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Corporate Internet BrandingBrand 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 Genitope must continue trial of cancer vaccine; shares fallGenitope Corp.'s shares fell 27.9 percent Tuesday after the company said that its independent Data Safety Monitoring Board recommended continuing the Phase III trial of MyVax Personalized Immunotherapy, which is intended to treat follicular non-Hodgkin's lymphoma, as planned. The study of MyVax, Genitope's lead product candidate, is designed to evaluate the safety and efficacy of the immunotherapy by comparing patients treated with MyVax to patients taking a nonspecific immunotherapy control. The Los Angeles Times reported that the 300-patient trial was scheduled to be completed in 2007, but Genitope had hoped MyVax might produce results sooner. According to TheStreet.com, the monitoring board's recommendation will slow discussions with the Food and Drug Administration about the vaccine's approval. Genitope said the next interim review of the data is scheduled for mid-2006. A lot is riding on the MyVax trial, the LA Times reported, adding that Genitope has between 12 and 18 months of cash remaining. Shares of Genitope closed at $8.80, down $3.41, in heavy trading on the Nasdaq. Corporate Internet Branding FDA accepts NDA for Neurocrine's indiplon tablets Neurocrine Biosciences Inc. said the Food and Drug Administration accepted the company's New Drug Application for indiplon tablets for review for the treatment of insomnia in adult and elderly patients. Indiplon, a non-narcotic, nonbenzodiazapine agent that acts on a specific site of the GABA-A receptor, was developed to address different types of sleep problems and has been shown to bind selectively to the specific subtype of GABA-A receptors in the brain that are thought to be responsible for promoting sleep, the company said. In May, Neurocrine resubmitted an NDA for indiplon tablets to address formatting difficulties associated with an electronic NDA submitted in November 2004. Last month, the FDA accepted the company's NDA for indiplon capsules. "This is an exciting milestone for Neurocrine and represents the company's first completed NDA filing," said Gary Lyons, chief executive officer of Neurocrine. "Data from these two submissions are supported by one of the most comprehensive clinical trial programs in insomnia and demonstrates the long-term safety and efficacy profile of indiplon in helping patients with sleep onset and sleep maintenance problems." Neurocrine licensed the drug from DOV Pharmaceutical Inc. in 1998. If approved, indiplon will be co-promoted in the United States with Pfizer Inc. Corporate Internet Branding Biogen Idec's Q2 earnings, revenue rise Despite taking $20 million in charges related to its suspended multiple sclerosis drug Tysabri (natalizumab), Biogen Idec Inc. posted sharp second-quarter earnings gains, largely due to increased revenue from an older MS treatment, Avonex (interferon beta-1a), and non-Hodgkin's lymphoma drug Rituxan (rituximab). For the second quarter, net income totaled $34.5 million, or $0.10 per diluted share, compared with $0.8 million, or nil per share, in the previous-year period. Excluding charges, the company earned $149 million, or $0.43 per share, which is $0.07 more than what analysts polled by Reuters Estimates expected. This compares with adjusted earnings of $121.7 million for the second quarter of 2004. Total revenue rose 12 percent to $605.6 million, up from $538.8 million in the second quarter of 2004. Avonex sales grew 10 percent to $381.8 million, while the firm's revenue from its joint venture with Genentech Inc. for Rituxan increased 22 percent to $184.9 million. James Mullen, Biogen Idec's chief executive officer, added that an extensive safety evaluation of Tysabri is ongoing. "We look forward to the expected completion of the evaluation by the end of the summer and to further discussion with the regulatory authorities regarding the path forward for Tysabri," Mullen said. Biogen Idec and Elan Corp. Plc 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. Corporate Internet Branding Topamax shows potential in new study as treatment for cigarette smoking in alcohol-dependent individuals Ortho-McNeil Neurologics Inc.'s Topamax (topiramate) demonstrated potential as a safe and promising therapy for the treatment of cigarette smoking in alcohol-dependent individuals, according to trial results published in the July 25 issue of the Archives of Internal Medicine. In a subgroup analysis of a 150-patient, double-blind, randomized, 12-week study comparing Topamax with placebo as a treatment for alcohol dependence, researchers compared the drug with placebo in 94 cigarette-smoking, alcohol-dependent individuals. The