DRAXIS Files New Drug Submission for Levulan(R) Photodynamic Therapy to Treat Actinic Keratoses.Business Editors/Health Writers MISSISSAUGA, Ontario--(BUSINESS WIRE)--March 28, 2000 DRAXIS Health Inc. (Nasdaq:DRAX)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.) today announced that it has filed a New Drug Submission with the Therapeutic Products Programme of the Canadian Health Protection Branch in respect of Levulan(R) 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 the treatment of 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 (precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. skin lesions Skin Lesions Definition A skin lesion is a superficial growth or patch of the skin that does not resemble the area surrounding it. Description Skin lesions can be grouped into two categories: primary and secondary. ) of the face and scalp. DRAXIS Health holds the exclusive Canadian rights to Levulan(R) PDT and Photodetection (PD) through 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. (Nasdaq:DUSA) under patents licensed from PARTEQ Research and Development Innovations, Kingston, Ontario. Dr. Martin Barkin, DRAXIS Health's President and Chief Executive Officer, stated, "Levulan(R) PDT/PD is one of the leading agents in the exciting, emerging area of photodynamic therapy and photodetection. It holds considerable promise in a number of therapeutic and detection applications and has the potential to become the first standardized, physicent of Actinic Keratoses. We look forward to expanding our pharmaceutical portfolio to include this novel treatment." DUSA is developing Levulan(R) PDT/PD, under an exclusive worldwide license of patents and technology (excluding Canada) from PARTEQ. In December 1999 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. approved the Levulan(R) Kerastick(TM) 20% topical solution with PDT for the treatment of Actinic Keratoses of the face and scalp. In November 1999, DUSA entered into a marketing, development and supply agreement with Schering AG of Germany whereby Schering was granted the marketing and distribution rights to the Levulan(R) Kerastick(TM) with PDT for Actinic Keratoses and for other dermatology indications which DUSA and Schering AG may co-develop. The agreement with Schering covers all jurisdictions, other than Canada. Actinic Keratoses is a common skin condition caused by excessive sun exposure, especially in fair-skinned individuals. When left untreated, Actinic Keratoses can progress to become skin cancer, which carries the risk of spreading to other parts of the body. In the United States, it is estimated that approximately three million visits to dermatologists annually are related to Actinic Keratoses. The use of PDT/PD to achieve a therapeutic or diagnostic effect involves the application of a drug, which collects preferentially in target tissue, followed by the application of controlled light to the photosensitized cells. The appropriate combination of drug and light can affect target tissue with relatively minimal damage to surrounding tissue. DUSA is developing Levulan(R) PDT/PD for several other potential dermatology and internal conditions. Under the terms of its agreement with DUSA, DRAXIS Health will be provided with DUSA's clinical trial results to support the approval of additional indications for Levulan(R) PDT/PD in Canada. 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 or PD. The Company is incorporated in New Jersey, with offices in Wilmington, MA, Valhalla, NY, and Toronto, Ontario. DRAXIS Pharmaceutica is the pharmaceutical division of DRAXIS Health Inc. and is responsible for overseeing clinical trials, regulatory approval, marketing, and sales of pharmaceutical products in Canada. Its current focus is in the areas of neurology and dermatology. Neurology products currently available through Pharmaceutica include Mysoline(R) and Diastat(R) for epilepsy, Permax(R), Novo-Selegiline(R) and Eldepryl(R) for Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. , Alertec(R) for narcolepsy narcolepsy, a sleep disorder characterized by excessive daytime sleepiness and recurring unwanted episodes of sleep ("sleep attacks"). People with narcolepsy may abruptly fall asleep at almost any time, including while talking, eating, or even walking. , and Zanaflex(R) for the treatment of spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2). spas·tic·i·ty n. 1. A spastic state or condition. 2. Spastic paralysis. associated with conditions such as multiple sclerosis, stroke, spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. , cerebral palsy and traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain . Pharmaceutica's line of dermatology products includes SpectroJel(R), Canada's leading non-soap cleanser. DRAXIS Health Inc. is a diversified speciality pharmaceutical company operating in three niche markets: Radiopharmaceuticals (DRAXIMAGE), Canadian sales and marketing (DRAXIS Pharmaceutica) and Companion Animal Health (through its global alliance with Pfizer Inc.). Draxis supports its own as well as third party manufacturing requirements through its subsidiary, DRAXIS Pharma, located in Kirkland, Quebec. Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties, which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, clinical trial results, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development, regulatory approval and market acceptance of the Company's products, and other risks detailed from time-to-time in the Company's filings with the US Securities and Exchange Commission and Canadian securities authorities |
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