DRAX 5.46 DRAXIS Files DRAXIMAGE(R) Sestamibi in Europe
Jul 25, 2007 8:00:00 AM
MONTREAL, July 25 /PRNewswire-FirstCall/ - DRAXIMAGE, the radiopharmaceutical division of DRAXIS Health Inc. (TSX: DAX) (NASDAQ: DRAX), has taken another significant step in its product development strategy with the filing of its DRAXIMAGE(R) Sestamibi with European regulatory authorities. DRAXIMAGE(R) Sestamibi is a generic kit for the preparation of Tc-99m Sestamibi for injection, which is an imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart and is the largest radiopharmaceutical product in the nuclear medicine market segment.
"Filing DRAXIMAGE(R) Sestamibi in Europe marks another milestone in our comprehensive plan to pursue major MPI markets globally," said Jean-Pierre Robert, President of DRAXIS Specialty Pharmaceuticals Inc., the operating subsidiary of DRAXIS Health. "DRAXIMAGE(R) Sestamibi is one of our highest priority growth drivers and the filing of marketing applications in Europe and in the U.S. means that we are one step closer to the realization of our strategy. In addition, we are actively pursuing marketing and distribution partnerships for Sestamibi in Europe and in North America."
The U.S. Food and Drug Administration (FDA) recently acknowledged receipt and acceptance for review of the Abbreviated New Drug Application (ANDA) for DRAXIMAGE(R) Sestamibi that was submitted to the FDA earlier this year.
According to AMR/Arlington Medical Resources, in 2005 there were more than 7 million cardiac studies conducted in the U.S. out of a total of over 15 million nuclear medicine procedures; making MPI the most widely performed nuclear medicine scan in the US. While such cardiac procedures are not nearly so widely performed in Europe, DRAXIMAGE believes that significant opportunities do exist in the European market. Recent market research estimates indicate that existing MPI products generate revenues in excess of $500 million annually in the U.S. and in excess of $50 million in Europe.
Once its product is approved, DRAXIMAGE plans to enter the MPI market after key patents for the currently marketed Tc-99m Sestamibi product expire, which is expected to be in 2008 for the United States and from 2007 onwards in various European countries. DRAXIMAGE also plans to file for marketing approvals in additional jurisdictions other than the US and Europe.
Cardiac Imaging with Tc-99m Sestamibi
The sestamibi kit is used in nuclear medicine imaging to show how well the heart muscle (myocardium) is supplied with blood (perfused) both at rest and during strenuous activity. The radioisotope Technetium-99m is attached to the sestamibi molecule forming Tc-99m Sestamibi. When injected into the bloodstream this radiopharmaceutical agent is distributed throughout the heart muscle in proportion to the blood flow received by various portions of the heart. Heart images are then obtained using a gamma camera that can detect the Technetium-99m. Two sets of images are typically taken, one while the patient is at rest and a second set while the patient is under stress, often by exercising on a treadmill or stationary bicycle. The resulting two sets of images are compared with each other to diagnose the presence of coronary heart disease by detecting areas of the heart that may not be receiving normal blood flow. This imaging technique is known as cardiac stress testing or myocardial perfusion imaging (MPI).
About DRAXIMAGE
DRAXIMAGE develops, manufactures and markets diagnostic and therapeutic radiopharmaceuticals for the global marketplace. Products currently include a line of lyophilized technetium-99m kits used in nuclear imaging procedures and therapeutic products labeled with a variety of isotopes including radioiodine.
About DRAXIS Health Inc.
DRAXIS Health, through its wholly owned operating subsidiary, DRAXIS Specialty Pharmaceuticals Inc., provides products in three categories: sterile products, non-sterile products and radiopharmaceuticals. Sterile products include liquid and freeze-dried (lyophilized) injectables plus sterile ointments and creams. Non-sterile products are produced as solid oral and semi-solid dosage forms. Radiopharmaceuticals are used for both therapeutic and diagnostic molecular imaging applications. Pharmaceutical contract manufacturing services are provided through the DRAXIS Pharma division and radiopharmaceuticals are developed, produced, and sold through the DRAXIMAGE division. DRAXIS employs approximately 500 staff in its Montreal facility.
For additional information please visit www.draxis.com.
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SOURCE DRAXIS Health Inc.
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Jerry Ormiston
Executive Director
Investor Relations
DRAXIS Health Inc.
Phone: 1-877-441-1984
