DRAXIS Commences Production in New Lyophilization Facility.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--Dec. 11, 2001 DRAXIS Health 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 :DRAX)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.) 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. Approves Manufacturing Transfer of First Lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. (Freeze-Dried) Product DRAXIS Health Inc.'s (NASDAQ:DRAX)(TSE:DAX.), radiopharmaceutical subsidiary, DRAXIMAGE Inc., has received U.S. Food and Drug Administration (FDA) approval to transfer production of DTPA DTPA diethylenetriamine pentaacetic acid; see pentetic acid. DTPA diethylenetriamine penta-acetic acid. (Diethylene Triamine Pentaacetic Acid; Tc99m Pentetate Injection) to the Company's own lyophilization lyophilization /ly·oph·i·li·za·tion/ (li-of?i-li-za´shun) the creation of a stable preparation of a biological substance by rapid freezing and dehydration of the frozen product under high vacuum. production facility. DTPA, a diagnostic agent widely used in hospitals for kidney, brain and lung scans, is one of four DRAXIMAGE lyophilized medical imaging products. DRAXIMAGE is the sole North American supplier of DTPA kits and the only company marketing a kit indicated for lung ventilation studies, the primary clinical application for DTPA. The manufacturing site change is effective immediately and shipments of DRAXIS produced DTPA are scheduled to begin within weeks to Nuclear Medicine departments in the United States and Canada. This approval eliminates the need for DRAXIMAGE to outsource DTPA. Applications have also been filed with the FDA to transfer production of the three other DRAXIMAGE medical imaging kits to the DRAXIS lyophilization facility. "This first site-transfer approval signals the start of revenue-generating production in our lyophilization operation," said Dr. Martin Barkin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DRAXIS Health. "It also means that we can satisfy pent-up demand for DTPA, particularly in the important U.S. market. DRAXIS will benefit in the long term from substantially improved gross margins on its lyophilized products as a result of in-house manufacturing and productivity improvements once site transfers for all the DRAXIMAGE imaging products are in place." DTPA, which is labelled at the site of use with radioactive Technetium (Tc 99m), is used to perform kidney and brain imaging, to assess renal perfusion and to estimate glomerular filtration rate glomerular filtration rate n. Abbr. GFR The volume of water filtered out of the plasma through glomerular capillary walls into Bowman's capsules per unit of time. . DTPA can also be administered by inhalation, following nubulization to a radio-aerosol, to perform lung ventilation studies as an aid in assessing pulmonary embolic or obstructive airway disease. Nuclear Medicine imaging nuclear medicine imaging, n the diagnostic imaging field that evaluates organ function by injecting isotopes into a structure and documenting the amount of radiation emanating from the tissues. is a safe, non-invasive and cost-effective medical specialty that provides valuable information to physicians about the structure and the biological functioning of target organs, unlike other techniques such as X-ray, MRI and CAT scans. In the U.S., it is estimated that over 14 million Nuclear Medicine procedures are conducted yearly and that one in three hospital stays involve at least one such procedure. About DRAXIMAGE Inc. DRAXIMAGE discovers, develops, manufactures and markets diagnostic imaging products and therapeutic radiopharmaceuticals internationally. Products currently marketed by DRAXIMAGE include a line of lyophilized technetium-99m kits used in nuclear imaging procedures, a line of imaging and therapeutic products labeled with a variety of isotopes including radioiodine radioiodine /ra·dio·io·dine/ (-i´o-din) any radioactive isotope of iodine, particularly 123I, 125I, and 131I; used in diagnosis and treatment of thyroid disease and in scintiscanning. , and BrachySeed(TM), a next-generation brachytherapy implant for prostate cancer. DRAXIMAGE has several products in late-stage development, including: Fibrimage(R) for imaging deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. currently in Phase III, Amiscan(TM) for the early diagnosis of acute myocardial infarct currently in Phase II, and INFECTON for imaging infection. About DRAXIS Health Inc. DRAXIS Health Inc. is a diversified specialty pharmaceutical company with operations in three niche markets: radiopharmaceuticals (DRAXIMAGE Inc.), contract pharmaceutical manufacturing (DRAXIS Pharma Inc.) and pharmaceutical sales and marketing (DRAXIS Pharmaceutica). 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 U.S. Securities and Exchange Commission and Canadian securities authorities. |
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