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			Slogans 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 FTC conditionally approves J&J acquisition of Guidant; J&J may not proceed The Federal Trade Commission conditionally approved Johnson & Johnson's proposed acquisition of Guidant Corp. To receive FTC clearance, J&J must divest certain rights and assets of its businesses in drug-eluting stents, endoscopic vessel harvesting products and anastomotic assist devices. However, J&J believes that Guidant's previous product recalls and related regulatory investigations and claims "have had a material adverse effect on Guidant." As a result of these events, J&J, under the terms of the merger agreement, is not required to close the Guidant acquisition. J&J and Guidant have had discussions regarding restructuring terms of the transaction, although they have not come to an agreement. It is not certain whether the companies will continue discussions, and, if they do, whether they will reach an agreement based on the revised terms, J&J said. In December 2004, J&J announced it would acquire Guidant for $23.9 billion in cash and stock. Since then, Guidant has recalled a series of products for potential malfunctions. The recalls prompted concerns that J&J might change its plans to acquire Guidant; however, according to Reuters, in July, Guidant said the plans were "still on track." Since June, Guidant has issued warnings on or recalled 88,000 heart defibrillators and nearly 200,000 pacemakers because of reported malfunctions. The company has also faced several lawsuits from patients and shareholders and a reported criminal investigation by the Food and Drug Administration, according to The Wall Street Journal. In August, J&J offered several health care product divestitures as part of a proposal that could guarantee European antitrust clearance of its acquisition of Guidant, according to sources familiar with the transaction, Dow Jones Newswires reported. Guidant shares closed at $60.40, down $2.70, or 4.3 percent, while J&J shares closed at $61.30, down $0.60, or 1 percent, both in heavy trading on the New York Stock Exchange. Slogans Tarceva in combination with Gemzar approved to treat advanced pancreatic cancer The Food and Drug Administration approved Tarceva (erlotinib) for use with Gemzar (gemcitabine hydrochloride) to treat advanced pancreatic cancer in patients who have not previously received chemotherapy. OSI Pharmaceuticals Inc., Genentech Inc. and F. Hoffmann-La Roche Ltd. market Tarceva, while Eli Lilly and Co. markets Gemzar. The new approval for Tarceva, which is already approved for use in non-small-cell lung cancer, was based on results from a randomized, double-blind, placebo-controlled Phase III trial conducted in patients with unresectable locally advanced or metastatic pancreatic cancer. When compared with Gemzar/placebo, 100 mg of Tarceva plus Gemzar led to a statistically significant 23 percent improvement in overall survival. After one year, 24 percent of the patients who received Gemzar/Tarceva were still alive compared with 19 percent of the patients who received Gemzar alone. The patients did not demonstrate a difference in tumor response, but the rate of disease control was significantly improved when Tarceva was added to Gemzar. "The disease is incredibly deadly with most patients not surviving past one year," said Julie Fleshman, chief executive officer of The Pancreatic Cancer Action Network, a national advocacy group. "For years, treatments for pancreatic cancer have lagged behind other cancers, so the availability of Tarceva means patients now have more treatment options as they make informed decisions." Slogans Sucampo's lubiprostone may reduce symptoms of chronic constipation Sucampo Pharmaceuticals Inc.'s lubiprostone increases the frequency of spontaneous bowel movements (SBMs) and sustains this effect in patients with chronic constipation, according to findings presented in Honolulu at the annual meeting of the American College of Gastroenterology. The Phase III, double-blind trial included 237 patients who had a history of less than three SBMs per week and six months or more of other chronic constipation symptoms. They were randomized to receive 24 mcg of lubiprostone or placebo twice per day for 28 days. On average, the lubiprostone group increased to 5.89 SBMs during the first week compared with 3.99 SBMs in the placebo arm. Specifically, more than one-half of lubiprostone-treated patients (61 percent) experienced at least one SBM within the first 24 hours compared with 31.4 percent of controls. Lubiprostone-treated patients also experienced a decrease in straining severity as well as improved stool consistency and constipation severity, effects that were sustained throughout the trial. A New Drug Application was submitted to the Food and Drug Administration in March, seeking approval for lubiprostone to treat chronic idiopathic constipation and associated symptoms in adults. The drug, which will be marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America Inc. if it is approved, is also being studied in patients with constipation-predominant irritable bowel syndrome. Slogans Addition of Xeloda to Gemzar seems to improve survival in patients with advanced pancreatic cancer Patients with advanced pancreatic cancer who were treated with Eli Lilly and Co.'s Gemzar (gemcitabine hydrochloride) as first-line therapy lived significantly longer if they added F. Hoffmann-La Roche Ltd.'s Xeloda (capecitabine) to their regimen as compared with patients treated with Gemzar alone, according to interim data from a large Phase III trial. In the study, 533 untreated patients with locally advanced or metastatic pancreatic cancer received Gemzar or Gemzar plus Xeloda. Results showed that patients in the Gemzar/Xeloda group lived significantly longer than did those in the Gemzar monotherapy arm (median survival, 7.4 months vs. six months). Indeed, rates of survival at 12 months were 26 percent and 19 percent with the combination therapy and monotherapy, respectively. "This is the first time that adding another cytotoxic drug to [Gemzar] has improved the outcome for patients with inoperable pancreatic cancer, and the trial results are therefore an important milestone," said Dr. David Cunningham, from the U.K. Institute of Cancer Research and lead investigator, in a Roche press release. "The combination of [Gemzar] and [Xeloda] should now be considered one of the standard