For release at 6:30 a.m.
Company Contacts:
Robert F. Doman, President & CEO – 978.909.2216
Investor Relations Contact:
Chad Rubin, The Trout Group LLC – 646.378.2947
Media Contact:
Dayna Hochstein, Spectrum – 202.955.6222
DUSA Pharmaceuticals Reports
Notice of Allowance for Key PDT Device Patent
New patent will cover Levulan® PDT therapy until 2019
WILMINGTON, Mass. – May 7, 2010 — DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT), today announced that the United States Patent and Trademark Office has issued a notice of allowance for a key patent related to its proprietary PDT light source, the BLU U®, Blue Light Photodynamic Therapy Illuminator. The new patent will have method of treatment claims which cover the use of DUSA’s blue light technology and aminolevulinic acid HCL (Levulan®) for the treatment of actinic keratosis as well as the diagnosis and treatment of other disease states such as acne, cancer, psoriasis and photodamaged skin. The patent also has claims that will cover DUSA’s blue light technology in conjunction with its proprietary Levulan® Kerastick® formulation of aminolevulinic acid HCL. The patent, once issued, which is scheduled to occur on May 25, 2010, will cover our approved Levulan® PDT therapy until June, 2019.
Robert Doman, DUSA’s President and CEO, said, “This patent further strengthens the protection of our Levulan® PDT therapy because the claims cover the use of the BLU-U®, aminolevulinic acid, and our proprietary Levulan Kerastick formulation together to treat actinic keratoses.” Mr. Doman continued, “The successful execution of this intellectual property protection strategy significantly enhances DUSA’s patent portfolio for our Levulan® PDT technology. This provides DUSA with the opportunity to continue on its path of revenue growth and additional time to explore new indications and life cycle management strategies.”
About Levulan® PDT and the BLU-U®
Levulan® Kerastick® for Topical Solution plus blue light illumination using the BLU-U®
blue light photodynamic therapy illuminator is indicated for the
treatment of minimally to moderately thick actinic keratoses (AKs) of
the face or scalp. AKs are the most frequently diagnosed skin disease
by U.S. dermatologists with over 5M treatment visits per year. DUSA is
also in clinical development of its Levulan® PDT
technology platform for the broad-area treatment of AKs and the
prevention of new non-melanoma skin cancer in chronically
immunosuppressed solid organ transplant recipients.
Other Uses of the BLU-U®
DUSA’s patented BLU-U® Blue Light Photodynamic
Therapy Illuminator also offers effective, non-invasive and pain-free
light treatment for moderate inflammatory acne. Narrow band blue light
causes a photodynamic effect within the pilosebaceous gland that kills
P. acnes, the bacteria primarily responsible for acne. BLU-U®
treatments can be a primary treatment, an alternative to
pharmaceuticals and topicals, or an addition to skin care programs. In
September 2003, DUSA received clearance from the U.S. Food and Drug
Administration (FDA) to market the BLU-U® without Levulan® PDT for the treatment of moderate inflammatory acne vulgaris and general dermatologic conditions.
About Actinic Keratoses
Actinic keratoses are rough-textured, dry, scaly patches on
the skin caused by excessive exposure to ultraviolet light, such as
sunlight. They occur most frequently on sun exposed areas such as the
face, scalp, ears, neck, hands and arms. They form on the outermost
layer of skin and they can range in color from skin toned to reddish
brown. They can also range in size from as small as a pinhead to
larger than a quarter.
About Acne
According to the American Academy of Dermatology, acne is the
most common skin disorder in the U.S., affecting 40 to 50 million
Americans. There are many types of acne, the most common of which is
called acne vulgaris. Just beneath the surface of the skin lie
hundreds of tiny glands called sebaceous glands. Their function is to
collect and excrete the oily substance called sebum, to keep the skin
healthy. However, the tiny pathway for the sebum to escape often
becomes clogged and a bacterium called P. acnes grows
inside. In a short time, the area swells up and forms a lesion on the
skin. At certain times of life, this process becomes very active,
troublesome and hard to control.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology
pharmaceutical company focused primarily on the development and
marketing of its Levulan® photodynamic therapy (PDT) technology platform, and other dermatology products. Levulan®
PDT is currently approved for the treatment of minimally to
moderately thick actinic keratoses (AKs) of the face or scalp. DUSA is
researching the use of Levulan® PDT to prevent AKs and
squamous cell carcinomas in immunosuppressed solid organ transplant
recipients and is supporting research related to oral leukoplakia in
collaboration with the National Institutes of Health (NIH). DUSA also
markets other dermatology products, including ClindaReach®. DUSA is based in Wilmington, Mass. Please visit our website at www.dusapharma.com.
Forward Looking Statements
Except for historical information, this news release contains
certain forward-looking statements that represent our current
expectations and beliefs concerning future events, and involve certain
known and unknown risk and uncertainties. These forward-looking
statements relate to the issuance of a patent and the methods of use
and diseases covered by the claims in the patent, the enhancement of
the Company’s patent portfolio, continued revenue growth, the expected
issue date and expiration date of the patent. These forward-looking
statements are further qualified by important factors that could cause
actual results to differ materially from future results, performance or
achievements expressed or implied by those in the forward-looking
statements made in this release. These factors include, without
limitation, actions by regulatory authorities, the status of our patent
portfolio, action of third parties, the impact of competitive
products, and other risks and uncertainties identified in DUSA's Form
10-K for the year ended December 31, 2009.
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