New Company Name - Brand Institute, inc.



			New 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 Warning added to Bayer's Nimotop label; FDA asks for oral solution of product The Food and Drug Administration asked Bayer AG to add a boxed warning to the label of Nimotop (nimodipine) and also to develop an oral solution formulation of the product. Reports of cardiac arrest, cardiovascular collapse, hypotension, bradycardia and even death after patients took Nimotop intravenously prompted the new warning. Because the drug is a calcium channel blocker, its effect of lowering blood pressure can be much stronger if it is given intravenously rather than orally. Nimotop is approved for oral administration to improve neurological outcome by reducing the frequency and severity of ischemic deficits in patients who have subarachnoid hemorrhage due to ruptured intracranial berry aneurysms. The boxed warning now states that the drug should not be administered by intravenous or other parenteral routes. The regulatory agency recommended that if patients are unable to swallow the Nimotop capsule, the gel should be extracted from the capsule by using a syringe, administered through nasogastric tubes or G-tubes and followed by 30 mL of normal 0.9% saline solution. According to Dow Jones Newswires, Bayer is complying and informing physicians about the label change. New Company Name ActivBiotics' rifalazil receives fast track status The Food and Drug Administration granted ActivBiotics fast track status for rifalazil, an investigational peripheral arterial disease (PAD) treatment. The currently approved PAD treatments do not currently target underlying incipient contributors to disease progression, which are thought to be related to Chlamydia pneumoniae infection, the FDA noted. Rifalazil is a bactericidal antichlamydial agent that shows the potential to eliminate this possible underlying cause of PAD. ActivBiotics expanded its trial plans and began enrolling patients in the Phase III PROVIDENCE-1 study. This prospective, randomized, double-blind trial involves patients with PAD with intermittent claudication. The researchers will assess symptoms, prognostic criteria and functional capabilities during a one-year period. More than 11 million people in the United States have PAD and more $30 billion is spent annually on PAD treatment. New Company Name Lorus' Virulizin study generates positive results in second-line treatment of pancreatic cancer Further exploratory analysis of Lorus Therapeutics Inc.'s Phase III clinical trial for Virulizin, an investigational pancreatic cancer treatment, yielded positive results. In the double-blind trial, chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer were randomized to Eli Lilly and Co.'s Gemzar (gemcitabine hydrochloride) plus either Virulizin or placebo as first-line therapy. In the optional stage three part of the study, a subgroup of patients began second-line therapy, continuing Virulizin or placebo alone or in combination with 5-flurouracil. Researchers discovered that Virulizin showed significant survival benefits for the subgroup of patients who continued to receive Virulizin after entering stage three. Those who remained on Virulizin experienced a median survival of 10.9 months compared with 7.4 months for both intent-to-treat and efficacy-evaluable patients who took placebo. In October 2005, Lorus released top-line results from the trial, which revealed that Virulizin did not demonstrate statistical significance in overall median survival in first-line treatment analysis, although the top-line results did show median survival differences in certain patient subgroups. New Company Name Older, newer AEDs seem to demonstrate similar efficacy for treating new-onset epilepsy, guidelines say Recent clinical practice guidelines in neurology have found similar efficacy between older and newer antiepileptic drugs for initially treating adults who have epilepsy, as all recommended first-line use of the older drugs. A systematic review was conducted among relevant clinical practice guidelines published in English between January 2000 and June 2005 by governmental and prominent professional organizations throughout the world. Three guidelines--those by the American Academy of Neurology (AAN), the Scottish Intercollegiate Guidelines Network (SIGN) and the United Kingdom's National Institute for Health and Clinical Excellence (NICE)--best addressed treatment of new-onset epilepsy in adults. AAN recommended both new AEDs (gabapentin, GlaxoSmithKline Plc's Lamictal [lamotrigine], Ortho-McNeil Neurologics Inc.'s Topamax [topiramate] and Novartis AG's Trileptal [oxcarbazepine]) and standard AEDs (carbamazepine, phenytoin, valproic acid/divalproex and phenobarbital) as first-line therapies in these patients. However, only Trileptal and Topamax are approved for use in the United States as monotherapy in newly diagnosed patients. In a similar manner, guidelines from SIGN advised use of some new and older AEDs as first-line treatment, explaining that they have similar efficacy, but adding that Lamictal and Trileptal "seem to be better tolerated and may produce fewer long-term side effects and adverse interactions." title="branding company" In contrast, NICE suggested that older AEDs be used as first-line treatment and newer AEDs as second-line therapy, because "[a]lmost all studies comparing newer drugs with older drugs have found no statistically significant differences in terms of seizure-related outcomes ... . However, it cannot be concluded that the drugs have been shown to be equivalent in terms of efficacy ... ." title="branding company" The group said a review of adverse events and tolerability during clinical trials provided inconsistent results, precluding support for preferring newer AEDs to older ones. NICE also conducted an evidence review for health-related quality of life, but found insufficient evidence from trials to prove that newer AEDs are superior to standard ones at improving this outcome in patients. Robust economic evaluations comparing the two drug groups were also lacking, but NICE noted that older AEDs were more cost effective than were newer AEDs. Thus, the study reviewers summarized that standard, less-expensive AEDs continue to have an important role as first-line drugs in this indication, while the role of newer AEDs is still controversial. "Until efficacy, quality-of-life or cost data for the newer agents demonstrates a superior outcome, older AEDs remain viable options as first-line for monotherapy in newly diagnosed patients and may provide cost benefits over newer agents," title="branding company" they concluded. This study appeared in the January/February