Miravant to Initiate PHOTREX Confirmatory Phase III Clinical Trial in

    Business Editors/Health/Medical Writers

    SANTA BARBARA, Calif.--(BUSINESS WIRE)--March 10, 2005--Miravant Medical Technologies (OTCBB:MRVT), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy (PDT), today announced that it will conduct a confirmatory Phase III clinical trial for PHOTREX(TM) (rostaporfin, formerly known as SnET2) at investigational sites in Central and Eastern Europe (CEE) and the United Kingdom. Miravant has selected Kendle (Nasdaq:KNDL), a leading international contract research organization with locations worldwide, to provide clinical development services for the Phase III trial. The randomized, placebo-controlled study, reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment, will evaluate a range of patients with wet age-related macular degeneration (AMD), including both classic and occult lesions.
    "Miravant selected Kendle based on its significant Phase III experience and expertise in Europe, particularly its patient access capabilities in CEE," said Gary S. Kledzik, Ph.D., chairman and chief executive officer. "These countries are proving to be desirable locations for conducting pharmaceutical clinical trials, with motivated, cost-effective research centers and high patient productivity. We are confident that Kendle's integrated study teams can efficiently manage the trial and satisfy our strategic regulatory requirements."
    Alan Boyce, Vice President, Europe for Kendle added, "We are extremely pleased to be working in partnership with Miravant to conduct this late-stage clinical trial for a major disease indication and significant medical need. PHOTREX is a promising drug with an already substantial body of clinical evidence. Kendle is committed to deliver timely patient recruitment and high quality clinical data to Miravant, providing expert regulatory and clinical guidance."
    The FDA requested this single confirmatory study in its Approvable Letter for PHOTREX issued September 2004. The trial will be conducted at approximately 50 investigational sites in CEE and the UK. The Company currently plans to conduct a primary efficacy endpoint analysis at 12 months (one year after initial treatment), and expects a total of approximately 600 patients to be analyzed.
    Additional information about the relationship with Kendle will be contained in Miravant's Form 8-K to be filed with the Securities and Exchange Commission upon completion of the final contract between the parties.

    Wet AMD

    Wet AMD is a vision-threatening disorder characterized by the growth of abnormal, leaking blood vessels at the back of the eye that can lead to fluid build-up, scarring and severe loss of central vision. PHOTREX uses a light-activated drug designed to selectively destroy these abnormal blood vessels at the back of the eye and stabilize vision loss. It is estimated that 200,000 people in the U.S. will develop wet AMD each year, with similar numbers outside the U.S. In addition to the confirmatory Phase III study discussed above, the Company plans to initiate a future U.S. study of PHOTREX PDT in combination with other drug agent(s) for this challenging eye disease.

    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's lead drug, PHOTREX(TM) (rostaporfin, formerly known as SnET2) is a proposed treatment for wet age-related macular degeneration that has received an FDA Approvable Letter and a Special Protocol Assessment for a Phase III confirmatory trial. Miravant's cardiovascular program focuses on life-threatening coronary artery diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, atherosclerotic vulnerable plaque and restenosis.

    About Kendle

    Kendle International Inc. (Nasdaq: KNDL) is among the world's leading global clinical research organizations. Kendle delivers innovative and robust clinical development solutions -- from first-in-man studies through market launch and surveillance -- to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With headquarters in Cincinnati, Ohio, and more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory and validation services in more than 60 countries. Additional information and investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202 or from the Company's Web site at www.kendle.com.

    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 those by Dr. Kledzik, Mr. Boyce and other statements about the timing and commencement of the confirmatory Phase III clinical trial in Europe; the experience and expertise of Kendle to adequately manage the study, satisfy regulatory requirements, provide timely patient recruitment and high quality clinical data; high patient productivity and cost-effective research in CEE; plans to conduct a primary endpoint analysis at twelve months of approximately 600 patients; plans to conduct a future combination study; the estimated incidence of wet AMD; 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: our operating capital may not be sufficient to continue some or all of our development programs, complete the PHOTREX Phase III clinical trial, complete the NDA review process or continue as a going concern; we may not meet the covenants of the December 2002 Debt Agreement, the August 2003 Convertible Debt and Warrant Purchase Agreement, or the March 2005 convertible Note and Warrant Purchase Agreement, which would give the holders under these agreements the right to call outstanding debt immediately due and payable; we may not achieve certain milestones required to receive future investments under our Collaboration Agreement with Guidant Corporation; our appointment of Kendle is subject to completion of the final contract; the course of the clinical trial, its management by Kendle and the generation of definitive clinical data cannot be guaranteed by the Company; we 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 PHOTREX marketing approval, or may limit labeling claims, or may not grant marketing approval at all; even if approved, we may not have the necessary resources or corporate partnering relationship(s) to commercialize PHOTREX and its degree of acceptance cannot be guaranteed; estimates of disease incidence may be incorrect or may change over time; we may not initiate a future combination study for PHOTREX; we may decide not to or may be unable to further develop our PhotoPoint drugs in ophthalmology, dermatology, cardiovascular disease and/or oncology; we may not be able to demonstrate the safety or efficacy of our drugs in development or achieve their regulatory approvals; and/or partnering discussions may not progress or may not provide the funding and support the Company needs. 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, our quarterly report on Form 10-Q for the quarter ended September 30, 2004, 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. PHOTREX(TM) is a trademark of Miravant Medical Technologies.

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CONTACT: Miravant Medical Technologies Tom Herrick, 805-685-9880 (Investor Relations)

KEYWORD: CALIFORNIA OHIO UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: CONSUMER/HOUSEHOLD PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT MARKETING AGREEMENTS SOURCE: Miravant Medical Technologies

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