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			Slogan Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management GUIDANT NOTIFIES PHYSICIANS OF IMPLANTED HEART DEFIBRILLATOR FAILURES ------------------------------------------------------------------------------- Guidant Corp. alerted physicians that there have been 26 reports of failure, including one recent death, related to its Ventak Prizm 2 DR Model 1861 implantable cardioverter defibrillators (ICDs). However, the company did not recommend early replacement of the approximately 24,000 such devices still implanted worldwide, stating that this defect is very rare and that "the risk of malfunction is lower than the risk of replacement," The Wall Street Journal reported. The company said Ventak Prizm 2 DR ICDs manufactured before November 2002 may fail and be unable to deliver therapy. According to The New York Times, 37,000 units were made prior to that date, meaning the overall failure rate is 0.07 percent. The company said it changed its manufacturing process in 2002 to correct the problem, The Times added. Physicians should continue monitoring patients every three months, per the product labeling, Guidant said. The firm also recommended that patients with questions regarding the device should contact their physician, especially if they have recently received a defibrillation shock. In a patient advisory on its Web site, Guidant said the defibrillator "continues to exceed design expectations and ranks overall as one of the most reliable ICD products available." Guidant said it worked on the letter to physicians with the Food and Drug Administration and will continue to work with agency on this "issue." According to The Journal, an FDA spokesman confirmed that Guidant notified the agency of each incident and of its 2002 manufacturing change. The Times added that FDA officials met with the company Tuesday to discuss the situation. "[T]he company will continue to undertake further specific physician communications to improve patient outcomes or limit adverse events related to device behavior," Guidant added. The Times reported Tuesday that Guidant failed to inform physicians of the problem for three years, adding that the advisory was issued after the firm found out that The Times was going to run an article about the device. According to The Times, the defect came to light after a 21-year-old student with a genetic heart disease died during a bicycling trip in Utah. Guidant acknowledged that the device short-circuited and told his physicians about the 25 other failures. The physicians said they would have replaced the young man's device if they had known of the failures "because he was at high risk of sudden death," The Times said. Dr. Joseph Smith, chief medical officer for Guidant, told The Journal, "This device did not cause his death." In a separate statement, Johnson & Johnson said it "continues to be confident in its decision to acquire Guidant," a $23.9 billion purchase that was announced last December. J&J anticipates that the transaction will close during the third quarter of 2005. -=- FDA ISSUES APPROVABLE LETTER FOR ALCON'S RETAANE FOR PRESERVING VISION AMONG PATIENTS WITH WET AMD ------------------------------------------------------------------------------- The Food and Drug Administration issued an approvable letter for Alcon Inc.'s New Drug Application for Retaane (anecortave acetate for depot suspension), an investigational treatment for maintaining vision in patients with wet age-related macular degeneration (AMD). Alcon plans to "meet with the FDA to discuss the approvable letter, the clinical studies submitted with the NDA and other ongoing clinical studies for Retaane suspension to determine the steps necessary to gain final approval for the wet AMD indication." The NDA is based on two pivotal clinical studies. The first study showed that 79 percent of patients treated with Retaane suspension and 53 percent treated with a "sham application" maintained their vision after one year. A separate study "demonstrated that after one year, the visual outcomes in patients who received Retaane suspension were not statistically different from those of patients who received photodynamic therapy with [Novartis AG and QLT Inc.'s] Visudyne [verteporfin]." The NDA is under a fast track designation and was also accepted into the FDA's Pilot 1 Continuous Marketing Application program. Retaane is an angiostatic cortisene that inhibits the abnormal growth of blood vessels. Retaane suspension is delivered behind the eye without puncturing the eyeball and requires one dose every six months. Certain other investigational drugs are injected into the eye up to 12 times a year, Alcon added. Alcon shares closed at $102.90, down $1.71, or 1.6 percent, in moderate trading on the New York Stock Exchange. -=- BARRIER THERAPEUTICS RECEIVES NOT APPROVABLE LETTER FOR ZIMYCAN ------------------------------------------------------------------------------- The Food and Drug Administration sent a not approvable letter to Barrier Therapeutics Inc. regarding its New Drug Application for Zimycan (miconazole nitrate 0.25%/zinc oxide 15%/white petrolatum