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Trademark NamesBrand 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 plans to triple flu vaccine production as President Bush meets with flu vaccine developers A company spokeswoman said GlaxoSmithKline Plc expects to triple its North American flu vaccine manufacturing capacity during the next three years, Dow Jones Newswires reported.The drug maker is also developing a vaccine to fight avian flu and planning on increasing production of influenza drug Relenza (zanamivir). Separately, President Bush met with executives from flu vaccine companies GSK, Wyeth, Chiron Corp., Merck & Co. Inc., MedImmune Inc. and sanofi-aventis Group to discuss ways to increase production of avian flu vaccines in a shorter period of time. In a press conference after the meeting, Michael Leavitt, secretary of the U.S. Department of Health and Human Services, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, explained that the important issue is to build a sustainable capacity for an influenza vaccine by using a two-pronged approach so there is a sustainable capacity for any short- or long-term threats. Leavitt said the administration will be releasing a plan in a few weeks laying out details for shortening vaccine production times and broadening production capabilities. "[B]y creating an ethic of vaccinations, for example, for the ordinary flu, it increases not only the health of our country, but the certainty of the capacity that we need in time of crisis," he said. Trademark Names Express Scripts pulls some Pfizer drugs from preferred formulary Pharmacy benefits manager Express Scripts Inc. said it is removing some of Pfizer Inc.'s most popular drugs from its preferred formulary in 2006, giving cheaper generic drugs and rivals preference, Reuters reported. Drugs being removed include cholesterol fighter Lipitor (atorvastatin calcium), blood pressure drug Norvasc (amlodipine besylate), blood pressure and cholesterol combination drug Caduet (amlodipine besylate/atorvastatin calcium), erectile dysfunction treatment Viagra (sildenafil citrate) and incontinence drug Detrol LA (tolterodine tartrate). Patients' copays for non-preferred drugs are significantly higher than for those on the preferred formulary list. "The conspicuous exclusion of nearly all of Pfizer's major products from the Express Scripts National formulary indicates to us that this PBM has adopted a very aggressive stance, requiring pricing concessions that perhaps Pfizer was unwilling to accept," wrote Deutsche Bank analyst Barbara Ryan in a research note, Reuters reported. "We are certainly concerned that Express Scripts' decision means that patients and doctors may have less choice of medicines or be forced to spend more to stay on medicines that have proven beneficial," Jack Cox, a Pfizer spokesman, told Reuters. If the other major PBMs, such as Medco Health Solutions Inc. and Caremark Rx Inc., follow Express' decision, Pfizer could face serious problems, Reuters said. However, Medco has no plans to remove any of Pfizer's drugs, according to Reuters. "Lipitor will be staying on our standard formulary," said Medco spokeswoman Ann Smith. Merck & Co. Inc.'s cholesterol-lowering therapy Zocor (simvastatin) will be on Express Scripts' preferred list next year in anticipation of the mid-year availability of the generic version of the drug. Trademark Names Wyeth releases 2006 earnings guidance, projects 2005 Q3 earnings per share to exceed analysts' estimates Wyeth released its earnings guidance for 2006 and said its 2005 third-quarter pro forma diluted earnings per share is expected to exceed analysts' estimates. The company forecast third-quarter earnings per share, excluding items, in the mid to upper 70-cent range, which it noted exceeds the current Reuters Estimates mean analyst estimate of $0.72 diluted earnings per share. If current business trends continue, full year earnings would likely reach or even exceed the upper end of the $2.80 to $2.90 range of Wyeth's 2005 full-year pro forma diluted earnings per share guidance, the company added. However, analysts were already predicting that Wyeth would earn $2.91 per share for the year, according to Reuters. Year-over-year earnings growth in 2006 is anticipated to be in the high single-digit range, which assumes a 2005 pro forma earnings adjustment of approximately $0.17 per share to reflect the impact of expensing stock options, Wyeth said. In a conference call, Chief Financial Officer Kenneth Martin said the company stands by its previous forecast for full-year R&D spending of $2.7 billion, Reuters reported, and that costs during the first half of the year had been less than anticipated. Wyeth shares closed at $45.71, down $0.36, or 0.8 percent, in heavy trading on the New York Stock Exchange. Trademark Names Reckitt to buy Boots' BHI unit for approximately $3.4 billion Reckitt Benckiser Plc will buy the over-the-counter health care business of Boots Group Plc for approximately $3.4 billion. Reckitt is paying significantly more than the approximately $2.11 billion analysts originally forecasted after Boots put the unit up for sale in April, Dow Jones reported. Reckitt will pay cash for Boots Healthcare International (BHI), which makes Nurofen pain relievers, Strepsils throat lozenges and Clearasil acne treatments. Boots decided to sell BHI in order to focus on the performance of its 1,400 U.K. outlets. Boots will retain approximately $705 million from the sale and return approximately $2.53 billion to shareholders by means of a special dividend of approximately $3.50 per share. Reckitt's Chief Executive Bart Becht said the sale will result in a 90 percent raise in its health and personal care revenue. The company is expecting combined cost synergies of approximately $132.1 million each year by 2008, although there will be a one-off integration and restructuring charge of approximately $264.2 million. "BHI will substantially strengthen Reckitt Benckiser's global position in both health care and personal care, very attractive businesses as evidenced by the strong growth rates at good margins at both BHI