MOA | History and Development | IRMs and the Future 3M Pharmaceuticals has a rich product development pipeline based on the Immune Response Modifier (IRM) technology platform. The IRMs are a class of unique, proprietary synthetic molecules developed by 3M Pharmaceuticals that have a broad range of potential therapeutic applications, including promising treatments for a variety of viruses and tumors. Mechanism of Action The IRMs are a new class of drug. They act by stimulating the body to produce cytokines, naturally occurring proteins used by cells of the immune system to communicate with each other. The cytokines induced by IRMs enhance cell-mediated immunity, a natural process by which the body controls or eliminates virus infected cells and tumor cells. Because the IRMs assist the immune system – rather than target specific viruses or tumors – they have potential uses in a wide variety of diseases. The IRMs can be formulated into many dose forms, each appropriate for a specific disease. History and Development Scientists at 3M Pharmaceuticals research laboratories in St. Paul, Minnesota synthesized imiquimod, the first commercially available IRM, in the 1980s. Early research with imiquimod and related molecules produced encouraging results in a variety of animal virus and tumor models. These studies concluded that imiquimod induced a range of cytokines, especially interferon-alpha, a key cytokine associated with the human immune response. In nearly every animal model studied, imiquimod induced antiviral or antitumor activity. 3M Pharmaceuticals evaluated a variety of human diseases in which interferon has shown clinical benefit. One of these disease targets was genital warts, a common sexually transmitted viral infection caused by certain types of human papilloma virus (HPV). HPV infection presented an attractive target for immune response modification. By one estimate, at least 10% of sexually active adults are infected with HPV, with perhaps 1-2% having genital warts. Unlike some other sexually transmitted diseases, prevention of transmission is difficult and satisfaction with current therapies is low. Most treatments are aimed at destroying the wart tissue and do not treat the underlying viral infection, so the reappearance of warts at a previously treated site (recurrence) is common. Because such therapies are tissue destructive – including surgery, laser vaporization, scissor excision or freezing with liquid nitrogen – scarring and pain are frequent side effects. 3M Pharmaceuticals recognized an unmet clinical and patient need, and the imiquimod program moved forward with a New Drug Application (NDA) filing to the Food and Drug Administration (FDA) in July 1996. FDA approval was granted in February 1997 - a rapid review. 3M Pharmaceuticals launched Aldara™ (imiquimod) Cream, 5%, later in 1997 for external genital and perianal warts. By early 2000, Aldara was available in over 40 countries around the world. Immune Response Modifiers and the Future Treatment of genital warts is the first in a planned series of 3M indications for the Immune Response Modifiers, either in the form of Aldara , other imiquimod formulations or other IRM molecules. IRMs are now being studied around the world by 3M Pharmaceuticals for the treatment of actinic keratosis and superficial basal cell carcinoma. In 2000, the phase II clinical program for BCC was completed, showing promising results in the treatment of this common, non-melanoma skin cancer. Study results were published in the May 2001 issue of the Journal of the American Academy of Dermatology. Physicians have been quick to see the potential for an IRM approach to various diseases. The potential for the IRMs has been discussed in a variety of publications, most recently in the Journal of Cutaneous Medicine and Surgery, May 2001. In this article, physicians from Johns Hopkins featured Aldara in an article entitled, "New immune therapies for skin disease: Imiquimod and related compounds". Beyond these mid-term opportunities of actinic keratosis, superficial basal cell carcinoma, and genital herpes, 3M Pharmaceuticals is investing in a "medicine cabinet" of other Immune Response Modifier molecules to treat other diseases, including asthma. Five new INDs are expected to be submitted to the US Food and Drug Administration in 2002. 3M Pharmaceuticals continues to develop the IRM science targeting additional high profile diseases with clear unmet clinical and patient needs and significant commercial potential. To the extent that any statements made in this document contain information that is not historical, these statements are essentially forward-looking. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the timing and outcome of legal proceedings; the difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA") approvals; the difficulty in predicting the timing and outcome of FDA decisions on patent challenges; market and customer acceptance and demand for new pharmaceutical products; ability to market proprietary products; the impact of competitive products and pricing; timing and success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; and other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "estimates," "intends," "may," and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should the Company's assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements. Revised: September 2002 Back to Top | 3M Pharmaceuticals Home | 3M Health Care