Product Launches - Brand Institute, inc.



			Product Launches 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 board agrees to merger with Boston Scientific, cancels agreement with J&J Guidant Corp.'s board of directors unanimously approved and entered into a $27 billion merger agreement with Boston Scientific Corp. after terminating its former arrangement with Johnson & Johnson. "We believe the transaction and the strategic rationale for this combination are in the best interests of our patients, employees, customers and shareholders--reflecting the full value of our firm. The combination of these two companies provides faster, more consistent revenue growth opportunities to shareholders," title="branding company" said Jim Cornelius, Guidant's chief executive officer. Thus, Boston Scientific will acquire all outstanding Guidant shares for $80 each in cash and stock. Based on the average closing price of Boston Scientific's stock during the 20 days ending three days prior to the transaction closing date, Guidant shareholders will receive $42 in cash and between 1.6799 and 1.3167 Boston Scientific shares for each Guidant share. "As a highly diversified company with leading positions in growth markets, Boston Scientific/Guidant will be one of the world's preeminent medical device companies, with total revenue in 2006 of nearly $9 billion," title="branding company" Boston Scientific explained. J&J said it "determined not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders." title="branding company" Guidant noted that the $705 million termination fee it owes to J&J by Jan. 26 under terms of their prior merger agreement will be reimbursed by Boston Scientific. Additionally, the meeting scheduled for Jan. 31, during which Guidant shareholders were to vote on the merger between the company and J&J, has been cancelled. Abbott will still provide Boston Scientific with $6.4 billion in cash on or around the closing date of the Guidant transaction, which includes $4.1 billion to purchase Guidant's vascular intervention and endovascular businesses from Boston Scientific. The transaction between Boston Scientific and Guidant is subject to usual closing conditions and approval of the firms' shareholders, but Boston Scientific hopes to complete the deal by the end of the first quarter. On the New York Stock Exchange, Guidant shares closed at $75.19, down $1.59, or 2.1 percent, in moderate trading, while Boston Scientific shares closed at $23.54, down $0.46, or 1.9 percent, and J&J shares closed at $58.50, down $0.86, or 1.5 percent, both in heavy trading. Product Launches Berlexs investigational PMDD treatment, Yaz, receives approvable letter The Food and Drug Administration sent an approvable letter to Schering AG's U.S. affiliate, Berlex Inc., for Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) for the indication of premenstrual dysphoric disorder. Although the FDA did not request additional clinical trials, the agency needs to review recently submitted data before approval is granted. Schering expects a decision to be made in the first quarter of this year. In 2004, Berlex received an approvable letter for Yaz's use as an oral contraceptive; the FDA's approval for that indication is still pending. Yaz is a lower-dose form of Schering's oral contraceptive, Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg), according to Reuters. Analysts predict that these two drugs, combined, will reach blockbuster status. Product Launches CepTor's Myodur receives orphan drug status for two muscular dystrophy indications The Food and Drug Administration granted CepTor Corp. orphan drug designation for its lead product, Myodur (C-101), to treat both Duchenne and Becker muscular dystrophies. CepTor said Duchenne muscular dystrophy is more common and aggressive than Becker, but both affect only males and are characterized by progressive weakness and degeneration of the skeletal or voluntary muscles that control movement. Duchenne affects approximately 25,000 boys in the United States and the European Union and usually results in walking braces for boys between the ages of 6 and 8 years, wheelchair dependency for boys aged between 10 and 13 years and death in late adolescence. The biopharmaceutical firm said Myodur includes a carnitine carrier molecule and leupeptin analogue and has been specifically designed to target muscle cells and normalize the calpain levels in order to preserve muscle tissue. Previous studies have linked abnormally high upregulation of calpain with muscular degenerative diseases. CepTor submitted an Investigational New Drug application earlier this month to initiate a Phase I/II trial of Myodur. The company said Myodur demonstrated a statistically significant effect in