Mar-04

Guildford Pharmaceuticals Launches U.S. Marketing Program for Aggrastat® Injection Guilford Pharmaceuticals Inc. announced that it has launched marketing efforts for Aggrastat® Injection (tirofiban hydrochloride) in the United States. Guilford acquired U.S. marketing rights to Aggrastat Injection from Merck and Co., Inc. in October 2003. Aggrastat is currently available in 82 countries worldwide and is marketed by Merck in all countries outside the United States and its territories. The Company also announced that it intends to begin a Phase III registration trial during the second half of 2004 for use of Aggrastat in patients undergoing percutaneous coronary intervention (PCI) in order to expand the product’s labeled indication. Aggrastat, a glycoprotein GP IIb/IIIa receptor antagonist, is currently indicated and used for the treatment of acute coronary syndrome (ACS) including unstable angina and non-Q-wave myocardial infarction (MI). In these patients, Aggrastat reduces the risk of heart attacks by 47 percent within the first seven days and 30 percent within the first month. Aggrastat may also be used to treat patients prior to undergoing angioplasty. Craig R. Smith, MD, Chairman, President and Chief Executive Officer of Guilford, remarked, Since announcing our acquisition of Aggrastat two months ago, we have also advanced plans to begin a Phase III clinical trial of Aggrastat (tirofiban hydrochloride) for use in PCI and expect to begin this trial later in the year. We see great opportunity to expand the market for Aggrastat both in the upstream, early medical management of patients with ACS and in the PCI market, pending the results of the upcoming Phase III clinical trial and successful FDA review of a supplemental New Drug Application. Dr. Smith continued, We’re also very pleased to announce that Eric Topol, MD, Department Chairman of Cardiovascular Medicine at the Cleveland Clinic Heart Center, has been designated program leader for the company's Phase III PCI study. Dr. Topol has extensive expertise with this class of therapeutics, and with Aggrastat specifically, and his role as a thought leader in this sector will no doubt greatly benefit the design and analysis of the clinical trial. Dr. Topol commented, Data from clinical studies of Aggrastat, including the TACTICS-TIMI 18 trial and the PRISM-PLUS trial, demonstrate the usefulness of treatment with Aggrastat in combination with an aggressive early interventional approach in upstream ACS therapy. The new Phase III protocol will evaluate the downstream effectiveness of Aggrastat in the cath lab, using higher bolus doses of Aggrastat than previously studied. Recently published clinical data suggest that a higher initial bolus dose of Aggrastat can achieve greater than 90% platelet inhibition, a great target for use in PCI. Aggrastat was approved by the Food and Drug Administration (FDA) on May 14, 1998. Aggrastat, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. Aggrastat (tirofiban hydrochloride) is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to Aggrastat include: a history of thrombocytopenia following prior exposure to Aggrastat; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; or history, symptoms, or findings suggestive of aortic dissection. Aggrastat is also contraindicated in patients with: severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis. Bleeding is the most common complication encountered during therapy with Aggrastat. Administration of Aggrastat is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with Aggrastat occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. Aggrastat should be used with caution in patients with platelet count Tomball Regional Hospital Receives Gold Seal of Approval in Cardiac Care Tomball Regional Hospital is now recognized as one of the top 10 percent performing hospitals in the country in cardiac care, according to a recent study commissioned by Duke University. The initative, CRUSADE (Can rapid risk stratification of unstable angina patients suppress adverse outcomes with early implementation of the American College of Cardiology/American Heart Association Guidelines), measures more than 600 hospitals nationwide on their responsiveness, diagnosis and treatment of chest pain patients arriving at a hospital’s emergency department. The Outstanding Care Award is given to only those hospitals with the best treatment practices and outcomes. By continuing to demonstrate excellence in cardiac and overall healthcare quality, Tomball Regional Hospital has also been awarded the Gold Seal of Approval and has achieved Disease-Specific Care Certification from the Joint Commission of Accreditation of Hospital’s (JCAHO). Reviewers