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			Register Company 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 FDA releases documents about psychiatric adverse events linked to ADHD drugs prior to pediatric committee meeting; committee to discuss other drugs, adverse events, possible pediatric indications The Food and Drug Administration released documents in advance of a March 22 Pediatric Advisory Committee meeting that called for stronger warnings about possible psychiatric adverse events linked to methylphenidate products used to treat attention deficit/hyperactivity disorders in children. In the review of ADHD treatments, the FDA said improved labeling was needed for these products. "Current approved labeling for drug treatments of ADHD does not clearly address the risk of drug-induced signs or symptoms of psychosis or mania (such as hallucinations) in patients without identifiable risk factors, and occurring usual doses," according to a March 3 memo issued by agency staff. The memo also stated that "current labeling does not clearly state the importance of stopping drug therapy in any patient who develops hallucinations, or other signs or symptoms of psychosis or mania, during drug treatment of ADHD." Last month, the FDA's Drug Safety and Risk Management Advisory Committee voted in favor of adding a black box warning to these drugs to advise patients that use of the drugs may increase the risk of cardiovascular problems. An update on efforts to better understand cardiovascular adverse events possibly related to ADHD drugs will also be presented at the meeting. Some of the ADHD drugs possibly linked to the psychiatric adverse events include Johnson & Johnson's Concerta (methylphenidate hydrochloride), Shire Pharmaceuticals Inc.'s Adderall (mixed amphetamine salts), Novartis AG's Focalin (dexmethylphenidate hydrochloride) and Eli Lilly & Co.'s Strattera (atomoxetine hydrochloride). In addition, the agency released documents related to adverse events possibly linked to Genzyme Corp.'s Clolar (clofarabine), a treatment for pediatric acute lymphoblastic leukemia; Sanofi-Aventis Group's Avapro (irbesartan), a treatment for high blood pressure; and Abbott's Meridia (sibutramine), an obesity treatment. The FDA documents said that Clolar is safe and effective for children with acute lymphoblastic leukemia, but that it is not approvable for acute myelogenous leukemia. The agency also found there was not enough data to determine whether Avapro is effective in treating children with high blood pressure and that Meridia should not be approved to treat obesity in children based on current clinical data. Register Company Name GSK's Arixtra reduces risk of death, MI in patients with acute coronary syndromes, data show GlaxoSmithKline Plc's Arixtra (fondaparinux sodium), a factor Xa inhibitor, significantly reduced the risk of death or recurrent myocardial infarction as compared with placebo in patients with acute ST-segment elevation MI, according to trial data published March 14 online in JAMA and presented at the 55th Annual Scientific Session of the American College of Cardiology in Atlanta. The double-blind OASIS-6 trial included 12,092 patients with STEMI who were randomized to treatment with Arixtra 2.5 mg once daily or usual care for up to eight days. Usual care consisted of placebo in patients in whom unfractionated heparin is not indicated or unfractionated heparin for up to 48 hours followed by placebo. The primary endpoint of the study was a composite of death or recurrent MI at 30 days, while secondary endpoints included the same assessment at nine days and at the final follow-up (three or six months). At 30 days, the composite of death or reinfarction was significantly reduced in those who received Arixtra as compared with those who received usual care (9.7 percent vs. 11.2 percent, respectively). Furthermore, the composite of death or reinfarction was significantly reduced at nine days and at the end of the study for Arixtra-treated patients. At nine days, the relative risk reduction was 17 percent; at 30 days, the relative risk reduction was 14 percent; and at study end, the relative risk reduction was 12 percent. According to the authors, there was a nonsignificant trend toward fewer severe bleedings in patients treated with Arixtra as compared with patients in the usual care group. "[Arixtra] reduces mortality and reinfarction early, and this benefit persists long term," the authors concluded. "The consistent results from OASIS-5 and OASIS-6 confirm the value and safety of [Arixtra] as a simple and widely applicable antithrombotic therapy in a broad group of patients with acute coronary syndrome." Arixtra, which is not approved by the Food and Drug Administration to treat acute coronary syndrome, has indications in the prevention of venous thromboembolism and the treatment