NEWS — JANUARY 13, 2003 - JANUARY 19, 2003

BLOOD PRESSURE MONITORS

An Ongoing Controversy... As new models are introduced to replace environmentally unfriendly mercury-based devices, there are ongoing concerns among medical professionals that alternative technologies are not as accurate. One of the most vocal groups with respect to this issue is the American Heart Association (AHA; Dallas TX), which is promoting efforts to conduct more research. Meanwhile, approximately 24 hospitals in the United States have already replaced mercury blood pressure monitors, well ahead of the voluntary deadline targeted for 2005.

Among the important considerations with new models is regular testing to ensure that the increased number of parts are in good working condition. A three-year study at the Mayo Clinic (Rochester MN) suggests a very low failure rate in aneroid monitors, if the products are well-maintained. Physicians, however, may be unaware of the need for periodic testing, which can lead to low blood pressure readings. This represents a potentially serious problem, since estimated 1.0 million measurements are performed daily in the United States. On the other hand, rare but occasional mercury spills can be costly to ensure complete clean-up and recycling of the waste. According to information provided in an article published by the Associated Press, spills at the Mayo Clinic over a two-year period cost approximately $26,000.

Home Testing... In recent years, physicians are more frequently recommending self-testing for patients with hypertension. A variety of home devices are sold in retail settings, and regular monitoring may help identify early stages of heart attacks or strokes. According to data from Information Resources (Chicago IL) that was reported in a recent article published online by The Wall Street Journal, October 2002 sales demonstrated a 34% increase over the same period in 2001. Furthermore, the total market for consumer blood pressure monitors may generate more than $100.0 million in annual revenues within the United States.

Perhaps even more interesting was an informal test of consumer devices conducted for the WSJ article by a hypertension specialist. Using monitors that ranged in price from a low of $75.00 to a high of $150.00, measurements were made and compared with those obtained with a professional blood pressure monitor (sphygmomanometer). While there was fairly good agreement in the measurements undertaken in this particular survey, it's important for patients to carefully follow instructions to minimize activities that could affect accurate measurement (such as movement or talking). Wrist devices are apparently more vulnerable to movement than upper arm models, although manufacturers state that readings are fine with proper usage. To be safe, patients may want to take several readings.

Cardiac Care:

The Indiana Heart Hospital... With planned opening in February 2003, the new all digital facility integrates diagnostic, electronic patient record, heart monitoring, imaging, and information technologies with minimum usage of traditional film and paper media. At a an estimated cost of $60.0 million, the Indiana Heart Hospital features the highest level of care, with workflow that was designed by hospital staff and representatives from GE Medical Systems (GE; Fairfield CT). The GE Centricity system incorporates various forms of data, ranging from images to medical history and test results in a single record that is readily accessible during a patient's lifetime.

Also available from GE this year is the new e-Speed electron beam tomography scanner that allows monitoring of blood flow, coronary calcification, heart wall motion, and perfusion. All of these measurements are achieved with a non-invasive technology that can be used as an alternative to cardiac catheterization. Additionally, diagnosis of patients who are at risk for heart disease is often achieved in less than 15 minutes, an extremely fast rate when compared with other technologies.

Consumer-Driven Health Care:

New Health Plan Options In 2003... Whether using the term "consumer-driven" * or "consumer-directed", several companies are actively promoting health plans in which members choose the elements included in their benefit packages. A new subscription newsletter entitled Inside Consumer-Directed Care from Atlantic Information Services Inc. (Washington DC) premiered in November 2002 to cover major issues. This hot new topic is also being analyzed by Mercer Human Resources Consulting (King Of Prussia PA), and Company forecasts suggest that nearly 30+% of large employers may offer consumer-directed health plan options in 2003. A report published in December 2002 was expected to include an estimate that 20% of beneficiaries in the commercial market would be enrolled in some kind of consumer-directed health plan by 2005.
* Feedback Research Services published the Consumer-Driven Health Markets report in April 2002.

Dermatology:

Barrier's Clinical Trials Schedule... In a presentation last week, Barrier Therapeutics Inc. released progress reports on three dermatology products. In early 2003, final Phase II trails are planned for Zimycan, a treatment for Candida-associated diaper dermatitis. Patients are also being sought for European and U.S. Phase III studies of Seboride (ketoconazole and desonide) for seborrheic dermatitis. Additionally, bioavailability and bioequivalency testing of Sporamelt (itraconazole) is scheduled to begin by the end of March 2003.

New Acne Drug... Duac (a clindamycin/benzoyl peroxide gel) was launched by Stiefel Laboratories (Coral Gables FL) in early January, after a relatively long review by the U.S. Food And Drug Administration (FDA; Rockville MD). This acne product is the first to combine clindamycin and benzoyl peroxide in a ready-to-dispense in a formulation that doesn't require refrigeration and is easier for patients to use. Market revenues for Duac may eventually reach $50.0 million in the United States.

Velac Gel Studies... Nearly two quarters ahead of schedule, Connetics Corporation (Palo Alto CA) announced initiation of Phase III clinical trials of Velac Gel (a "first in class" clindamycin/tretinoin combination) for treatment of acne. If progress continues in this manner, a product launch could happen as soon as mid-2005. The Company is also conducting Phase III trials of Actiza, a foam version of clindamycin.

Diabetes:

New Monitors... Two blood glucose monitors from Becton, Dickinson And Company (BD; Franklin Lakes NJ) were cleared by the FDA last year and are now available in the United States. The BD Logic and Latitude systems offer the thinnest lancets as well as test strips using small amounts of blood, both of which contribute to accurate measurements that can be achieved in only five seconds. The improvements are important for people who need to monitor blood glucose levels on a daily or more frequent basis. In addition to obtaining fast and reliable results, patients experience greater convenience and less pain.

Diabetes Research Forum... In this new initiative, the American Diabetes Association (ADA; Alexandria VA) is featuring Johnson & Johnson Pharmaceutical Research And Development LLC (JJPRD; New Brunswick NJ) as the first participant. The Diabetes Research Forum represents a collaborative effort between ADA and Entelos Inc. (Foster City CA). The Entelos Diabetes PhysioLab technology will be made available to companies such as JJPRD to optimize clinical trial components, prioritize targets, and select lead candidates to minimize disease progression and perhaps eventually provide a cure for diabetes.