Consumer Research - Brand Institute, inc.



			Consumer Research 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 Sanofi-aventis reports increased sales in Q2; some drug sales fall below analyst expectations Sanofi-aventis Group said net sales for the second quarter of 2005 increased 6.5 percent on a reported basis. Despite the increase in sales, shares fell as sales of leading drugs increased less than analysts expected. Net sales for the quarter increased from approximately $7.65 billion (pro forma net sales on a reported basis) in the comparable period a year ago to approximately $8.09 billion this year, improving the company's world market share to 5.6 percent. Second-quarter sales of the stroke drug Plavix (clopidogrel bisulfate) were approximately $612.2 million; the diabetes drug Lantus (insulin glargine [rDNA origin] injection) had sales of approximately $353.3 million; and the cancer drug Eloxatin (oxaliplatin) had approximately $446.4 million in net sales. Sanofi-aventis said that it had received 100 percent of Plavix rights in Japan as of July 5. Sales of sleeping drug Ambien (zolpidem tartrate) and cancer drug Taxotere (docetaxel), however, missed analysts' estimates, which may have caused the company's shares to drop on Tuesday, Dow Jones Newswires reported. Ambien sales rose 6.9 percent to approximately $372.6 million, while analysts had predicted a 9 percent increase. Taxotere sales, meanwhile, improved 8.7 percent to $482.7 million, against the analysts' estimate of 15 percent, according to Dow Jones. The blood thinner Lovenox (enoxaparin sodium), sanofi-aventis' top sales performer, reached sales of $629.1 million, which was below expectations, Reuters reported. In addition to releasing sales information, sanofi-aventis said in a conference call that it submitted dronedarone, an arrhythmic drug, for marketing approval in the United States and in Europe, Dow Jones reported. Dronedarone is expected to be a blockbuster with annual revenue of $1 billion or more, Dow Jones said. Sanofi-aventis shares closed at $42.29, down $0.36, or 0.8 percent, in heavy trading on the New York Stock Exchange. Consumer Research Vertex, GSK's HIV drug receives fast track status from FDA Vertex Pharmaceuticals Inc. said the Food and Drug Administration granted fast track designation for the HIV protease inhibitor 640385 (VX-385) to GlaxoSmithKline Plc, which collaborates with Vertex on the development of HIV protease inhibitors. The fast track designation was based on a Phase IIa trial of 640385 as well as on in vitro studies that showed the drug's antiviral activity against HIV-1 strains that are resistant to many currently available protease inhibitors, Vertex said. "This designation recognizes the clinical and nonclinical results for 640385, which support the potential to address the needs of patients with resistant HIV strains," said Joshua Boger, chief executive officer of Vertex. GSK expects to begin a Phase IIb trial of 640385 in patients with HIV in the third quarter of this year, Vertex noted, adding that GSK plans to present preliminary Phase IIa data at a medical conference later this year. Vertex said the drug is the third orally active HIV protease inhibitor to be developed in its collaboration with GSK. Vertex co-promotes Lexiva (fosamprenavir calcium), an HIV protease inhibitor, with GSK. Consumer Research Combination therapy with Tysabri, Avonex shown to reduce disability, relapse rate among patients with MS New findings from the Sentinel trial, a Phase III add-on trial evaluating the use of Biogen Idec Inc. and Elan Corp. Plc's Tysabri (natalizumab) in conjunction with Biogen Idec's Avonex (interferon beta-1a), suggest this combination reduces disability and clinical relapse rate among patients with relapsing-remitting multiple sclerosis (RRMS) more than Avonex alone. The study data were reported in a Biogen Idec press release. The trial included 1,171 Avonex-treated patients with RRMS. Of these patients, those who continued to experience disease activity were randomized to receive Tysabri (n=589) or placebo (n=582) in addition to their standard Avonex regimens. After two years of treatment, the combination of Tysabri and Avonex reduced the risk of disability progression by 24 percent compared with Avonex plus placebo. Biogen Idec and Elan also noted that the Avonex-Tysabri combination significantly reduced the rate of clinical relapse