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Naming ToolsBrand 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 FDA approves new indication for Abbott's Depakote ER The Food and Drug Administration approved Abbott's Depakote ER (divalproex sodium) extended-release tablets for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.Depakote ER provides a more consistent level of the drug in the body as compared with Depakote delayed-release tablets, according to Abbott. "Depakote ER produces consistent concentrations of medication throughout a 24-hour period," said Dr. Charles Bowden, professor of psychiatry and pharmacology at the University of Texas Health Science Center at San Antonio. "Depakote has been trusted by psychiatrists for a decade and this once-a-day formulation is important for patients." The new approval was based in part on a randomized, double-blind, placebo-controlled, three-week study. The study's primary endpoint was defined as the total score on the Mania Rating Scale (MRS) assessed as the mean change from baseline to day 21, the final day of the trial. Results of the trial showed that Depakote ER was significantly more effective than placebo in the reduction of the MRS total score (mean change, -11.5 vs. -9, respectively). Depakote ER is the once-daily formulation of Depakote delayed-release tablet, which was originally approved in 1995. Depakote ER is currently approved as monotherapy and adjunctive therapy in the treatment of adults and children aged 10 years or older with complex partial seizures that occur either in isolation or in association with other types of seizures. It is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children aged 10 years or older, and as adjunctive therapy in adults and children aged 10 years or older with multiple seizure types that include absence seizures. Depakote ER is also approved for migraine prevention in adults. Naming Tools NDA submitted for abuse-resistant ADHD drug New River Pharmaceuticals Inc. filed a New Drug Application with the Food and Drug Administration seeking approval of NRP104 as a treatment for attention-deficit/hyperactivity disorder in pediatric patients aged 6 to 12 years. The compound, a derivative of amphetamine, is designed to provide better overdose protection and reduce the possibility of drug abuse, the company said. In several hydrolysis studies that compared the extractability of amphetamine from NRP104 and other available alternatives, extraction of amphetamine from NRP104 was more difficult than extraction from the comparators. NRP believes the complexity involved in extracting amphetamine from the NRP104 capsule and the low yields from the extraction process make NRP104 a less attractive drug for tampering compared with other ADHD drugs. Results from two clinical abuse liability studies were included in the NDA; data from a third clinical abuse liability study currently underway are anticipated for submission during the FDA's review. The product's approval and launch are anticipated for 2006. NRP and Shire Pharmaceuticals Group Plc have already entered into an agreement related to the global commercialization of NRP104 in ADHD and other possible indications. Naming Tools Efficacy of Lilly's Cymbalta in patients who switched from current antidepressant comparable to that in patients who initiated Cymbalta In patients with major depressive disorder who have had a suboptimal response to selective serotonin reuptake inhibitors or Wyeth's Effexor (venlafaxine hydrochloride), an immediate switch to Eli Lilly and Co.'s Cymbalta (duloxetine hydrochloride) was shown to be both effective and well tolerated. Similar efficacy results were seen in patients who initiated therapy with Cymbalta, according to a study published in the December issue of the Journal of Clinical Psychopharmacology. The 12-week, open-label trial included two groups: one group consisted of patients who were not currently receiving an antidepressant treatment and the second group consisted of patients who had a suboptimal response or poor tolerability to the antidepressant they were currently receiving. Patients who experienced suboptimal response or poor tolerability to their current antidepressant were switched to Cymbalta 60 mg once daily without intermediate tapering or titration of the dosing. Patients who were not currently receiving antidepressants were randomized to receive Cymbalta 30 mg or 60 mg once daily. Following the first week of the trial, patients who originally received Cymbalta 30 mg had their doses increased to 60 mg once daily. Throughout the remainder of the trial, the doses of Cymbalta were titrated between 60 mg and 120 mg based on the patients' degree of response. The study's efficacy measures included the Hamilton Rating Scale for Depression (HAMD-17) total score, the Hamilton Rating Score for Anxiety (HAMA) total score, the Clinical Global Impression of Severity (CGI-S) scale, Patient Global Impression of Improvement (PGI-I) emotional and physical scales, visual analog scales (VAS) of pain severity and the Symptom Questionnaire-Somatic Subscale. Researchers defined a response as a reduction of 50 percent or greater in the HAMD-17 total score from baseline and remission as a HAMD-17 total score of 7 or less. Researchers did not observe any significant differences between the two groups in mean changes on the