-----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, NhsKC0+Akm+q0Z3WpRjBgkuVBRQEuLDdw1COz92Qg0QMf5yc3AJk4iUEvsBR4KMd gxebmuJmrCbAwIwejuwOiw== 0000933745-04-000028.txt : 20040602 0000933745-04-000028.hdr.sgml : 20040602 20040602120512 ACCESSION NUMBER: 0000933745-04-000028 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040601 ITEM INFORMATION: Other events FILED AS OF DATE: 20040602 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MIRAVANT MEDICAL TECHNOLOGIES CENTRAL INDEX KEY: 0000933745 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 770222872 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-25544 FILM NUMBER: 04843392 BUSINESS ADDRESS: STREET 1: 336 BOLLAY DRIVE CITY: SANTA BARBARA STATE: CA ZIP: 93117 BUSINESS PHONE: 8056859880 MAIL ADDRESS: STREET 1: 336 BOLLAY DRIVE CITY: SANTA BARBARA STATE: CA ZIP: 93117 FORMER COMPANY: FORMER CONFORMED NAME: PDT INC /DE/ DATE OF NAME CHANGE: 19941214 8-K 1 form8kjune2004.txt FORM 8-K JUNE 1, 2004 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549-1004 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (date of earliest event reported): June 1, 2004 MIRAVANT MEDICAL TECHNOLOGIES (Exact name of Registrant as specified in its charter) Delaware 0-2554 77-0222872 (State or other jurisdiction of (Commission File Number) I.R.S. Employer incorporation or organization) Identification Number) 336 Bollay Drive Santa Barbara, CA 93117 (Address of principal executive offices) (805) 685-9880 (Registrant's telephone number, including area code) ITEM 5. Other Events On June 1, 2004, the Company announced that the U.S. Food and Drug Administration, or FDA, has accepted for filing the Company's New Drug Application, or NDA, for SnET2 and has also granted a Priority Review designation. Acceptance of the filing means that the FDA has made a determination that the NDA meets the standard for substantive review, and the Priority Review designation expedites the review period. The Company is seeking approval from the FDA for its proprietary new drug SnET2 as a treatment for patients with wet age-related macular degeneration, or AMD, a leading cause of blindness in older adults. Wet AMD is a major health problem with an estimated 500,000 new cases each year worldwide. The disease is characterized by abnormal blood vessels at the back of the eye that leak fluid and blood and can lead to severe loss of central vision. The SnET2 treatment uses a light-activated drug intended to selectively destroy these abnormal blood vessels and stabilize vision loss. A copy of the press release issued on June 1, 2004 by Miravant announcing the FDA acceptance of our filing for review is attached hereto as Exhibit 99.1 and is incorporated by reference in its entirety. ITEM 7. FINANCIAL STATEMENTS ANDEXHIBITS Exhibit Number Exhibit 99.1 Press release dated June 1, 2004 announcing the acceptance for filing by the Food and Drug Administration of the Company's completed New Drug Application for SnET2 in the treatment of patients with wet age-related macular degeneration. SIGNATURE Pursuant to the requirements of the Securities Exchange Act or 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Miravant Medical Technologies (Registrant) Date: June 2, 2004 By: /s/ John M. Philpott ------------------------- Name: John M. Philpott Title: Chief Financial Officer Exhibit Index Exhibit Number Exhibit 99.1 Press release dated June 1, 2004 announcing the acceptance for filing by the Food and Drug Administration of the Company's completed New Drug Application for SnET2 in the treatment of patients with wet age-related macular degeneration. EX-99 2 exhibit99_1.txt EXHIBIT 99.1 Exhibit 99.1 For more information please visit our web site at: www.miravant.com FOR IMMEDIATE RELEASE Contact: Tom Herrick Investor Relations (805) 685-9880 MIRAVANT'S SnET2 NEW DRUG APPLICATION ACCEPTED FOR FILING BY FDA WITH PRIORITY REVIEW DESIGNATION Santa Barbara, CA, June 1, 2004 - Miravant Medical Technologies (OTCBB: MRVT), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy (PDT), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for SnET2 and has also granted a Priority Review designation. Acceptance of the filing means that the FDA has made a determination that the NDA meets the standard for substantive review, and the Priority Review designation expedites the review period. Miravant is seeking approval from the FDA for its proprietary new drug SnET2 as a treatment for patients with wet age-related macular degeneration (AMD), a leading cause of blindness in older adults. Wet AMD is a major health problem with an estimated 500,000 new cases each year worldwide. The disease is characterized by abnormal blood vessels at the back of the eye that leak fluid and blood and can lead to severe loss of central vision. The SnET2 treatment uses a light-activated drug intended to selectively destroy these abnormal blood vessels and stabilize vision loss. About Miravant Miravant Medical Technologies specializes in pharmaceuticals and devices for photoselective medicine, developing its proprietary PhotoPoint photodynamic therapy (PDT) for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology. PhotoPoint PDT uses photoreactive (light-activated) drugs to selectively target diseased cells and blood vessels. The Company has submitted a New Drug Application (NDA) for the drug SnET2 for the treatment of patients with wet age-related macular degeneration. Miravant's cardiovascular program focuses on life-threatening diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, atherosclerotic vulnerable plaque and restenosis. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, including but not limited to statements about the FDA expedited review of the SnET2 NDA; potential use and benefits of SnET2 to treat patients with wet AMD; the size of the potential market; and development programs for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology are forward-looking and relate to our future plans, objectives, expectations and intentions. Our actual results may differ materially from those described in these statements. For instance, the occurrence of one or more of the following may cause our results to differ from our plans: the Company's operating capital may not be sufficient to continue some or all of its development programs, complete the NDA review process or continue as a going concern; potential future funding may not be available when needed if at all or under terms acceptable to the Company; the Company may be unable to resolve all issues or contingencies associated with the NDA; the FDA may require further clinical or non-clinical studies before granting marketing approval, or may limit labeling claims, or may not grant marketing approval at all; even if approved, the Company may not have the necessary resources or corporate partnering relationship(s) to commercialize SnET2 and the degree of acceptance of SnET2 cannot be guaranteed; the size of the potential market can change due to a number of factors; the Company may decide not to or may be unable to further develop its PhotoPoint drugs in ophthalmology, dermatology, cardiovascular disease and/or oncology; and/or the Company may not be able to demonstrate the safety or efficacy of its drugs in development or achieve their regulatory approvals. For a discussion of additional important risk factors that may cause our results to differ from those described above, please refer to our annual report on Form 10-K for the year ended December 31, 2003, and other quarterly and periodic reports filed with the Securities and Exchange Commission. Our products require regulatory approval before marketing, sales or clinical use. PhotoPoint(R) is a registered trademark of Miravant Medical Technologies. -----END PRIVACY-ENHANCED MESSAGE-----