Clinical and Industry News: November 2006

FDA Grants Priority Review For Arixtra® (fondaparinux Sodium) in the Treatment of Acute Coronary Syndromes GlaxoSmithKline plc announced that the supplemental new drug application for its anticoagulant product Arixtra® (fondaparinux sodium) Injection has been accepted for priority review by the U.S. Food and Drug Administration. This application was based on positive results from two pivotal Phase III trials (OASIS 5 and 6) that evaluated Arixtra in the treatment of a broad spectrum of patients with acute coronary syndromes (ACS). The sNDA was submitted on July 31, 2006. The filing submission data included the OASIS 5 clinical trial results, which compared Arixtra to Lovenox (enoxaparin)* in patients with UA (Unstable angina)/NSTEMI (Non-ST elevation myocardial infarction)1, and OASIS 6, which compared Arixtra to standard therapies (unfractionated heparin or placebo) in STEMI (ST elevation myocardial infarction) patients.² Arixtra is not currently approved for patients with ACS in any country in the world. Fondaparinux is the first in a class of antithrombotics that selectively inhibits Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin. Arixtra is currently approved in the U.S. for the prevention of VTE, which includes DVT and PE, in patients undergoing surgery for hip fracture (including extended prophylaxis), knee replacement, hip replacement, and in abdominal surgery patients who are at risk for thromboembolic complications. Additionally, Arixtra is indicated for the treatment of acute DVT when administered in conjunction with warfarin sodium and for the treatment of acute PE when administered in conjunction with warfarin sodium, when initial therapy is administered in the hospital. For more information about Arixtra please visit https://www.gsk.com. In Europe and the U.S., Arixtra is contraindicated in patients with severe renal impairment. In the U.S., Arixtra is also contraindicated in patients weighing less than 50 kg (less than 110 lbs) who are undergoing major surgery of the lower limbs and abdominal surgery. Arixtra is contraindicated in patients with active major bleeding, bacterial endocarditis, and patients with hypersensitivity to fondaparinux sodium. When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated with low-molecular-weight heparins, heparinoids or fondaparinux sodium are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events may be higher with postoperative use of indwelling epidural catheters or concomitant use of drugs affecting hemostasis. Spinal/epidural anesthesia should not be used concurrently with Arixtra for the treatment of VTE (See boxed warning in U.S. prescribing information). Arixtra is not intended for intramuscular administration. Arixtra should be used with caution in all patient groups with increased risk of bleeding. This includes the elderly, and patients with moderate renal or severe hepatic impairment. In the EU, Arixtra should be used with caution in those patients weighing less than 50kg (less than 110lbs). Arixtra should not be co-administered with drugs that may increase the risk of bleeding. The efficacy and safety of Arixtra in patients with heparin-induced thrombocytopenia type II has not been studied. Thrombocytopenia can occur during a treatment with Arixtra and if the platelet count falls below 100,000/mm3, Arixtra should be discontinued. Lovenox® (enoxaparin) is the registered trademark of Sanofi-Aventis. References 1. The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes. N Engl J Med 2006 354: 1464-1476. 2. Effects of Fondaparinux on Mortality and Reinfarction in Patients with Acute ST-Segment Elevation Myocardial Infarction. JAMA 2006 295: 1519-1530. CardiacAssist Wins FDA Approval for TandemHeart® Escort Controller CardiacAssist, Inc. has received FDA 510(k) market approval for its new TandemHeart® Escort® Controller. The new, lightweight, space-saving Escort Controller is one of three primary components that make up the TandemHeart PTVA® System. The TandemHeart System provides circulatory support through a cardiac catheterization procedure in as little as 30 minutes. It is FDA approved for extracorporeal circulatory support for up to six hours for procedures not requiring full cardiopulmonary bypass. Weighing only 21 pounds, the Escort Controller replaces the original 93-pound TandemHeart Controller. It can be mounted at bedside, on an IV pole or on a table top. It is intended primarily for AC power use, but has enough battery back-up power for an hour of operation. CardiacAssist, Inc. collaborated on the project with Minnetronix, a contract design and manufacturing company serving the medical device industry. The Escort Controller design retains proven subsystems that have been in use for years in the current controller, such as the pump motor driver circuits, flow estimator, air bubble detector, IV pump, and infusion system. Retaining these subsystems maintains compatibility between the two generations of controllers and ensures a high degree of reliability. The TandemHeart System is fully reimbursed by Medicare under existing DRG codes. It can be placed rapidly in the cath lab or operating room, providing reliable extracorporeal circulatory support via percutaneous access. The TandemHeart System is used in 17 of the top 20 heart and heart surgery hospitals in the U.S. and 11 of the nation’s top 14 hospitals overall. To date, more than 700 uses of the system in 28 countries at 70 different facilities by 120 different physicians have been recorded. New IMV Study Identifies Expected Changes in Cardiologist Referrals for Imaging Technologies According to a recent study published by IMV Medical Information Division, Present Practices and Future Directions in Cardiac Imaging: The Cardiologist’s Perspective, the top three imaging modalities currently used by cardiologists for diagnosing key cardiac conditions include echocardiography, SPECT and cardiac cath. However, cardiologists expect the top three modalities to change significantly over the next three years, with CT angiography (CTA) and MR angiography (MRA) to be used more routinely, with CTA superceding SPECT and diagnostic catheterization procedures for diagnosing certain cardiac conditions. Rapid advances in imaging technology have dramatically expanded the diagnostic capabilities of physicians in general and cardiologists in particular. Increasingly, U.S. cardiologists are evaluating the feasibility of using advanced imaging technologies to enhance patient care, observed Mary C. Patton, Director, Market Research. In addition to deciding which imaging modalities are most effective for particular cardiac indications, physicians will choose whether to refer patients out or to acquire these new imaging technologies for their practices. The primary objective of this study is to provide insights on U.S. cardiologists’ roles in ordering and performing diagnostic cardiac imaging procedures today and in the near future, specifically focusing on the next three years. IMV’s report Present Practices and Future Directions in Cardiac Imaging: The Cardiologist’s Perspective discusses the modalities used in the diagnostic evaluation of nine cardiac conditions and two post-surgical situations where cardiologists routinely use advanced imaging modalities, with focus on the present and future use of echocardiography, cardiac cath, SPECT and SPECT/ CT, coronary CTAs, CT for calcium scoring, MR and MR Angiography, and PET and PET/CT. The report also explores cardiologists’ plans to purchase specific types of diagnostic imaging equipment within the next three years. Other highlights include: U.S. cardiologists presently consider echocardiography as the number one diagnostic imaging modality used to evaluate congestive heart failure, valvular heart disease, endocarditis, syncope and recent survivors of myocardial infarction and ventricular fibrillation. An estimated 72% of U.S. cardiologists presently order CTA procedures and 59% order MR or MRA procedures on a monthly basis. Over the next three years, cardiologists predict that CTA will become one of the top three modalities used for seven of the eleven major cardiac conditions covered in this report. Cardiologists identify SPECT as one of the modalities they use more today than three years ago, and 96% routinely order SPECT procedures on a monthly basis. The data collection for this study utilized primary research with over 200 U.S. cardiologists during July 2006, supplemented by interviews with key opinion leaders. For more information about this report or to purchase this report, visit the corporate website at www.imvinfo.com. Since 1977, IMV has been a supplier of market information to the diagnostic healthcare industry, providing site-specific databases and comprehensive market reports that address the radiology, cardiology and oncology markets.

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