primary outcome was smoking cessation determined by self-report and confirmed by the level of nicotine's major metabolite, serum cotinine. Results showed that patients who received Topamax were significantly more likely to abstain from smoking than the patients in the placebo group. With a benchmark serum cotinine level of 28 ng/mL used to separate smokers and nonsmokers, researchers found that the Topamax group had 4.97 times the odds of being nonsmokers. In addition, the Topamax group had smoking cessation rates of 19.4 percent and 16.7 percent at weeks nine and 12, respectively, compared with 6.9 percent at both time points for patients who received placebo. "This finding should garner scientific interest because no medication has been established as an effective treatment for comorbid alcohol and nicotine dependence," the study authors concluded. According to Dr. Bankole Johnson, the study's lead author, approximately 80 percent to 90 percent of alcoholics are also addicted to nicotine, Dow Jones Newswires reported. Johnson also said that since the area of the brain that processes alcohol is different from the area that processes nicotine, researchers think the addictions are different and are looking into individual treatments for each addiction. A spokeswoman for Ortho-McNeil Neurologics confirmed that the company is funding another alcohol study but added that it was too soon to determine if an alcohol- or smoking-cessation indication would be sought for Topamax, Dow Jones Newswires stated. Topamax is indicated as a treatment for epilepsy and to prevent migraines. Corporate Internet Branding Procter & Gamble's testosterone patch may increase sexual desire in surgically menopausal women, study shows Procter & Gamble Co.'s Intrinsa (testosterone) patch increased sexual desire and frequency of satisfying sexual activity in women who had lower libido following surgical menopause, according to a study published in the July 25 issue of Archives of Internal Medicine. The 24-week, randomized, double-blind, placebo-controlled trial included 447 women (aged 24 to 70 years) who developed hypoactive sexual desire disorder after salpingo-oophorectomy and hysterectomy and who were being treated with oral estrogen therapy. All women also had to be in a monogamous sexual relationship with a sexually functioning partner for at least one year; 318 women completed the study. Patients were randomized to receive Intrinsa patches in dosages of 150 mcg/day (n=107), 300 mcg/d (n=110) or 450 mcg/d (n=111) or placebo twice a week for 24 weeks. The primary endpoints were sexual desire and frequency of satisfying sexual activity. Women who used the 300 mcg/d patch demonstrated significantly greater increases from baseline in sexual desire and in frequency of satisfying activity compared with women who took placebo (67 percent vs. 48 percent and 79 percent vs. 43 percent, respectively). Women who used the smaller dose patch showed no evidence of a treatment effect, while the 450 mcg/d group was not statistically different from the placebo or 300 mcg/d groups. Researchers noted that the participants in the study had a strong placebo response, but speculated that participation in the study "may have increased dialogue between the study subjects and their partners, leading to improvements in sexual satisfaction." "Despite the placebo response, our study did find statistically significant improvements in sexual functioning in women receiving transdermal testosterone at a dosage of 300 mcg/d compared with women receiving placebo," the researchers concluded. In December 2004, a Food and Drug Administration advisory panel unanimously recommended the agency require additional safety testing prior to granting approval of the patch, The Associated Press reported. Later that month, P&G withdrew its application for the patch. The Wall Street Journal said the company hoped to submit a new application following the results of a Phase III trial testing the patch in naturally menopausal women. P&G, which funded the study, is developing Intrinsa in collaboration with Watson Pharmaceuticals Inc. Corporate Internet Branding Retail pharmacy sales for 12 months ended in May rise 6 percent in key global markets Drug sales through retail pharmacies in 13 key markets rose 6 percent at a constant exchange rate to $359.07 billion from June 2004 to May 2005, according to IMS Health's Retail Drug Monitor. For the 12-month period ended May 2004, retail pharmacy drug sales totaled $330.69 billion. U.S. retail drug sales grew 6 percent to $178.38 billion during the period, led by $41.2 billion in sales of central nervous system drugs. In the United States and Canada, cardiovascular drugs experienced a growth of 11 percent at constant exchange, reaching $35.71 billion. Sales growth