of deep vein thrombosis and acute pulmonary embolism. Register Company Name AstraZeneca's Atacand may delay, reduce risk of hypertension in patients with pre-hypertension AstraZeneca Plc's blood pressure and heart failure drug Atacand (candesartan cilexetil) may delay or reduce the risk of the development of hypertension among patients with pre-hypertension, new data show. The trial included 772 patients aged 30 to 65 years who had pre-hypertension. Researchers determined that patients had pre-hypertension if their systolic pressure was between 130 mm Hg and 139 mm Hg and their diastolic pressure was 89 mm Hg or lower, or if their systolic pressure was 139 mm Hg or lower and their diastolic pressure was 85 mm Hg to 89 mm Hg. Patients in the study were treated with either 16 mg of Atacand or placebo for two years. All patients then received placebo for another two years, and researchers evaluated blood pressure changes. The primary objective of the trial was to determine whether a two-year treatment period with Atacand would reduce the proportion of subjects who developed hypertension during the four-year trial period, with the primary endpoint being the development of hypertension. Of the 391 patients in the Atacand group, 53 patients developed hypertension during the first two years of the study compared with 154 patients in the placebo group (n=381). Therefore, the relative risk reduction for those who received Atacand was 66.3 percent during two years of treatment. By the end of the trial, 208 patients in the Atacand group developed hypertension, while 240 patients in the placebo group developed hypertension. This represented a 15.6 percent relative risk reduction for patients in the Atacand group. "Although the observations in this study indicate that [Atacand] may ameliorate blood pressure in persons with pre-hypertension, we do not advocate treatment of the 25 million people with pre-hypertension," the authors concluded, adding that they do not know of any ongoing prospective trials in pre-hypertension but hope these results prompt further research. The study was presented at the annual meeting of the American College of Cardiology in Atlanta and published online by The New England Journal of Medicine on March 14. Register Company Name Rozerem significantly reduces subjective sleep latency after one week of treatment; improvement maintained for five weeks During a recent study, Takeda Pharmaceuticals North America Inc.'s Rozerem (ramelteon) significantly improved sleep latency at one week in older adults who had severe sleep-onset difficulties and the response was sustained for five weeks. The outpatient, double-blind trial was conducted among 829 adults aged 65 years or older. A subanalysis included only patients who were prescribed Rozerem or placebo and who had received a diagnosis of chronic insomnia with symptoms for at least three months. Patients in this group also had a history of daytime complaints linked to disturbed sleep. Based on a randomization scheme, the patients received 8 mg of Rozerem or placebo each night for 35 nights. In total, 327 of the patients met the criteria for this subanalysis. Average baseline subjective sleep latency (sSL) was 106.6 minutes in the placebo group and 115.7 minutes in the Rozerem group. At week one, the average reduction in sSL was statistically significant with Rozerem as compared with placebo (-23.2 minutes vs. -7.5 minutes). This improvement was maintained through week three, at which time sSL levels fell by an average of 33.7 minutes in the Rozerem arm and an average of 19.8 minutes in the placebo arm from baseline. By week five, sSL had fallen by an average of 37.4 minutes and 17.1 minutes with Rozerem and placebo, respectively, from baseline. Throughout the trial, the incidence of adverse events was low, with most being considered mild or moderate in intensity. Dizziness, dysgeusia, myalgia and headache not otherwise specified occurred in at least 5 percent of patients, but no single adverse event was reported in more than 9 percent of patients. "The absolute degree of sSL reduction (in minutes) showed continued improvement over each subsequent time point from week one to week five for the [Rozerem]-treated group. ... In older adults with severe baseline sleep difficulties, [Rozerem] effectively promoted sleep while being well tolerated," the study authors summarized. These data were presented at the annual meeting of the American Association of Geriatric Psychiatry in San Juan, Puerto Rico. Register Company Name OrthoLogic's wrist fracture treatment fails to meet study's endpoint OrthoLogic Corp.'s Chrysalin, a synthetic peptide intended to treat wrist fractures, did not significantly lessen the time to removal of immobilization, the primary endpoint of the drug's Phase III trial. The prospective, double-blind trial included 503 patients