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			Brand Name 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 Merck's HPV vaccine effective at blocking all precursors to cervical cancer associated with HPV 16 and 18, study shows Merck & Co. Inc. said a Phase III study of its investigational quadrivalent human papillomavirus (HPV) vaccine, Gardasil, showed the vaccine is capable of preventing 100 percent of high-grade cervical pre-cancers known as cervical intraepithelial neoplasia (CIN) and noninvasive cervical cancers, such as adenocarcinoma in situ (AIS), associated with HPV types 16 and 18. In this study, titled FUTURE II, women aged 16 to 26 years who were not infected with HPV 16 or 18 received three doses of Gardasil or placebo and were followed for an average of two years to determine whether the vaccine was effective at preventing CIN and AIS in these patients. The primary analysis revealed that no cases of CIN or AIS were reported among 5,301 patients who received Gardasil compared with 21 cases reported among 5,258 patients who received placebo. A secondary analysis evaluated the incidence of CIN and AIS in a broader group of women, which included those who may have become infected with HPV 16 or 18 during the vaccination period or who may have significantly violated the study protocol. In this group, only one case of CIN or AIS was reported in the 5,736 women who received the vaccine compared with 36 cases in the 5,766 women who received placebo. The vaccine was well tolerated, with local discomfort at the injection site reported as the most common adverse event. Results from the study will be presented at the annual meeting of the Infectious Diseases Society of America. According to Reuters, analysts believe Gardasil could bring in peak annual sales of more than $2 billion. This total would provide a much-needed jolt to Merck's coffers, which may suffer as a result of the thousands of lawsuits the company faces from former Vioxx users and their families. Brand Name Statins seem to reduce fracture risk in elderly men A recently published retrospective study showed that male veterans who took statins had a significant reduction in fracture risk when compared with those who took nonstatin lipid-lowering drugs or no lipid-lowering therapy. The researchers studied 91,052 patients who received care in the New England Veterans Affairs health care network between January 1998 and June 2001. Of these patients, only 4,321 were women. When segmented by type of lipid-lowering treatment, 28,063 received only statins, 2,195 received only nonstatin lipid-lowering agents and 60,794 received no lipid-lowering medication. Overall, 394 fractures occurred in the statin-only group, 51 occurred in the nonstatin lipid-lowering group and 2,018 occurred in the no-therapy group. In the adjusted logistic regression model, statin use was associated with a 36 percent reduction in fracture risk when compared with no use of lipid-lowering therapy and a 32 percent reduction in fracture risk when compared with nonstatin lipid-lowering drugs. The difference in fracture risk between the nonstatin therapies and no treatment was not significant. A similar finding was evident in a nested retrospective cohort study of new statin users, defined as patients who had been observed for at least three months before receiving a statin prescription. The investigators explained that many previous studies have demonstrated the reduced fracture risk in elderly women who take statins, but they wanted to see if the results would be similar in elderly men. Because the debate continues as to whether statins reduce fractures, the researchers said "[i]t is evident that more studies need to be performed to address this controversy." The complete study was published in the Sept. 26 issue of Archives of Internal Medicine. Brand Name Treatment with Cialis gives men with ED more flexibility in sexual timing, study finds Treatment with Lilly ICOS LLC's Cialis (tadalafil), which has a duration of action of 36 hours, may provide men with erectile dysfunction more flexibility in deciding when to attempt intercourse, according to data from a study published in the October issue of the Journal of Urology. Data were pulled from two identically designed, randomized, double-blind, parallel-group studies in which 544 patients with ED self-administered Cialis 20 mg or placebo as needed for 12 weeks. The researchers assessed the frequency, timing and success of the patients' intercourse attempts to determine whether they took advantage of the drug's pharmacological profile. Throughout a 36-hour post-dose period, patients who received Cialis achieved significantly higher rates of intercourse success compared with patients who received placebo; 61 percent to 69 percent of patients in the Cialis groups reported success rates exceeding 75 percent compared with 19 percent to 30 percent of patients in the placebo groups who reported such success. The researchers also found that 63 percent of the