from JCAHO recently evaluated Tomball Regional Hospital’s Acute Coronary Syndrome Program to assess its compliance with national standards and performance measurement expectations for the management of chronic care illnesses, and found it to offer exceptional cardiac care. More than 60,000 patients have been monitored nationwide and this award has only been presented to a handful of hospitals. Tomball Regional Hospital is the first in the nation to be awarded the Gold Seal of Approval. We voluntarily pursued this comprehensive evaluation to enhance the safety and quality of care we provide, said Robert Schaper, President/CEO of Tomball Regional Hospital. The Joint Commission has more than 50 years of recognized and respected experience and expertise in evaluating clinical care quality in all types of healthcare settings, and we are proud to achieve this distinction and recognition from both JCAHO and CRUSADE on our cardiac program. A new Heart Center is underway at Tomball Regional Hospital and expected to be complete in 2004. All cardiac services will be centralized in one area for the convenience of the patients. The Heart Center will include two new cardiac catheterization labs, nuclear cardiology, an ECHO vascular lab and cardiac rehab. American Heart Association Says President’s Proposed FY 2005 HHS Budget Neglects Americans’ Health President Bush’s fiscal year (FY) 2005 budget comes up short in the battle against our nation’s most deadly and costly health threats, such as heart disease, stroke and obesity, according to the American Heart Association. The proposed new budget calls for only a 2.5 percent increase next fiscal year for the National Institutes of Health (NIH), and an even smaller increase for the Centers for Disease Control and Prevention’s programs aimed at combating chronic diseases. In reality, this does not even add up to an increase, said Coletta C. Barrett, RN, MHA, chairman of the board for the American Heart Association. Given inflation, this will either be no increase, or an actual loss for critical biomedical research and prevention programs. For the second year in a row, our nation’s health is being shortchanged. America’s health is steadily declining, continued Barrett. Heart disease remains our nation's No. 1 killer, and stroke follows closely at No. 3. In total, 64 million Americans suffer from cardiovascular diseases like heart disease and stroke, and almost one million will die annually as a result. And the cost to America is astounding nearly $370 billion in direct healthcare costs and lost productivity. The only way to combat this high cost in lives, money and life years lost, is through medical research and disease prevention. Although 2003 marked the completion of a five-year plan to double the budget for the NIH, future prospects look grim. Given a second year with a no-growth budget, it is projected that the institute will fund nearly 600 fewer new research grants. The U.S. obesity epidemic is everywhere in the news, added Barrett. Two-thirds of Americans are overweight or obese. Our adolescents rank as the most overweight in the industrialized world. Almost 40 percent of Americans are sedentary. We all see that our health is getting worse, yet the President’s 2005 budget cuts the funds that could lead to finding cures and solutions to these very problems. In a January 2004 poll conducted by International Communications Research on behalf of the American Heart Association, almost 92 percent of respondents thought the federal government should increase the investment for research into cures for both heart disease and stroke, and 70 percent thought it was possible to cure heart disease if only more money was invested in research. According to the American Heart Association, critical budgeting areas include:

•Commit to preventing chronic diseases and seeking cures •Significantly enhance funding for the Centers for Disease Control and Prevention's Heart Disease and Stroke Prevention Program, and invest in promising opportunities by dramatically boosting funding for National Institutes of Health (NIH) heart disease and stroke research. Funding for heart disease and stroke research falls far short of what is needed. •Fight obesity that leads to chronic illness Prevent the growing childhood obesity epidemic by investing in programs that improve childhood nutrition and increase physical activity for all Americans. •Ensure that heart disease and stroke patients have prompt access to quality care seliver timely, high quality emergency care by supporting automated external defibrillation funding initiatives. •Expand the CDC WISEWOMAN program support heart disease, stroke and breast and cervical cancer screenings.

