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			Product Positioning 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 GSK TO BUY CORIXA FOR APPROXIMATELY $300 MILLION GlaxoSmithKline Plc signed a definitive agreement to acquire Corixa Corp. for $4.40 per share, or approximately $300 million. Most critical to GSK is the acquisition of Corixa's monosphosphoryl lipid A, a novel adjuvant utilized in many of the vaccines currently in GSK's pipeline, such as hepatitis B vaccine, Fendrix, and human papillomavirus vaccine, Cervarix. GSK will also acquire rights to antigens discovered by Corixa under a 1998 multi-field vaccine discovery collaboration between the two companies. The antigens are part of immunotherapeutic cancer vaccines being developed by GSK Biologicals, GSK said. Other assets that GSK will gain include a candidate prophylactic tuberculosis vaccine and compounds such as Toll-like receptor 4 agonists and antagonists. The transaction price represents a 42 percent premium from Corixa stock's Friday closing price of $3.09 on the Nasdaq. GSK said it owns approximately 8 percent of outstanding Corixa shares. Holders of approximately 11 percent of Corixa's shares have agreed to vote in favor of the transaction. The transaction is expected to close in the third quarter of this year. GSK and Corixa co-developed Bexxar (tositumomab/iodine l 131 tositumomab), a treatment for non-Hodgkin's lymphoma that is refractory to Genentech Inc.'s Rituxan (rituximab). -=- FDA APPROVES AMYLIN, LILLY'S BYETTA AS ADJUNCTIVE THERAPY FOR TYPE 2 DIABETES PATIENTS The Food and Drug Administration approved Amylin Pharmaceuticals Inc. and Eli Lilly and Co.'s Byetta (exenatide) injection as an adjunctive therapy for type 2 diabetes patients who have not responded well to oral diabetes drugs metformin and/or a sulfonylurea. The FDA also said the fixed-dose, subcutaneous injection was approvable as a monotherapy for the treatment of type 2 diabetes. If the companies submit any additional data supporting monotherapy use, the FDA will review it within six months. In 30-week clinical studies, Byetta has been shown to help control blood sugar levels, the companies said. The drug improves post-meal and fasting glucose levels, which leads to better overall long-term blood sugar control. Most patients taking Byetta in the controlled trials also lost weight, the companies noted. Byetta is part of a new drug class called incretin mimetics, which lower glucose levels by mimicking naturally occurring human hormones. Injections come in doses of 5 mcg and 10 mcg and come in prefilled pen-injector devices. Amylin shares closed at $17.00, down $1.18, or 6.5 percent, in heavy trading on the Nasdaq. -=- BAYER'S Q1 NET INCOME UP MORE THAN 50 PERCENT Bayer AG's first-quarter net income in 2005 grew 56 percent as all of its units performed well, according to a preliminary earnings report released Friday. The company achieved net income of approximately $845.7 million, or approximately $1.15 per share, compared with approximately $543.5 million, or approximately $0.74 per share, in the first quarter of 2004. According to estimates compiled by Vara Research GmbH and reported by Bayer, analysts had expected net income of approximately $433.2 million on average. Sales from continuing operations met Vara's analyst estimate of approximately $8.7 billion, up more than 15 percent from approximately $7.51 billion in the previous-year period. Bayer's operating results from continuing operations before special items grew 50 percent, from approximately $987.1 million in first quarter of 2004 to approximately $1.48 billion. Analysts polled by Vara and Reuters expected the company's operating results from continuing operations before special items to total approximately $1.1 billion on average and approximately $1.2 billion, respectively. The operating results from continuing operations before special items realized by the company's MaterialScience unit "roughly tripled year on year" while the unit's currency- and portfolio-adjusted sales rose by 34 percent. In 2005, Bayer said it is targeting an increase of more than 5 percent in currency- and portfolio-adjusted sales from continuing operations, to approximately $32.4 billion. The company also reaffirmed its target of improving its operating results from continuing operations before special items "by around 20 percent" despite an increase in raw material costs. For the full-year 2005, analysts polled by Vara expect the company to achieve net income of approximately $1.26 billion, or approximately $1.73 per share, and sales from continuing operations of approximately $33.1 billion. "Our pharmaceutical research activities will focus in the future on cardiovascular risk management--including diabetes--and cancer," said Werner Wenning, Bayer's management board chairman. "We are confident that concentrating on these areas will allow us to sustainably increase the productivity of our pharmaceutical [research and development]." Bayer said an interim analysis of data from Phase III clinical trials of sorafenib, its Raf kinase and vascular endothelial growth factor receptor inhibitor, show the product significantly lengthens progression-free survival in patients with kidney cancer. Sorafenib is also being evaluated in Phase III trials as a treatment for patients with advanced liver cancer. The company is planning to launch sorafenib in the United States in 2006 as a treatment for kidney cancer. Bayer is also planning to initiate Phase III trials of its Factor Xa inhibitor for the prevention and therapy of