edition of the Journal of Managed Care Pharmacy. New Company Name Roche's drug sales strong in 2005, but net earnings remain relatively stable Although Roche's 2005 pharmaceutical sales reached their highest in the company's history, net income fell compared with 2004, which had results that were boosted by a one-time gain. Overall sales from continuing businesses increased from approximately $22.94 billion in 2004 to approximately $27.6 billion in 2005, spurred by a 25 percent increase in pharmaceutical sales to approximately $21.2 billion from approximately $16.86 billion. This growth was four times faster than the global market and was driven by Roche's oncology products, whose sales grew 42 percent to account for 40 percent of the pharmaceutical division's sales. Indeed, non-Hodgkin's lymphoma drug Rituxan (rituximab) achieved sales of approximately $3.23 billion in 2005. Non-small cell lung and pancreatic cancer therapy Tarceva (erlotinib) grew by 2,224 percent to approximately $301 million. Other key growth and sales drivers were Avastin (bevacizumab), for advanced colorectal cancer, and Tamiflu (oseltamivir phosphate), for influenza. In the fourth quarter of 2005, Rituxan also had the highest sales at approximately $893.5 million, while Tarceva, Tamiflu and Avastin showed the greatest sales growth. Total sales, which included a 34 percent rise in pharmaceutical sales to approximately $6.08 billion, increased to approximately $7.82 billion during the quarter from approximately $5.93 billion in the fourth quarter of 2004. Full-year net income was approximately $5.23 billion, 5 percent below last year's approximately $5.49 billion earnings. Roche said 2005 net income compensates for the approximately $1.79 billion earned in 2004 by divesting its consumer health business. The company continues to expect double-digit sales growth in its pharmaceuticals division and overall, with stronger growth anticipated for the second half of the year. New Company Name Chiron's financial results show benefit of Fluvirin's return Chiron Corp. reported increased revenue and product sales in the fourth quarter and full year of 2005, profiting from the return of its Fluvirin influenza vaccine to the U.S. market. For the fourth quarter, Chiron earned $144.2 million, or $0.71 per share, compared with a loss of $23.1 million, or $0.12 per share, in the fourth quarter of 2004. Excluding special items, earnings per share were $0.81 during the most recent quarter, beating the average $0.51 estimated by analysts who were polled by Thomson First Call, The Wall Street Journal reported. During the fourth quarter of 2005, total revenue of $615.7 million was made up of $475.3 million in net product sales. In the prior-year period, net product sales accounted for $330.5 million of the $434.4 million in total revenue. Full-year net income increased 136 percent to $186.6 million, or $0.97 per diluted share, up from $78.9 million, or $0.41 per share, in 2004. Full-year revenue jumped 11 percent to $1.92 billion, due primarily to higher net product sales, increases in royalty and license fee revenue, as well as revenue from a contractual arrangement with Ortho-Clinical Diagnostics Inc. Fluvirin vaccine sales of $96 million, rather than $2 million in 2004, helped drive a 12 percent increase in total product sales to $1.42 billion from $1.27 billion. Along with the return of Fluvirin, these financial results were also affected by the loss of sales for the Begrivac influenza vaccine, a drop in the effective tax rate to 11 percent for the year ended Dec. 31, 2005, and by foreign exchange rates that caused an approximate $0.01 decrease in earnings per share for 2005. Chiron did not provide financial guidance for the future, but said it expects its acquisition by Novartis AG to be completed in the first half of this year. Shares of Chiron closed at $45.63, up $0.03, or 0.1 percent, in moderate trading on the Nasdaq. New Company Name New Company Name GlaxoSmithKline Plc GlaxoSmithKline Plc's Avandaryl (rosiglitazone maleate/glimepiride), a fixed-dose combination tablet indicated to treat type 2 diabetes, is now available to patients. The drug is the first and only treatment that combines a thiazolidinedione, rosiglitazone maleate, which GSK markets as Avandia, with a sulfonylurea, glimepiride, the company said. Avandaryl is indicated to improve blood sugar control in patients with type 2 diabetes who are already using a sulfonylurea and Avandia combination therapy, or for those whose blood sugar is not sufficiently controlled by either a sulfonylurea or Avandia alone. New Company Name New Company Name Procter & Gamble Pharmaceuticals Inc. Procter & Gamble Pharmaceuticals Inc. entered into an agreement with Nastech Pharmaceutical Co. Inc. to develop and commercialize Nastech's parathyroid hormone (PTH1-34) nasal spray, an investigational osteoporosis treatment. Under terms of the agreement, P&G will have the worldwide development and commercialization rights to PTH1-34 in exchange for a $10 million up-front fee, milestone payments of up to $22 million in the first year and royalties on product sales. The two companies will jointly develop the drug, and Nastech will be responsible for the chemistry, manufacturing and controls sections of regulatory submission. P&G will reimburse Nastech for any development activities. New Company Name New Company Name Altea Therapeutics Corp. Altea Therapeutics Corp. entered into a licensing agreement with Teikoku Seiyaku Co. Ltd. to develop and commercialize a transdermal patch therapy to treat Parkinson's disease that uses Altea's PassPort system, a technology that delivers active pharmaceutical ingredients through the skin. Under terms of the agreement, Altea will receive a signing fee and additional payments from Teikoku Seiyaku upon completion of certain development milestones. Teikoku Seiyaku will also pay royalties on net sales and/or net revenues and will fund the cost of Japanese product development. New Company Name New Company Name Abeille Pharmaceuticals Inc. Abeille Pharmaceuticals Inc. initiated a Phase I pharmacokinetic study of AB-1001, a transdermal patch for chemotherapy-induced nausea and vomiting (CINV). The patch is designed to deliver a commercially available CINV treatment, a 5HT3-antagonist, for a continuous period of up to five days. The open-label, three-way, randomized, crossover trial will be conducted among healthy volunteers and will evaluate the comparative pharmacokinetics of two doses of AB-1001 with an intravenous administration of the product. The study is expected to be completed within three months. New Company Name


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