patients made at least a quarter of their attempts and 42 percent of the patients made at least half of their attempts at intercourse more than four hours after dose. Furthermore, 85 percent, 75 percent and 52 percent of the patients attempted intercourse at least once after eight, 12 and 24 hours, respectively, indicating that patients did indeed take advantage of Cialis' extended period of efficacy. The drug appeared to be well tolerated in these studies. "Flexibility in deciding when to dose and when to attempt intercourse with no food restrictions, coupled with a high success rate, may enhance spontaneity and enable some men to forget their problem and return to sex patterns from before the onset of ED," the authors suggested. "These data support the concept that a long duration of action may loosen the link between dose and intercourse, allowing more desirable sexual behavior patterns to emerge." Brand Name In recurrent genital herpes, Famvir reduces time to viral shedding cessation, lesion healing, study shows Novartis AG's Famvir (famciclovir), dosed twice daily for five days, proved to be significantly more effective than placebo was at reducing the duration of viral shedding from all genital lesions and accelerating the time to lesion healing in immunocompetent adults who had recurrent genital herpes, according to a recently published study. The double-blind study was conducted in five Canadian clinics; included were 308 patients who had recurrent genital herpes with genital lesions that had not progressed beyond the ulcer stage and had not been present for more than 6.5 hours at the time of initial dosing. Patients were randomized to receive placebo or Famvir in doses of 125 mg, 250 mg or 500 mg twice daily for five days. Viral shedding from all genital lesions stopped significantly more quickly with Famvir than with placebo; indeed, the median time to cessation of viral shedding for all lesions was 1.6 days with Famvir 125 mg, 1.7 days with Famvir 250 mg, 1.4 days with Famvir 500 mg and 3.4 days with placebo. The time to complete healing of the original lesions, the other primary efficacy variable, also was significantly shorter with Famvir as compared with placebo. "All dosages of [Famvir] stopped viral shedding twice as fast as did placebo and effected lesion healing at least one-half of a day faster than did placebo. Patients receiving [Famvir] were significantly less likely to form new lesions. Furthermore, treatment with [Famvir] significantly reduced the duration of lesion-associated symptoms, including tenderness, itching and pain, taken separately and together," the study authors concluded. Complete data are available in the Oct. 15 issue of the journal Clinical Infectious Diseases. Brand Name Boniva appears to be similarly safe, tolerable in younger, older patients with fractures Older patients who receive F. Hoffmann-La Roche Ltd. and GlaxoSmithKline Plc's Boniva (ibandronate sodium) do not have a greater risk of adverse events when compared with their younger counterparts or patients who receive placebo, according to a subgroup analysis of the BONE trial. The Phase III BONE study included postmenopausal women who had one to four prevalent vertebral fractures. They were randomized to receive placebo, a daily oral dose of 2.5 mg of Boniva or an intermittent oral dose of Boniva for more than three years. A subgroup safety analysis was also performed, separating patients into those younger than 70 years old and those aged 70 years or older. The older patients experienced a similar incidence of adverse events, regardless of treatment type (89.7 percent for daily Boniva, 91 percent for intermittent Boniva and 88.6 percent for placebo). The percentage of drug-related adverse events also was generally comparable between older and younger patients who received either dosage of Boniva and between the patients who received Boniva or placebo. Moreover, the frequency of upper gastrointestinal adverse events was similar among the older patients in all treatment groups: rates were 22.5 percent for those who took daily Boniva, 22.3 percent for those who took intermittent Boniva and 25.2 percent for those in the placebo group. "That older patients in both [Boniva] groups and the placebo arm experienced slightly more serious adverse events and adverse events leading to study withdrawal than younger patients probably reflects the higher general comorbidity in older patients," the study authors noted. This analysis appears in the October issue of The Journal of Rheumatology. Although oral Boniva is approved in the United States to treat postmenopausal osteoporosis, it has not yet been distributed. Once-monthly oral and intermittent intravenous injections of Boniva are currently being evaluated in late-stage clinical studies. Brand Name St. John's wort more effective than fluoxetine, placebo in study of patients with major depressive disorder Researchers found that patients with major depressive disorder (MDD) who were treated with Hypericum