preserving muscular skeletal tissue among treated Duchenne muscular dystrophy genetic animal models compared with untreated models in in-vivo studies. Product Launches Effexor appears to relieve comorbid somatic pain in patients with depression, anxiety disorders A recent double-blind, placebo-controlled trial indicates that Wyeth's Effexor XR (venlafaxine hydrochloride) extended-release may effectively relieve certain types of somatic physical symptoms, especially pain, in patients who have depression and/or anxiety disorders. The study, published in the January edition of the Journal of Clinical Psychiatry, included 112 outpatients with multisomatoform disorder along with major depressive disorder, generalized anxiety disorder or social anxiety disorder. To receive a diagnosis of multisomatoform disorder, patients must have presented with at least three bothersome symptoms and a two-year history of somatization (the conversion of emotional, mental and/or psychosocial problems into physical symptoms). The patients were randomized to therapy with titrated Effexor XR or placebo for 12 weeks. The primary efficacy variable was the change in somatic symptom severity score on the 15-item Patient Health Questionnaire (PHQ-15; total score range, 0 to 30). Treatment with either Effexor or placebo led to significant declines in the PHQ-15 somatic symptom severity scores of 8.3 and 6.6, respectively, but the between-group difference was not significant. However, Effexor-treated patients showed a greater rate of response (defined as a PHQ-15 total score of less than 10) than did placebo-treated patients (51 percent vs. 37 percent), with a difference that approached statistical significance. The time to response was also quicker with Effexor rather than with placebo (54 days vs. 71 days). On the PHQ-15 pain subscale and the Medical Outcomes Study Short Form 36-item questionnaire, the Effexor arm also showed greater improvement than did the placebo group. As one of the few trials conducted in patients with a somatization spectrum disorder, this study suggested that Effexor "was generally well tolerated and showed significantly greater improvement than placebo on some measures of global clinical improvement, patient-rated pain symptoms and functional status in the mental health domain," title="branding company" the authors summarized. Effexor is currently indicated to treat major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder. Product Launches BMS' Q4, full-year results reflect increased drug competition Bristol-Myers Squibb Co. reported higher fourth-quarter and full-year earnings in 2005, but lower sales due partly to increased generic competition for certain products. Fourth-quarter earnings totaled $499 million, or $0.26 per diluted share, an increase from $139 million, or $0.07 per share, reported in the year-ago period. Excluding charges, earnings from continuing operations were $601 million, or $0.31 per diluted share, for the fourth quarter compared with $776 million, or $0.39 per diluted share, in the fourth quarter of 2004. Analysts at Reuters Estimates expected earnings of $0.28 per share in the fourth quarter. BMS posted $5.02 billion in sales in the fourth quarter, a decrease of 1 percent from 2004. BMS earned $3 billion, or $1.52 per diluted share, for the full year compared with $2.39 billion, or $1.21 per diluted share, in 2004. Net sales fell 1 percent from $19.38 billion to $19.21 billion. Worldwide and U.S. sales for BMS and sanofi-aventis Group's antiplatelet drug, Plavix (clopidogrel bisulfate), continued to grow in the fourth quarter and full year of 2005, recording U.S. sales of $906 million for the fourth quarter and $3.24 billion for the full year. For 2006, BMS expects full-year earnings to total between $1.15 and $1.25 per diluted share on an adjusted basis. The firm noted that it expects reduced net sales again for certain products due to exclusivity losses and expected generic competition, such as in the case of its cholesterol drug, Pravachol (pravastatin sodium). Also, as previously reported, Apotex Inc.'s generic version of Plavix was recently approved. Sanofi-aventis contends that clopidogrel bisulfate is still under patent protection, noting that a patent trial is slated for April. Furthermore, BMS added that it is involved in "a number of significant pending lawsuits, claims, proceedings and investigations," title="branding company" but that it would not be able to account for their final outcomes. BMS shares closed at $21.97, up $0.64, or 3 percent, in heavy trading on the New York Stock Exchange. Product Launches Abbott posts sales growth, slightly higher net income in Q4, full year Net sales of Abbott jumped for the fourth quarter and full year ended