ointment 81.35%) as a treatment for diaper dermatitis complicated by candidiasis. The regulatory agency said there is insufficient information to characterize the systemic exposure to miconazole, a component of the safety evaluation, in infants. Specifically, the percutaneous study in the application concluded there was minimal systemic absorption of miconazole, but the FDA said this study was not sufficient, because the product used a different grade of petrolatum than that used in the pivotal clinical studies. Geert Cauwenbergh, chief executive officer of Barrier, said the company is "disappointed and surprised" by the agency's decision. "The company stands fully behind the safety profile of this 0.25% concentration of miconazole. Barrier will continue discussions with the agency and is looking at all available options. We believe that one option is to conduct a second percutaneous absorption study using the current product," he said. The miconazole in the product is designed to treat the infection, while the zinc and petrolatum help to keep excessive moisture away from the skin. In November, Barrier submitted an amendment to the NDA that included results from a Phase III study showing Zimycan achieved statistical significance in overall cure at day 14 as compared with placebo. The firm had expected to receive a response from the FDA within six months. Barrier shares closed at $15.40, down $1.63, or 9.6 percent, in heavy trading on the Nasdaq. -=- GENVEC RESUMES TNFERADE TRIALS FOR TREATMENT OF RECTAL, ESOPHAGEAL CANCER ------------------------------------------------------------------------------- The Food and Drug Administration informed GenVec Inc. that it may resume the Phase II trial of TNFerade for the treatment of rectal cancer. The regulatory agency said the clinical hold issues have been satisfactorily addressed for the rectal and esophageal indications, so the hold has been removed from TNFerade's Investigational New Drug application. Thus, GenVec will again begin enrolling patients for the Phase II rectal study; follow-up of patients in the esophageal study is ongoing. In October, the FDA placed TNFerade clinical trials on hold while it reviewed the potential increase in the incidence of blood clots among patients with esophageal cancer who had received the highest dose of the drug in a Phase II trial. In February, the regulatory agency allowed GenVec to proceed with its TNFerade Phase II trials in patients with locally advanced pancreatic cancer. "We are pleased to resume clinical testing of TNFerade for the treatment of rectal cancer and greatly appreciate the FDA's efforts to resolve the clinical hold on this program," said Paul Fischer, chief executive officer of GenVec. "Our clinical results to date with TNFerade in a variety of solid tumors, including pancreatic and rectal cancer, have been very encouraging and we look forward to expanding our efforts in rectal cancer." GenVec shares closed at $1.84, up $0.06, or 3.4 percent, in heavy trading on the Nasdaq. -=- ENCYSIVE PHARMACEUTICALS COMPLETES SUBMISSION OF NDA FOR PAH TREATMENT, THELIN ------------------------------------------------------------------------------- Encysive Pharmaceuticals Inc. completed the submission of a New Drug Application to the Food and Drug Administration for its pulmonary arterial hypertension (PAH) treatment, Thelin (sitaxsentan sodium) 100 mg. The NDA includes "the largest database ever assembled in a regulatory filing for PAH, with approximately 900 PAH patients receiving Thelin in clinical evaluations," Encysive said. The NDA is based on results from two pivotal Phase III studies. One of these studies, Sitaxsentan To Relieve ImpaireD Exercise (STRIDE-2), met its primary endpoint of improved six-minute walk and also demonstrated that patients with PAH who received Thelin had a statistically significant increase of 31.4 meters over those receiving placebo. The 18-week study--which was conducted under a special protocol assessment from the FDA--also found that liver function abnormality occurred in 3 percent of the Thelin 100 mg group, 6 percent of the placebo group and 11 percent of patients receiving Actelion Pharmaceutical Ltd.'s Tracleer (bosentan), the only approved oral treatment for PAH. Thelin, a small-molecule endothelin antagonist, was granted orphan drug status by the FDA last November. PAH affects approximately 100,000 to 200,000 people worldwide, the company said. -=- MEDTRONIC POSTS MIXED Q4, FY 2005 RESULTS ------------------------------------------------------------------------------- Medtronic Inc. posted lower earnings in the fiscal fourth quarter and fiscal year of 2005 than those achieved one year ago, but reported an increase in revenue. For the fourth quarter ended April 29, revenue from implantable cardioverter defibrillators (ICDs) totaled $682 million, giving Medtronic 50 percent of the global ICD market share. The strong operating performance of ICDs and spinal products together represented more than 42 percent of the total $2.78 billion in revenue. Analysts polled by Thomson First Call had estimated, on average, sales of $2.83 billion, Dow Jones reported. In the