perforatum, more commonly referred to as St. John's wort, had significantly improved scores on a commonly used depression rating scale as compared with patients treated with fluoxetine hydrochloride. The double-blind study, which compared the efficacy and safety of St. John's wort with that of fluoxetine and placebo, included 135 patients with a diagnosis of MDD and a score of at least 16 on the Hamilton Rating Scale for Depression (HAMD-17). After a one-week washout period, patients were randomized to one of three treatment regimens: 900 mg/day of St. John's wort (taken in three 300 mg doses), 20 mg/d of fluoxetine or placebo. The treatment period lasted 12 weeks. The primary efficacy endpoint was the change in HAMD-17 score from baseline to week 12. Secondary efficacy measures included the Clinical Global Impressions (CGI) Severity of Illness and CGI Improvement scales and the Beck Depression Inventory. Rates of study completion among the groups were 60 percent for the St. John's wort group, 51 percent for the fluoxetine group and 49 percent for the placebo group. Overall, those treated with St. John's wort exhibited a significantly greater decrease in HAMD-17 scores as compared with patients treated with fluoxetine. A trend toward a significantly greater decrease in HAMD-17 scores was observed at week 1 and week 12 when the St. John's wort group was compared with the placebo group. In addition, patients who received St. John's wort demonstrated higher rates of remission, indicated by a HAMD-17 score of less than 8, than did patients in the fluoxetine and placebo groups, although the differences between the groups were not statistically significant. Further, the St. John's wort group showed either significantly lower scores or a trend toward significantly lower scores on the CGI scales as compared with the other two treatment groups. "In summary," the researchers wrote, "in our study of outpatients with mild to moderate MDD, a well-standardized preparation of H. perforatum extract was significantly more effective than fluoxetine and showed a trend toward superiority over placebo." They also noted that St. John's wort appeared to be safe and well tolerated. Headache was the most commonly reported adverse event in the trial, reported by 42 percent, 26 percent and 28 percent of patients treated with St. John's wort, fluoxetine and placebo, respectively. The formulation of St. John's wort used in the study was Lichtwer Pharma AG's LI-160, and Eli Lilly and Co.'s Prozac was the formulation of fluoxetine used. St. John's wort products are available from multiple manufacturers, as are generic versions of fluoxetine. Results of the study were published in the October issue of the Journal of Clinical Psychopharmacology. Brand Name Brand Name Centocor Inc. Centocor Inc.'s Remicade (infliximab) received approval from the European Commission as a treatment for moderate to severe plaque psoriasis in adults who have not responded to, have a contraindication to or are intolerant of other systemic therapies. The approval was based on successful results of the SPIRIT and EXPRESS trials. The drug is marketed by Centocor in the United States, while Schering-Plough Corp. markets it outside of the United States, except in parts of Asia where it is marketed by Tanabe Seiyaku Co. Ltd. or Xian-Janssen. Brand Name Brand Name Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. reported a supply outage of BiCNU (carmustine), an injectable chemotherapy. The company previously reported a supply shortage in May and said it is continuing to work toward resolving the problem. In the meantime, BMS recommends the use of alternative treatment approaches when possible. Brand Name Brand Name ActivBiotics Inc. ActivBiotics Inc. will proceed with the clinical development of its lead compound, rifalazil, to be used in the treatment of peripheral arterial disease (PAD). ActivBiotics said the compound represents a promising new approach to treating the debilitating condition, which is a complication of atherosclerosis. The company plans to conduct a randomized, placebo-controlled study of the drug, which focuses on symptomatic relief in patients with lower extremity PAD. Rifalazil was originally developed to treat chlamydia. Brand Name Brand Name Telik Inc. Telik Inc. received clearance from the Food and Drug Administration to move forward with its clinical trials of an oral formulation of Telintra (TLK199). The company is currently conducting a trial of Telintra as a parenteral formulation. The first clinical study of the oral formulation will be conducted in patients with myelodysplastic syndrome; if this trial is successful, the company said it may evaluate the drug for other indications. The small molecule product candidate is designed to stimulate the production of blood cells in bone marrow. Insufficient blood cell levels can occur with myelodysplastic syndrome or with the use of chemotherapeutic drugs. Brand Name Brand Name


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