rates in the top five European markets, the top three Latin American markets and Japan were 4 percent, 15 percent and 4 percent, respectively. Once again, Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin calcium), was the best-selling drug, with global sales totaling more than $10.9 billion. Bristol-Myers Squibb Co. and sanofi-aventis Group's thrombosis treatment, Plavix (clopidogrel bisulfate), again experienced the highest rate of growth, at 24.8 percent. Corporate Internet Branding Corporate Internet Branding Invitrogen Corp. Invitrogen Corp. signed a definitive agreement to acquire BioSource International Inc. for approximately $130 million in cash. BioSource shareholders will receive $12.50 per share. Invitrogen said the acquisition will expand its collection of proteins and primary antibody products that it obtained from its recent purchases of Zymed Laboratories Inc. and Caltag Laboratories and will give the company access to new markets in immunology, oncology and neurodegenerative disease. The acquisition is expected to close by the end of the year. Invitrogen does not expect the acquisition to affect 2005 earnings, but believes it should increase 2006 income by $0.04 a share. Invitrogen shares closed at $86.50, up $1.47, or 1.7 percent, in moderate trading on the Nasdaq and BioSource shares closed at $12.32, up $0.92, or 8.1 percent, in heavy trading on the Nasdaq. Corporate Internet Branding Corporate Internet Branding Epimmune Inc. Epimmune Inc.'s multi-epitope recombinant protein vaccine, EP-1043, will be tested under an active Investigational New Drug application held by the National Institute of Allergy and Infectious Diseases as a vaccine component intended to prevent HIV infection. The HIV Vaccine Trials Network will evaluate the vaccine candidate, which is designed to induce HIV-1 specific helper T-lymphocyte responses, in a randomized, placebo-controlled, dose-escalation Phase I trial. Part A of the two-part trial will test the safety and maximum tolerated dose of EP-1043 and Part B will determine the safety and tolerability of EP-1043 when administered in combination with the company's EP-1090, which is currently being tested in Phase I clinical trials for the treatment of HIV infection. Corporate Internet Branding Corporate Internet Branding Valeant Pharmaceuticals International Valeant Pharmaceuticals International plans to begin enrolling patients in the third quarter of 2005 for a Phase III trial of retigabine, a potential adjunctive treatment for partial-onset seizures in patients with epilepsy. A second Phase III trial is expected to begin enrollment in the fourth quarter of the year. Valeant based the decision to start the trials after consultation with the Food and Drug Administration regarding the study's protocol design. Retigabine, which works as a potassium-channel opener and a potentiator of gamma aminobutyric acid, "represents an entirely new mechanism of action for the treatment of partial onset seizures," said Timothy Tyson, Valeant's chief executive officer. He noted that the drug has the potential of reaching more than $500 million in sales just in the treatment of epilepsy. Results from the two studies are expected to be ready in the second half of 2007. Valeant shares closed at $19.96, up $0.56, or 2.9 percent, in moderate trading on the New York Stock Exchange. Corporate Internet Branding Corporate Internet Branding Zars Inc. Zars Inc. said the Food and Drug Administration approved its Synera (lidocaine 70 mg/tetracaine 70 mg) topical local anesthetic patch. Synera, which was developed under the name S-Caine Patch, is Zars' first product to receive FDA approval, the company said. The patch is designed to numb the skin before medical procedures. It is indicated for use in children and adults and will be available soon in the United States. Corporate Internet Branding Corporate Internet Branding Dor BioPharma Inc. Dor BioPharma Inc. and Dowpharma, a unit of The Dow Chemical Co., entered into a joint development agreement for DOR's proprietary oral botulinum vaccine, BT-VACC, which is designed to protect against exposure to botulinum neurotoxins, which the U.S. government identifies as one of five Category A bioterrorism threats. Using its Pfenex Expression Technology, which accelerates the time it takes vaccines and biotherapeutics to reach the market, "Dowpharma will provide process development leading to current Good Manufacturing Practices production services for BT-VACC ... ." BT-VACC administered orally produces protective antibodies that provide protection or prolonged survival of treated animals 30,000 times the lethal dose of botulinum toxin serotype A, DOR said. Corporate Internet Branding Corporate Internet Branding
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