HAMD-17, HAMA, CGI-S, PGI-I or VAS scales. However, significant improvements were seen for the mean changes in VAS headache severity and VAS time in pain while awake from week one to week two in patients who switched to Cymbalta compared with those who initiated the therapy. Response rate and remission did not differ significantly between the two groups at the endpoint. "In this 12-week open-label study, suboptimally responsive patients who were switched directly from an SSRI or [Effexor] to [Cymbalta] demonstrated an improvement in depressive symptoms similar in magnitude to that observed in currently untreated patients initiating [Cymbalta] therapy," the researchers concluded. Naming Tools Few adverse events reported with MedImmune's FluMist Reports to the U.S. Vaccine Adverse Event Reporting System (VAERS) during the first two seasons of use with MedImmune Inc.'s FluMist (trivalent live, attenuated influenza vaccine) revealed there were not any unexpected serious risks observed with this vaccine when used as indicated, according to a study published in the Dec. 7 issue of JAMA. Researchers reviewed all adverse events reported to VAERS during the 2003-2004 and the 2004-2005 influenza seasons "to describe the characteristics of reported adverse events and to identify new or unexpected adverse events, including rare events." Approximately 2.5 million people received FluMist during the first two influenza seasons following licensure. Of these, approximately 500,000 received the vaccination during the 2003-2004 influenza season and approximately 2 million received the vaccination during the 2004-2005 season. As of Aug. 16, 2005, VAERS received 460 reports of adverse events regarding vaccinations from August 2003 through July 2005. Forty of the reports were considered serious, although there were no fatalities reported. There were seven reports of possible anaphylaxis, two reports of Guillain-Barré syndrome, one report of Bell palsy and eight reports of asthma exacerbation among those who had a prior history of asthma. "The finding of a high proportion of vaccine administration errors and the reports of use among persons for whom this vaccine was not indicated underscore the need for the clinician to follow the package insert indications regarding vaccine administration and patient eligibility," the researchers concluded. "Potential advantages of FluMist over the trivalent inactivated influenza vaccine, or 'flu shot,' include its intranasal route of administration and induction of both mucosal and systemic immune responses," wrote Dr. Kathleen Neuzil in an accompanying editorial. "Evidence suggests that FluMist is efficacious during years in which mismatches between the vaccine and circulating influenza strains occur. However, since FluMist is licensed only for individuals at low risk for influenza complications, the criteria for an acceptable level of adverse events must be stringent." Separately, MedImmune said it licensed BioWa Inc.'s Potelligent technology to research and develop select MedImmune antibodies for possible therapeutic applications requiring enhancement of antibody-dependent cellular cytotoxicity. The company also acquired exclusive worldwide rights to certain intellectual property owned by Mount Sinai School of Medicine for reverse genetics. Naming Tools Ibuprofen, but not other NSAIDs, linked to lower risk of developing Parkinson's disease Use of ibuprofen may reduce or even prevent the risk of developing Parkinson's disease, according to a study published in the December edition of Annals of Neurology. Researchers examined the relationship between nonsteroidal anti-inflammatory drug use and risk of Parkinson's disease using data from the Cancer Prevention Study II Nutrition Cohort (CPS-II). A group of 147,795 survey respondents were followed from 1992 until the first symptoms of Parkinson's disease were observed or until Sept. 30, 2001. The subjects' use of NSAIDs (aspirin, acetaminophen, ibuprofen or other nonsteroidal analgesic) was pooled with ibuprofen use from the Health Professionals Follow-up Study and the Nurses' Health Study. A total of 413 incident cases of Parkinson's disease were identified during approximately 1.3 million person-years of follow-up. Using data from the nutrition cohort, the risk of Parkinson's disease was reduced by 22 percent among the subjects who used ibuprofen or other nonaspirin NSAIDs as compared with nonusers. But when results from the CPS-II were pooled with data from the two other studies, nonaspirin NSAID users had a 26 percent lower risk of Parkinson's disease as compared with nonusers. The cumulative updated dosage of ibuprofen, though, actually had a significant inverse association with Parkinson's disease risk. Although the duration of ibuprofen use reported at baseline was not significantly related to the risk of Parkinson's disease (reduced risk ranged from 21 percent to 28 percent depending on length of use), patients who took ibuprofen had a 35 percent lower risk of developing Parkinson's disease as compared with nonusers. Finally, there was no association between Parkinson's disease risk and use of aspirin, other NSAIDs or acetaminophen. "In summary, the results of this large investigation based on a prospective assessment of NSAID use favor the hypothesis that ibuprofen reduces the risk for development of Parkinson's disease," title="branding