Could the Pollypill Reduce Cardiovascular Disease by 80 Percent? More than 675,000 people die each year from heart disease and stroke in the United States. Although notable gains have been made in prevention and treatment, according to Dr. Harvey B. Simon, there is more to do.There is now a proposal for the Pollypill, a medication that may have long-term benefits for those at risk for heart disease and stroke. The Pollypill is not yet on the market, but clinical trials show this drug may reduce the risk of these illnesses by more than 80 percent and possibly add 11 years of life to those who take it. A single tablet contains six different medications: a statin, three types of blood pressure medications, folic acid, and a small dosage of aspirin. The creators of Pollypill predict it will be taken by almost everyone over age 55, and younger people with cardiovascular disease. Florida Institute for Advanced Diagnostic Imaging Achieves a Milestone in Cardiovascular Diagnostic Imaging Florida Institute For Advanced Diagnostic Imaging (FIFADI) announced that it has reached the milestone of performing more than 400 coronary computed tomography angiography (CTA) procedures using the Aquilion 16 CFX. FIFADI utilizes the multislice CT system from Toshiba America Medical Systems (TAMS) to offer non-invasive cardiovascular diagnostic imaging for early detection of heart disease. Coronary CTA scans performed at FIFADI visually isolate the heart by removing surrounding structures to expose signs of disease through 3-D visualization of coronary arteries, calcified and/or soft plaque, heart chambers, bypass grafts and stents. In most cases, the primary advantage of a coronary CTA is the ability to visualize soft plaque, which would be invisible during an electrocardiograph, stress testing, calcium scoring and even cardiac catheterization. The Aquilion 16 CFX delivers up to 16 0.5 mm slices within a 400-millisecond gantry rotation. This 0.4-second scanning capability enhances the image quality of the scanner by effectively reducing any image artifact from internal organs and structure motion. As a result, the Aquilion 16 CFX delivers more accurate clinical images depicting fine details, including minute coronary arteries, soft plaque and small vessel structures for superior cardiovascular imaging studies. Maintaining Positive Patient Relationships A Basic Tenet of Loss Control/Risk Management Annie Pena, Director of Loss Control and Risk Management, NJ PURE (New Jersey Physicians United Reciprocal Exchange) Should you call patients after a procedure to ask how they’re doing, check to see why they missed an appointment, even give them flowers? Actually, such actions can be as important to your department or practice as any medical procedure. Recent studies have shown that patients expect the people who provide them with medical care to also care about them as individuals. Experience demonstrates that a patient who has a good relationship with the physician is usually a non-litigious one. Therefore, the best defense against malpractice suits is to make sure the patient feels confident in services and comfortable in your department or office. Patients react positively to an environment that is friendly, caring and welcoming. Creating such an environment starts with the basics speaking politely, listening carefully, maintaining a cheerful and tidy area, and providing prompt and efficient care. But it also involves small details that can make a big difference to the patient. Carolann Zappi, corporate manager at Capitol Open MRI and Imaging in Hamilton, New Jersey, harkens back to the days when Marcus Welby-type personal care was still prevalent. I come from a time and a place where patient comfort was foremost. Medicine is a business based on people, and we have to treat them with respect and caring. The imaging center where she works sets a fine example. A new patient entering the office is warmly greeted by the receptionist and taken into a conference room where a brief history can be taken in total privacy. Back out in the waiting room, there is a television to help nervous patients and family members wile away the time. For patients who do not speak English, there are several bilingual staff members at the facility. If a patient misses or cancels an appointment, the referring physician is notified and the patients are called and rescheduled. Before the procedure, the radiology technologist explains exactly what to expect. If the patient exhibits any signs of discomfort or fright, a staff member comes in to provide hand-holding support. If results indicate that further testing is necessary, those tests are administered immediately whenever possible, saving the patient from the need for a subsequent appointment and weeks of nervous waiting. Nor does the personal attention stop when the testing is concluded. Coffee and pastries are provided after the procedure and, upon leaving, each patient is given a carnation and asked to provide feedback via a patient satisfaction survey. The marketing manager follows up the visit by calling any patient who expresses dissatisfaction to discuss and try to rectify the issue and then sends a bouquet of flowers to each of those patients. Loss Control/Risk Managers often stress the importance of maintaining good patient-doctor and patient-staff communications. In essence, each interaction with the patient, whether verbal or not, is a form of communication. The tone of voice encountered by the patient when calling to make that first appointment, the attitude of the receptionist, the attention received from the nurse all these play an essential role in patient satisfaction. When meeting one-on-one with the doctor, the patient wants to know that he or she will be treated as an individual, not as a file number. Physicians