options for patients with advanced pancreatic cancer." The findings were presented in Paris at the European Cancer Conference. Xeloda is currently approved for use in metastatic breast cancer and colon cancer. Slogans Drugs spend more time in clinical phase, offset by shorter approval times, new analysis shows Drugs are spending more time in the clinical phase, but less time in the approval phase, leaving the total time to market basically unchanged during a 20-year period, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD). The study, which was published in the Tufts CSDD Impact Report, found that drugs approved by the Food and Drug Administration required an average of 8.5 years to move through the clinical and approval phases in the 2002 to 2004 period compared with an average of nine years in the 1984 to 1986 period. Since passage of the Prescription Drug User Fee Act of 1992 (PDUFA), which permits the FDA to collect payments from drug companies to hire additional reviewers and improve the drug review process, there has been a decline in approval phase times. In the 1990 to 1992 period, the average time a new drug spent in the approval phase was 2.6 years compared with an average of 1.5 years in the 2002 to 2004 period, according to the Tufts CSDD analysis. However, this contrasts with an increase in time spent in the clinical phase, which went from an average of six years in the 1984 to 1986 period to an average of seven years in the 2002 to 2004 period. The longer average clinical phase times have offset shorter approval phase times, according to Kenneth Kaitin, Tufts CSDD director, who added "that the number of new drug approvals by the FDA has fallen and that average clinical times for priority drugs are at their longest since before enactment of PDUFA." "As drug development becomes more complex and expensive, developers tend to concentrate available resources on fewer projects," said Kaitin. "Fewer development projects, in turn, lead to fewer new drug approvals." Slogans Retail pharmacy sales for 12 months ended August 2005 rise 5 percent in key global markets Drug sales through retail pharmacies in 13 key markets rose 5 percent to $363.73 billion from September 2004 to August 2005 at a constant exchange rate, according to IMS Health Inc.'s Retail Drug Monitor. For the 12-month period ended August 2004, retail pharmacy drug sales totaled $338.51 billion. U.S. retail drug sales grew 6 percent to $180.32 billion, again led by central nervous system drugs, which had sales of $41.4 billion. In the United States and Canada, the key therapeutic growth area was cardiovascular drugs; sales in this category again increased 10 percent at constant exchange. Sales growth rates (also at constant exchange) in the top five European markets, the top three Latin American markets and Japan were 3 percent, 18 percent and 5 percent, respectively, compared with last month's increases of 3 percent, 17 percent and 4 percent. Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin calcium), was still the best-selling drug, with global sales totaling more than $11.16 billion, although its sales growth decreased to 10 percent. Bristol-Myers Squibb Co. and sanofi-aventis Group's thrombosis treatment, Plavix (clopidogrel bisulfate), again experienced the highest rate of growth, at 20.9 percent. Slogans Slogans The Food and Drug Administration The Food and Drug Administration is now requiring drug manufacturers to submit prescription drug label information to the agency in an electronic, structured product labeling format that allows consumers and physicians to more easily access and search for specific information about the product. The electronic product labels will be freely accessible through the Daily Med Web site (http://dailymed.nlm.nih.gov) within one business day of an approval action or label change. Most existing product labels will be posted on the Web site within one year, while labels for biologics, medical devices, veterinary drugs and some food products will be added later. Slogans Slogans The U.S. Department of Health and Human Services The U.S. Department of Health and Human Services released strategies for implementing President Bush's $7.1-billion plan for preparing for an influenza pandemic. The agency said it would employ travel-related and community-based measures to attempt to prevent or reduce viral transmission or outbreaks. HHS advised that there should be enough vaccines for the entire U.S. population and enough antiviral drugs for 25 percent of Americans. Since vaccines and antivirals would probably be in short supply at the beginning of a pandemic, HHS, state and local governments would work together to develop guidelines and plans for distributing the products to high-priority groups. Slogans Slogans Takeda Pharmaceutical Co. Ltd. Takeda Pharmaceutical Co. Ltd. and Pronova Biocare AS entered into a license and supply agreement for Pronova's Omacor (omega-3-acid ethyl esters 90), a treatment for hypertriglyceridemia. Under the agreement, Takeda was granted an exclusive development, marketing and distribution right for Omacor in Japan. Pronova will receive an up-front payment, development milestones and royalties once the product is launched. Omacor is approved and is commercially available in the United States for the treatment of high triglyceride levels in adults. In parts of Europe, it is also approved for the treatment of post-myocardial infarction. Slogans Slogans Cambridge Antibody Technology Group Plc Cambridge Antibody Technology Group Plc (CAT) acquired oncology product candidates GCR-3888 and GCR-8015 from Genencor International Inc. for up to $16 million. Currently, GCR-3888 is in a Phase II trial for the treatment of hairy cell leukemia, and GCR-8015, which is an optimized version of GCR-3888, is in preclinical development for the treatment of B-cell malignancies such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Both candidates are "immunotoxins comprising an antibody fragment that targets the CD22 receptor on B-lymphocytes fused to a toxin molecule, " CAT said. CAT will pay $14 million to Genencor at the close of the transaction, which is expected to be on Nov. 4, and Genencor will subscribe $14 million for 1,170,277 new CAT ordinary shares. Genencor may receive an additional $2 million from CAT, dependent on the availability of GCR-8015 bulk product material produced by Genencor for use in a clinical trial. Slogans


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