CORRECTION: DUSA Reports Filing Of BLU-U PMA Supplement.Health/Medical Writers NOTE TO EDITORS: There was an error in the press release sent out earlier by DUSA DUSA Deputy Under Secretary of the Army DUSA Deakin University Student Association DUSA Dundee University Students' Association (Scotland) DUSA Designated Unclassified Subject Area Pharmaceuticals, Inc. The complete and corrected version follows: WILMINGTON, Mass.--(BW HealthWire)--March 27, 2000 DUSA Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DUSA) reports that on March 20 it filed a PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy Supplement with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the commercial version of its BLU-U(TM) brand light source. This supplement follows FDA approval of the Company's Levulan(R) Kerastick(TM) 20% topical solution with Photodynamic Therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. (PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ) for Actinic actinic /ac·tin·ic/ (ak-tin´ik) producing chemical action; said of rays of light beyond the violet end of the spectrum. ac·tin·ic adj. Keratoses (AKs) of the face and scalp and the clinical trial version of the BLU-U(TM) in December, 1999. While we believe the modifications we are making to our device do not affect its performance and FDA review should take approximately two to three months, FDA regulations give the agency up to six months to review a supplement. The agency also will inspect our Wilmington, Massachusetts facility before giving its approval. The FDA also may choose to reinspect our third-party manufacturer. DUSA's dermatology marketing partner, Schering AG, and its wholly-owned US affiliate, Berlex Laboratories, will launch the Levulan(R) Kerastick and the BLU-U(TM) in the US shortly after FDA approval of the PMA supplement. Launch is currently planned for the second quarter of this year. Berlex displayed the Levulan(R) Kerastick(TM) and its representatives were present to describe Levulan(R) PDT at the recent American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). (AAD AAD American Academy of Dermatology. AAD American Association of Dermatology ) annual meeting March 9-15 in San Francisco. The Berlex Dermatology exhibitor's booth received very strong interest from dermatologists. Dr. Mark Ling, one of DUSA's Phase III investigators, also reviewed the therapy at an AAD forum dedicated to PDT in dermatology, stating that, in his opinion, Levulan(R) PDT could become an important part of the management of AKs by dermatologists. DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in the development of Levulan(R) Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical indications. PDT and PD utilize light-activated compounds such as Levulan(R) to induce a therapeutic or detection effect. DUSA is a world leader in topically or locally applied PDT and PD. The Company is incorporated in New Jersey, with offices in Wilmington, MA, Valhalla, NY, and Toronto, Ontario. Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to FDA's approval of the commercial BLU-U(TM) system; expectations regarding the launch of the products by Berlex and expectations regarding the use of the products by dermatologists Such risks and uncertainties include, but are not limited to the regulatory approval process, dependence upon third-party manufacturers of the Kerastick(TM), the timing of the launch by Berlex of Levulan(R) PDT, ability to develop a market for the products, and other risks identified in DUSA's SEC filings from time to time, including its recently filed Form S-3 registration statement. |
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