must take the time to really listen to what the patients have to say, encourage them to ask questions, and make sure they understand the answers. When explaining a condition or procedure, use charts, drawings or models whenever possible. Gently suggest that the patient repeat what you have explained. Because many patients may be very sick, frightened or in pain at the time of their visit, they may not always hear what the doctor has to say. This is especially true when receiving news of a serious condition. Patients often complain of a ‘language barrier’ between themselves and the medical professionals. Laypeople shouldn’t be expected to understand medical jargon or complex terminology. After explaining any medication or treatment instructions, it helps to provide that same information in writing, together with any relevant patient information materials such as pamphlets and videos to be reviewed at home. When a patient does call for information, the call should be handled as soon as possible and referred to the appropriate person. No question should be considered too trivial for a complete, reassuring and respectful response. Realistically, larger facilities or practices with more staff are better able to follow up on the details of patient satisfaction. In a smaller, over-worked department or office, the patient is often kept waiting longer, receives less attention and can sense the harried nature of the practice as phones keep ringing, instructions are given in clipped tones, and one-on-one time gets cut short. But those who let civility and courtesy fall through the cracks are making a serious mistake. Because, to paraphrase an old adage, ‘if the patient ain’t happy, ain’t nobody happy.’ Annie Pena is Director of Loss Control and Risk Management for NJ PURE (New Jersey Physicians United Reciprocal Exchange), a not-for-profit medical malpractice insurance provider founded in the fall of 2002 by James J. Sheeran, a former state insurance commissioner, and Dr. Lena Chang, an award-winning insurance actuary. Pena, a registered nurse, has been in the health care field for 23 years and served as a consultant for the Johnson & Johnson Company. Inventory Management System Helps Hospital Departments Drive Down Supply Costs A new, web-based inventory management system from InnerSpace Corporation yields immediate, money-saving results for hospital departments with high levels of non-stock inventory. Called spaceTRAX®, the system helps departments such as interventional radiology and cardiac catheterization labs to drive down rising supply costs, minimize waste due to product expiration and reduce excess inventory. SpaceTRAX is a secure, completely web-based application that uses the barcode information already inplace on packaged medical products to efficiently manage inventory. Items are added or removed by scanning the manufacturer-printed product bar code. Bar codes are instantly matched to the spaceTRAX product database via the Internet, eliminating the need for users to build and manage their own database. SpaceTRAX works with all products regardless of manufacturer or supplier. Michael Carpenter, spaceTRAX product manager, says the database currently includes more than 10,000 items and is constantly being updated by spaceTRAX professionals. One of the benefits of a web-based application is the immediate access users have to the latest product information. We handle all the maintenance; users simply input their product usage. Easy access to real-time inventory data is the key to cost reduction, explains Carpenter. With just a few keystrokes, spaceTRAX provides a comprehensive view of a department’s inventory use and trends. Departments know when it’s time to reorder, when products are about to expire and what their usage patterns are. He adds, Managers can compare actual purchases to budgets or track costs by procedure, doctor, or manufacturer. Some departments use their data to verify volume and negotiate more favorable purchasing contracts. Carpenter describes the results achieved by a Midwestern university hospital within 90 days of going online with the system: spaceTRAX automatically calculates the number of weeks of supply on-hand for each item based on actual usage patterns and on-hand quantities. By establishing a target of a three-week supply, the department manager was able to reduce the quantity of items stocked by 21 percent. With three procedure rooms, this amounted to a reduction of $160,000 in excess inventory. Further, this manager used the data to negotiate a volume purchase discount with one vendor which will generate savings of at least $30,000 this year. SpaceTRAX resides entirely on secure web servers; there is no software to purchase or install. We assign a spaceTRAX product specialist to work closely with each customer to plan, coordinate, and perform a comprehensive and complete spaceTRAX implementation, explains Carpenter. From the initial conference call, to the on-site physical inventory and user training, the entire process can be completed in about a week. This includes an on-site visit by our specialist which typically occurs over a weekend to minimize disruption. SpaceTRAX is sold as a monthly subscription based on the number of procedure rooms in the department. There are no restrictions placed on any aspect of usage, including the number of users or the amount of data stored. No long-term contracts are required. A one-time implementation fee covers the cost of a spaceTRAX professional performing the physical inventory, importing departmental data into the database, initializing the application for the department and in-house staff training. For more information, please contact Michael Carpenter at (800) 467-7224 or visit www.spacetrax.com.

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