and Reckitt Benckiser's own health and personal care category," Becht said. Just last week, Boots and Alliance UniChem Plc agreed to merge in a transaction valued at approximately $5.29 billion, The Wall Street Journal reported. The combined firm, Alliance Boots, will be Europe's leading retail pharmacy business with nearly 3,000 retail outlets and a wholesale network across 11 European countries. In August, Reuters had reported that GlaxoSmithKline Plc was considered to be the most likely company to acquire the OTC health care unit of Boots. Trademark Names FDA adviser resigns over Plan B Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine and consultant to a Food and Drug Administration advisory panel, resigned from his FDA position in protest of the agency's decision regarding Plan B (levonorgestrel) contraceptive, The Associated Press reported. Plan B is sold by Duramed Pharmaceuticals Inc., a subsidiary of Barr Pharmaceuticals Inc. Davidoff resigned in September after the FDA postponed its decision to allow over-the-counter sales of the contraceptive indefinitely, even though scientists said it is safe. He is the second person to publicly resign over the postponement; Susan Wood, the top women's health official at the FDA, also resigned in protest in August. Former FDA Commissioner Lester Crawford resigned in September. Davidoff was a member of the FDA's Nonprescription Drugs Advisory Committee, one of several scientific advisory committees that provide the FDA with independent assessments of drugs, when it voted to approve Plan B for OTC sales in 2003. He said the agency is ignoring science in favor of politics by delaying approval of the drug for OTC sales, the AP reported. "There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision," Davidoff said in a phone interview. "I had to make the inference this was a decision that made on the basis of political pressure, and it seemed to me that was unacceptable." Plan B is an emergency morning-after contraceptive drug. Trademark Names Judge strikes Merck researcher's testimony from Vioxx trial A judge overseeing proceedings of the second product liability trial relating to Merck & Co. Inc.'s painkiller Vioxx (rofecoxib) struck the testimony of the company's first defense witness from the record. In New Jersey, Superior Court Judge Carol Higbee ruled the testimony of Merck researcher Dr. Briggs Morrison misled the jury because his testimony differed greatly from what he had said in a February deposition about internal studies to determine whether Vioxx posed heart risks, The Associated Press reported. Higbee noted that Morrison is not an expert on the studies he described to the jury that showed Vioxx did not trigger heart problems. She reprimanded Merck's legal team for failing to give sufficient notice about the contents of his testimony and barred him from taking the stand for the remainder of the trial, according to The Wall Street Journal. Merck is being sued by Frederick Humeston, an Idaho postal worker who blames Vioxx, which Merck voluntary withdrew from the market last year, for his 2001 heart attack, Reuters reported. Merck general counsel Kenneth Frazier said that the ruling denies Merck its fundamental right to a fair trial, the AP noted. Approximately 5,000 Vioxx lawsuits are expected against Merck. In August, the first of these resulted in a $253.4 million verdict that found Merck liable for the 2001 death of a Texas man who took Vioxx. The company is planning to appeal that decision. Trademark Names Trademark Names Ranbaxy Pharmaceuticals Inc. Ranbaxy Pharmaceuticals Inc. received Food and Drug Administration approval for glimepiride tablets in doses of 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg. Glimepiride is the bioequivalent to sanofi-aventis Group's Amaryl tablets, which are indicated as an adjunct therapy to diet and exercise to lower the blood glucose in patients with non-insulin-dependent type 2 diabetes mellitus whose hyperglycemia cannot be controlled by diet and exercise alone. Ranbaxy reported that Amaryl tablets had total annual sales of $349.5 million, according to IMS Health Inc. Trademark Names Trademark Names The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services' Medicare drug-benefit guide has an error regarding the new drug benefit that begins Jan. 1, The Associated Press reported. The guide lists all plans available to those with limited assets and income as having no monthly premium; however, only about 40 percent of the plans qualify for no premium. The 35 million handbooks are being shipped in waves; some beneficiaries may receive their copies this weekend. Gary Karr, a spokesman for CMS, said they will work with groups to provide the correct information. Trademark Names Trademark Names Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd.'s generic version of Bristol-Myers Squibb Co.'s antibiotic Tequin (gatifloxacin) was tentatively approved by the Food and Drug Administration. BMS and Japanese partner Kyorin Pharmaceutical Co. Ltd. have initiated a patent litigation trial regarding the drug, which has annual sales of approximately $129 million. The trial is scheduled to start in federal court in the Southern District of New York on May 1, 2006. Teva expects to receives final approval for the drug after either a victory in court or the expiration in June 2007 of a mandatory stay of approval, whichever comes first. Trademark Names Trademark Names Trillium Therapeutics Inc. Trillium Therapeutics Inc. (TTI), a Canadian biopharmaceutical firm, acquired all assets of Arthron Ltd. Pty., a subsidiary of Australian biotechnology company Prima Biomed Ltd. Arthron owns or controls intellectual property related to the activating receptor FcyRIIa, which may be an important target for treating autoimmune diseases. In return for Arthron's assets, Prima will receive an upfront cash payment and TTI common shares representing approximately 5.6 percent of the firm's outstanding share capital. Prima may receive additional TTI shares if certain milestones are achieved. Trademark Names Trademark Names
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