thromboembolic diseases. The company believes this substance could achieve annual sales of approximately $1.3 billion if the trials are successful. Bayer shares closed at $32.25, up $0.98, or 3.1 percent, in moderate trading on the New York Stock Exchange. -=- CANCER, DIABETES HAVE STRONGEST DRUG PIPELINES, ACCORDING TO EXPRESS SCRIPTS EXECUTIVE Cancer and diabetes have the two strongest drug pipelines in the pharmaceutical industry, according to a presentation given by Brian Kolling, Express Scripts Inc.'s senior director of emerging technologies, at the Academy of Managed Care Pharmacy's 17th Annual Meeting and Showcase in Denver. Innovations in oncology drugs have turned cancer into more of a chronic, manageable disease. More cancer therapies are now starting to emerge in an oral form, according to Kolling. Some cancer treatments to keep an eye on, Kolling said, are ones that are already approved and are being studied for other indications. For example, Novartis Pharmaceuticals Corp.'s Gleevec (imatinib mesylate) is indicated for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors but is also being tested as a treatment of lung and breast cancers and glioblastoma. Several new oncology drugs exist in the pipeline as well. Johnson & Johnson's Zarnestra (tipifarnib), an oral farnesyl transferase inhibitor that is expected to treat newly diagnosed acute myeloid leukemia in patients aged 65 years or older, has "had several hiccups along the way," but it is expected to be approved by the end of May, Kolling said. GlaxoSmithKline Plc's lapatinib, formerly known as GW572016, is an oral epidermal growth factor receptor dual kinase inhibitor being studied to treat solid tumors. Kolling expects a New Drug Application for lapatinib to be filed sometime this year, with an initial indication for solid tumors in breast cancer. According to Kolling, Genentech Inc.'s Avastin (bevacizumab) has become the standard of care for metastatic colorectal cancer and now other companies are trying to keep up. Amgen Inc. and Abgenix Inc. are developing panitumumab (ABX-EGF) as an intravenous (IV) infusion to treat metastatic colorectal cancer and are expected to file an NDA by late 2005. Telik Inc. is developing telcyta, formerly known as TLK286, to treat the same cancer. Telcyta is an IV infusion that activates the glutathione S-transferase (GST) P1-1 enzyme and is in Phase III trials; an NDA is expected to be filed in 2006. Diabetes drugs are also packing the drug pipeline, Kolling said. Because obesity and type 2 diabetes are often related, the growing obesity rate is expected to contribute to a growing diabetes rate. This trend may cause diabetes drugs to become the third or fourth largest drug class in the next several years, according to Kolling. "I think we are going to have three new [diabetes drug] classes plus inhaled insulin by 2008," Kolling said. Pfizer Inc., sanofi-aventis Group and Nektar Therapeutics' Exubera (inhaled human insulin powder) is expected to be the first inhaled insulin to market. Pfizer and sanofi-aventis filed an NDA in March, and although the product could launch as early as this year, Kolling expects it to have a long review process and launch in 2007. Novo Nordisk Inc.'s Levemir (insulin detemir) for the treatment of type 1 and type 2 diabetes received an approvable letter, and Kolling expects the drug to receive full approval in the middle of 2005. Overall, "there has been a dramatic increase in the number of products that are entering clinical trials," Kolling said, attributing the trend to the lull in production by the industry in the late 1990s. -=- SOME MAJOR RETAILERS, DRUGSTORES MOVE PSEUDOEPHEDRINE PRODUCTS BEHIND PHARMACISTS' COUNTERS, OFF SHELVES Spurred by concerns in Congress about limiting consumer access to over-the-counter pseudoephedrine-containing products that can be used in methamphetamine labs, Kmart Holding Corp., Target Corp., Wal-Mart Stores Inc. and several drugstore chains said they will move cold and allergy drugs containing the ingredient behind pharmacists' counters. Other store chains involved in the action are CVS Corp., Rite Aid Corp., Walgreen Corp., Longs Drug Stores Corp. and Albertson's Inc. All of the stores said their decisions were based on the growing use of pseudoephedrine products to make methamphetamine, an illegal, highly addictive drug. U.S. Sens. Dianne Feinstein, D-Calif., and Jim Talent, R-Mo., are leading the charge to pass the Combat Meth Act of 2005. "Hearing Sen. Feinstein describe the dramatic scope of this problem in California and nationally convinced me that Longs should not wait for a federal law directing us to move these products behind the counter," said Warren Bryant, chief executive officer of Longs. "We have the ability to tackle this issue now and perhaps prevent further abuse." Under the stores' new policies, cold and allergy drugs containing pseudoephedrine will no longer be over the counter, rather customers will have to ask pharmacists for the packages. A prescription will not be required, but several pharmacies will only sell two packages per transaction. Also, several stores that do not have pharmacies will no longer carry the drugs. Currently, six states allow only pharmacies to sell pseudoephedrine products and seven states restrict customer access to these products, The Wall Street Journal reported. Rite Aid said it intends to move single-ingredient pseudoephedrine products within a week and combination products by Aug. 1. CVS pharmacies said it will move all products containing the ingredient by July 1, and Wal-Mart stores