Dec. 31, but were offset by special charges, leading to a slight increase in net earnings. Net earnings in the fourth quarter rose slightly from $974.6 million to $976.4 million, or from $0.62 to $0.63 per diluted share. Excluding charges and litigation reserves, the firm would have earned $1.18 billion, or $0.76 per share, during the fourth quarter. This figure met analysts' forecasts, according to Reuters Estimates. Abbott's sales also increased in the fourth quarter, rising by 7 percent to $6.05 billion, up from $5.65 billion in the fourth quarter of 2004. For the full year, net earnings showed more growth, increasing 4.2 percent to $3.37 billion from $3.24 billion in the prior year. Per diluted share, the company earned $2.16 compared with $2.06 in 2004. Net sales increased 13.5 percent, from $19.68 billion in the prior year to $22.34 billion in 2005. Arthritis drugs Humira (adalimumab) and Mobic (meloxicam), anticonvulsant Depakote (divalproex sodium) and cholesterol drug Tricor (fenofibrate) spurred sales at both time points. Specifically, Humira and Mobic achieved global sales of $1.4 billion and $1.23 billion, respectively, in 2005, an increase of 64.4 percent and 107.8 percent, respectively, from 2004. Abbott is distributing and co-promoting Boehringer Ingelheim GmbH's Mobic in the United States. Abbott also confirmed its 2006 adjusted per-sharing earnings guidance of between $2.66 and $2.72 and predicted adjusted earnings of between $0.62 and $0.64 per share in the first quarter of this year. Humira is expected to achieve $1.9 billion in 2006 global sales. A Thomson First Call survey indicated that analysts expect average earnings of $0.63 per share in the first quarter and $2.68 for the full year, The Wall Street Journal noted. Abbott shares closed at $42.17, up $2.11, or 5.3 percent, in heavy trading on the New York Stock Exchange. Product Launches Product Launches Targeted Genetics Corp. Targeted Genetics Corp. plans to restructure its operations by reducing expenses and realigning resources in order to advance its lead product candidate, tgAAC94, an investigational inflammatory arthritis treatment. Targeted Genetics reduced its workforce by 26 employees, approximately 27 percent of its total workforce. Those laid off were primarily in early-stage research and development groups, operations and general administration. H. Stewart Parker, chief executive officer of Targeted Genetics, predicted a cash burn for 2006 to be at least 20 to 25 percent less than 2005, creating "a better opportunity to achieve [the company's] goals for 2006 and position the company for the future." title="branding company" Product Launches Product Launches WellPoint Inc. WellPoint Inc.'s net income for the fourth quarter of 2005 was $652 million, or $1.04 per diluted share. On a comparable basis, net income for the fourth quarter of 2004 was $406.8 million. Revenue for the quarter also increased, up from $10.8 billion on a comparable basis to $11.43 billion in 2005. In 2004, Anthem Inc. acquired WellPoint Health Networks Inc. and renamed the company WellPoint Inc. Previously, the company predicted it would earn $4.51 per share in 2006, but it increased the prediction to $4.54 per share. WellPoint shares closed at $72.86, down $0.33, or 0.5 percent, in heavy trading on the New York Stock Exchange. Product Launches Product Launches Kosan Biosciences Inc. Kosan Biosciences Inc. initiated a Phase I clinical trial of an oral formulation of KOS-1022 (DMAG), a second-generation heat shock protein 90 (Hsp90) inhibitor. Researchers will investigate whether treating patients with cancer with KOS-1022 capsules will lead to enhanced antitumor activity. The trial will include patients with advanced solid tumors and will evaluate the safety, pharmacokinetics, pharmacodynamics and bioavailability of escalating doses of the drug, as well as assess any preliminary evidence of antitumor activity. KOS-1022 in its intravenous form is currently being studied in multiple Phase I trials. Product Launches Product Launches GeoVax Inc. GeoVax Inc., a privately held biotechnology company, and Dauphin Technology Inc., a publicly traded company with no current business operations, agreed to merge. The merged company will be named GeoVax Labs Inc. Current shareholders of GeoVax will own 67 percent of the new company's outstanding capital, while Dauphin shareholders will own 33 percent. GeoVax expects the merger will help further develop, manufacture, test, license and commercialize vaccines for diseases caused by HIV-1 and other infectious agents. The merger is subject to approval by the shareholders of the companies and other customary closing conditions. Product Launches


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