by 56 percent compared with Avonex alone, a difference that was sustained throughout the two-year trial. The rate of infection was 1.6 per patient-year in both treatment groups; serious infections occurred in 2.9 percent of Avonex-treated patients and in 2.7 percent of patients treated with Avonex plus Tysabri. Hypersensitivity reactions, which have been linked with Tysabri use in the past, occurred in less than 1 percent of patients. "Tysabri continues to show benefit in the treatment of immune-mediated diseases," said Dr. Lars Ekman, president of research and development at Elan. "Patient safety is our top priority. We remain strongly committed to defining Tysabri's benefit-risk profile and determining the appropriate path forward." Biogen Idec and Elan voluntarily suspended U.S. sales and all trials of Tysabri in February based on reports of progressive multifocal leukoencephalopathy, a rare and potentially fatal demyelinating disease of the central nervous system. Consumer Research J&J's second-quarter earnings, revenue climb in 2005 compared with 2004 Johnson & Johnson reported increased net income in the second quarter of 2005 as a result of strong growth in sales in its medical devices and diagnostics division as well as in pharmaceuticals. Quarterly net earnings reached $2.68 billion, or $0.89 per diluted share, in 2005, compared with year-ago figures of $2.46 billion, or $0.82 per share. Excluding charges and a gain, earnings were $2.8 billion, or $0.93 per diluted share, versus $2.46 billion, or $0.82 per diluted share, in 2004. According to The Wall Street Journal, Thomson First Call estimated adjusted earnings per share of $0.91. Second-quarter sales rose 11.1 percent in 2005 to $12.8 billion from $11.48 billion in the second quarter of 2004. J&J noted its health care business as the key strength in the quarter. Each of its franchises in the Medical Devices and Diagnostics segment, including Cordis Corp.'s circulatory disease management products, had strong performance. Cordis' Cypher sirolimus-eluting coronary stent saw particularly strong growth. Furthermore, the company's Remicade (infliximab), which is indicated to treat rheumatoid arthritis, Crohn's disease, ankylosing spondylitis and psoriatic arthritis, and Topamax (topiramate), an antiepileptic drug and migraine prophylactic, demonstrated notable growth. Both of the drugs received additional approvals from the Food and Drug Administration during the quarter. J&J did recognize that sales of Duragesic (fentanyl) transdermal system for chronic pain were negatively impacted by generic competition. Furthermore, as reported, the FDA issued a Public Health Advisory for such skin patches last week although safety information was added to the Duragesic label earlier this month explaining the potency of fentanyl and cautioning that hypoventilation or potentially fatal fentanyl overdoses can occur. J&J shares closed at $65.02, up $0.42, or 0.7 percent, in heavy trading on the New York Stock Exchange. Consumer Research Chemokine Therapeutics' cancer drug granted orphan drug status Chemokine Therapeutics Corp.'s cancer drug, CTCE-9908, received orphan drug status from the Food and Drug Administration for the treatment of osteogenic sarcoma, a form of bone cancer that develops in children and young adults. CTCE-9908 belongs to a class of drugs known as cytostatic drugs, which are designed to slow the progression of cancer, according to Chemokine. The company added that these drugs are most effective when administered with cytotoxic drugs, which kill existing cancer cells. The drug was designed to block the CXCR4 receptor in order to prevent the growth of blood vessels that feed the tumor. Previous research has suggested that blocking this receptor may also increase chemotherapy's ability to kill cancer cells in the primary tumor, the company said. The drug has been successfully evaluated in a Phase I study; Chemokine plans to initiate a Phase Ib/II study during the fourth quarter of this year. "Like many cancers, osteogenic sarcoma is a cancer that spreads to distant sites, with the lungs as a secondary site for tumor development. We believe that the spread of cancer cells is due to an interaction between cancer cells and natural chemokine signals. Many researchers believe that blocking the signal can interrupt this migration," said Dr. Hassan Salari, Chemokine's chief executive officer. Consumer