fiscal fourth quarter of 2004, revenue was $2.67 billion. However, fourth-quarter net earnings were $194.4 million, or $0.16 per diluted share, down from $568.9 million, or $0.47 per share, in the year-ago period. Excluding charges, earnings were $645.4 million for the current quarter. Medtronic noted that the fourth quarter of 2005 included one less week than the prior-year period, which could have added between seven and eight percentage points to the recorded growth rates. Additionally, in a conference call after these financial results were released, Chief Financial Officer Gary Ellis said 13,000 of its ICDs were replaced during the past quarter due to a "field action" after the firm found a battery problem, Dow Jones reported. Approximately 87,000 devices were affected, but there were no patient deaths or injuries reported. For the full fiscal year of 2005, revenue increased to $10.06 billion from $9.09 billion generated in fiscal year 2004. The company posted full-year 2005 net earnings of $1.80 billion, or $1.48 per diluted share, as compared with $1.96 billion, or $1.60 per share, last year. Excluding charges, earnings were $2.27 billion for the current quarter. "Diabetes products also closed out the year on a favorable note, and Medtronic's annual revenues exceeded $10 billion for the first time in the company's history," said Art Collins, chief executive officer of Medtronic. Specifically, revenue from its diabetes business grew 20 percent to $179 million. Finally, Medtronic provided financial guidance for fiscal 2006 through fiscal 2008, excluding the effect of any special charges. For fiscal 2006, it projects revenue of between $11.1 billion and $11.6 billion, and diluted earnings per share of between $2.10 and $2.15. Dow Jones said on average, analysts surveyed by Thomson First Call estimate sales of $11.5 billion and earnings per share of $2.17. By 2008, the company expects revenue in the range of $14 billion and $16 billion and diluted earnings per share of between $2.70 and $2.90. Shares of Medtronic closed at $53.00, up $0.22, or 0.4 percent, in moderate trading on the New York Stock Exchange. -=- Slogan BOSTON SCIENTIFIC CORP. ------------------------------------------------------------------------------- Boston Scientific Corp. released updated financial estimates for 2005 that take into account recent acquisitions and anticipated global market share for its Taxus stent systems. The firm now expects full-year earnings per share, excluding charges, of between $1.85 and $2.00 and worldwide annual sales to be between $6.35 billion and $6.57 billion, including $2.62 billion to $2.76 billion in drug-eluting stent sales. The company had previously expected earnings per share for the full year to be between $2.00 and $2.20 and worldwide sales to be between $6.4 billion and $6.7 billion, including drug-eluting stent sales of between $2.7 billion and $3 billion. Boston Scientific shares closed at $29.46, down $1.14, or 3.7 percent, in heavy trading on the New York Stock Exchange -=- Slogan GUILFORD PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Guilford Pharmaceuticals Inc. eliminated an additional 38 positions as it works to reduce costs and realign its resources to focus on developing its Gliadel Wafer (polifeprosan 20 with carmustine implant) brain cancer therapy and Aquavan Injection (water-soluable prodrug propofol) for procedural sedation. Since December, the company has already reduced its workforce from 300 to 238. The realignment is expected to save approximately $6 million in expenses annually. -=- Slogan BIOVERIS CORP. ------------------------------------------------------------------------------- BioVeris Corp. entered into an option agreement with the University of Massachusetts at Amherst for exclusive patent rights to a chlamydia vaccine candidate. Under the agreement, BioVeris gained a first option for exclusive rights to market products that could be used in preventing, diagnosing and treating all chlamydial infections. The two groups also reached an agreement whereby BioVeris will sponsor up to $600,000 of research at the university to help develop the candidate through 2006. -=- Slogan CVS CORP. ------------------------------------------------------------------------------- CVS Corp. will no longer buy pharmaceutical drugs from wholesalers that trade in the secondary drug market. The firm noted increased trepidation "that wholesalers trading in the secondary market potentially provide an entry point for counterfeit or adulterated products to enter the legitimate pharmaceutical supply chain." Chris Bodine, CVS' executive vice president of merchandising and marketing, stated that the firm will only buy drugs directly from manufacturers or wholesalers that "certify" that they do not trade in the secondary drug market. "If we are unable to receive those assurances, those wholesalers' contracts will not be renewed," Bodine added. A spokesman for Walgreen Co. said its company already requires wholesalers to demonstrate that all drugs come directly from the manufacturer, the Associated Press reported. -=- Slogan


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