebo-controlled clinical trials, 724 patients with sBCC were treated with Aldara cream or vehicle cream once daily, five times per week or seven times per week for six weeks. The clinical studies showed the optimal dosing to be five times per week with a histological clearance rate of 82 percent compared to 3 percent with placebo.
Overall, in these controlled clinical studies, the most frequently reported adverse reactions were those of local skin or application site reactions including erythema, edema, induration, erosion, flaking/scaling, scabbing/crusting, itching and burning at the application site.
About Aldara Cream, 5%
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.
Forward-Looking Statements
This press release contains forward-looking statements about the potential of imiquimod for the treatment of superficial basal cell carcinoma and actinic keratosis 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.
About 3M
3M is a $16 billion diversified technology company with leading positions in health care; consumer and office; display and graphics; electronics and telecommunications; industrial; safety, security and protection; transportation and other businesses. Headquartered in St. Paul, Minn., the company has operations in more than 60 countries and serves customers in nearly 200 countries. 3M is one of the 30 stocks in the Dow Jones Industrial Average and also is a component of the Standard & Poor's 500 index. Get more information at www.3M.com.
3M Health Care is one of seven major 3M businesses, serving medical, dental, pharmaceutical and personal care markets. 3M Pharmaceuticals, a division of 3M Health Care, develops, manufactures and sells branded prescription drug products related to dermatology, women's health, sexual health, cardiology and respiratory medicine. Additional information is available at www.3M.com/pharma.
Aldara is a trademark of 3M.
3M, St. PaulInvestor Contact:Matt Ginter, 651/733-8206orDan Colvin, 651/736-2637orMedia Contact:John Cornwell, 651/733-7698