plan to complete the move by June. Two drugs included in the new policy are Pfizer Inc.'s Sudafed (pseudoephedrine hydrochloride) and Schering-Plough Corp.'s Claritin-D (loratadine/pseudoephedrine sulfate). Pfizer said it plans to reformulate Sudafed to remove the pseudoephedrine, according to The Journal. -=- MORE THAN 80 PHARMACIES NATIONWIDE RECEIVED ILLEGALLY DISTRIBUTED DRUGS, ACCORDING TO FDA The Food and Drug Administration said multiple prescription drug distributors were indicted by the U.S. Attorney for the District of Utah for allegedly distributing diverted drugs in more than 80 pharmacies nationwide. On its Web site, the agency posted a list of pharmacies that may have received diverted drugs, a list of the unauthorized distributors and a list of the specific types of drugs that were diverted. The list can be viewed at: http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html Only four of the pharmacies--two each in Georgia and Pennsylvania--are outside California, New York and New Jersey. More than 40 drugs are listed, including Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin), and its antidepressant, Zoloft (sertraline hydrochloride); Bristol-Myers Squibb Co.'s HIV drug Sustiva (efavirenz) and cholesterol-lowering drug, Pravachol (pravastatin); Gilead Sciences Inc.'s HIV drugs Viread (tenofovir disoproxil fumarate) and Truvada (emtricitabine/tenofovir disoproxil fumarate); and Merck & Co. Inc.'s asthma and allergy medication Singulair (montelukast sodium). Consumers should presume drugs are safe and effective unless they have purchased a listed drug from a listed pharmacy, according to an FDA talk paper. The agency also urged pharmacies that received drugs from one of the indicted distributors to check their inventories for remaining products, to stop dispensing the product and to notify patients who may have purchased an affected drug. "Diverted drugs are medications illegally bought, sold or otherwise circulated outside established distribution systems that assure their quality," the FDA said. The distributors named in the indictment are Pharma Discount, otherwise known as PDRX, of Salt Lake City, Utah; Empire Pharmaceuticals in Newbury Park, Calif.; Defonte Trading, also known as DRX Medical, of Aberdeen, N.J.; and PRNY Enterprises, AC Global, AC Healthcare and Afro Caribbean Healthcare, all located in Floral Park, N.Y. -=- Product Positioning BIOGEN IDEC INC. Biogen Idec Inc. said it intends to fully cooperate with the Boston District Office of the Securities and Exchange Commission in a formal investigation into the suspension of marketing and distribution of its multiple sclerosis treatment, Tysabri (natalizumab). The SEC will examine whether Biogen Idec violated federal securities laws in the withdrawal. Biogen Idec and its Tysabri partner Elan Corp. Plc took the drug off the market in February after one patient died from progressive multifocal leukoencephalopathy (PML) while participating in an MS clinical trial of the drug in combination with Avonex. -=- Product Positioning PACIFICARE HEALTH SYSTEMS INC. PacifiCare Health Systems Inc.'s 2005 first-quarter net income rose 28 percent to $85.7 million, or $0.89 per diluted share, compared with $67 million, or $0.71 per diluted share, in the prior-year period. Analysts polled by Reuters expected earnings of $0.88 per share. Total operating revenue grew 16 percent to $3.44 billion. The health care provider said commercial revenue increased 13 percent, and senior revenue rose 15 percent. Revenue from PacifiCare's pharmacy benefit manager, Prescriptions Solutions, increased 44 percent as its membership grew by 128,000 year-over-year. The company raised its full-year earnings-per-share guidance to between $3.70 and $3.85. Shares of PacifiCare closed at $59.76, up $5.66, or 10.5 percent, in heavy trading on the New York Stock Exchange. -=- Product Positioning CARDINAL HEALTH INC. Cardinal Health Inc.'s 2005 third-quarter earnings from continuing operations fell 15 percent from $430.1 million, or $0.99 per diluted share, in the same period a year ago to $367.6 million, or $0.84 per diluted share. Excluding $28.5 million in special items, Cardinal would have earned $0.90 per diluted share. Analysts polled by Thomson First Call expected earnings of $0.89 per share. Revenue increased 17 percent to $19.1 billion. Revenue from the company's pharmaceutical distribution and provider services unit rose 18 percent to $15.61 billion while revenue from its medical products and services unit increased 7 percent to $2.47 billion. The company did not change its full-year guidance and said it is still on track to realize $125 million of operating-earnings improvements during fiscal 2005 and $200 million during fiscal 2006. Shares of Cardinal closed $55.57, up $0.56, or 1 percent, in heavy trading on the New York Stock Exchange. -=- Product Positioning WEST PHARMACEUTICAL SERVICES INC. West Pharmaceutical Services Inc. signed a definitive agreement to acquire the business assets of The Tech Group Inc., a privately owned company based in Scottsdale, Ariz. that manufactures plastic components and assemblies for various medical markets. Under the agreement, West Pharmaceutical will pay $140 million in cash for The Tech Group's assets, including nine production facilities in Arizona, Michigan, Indiana, Puerto Rico, Mexico and Ireland. West Pharmaceutical will not acquire ownership interests in Tech Group Asia. The companies expect to complete the transaction by May 2005. -=- Product Positioning


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