-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Q7HL3RPaTg0niWOAZDqbFcGh7bIVdwchG/LiXLZxZAkuENU7gPyiVVVZoS7M3NUa d2cNi3Mg5IU0WLR297N2Lw== 0000897101-04-000433.txt : 20040303 0000897101-04-000433.hdr.sgml : 20040303 20040303172254 ACCESSION NUMBER: 0000897101-04-000433 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040303 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040303 FILER: COMPANY DATA: COMPANY CONFORMED NAME: 3M CO CENTRAL INDEX KEY: 0000066740 STANDARD INDUSTRIAL CLASSIFICATION: CONVERTED PAPER & PAPERBOARD PRODS (NO CONTAINERS/BOXES) [2670] IRS NUMBER: 410417775 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-03285 FILM NUMBER: 04646851 BUSINESS ADDRESS: STREET 1: 3M CENTER STREET 2: BLDG. 220-11W-02 CITY: ST PAUL STATE: MN ZIP: 55144-1000 BUSINESS PHONE: 6517332204 MAIL ADDRESS: STREET 1: 3M CENTER STREET 2: BLDG. 220-11W-02 CITY: ST. PAUL STATE: MN ZIP: 55144-1000 FORMER COMPANY: FORMER CONFORMED NAME: MINNESOTA MINING & MANUFACTURING CO DATE OF NAME CHANGE: 19920703 8-K 1 mmm041185_8k.htm 3M COMPANY 3M Form 8-K dated 01-20-2004

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report: March 3, 2004
(Date of earliest event reported)

3M COMPANY
(Exact name of registrant as specified in its charter)

File No. 1-3285
(Commission File Number)

Delaware 41-0417775
(State of incorporation) (I.R.S. Employer
Identification Number)

3M Center

55144-1000
St. Paul, Minnesota (Zip Code)

(Address of principal executive offices)

Registrant’s telephone, including area code:
(651) 733-1110







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ITEM 5.   OTHER EVENTS.

Attached is a press release dated as of March 3, 2004 in connection with 3M Pharmaceuticals obtaining FDA approval for first immune response modifier to treat actinic keratosis.

This press release contains forward-looking statements that reflect the current beliefs of 3M. 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 other indications for imiquimod will receive regulatory approval 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.

ITEM 7.   FINANCIAL STATEMENTS AND EXHIBITS.

(c) Exhibits Required by Item 601 of Regulation S-K

EXHIBIT NO.   DESCRIPTION  

99.1

 

Press Release
 






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SIGNATURE

        Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

3M COMPANY
  
By: /s/   Gregg M. Larson                
            Gregg M. Larson,
       Secretary
   
 Dated:   March 3, 2004






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Exhibit 99.1

3M Pharmaceuticals Obtains FDA Approval for First
Immune Response Modifier to Treat Actinic Keratosis

Patient-applied Aldara Cream clears precancerous skin lesions

ST. PAUL, Minn., March 3, 2004 — According to the American Academy of Dermatology, actinic keratosis (AK) affects as many as 10 million Americans each year. Caused by chronic sun exposure, actinic keratoses are precancerous skin lesions, many of which can occur on the face and scalp.

3M announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for Aldara™ (imiquimod) Cream, 5%, a topical prescription treatment for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Aldara Cream is the first immune response modifier (IRM) approved for AK.

“Aldara’s approval for actinic keratosis represents an important addition to current treatment approaches,” stated Barry Labinger, division vice president, 3M Pharmaceuticals. Labinger also confirmed that the FDA is currently reviewing the sNDA (supplemental new drug application) for Aldara Cream in the treatment of superficial basal cell carcinoma, a common form of nonmelanoma skin cancer.

Clinical trials demonstrated that most patients treated with Aldara Cream achieved clearance of 75 percent or more of their AK lesions, and nearly half experienced complete clearance.

The FDA’s approval for AK reinforces 3M’s confidence in the potential of the company’s IRM compounds, according to Labinger. “We look forward to expanding the IRM portfolio to treat a variety of diseases,” he said.

Clinical Studies

The FDA’s approval of Aldara Cream for AK is based on positive results from two double-blind, randomized, placebo-controlled clinical trials involving 436 patients with multiple AK lesions. Patients were treated with Aldara Cream or placebo twice a week for 16 weeks. Nearly half of the patients treated with Aldara Cream achieved complete clearance of all lesions compared to only 3 percent in the placebo group. A majority of patients experienced lesion clearance of 75 percent or more.







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The clinical studies also revealed another important feature of Aldara Cream. Among patients treated with Aldara Cream, a number of previously undetectable lesions appeared and cleared during treatment.

“Recent studies suggest that chronic sun exposure may cause immunosuppression in the skin,” stated lead investigator Mark G. Lebwohl, MD, FACP, professor and chairman, Department of Dermatology, Mount Sinai Medical Center, New York, NY “Aldara, an immune response modifier, is an exciting treatment advance for patients with AK.”

The most frequently reported adverse reactions were local skin reactions, including erythema, flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, weeping/exudates, and itching/ burning at the application site. Only 2 percent of patients reported pain at the lesion site. While 16% of patients had a rest period during treatment, only 2 percent discontinued treatment due to local skin or application-site reactions.

About Actinic Keratosis

Actinic keratosis appears as rough, red, scaly patches, or crusts on the skin. AK lesions usually measure less than one quarter inch in diameter and more than 80 percent of lesions occur on the upper limbs, head and neck. Individuals with fair skin, light hair and light-colored eyes are at greatest risk for AK. Because AK is caused by cumulative sun exposure, it can take years to develop. The condition usually appears first in older people, although cases have been reported in people in their 40s.

Common AK treatments include cryotherapy (freezing), excisional surgery, electrodesiccation (burning) and curettage, lasers, topical chemotherapy and photodynamic therapy.

About 3M Pharmaceuticals

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. 3M Health Care, the largest of 3M’s seven business segments, is dedicated to improving the practice, delivery and outcome of care in medical, dental, pharmaceutical, health information systems and personal care markets.

Media Contacts:

John Cornwell   651-733-7698
Theresa Kim  212-856-8550






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