with unstable and/or displaced distal radius fractures who were randomized to receive a single 1 mL percutaneous injection of Chrysalin at 10 mcg or a placebo injection. Both injections were administered into the fracture site under fluoroscopic guidance. Although Chrysalin did not provide a statistically significant benefit as compared with placebo in terms of the elapsed time between the date of fracture surgery and the physician's decision to remove all rigid immobilization hardware used to stabilize the fracture, it did meet one of the secondary endpoints. Specifically, Chrysalin-treated patients demonstrated a statistically significant benefit in radiographic evidence of time to radial cortical bridging. According to OrthoLogic, this benefit was also seen in a previous Phase I/II trial of the drug. There was no significant difference in adverse event rates between the treatment groups. "We will be conducting a full examination of these results in order to guide our program going forward, including a planned interim analysis of results from the ongoing Phase IIb dose-ranging trial of Chrysalin in distal radial fractures, which includes a 30 mcg dose," said Dr. James Pusey, OrthoLogic's chief executive officer. The company plans to share results of its interim analysis during the third quarter of this year. OrthoLogic shares closed at $2.64, down $2.55, or 49.1 percent, in heavy trading on the Nasdaq. Register Company Name Trial halted in U.K. after six patients treated with TeGenero's TGN1412 experienced serious adverse events In a Phase I trial of TeGenero AG's investigational monoclonal antibody, TGN1412, six men experienced serious adverse events that led to hospitalization. The drug was designed to treat immunological diseases such as multiple sclerosis, rheumatoid arthritis and certain types of cancer. The trial, which was being conducted in the United Kingdom, included eight men, six of whom were treated with TGN1412 and two of whom were given placebo. The six men treated with the drug were admitted into intensive care. "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers," said Dr. Benedikte Hatz, TeGenero's chief executive officer. The company further noted that the trial adhered to standard clinical guidelines and was approved by the Medicines and Healthcare products Regulatory Agency. The MHRA suspended the trial and notified other regulatory bodies outside the United Kingdom about the adverse events. TeGenero will conduct an investigation to determine the cause of the incidents. U.S. drug research company Parexel International Corp. performed the trial for TeGenero. Register Company Name Register Company Name Novo Nordisk A/S Novo Nordisk A/S and Nastech Pharmaceutical Co. Inc. entered into a multicompound, feasibility study agreement that involves certain Novo Nordisk compounds. Specific compounds and indications were not released, and no other terms of the agreement, financial or otherwise, were disclosed. Register Company Name Register Company Name Neurocrine Biosciences Inc. Neurocrine Biosciences Inc. and Pharmacopeia Drug Discovery Inc. extended their drug discovery and development collaboration to include an additional disease target, which Pharmacopeia is expected to produce drug candidates against for Neurocrine. The companies intend to apply drug discovery programs and development platforms to central nervous system and metabolic disease targets. Pharmacopeia may receive milestone payments if any of the candidates progress into and through clinical development, and is eligible to receive royalties from sales if any of the products are marketed. Register Company Name Register Company Name GenVec Inc. GenVec Inc. received approval from the Food and Drug Administration to expand its current Phase II trial with TNFerade, a modified live virus, in locally advanced pancreatic cancer into a Phase II/III trial with a 12-month survival endpoint. The expanded trial will increase the targeted enrollment from 74 patients to 330 patients and will include study sites outside of the United States. To fund the revamped trial, GenVec entered into a financing agreement with Kingsbridge Capital Ltd. This arrangement will provide GenVec up to $30 million in capital for a period of three years through the purchase of newly issued shares of GenVec common stock. Register Company Name Register Company Name Vyteris Holdings Inc. Vyteris Holdings Inc. regained U.S. rights to sell the LidoSite (epinephrine/lidocaine hydrochloride) active transdermal analgesic in physicians' offices from B. Braun Melsungen AG. LidoSite administers lidocaine and epinephrine through the skin by a mild electric current. Vyteris said it is an ideal solution for treating pain in patients undergoing treatment involving needles or catheters. Register Company Name


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