company" the investigators concluded. "However, there is insufficient information on the optimal dosage, and it remains uncertain whether this effect is mediated by COX inhibitions or through other mechanisms specific to ibuprofen and possibly some other selected NSAIDs." Naming Tools Drugs sales rose by 5 percent in 13 key global markets for year ended September 2005 For the 12 months ended September 2005, drug sales in key global markets increased by 5 percent at constant exchange, from approximately $341.48 billion in the prior-year period to $365.35 billion, the IMS Retail Drug Monitor reported. The United States had the highest sales at $180.99 billion, up 5 percent from $172.18 billion in the 12 months ended September 2004. The same percentage of sales growth occurred in Japan and Australia/New Zealand. Europe had slightly less growth at 3 percent to $90.69 billion, but drug sales in Latin America skyrocketed 19 percent to $15.52 billion. Globally, drugs in the cardiovascular therapeutic category had the highest sales, rising 5 percent to $71.67 billion. However, parasitology drug sales grew the most--15 percent from $492 million to $576 million. Sales of musculoskeletal drugs actually fell 3 percent to $21.93 billion. In North America, therapies for the central nervous system had the most sales ($43.73 billion) and sales growth (23 percent), boosted primarily by their sale in the United States ($41.44 billion). Of U.S. drug purchases, sales of cytostatic drugs grew the most, up 16 percent to $7.98 billion. Pfizer Inc.'s cholesterol-lowering Lipitor (atorvastatin calcium) was still the most valuable drug, worth more than $11.2 billion, but its sales growth dropped to 8.7 percent. Of all drugs, sales of Bristol-Myers Squibb Co. and sanofi-aventis Group's Plavix (clopidogrel bisulfate), which is used to reduce the incidence of atherothrombotic events, still saw the highest growth at 19.4 percent. Naming Tools Naming Tools GlaxoSmithKline Plc GlaxoSmithKline Plc's proposed acquisition of ID Biomedical Corp. was approved by the British Columbia Supreme Court along with a change that increases to nearly $8 the price to be paid for each 2003 warrant. Otherwise, holders may have the court fix the fair value of these warrants. ID Biomedical expects the acquisition, which was first announced in September, to be completed before the end of the year, but it is still subject to several conditions. Naming Tools Naming Tools Guidant Corp. Guidant Corp.'s board of directors provided information to Boston Scientific Corp. and entered into discussions with the company regarding its recent acquisition proposal. However, the board has not made any recommendation so far. Boston Scientific replied by saying it is pleased "that Guidant's board has determined that our proposal is reasonably likely to lead to a superior proposal [than Johnson & Johnson's proposal to acquire Guidant]." Boston Scientific added that it is immediately ready for due diligence, expects to be in position to sign a definitive merger by the end of December and to close the transaction in the first quarter of next year. Naming Tools Naming Tools Amgen Inc. Amgen Inc. and BioFocus, Galapagos NV's service division, extended their drug discovery collaboration through 2006. Under the terms of the extended agreement, which was first signed between the companies in January 2003, Galapagos will receive an up-front payment of $2.3 million as prepayment of full-time equivalent costs. The firm may also receive library and technology fees, research fees, milestone payments and bonuses. "Should all clinical and commercial events on a program be achieved, potential of event-dependent payments may exceed $30 million," Galapagos said. Also under the agreement, Galapagos will continue to supply Amgen with drug discovery expertise for multiple ion channel targets. Further financial terms were not disclosed. Naming Tools Naming Tools Alnylam Pharmaceuticals Inc. Alnylam Pharmaceuticals Inc. initiated a Phase I trial in Europe to evaluate the safety and pharmacology of ALN-RSV01, an RNAi therapeutic intended to treat respiratory syncytial virus, in 57 healthy adult men. In addition, the Food and Drug Administration approved the company's Investigational New Drug application to initiate a separate Phase I trial in the United States, which is expected to begin by the end of the month. "The initiation of this Phase I study represents significant progress in the field of RNAi as it is the first clinical trial of an RNAi therapeutic to treat an infectious disease," said John Maraganore, chief executive officer of Alnylam. Naming Tools Naming Tools Antigenics Inc. Antigenics Inc. narrowed its focus by postponing or decelerating all clinical, preclinical and research programs except for those with Oncophage (vitespen) and Aroplatin in cancer, AG-707 in genital herpes and research in autoimmune diseases. The firm also reduced its workforce by approximately one-third to 170 employees. The job cuts will cost approximately $2 million, but are expected to result in significant cost savings and a near-term reduction in net cash burn rate to approximately $40 million per year by the second quarter of 2006. Antigenics shares closed at $4.83, down $0.67, or 12.2 percent, in heavy trading on the Nasdaq. Naming Tools
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