Research Boston Scientific's Q2 earnings affected by acquisition-related costs Boston Scientific Corp. announced 2005 second-quarter financial results that reflected continued success of its Taxus paclitaxel-eluting coronary stent, but negative impact from one-time charges for three recent acquisitions. Net income, including charges of $199 million for research and development costs related to the acquisitions of TriVascular Inc., CryoVascular Systems Inc. and Rubicon Medical Corp., was $205 million, or $0.24 per diluted share, in the 2005 second quarter. Last year's second-quarter earnings including charges totaled $313 million, or $0.36 per diluted share. Excluding one-time items, earnings were $404 million, or $0.48 per share, in the latest second quarter, up from year-ago earnings of $377 million, or $0.44 per share. Net sales for the second quarter increased 11 percent from $1.46 billion last year to $1.62 billion this year, which includes a $26 million favorable impact from foreign currency fluctuations. This quarter, U.S. sales of the Taxus Express2 paclitaxel-eluting coronary stent system were $467 million. Worldwide sales of the Taxus paclitaxel-eluting coronary stent systems increased 11 percent to $663 million in the quarter. Boston Scientific shares closed at $28.32, up $1.15, or 4.2 percent, in heavy trading on the New York Stock Exchange. Consumer Research Consumer Research The U.S. Senate The U.S. Senate approved the nomination of Lester Crawford as commissioner of the Food and Drug Administration by a vote of 78-16. Crawford had been serving as acting FDA commissioner since 2004, a position he also held in 2002. According to Reuters, the nomination had been held up since February of this year because of controversies surrounding a delay in a decision regarding easier access to emergency contraceptives and allegations of an affair with a subordinate. The FDA plans to make a decision on the emergency contraceptives by Sept. 1, and a government investigation of the affair found no basis for the charges. Consumer Research Consumer Research Eli Lilly and Co. Eli Lilly and Co. and Alkermes Inc. initiated the first Phase III trial of their inhaled insulin system for the treatment of diabetes. During the trial, 400 nonsmoking patients with type 1 diabetes will be randomized to open-label treatment with the inhaled insulin system or injected insulin for 24 months. Lilly and Alkermes formed an alliance in 2001 to develop the system, which uses Alkermes' AIR pulmonary drug delivery technology to administer human insulin inhalation powder. Consumer Research Consumer Research Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. said the Food and Drug Administration granted tentative approval for its Abbreviated New Drug Application for tramadol and acetaminophen tablets, 37.5 mg/325 mg, the generic equivalent of Ortho McNeil Pharmaceutical Inc.'s Ultracet tablets indicated for the short-term management of acute pain. According to Teva, final approval is expected after patent litigation has been resolved. The company said annual sales of Ultracet are approximately $338 million. Consumer Research Consumer Research Gilead Sciences Inc. Gilead Sciences Inc. and Royalty Pharma entered into a $525 million agreement with Emory University to eliminate royalties due to the university for Gilead's HIV treatment Emtriva (emtricitabine). Gilead will pay 65 percent of the one-time cash payment while Royalty Pharma will pay 35 percent. Following the transaction, which is expected to close on or before July 29, Gilead will be obligated to pay royalty revenue to Royalty Pharma on future Emtriva net sales and will continue to pay certain royalties to GlaxoSmithKline Plc, fulfilling Emory's obligations under a previous agreement. Consumer Research Consumer Research Able Laboratories Inc. Able Laboratories Inc. filed a petition to claim bankruptcy under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of New Jersey. As reported, the firm suspended manufacturing operations and has recalled its product line and is currently not generating any income or revenue. The bankruptcy filing is intended to assist Able to continue while it works with the Food and Drug Administration to address a number of issues. Able shares closed at $1.66, up $0.26, or 18.6 percent, in heavy trading on the Nasdaq. Consumer Research


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