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			Unique Company Names 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 acquire ID Biomedical for approximately $1.4 billion GlaxoSmithKline Plc and ID Biomedical Corp. entered into a definitive agreement for GSK to acquire ID Biomedical for approximately $29.49 per share, or approximately $1.43 billion. GSK will also assume responsibility for ID Biomedical's net debt, which was $77 million on June 30, and will loan ID Biomedical up to $120 million to repay term debt and finance any cash requirements until the expected closing date. David Dean, an analyst at Sprott Securities, said the purchase price is "not nearly enough," and he doubts ID Biomedical's shareholders will agree to it, Dow Jones Newswires reported. "We look at the current share price as being disconnected with the level of risk associated with these cash flows that should be coming," he told Dow Jones. "We believe that ID Biomedical is very undervalued where it is." ID Biomedical is currently expanding and upgrading its manufacturing facilities in Canada in hopes that, beginning in 2007, it will produce approximately 75 million doses of its Fluviral (influenza virus vaccine trivalent, inactivated split-viron prepared in eggs) vaccine each year. The vaccine has already been granted fast track status by the Food and Drug Administration, and approval is expected in the spring, Dow Jones reported. "Combined with our recent investment to double influenza vaccine production capacity at our facility in Dresden, Germany, and our recent purchase of the Marietta vaccine site in Pennsylvania, USA, where we will develop new flu vaccine production technology, the acquisition of ID Biomedical could also represent a major step in GSK's approach against pandemic flu threat," said Jean Stephenne, president of GSK Biologicals. The transaction, which is still subject to approval by ID Biomedical's shareholders, regulatory clearances and other conditions, is expected to close by the end of this year or early next year. The boards of directors of both companies have unanimously approved the acquisition. With facilities in both the United States and Canada, ID Biomedical manufactures and develops vaccine products. Currently, it supplies approximately 75 percent of the Canadian government's purchases of influenza vaccine, Dow Jones said. ID Biomedical shares closed at $29.46, up $3.46, or 13.3 percent, in heavy trading on the Nasdaq, while GSK shares closed at $50.49, up $0.29, or 0.6 percent, in moderate trading on the New York Stock Exchange. Unique Company Names BLA for Lucentis to be filed in December; no fast track status, Genentech says Genentech Inc. anticipates filing a complete Biologics License Application for Lucentis (ranibizumab), a potential treatment for wet age-related macular degeneration (AMD), in December. Although the Food and Drug Administration did not grant the company's request for fast track designation, Lucentis may still obtain priority review. The firm is also currently discussing plans with the FDA for the Phase IIIb SAILOR trial set to begin by the end of the year. The study is designed to evaluate the safety of 0.3 mg and 0.5 mg of Lucentis when it is administered once per month for three months to patients with active wet AMD; approximately 5,000 enrollees are expected. Other Phase III studies are also under way or being planned. Preliminary Phase III data from the MARINA trial with Lucentis were released in July at the annual meeting of the American Society of Retina Specialists. Lucentis met the primary efficacy endpoint of maintaining vision in the patients with wet AMD. Also, 25 percent of those who received 0.3 mg of Lucentis and 34 percent of those who received 0.5 mg of Lucentis improved vision by a gain of at least 15 letters, as measured by the Early Treatment of Diabetic Retinopathy eye chart; only approximately 5 percent of patients in the control arm achieved this gain. Both Genentech and the Novartis Ophthalmics Business Unit are developing Lucentis. Genentech has commercial rights in North America, while Novartis has exclusive commercialization rights in the rest of the world. Unique Company Names Genentech's clot-busting drug, TNKase, linked to more deaths than placebo, study shows Genentech Inc.'s single-bolus thrombolytic, TNKase (tenecteplase), may result in more deaths compared with placebo among patients who undergo angioplasty, according to study findings presented at the European Society of Cardiology's annual meeting in Stockholm, Sweden, The Associated Press reported. The Phase IIIb/IV ASSENT 4 PCI study involved 1,667 patients with large acute myocardial infarctions (AMI) who received either placebo or TNKase while en route to angioplasty. Researchers found that 6 percent of people who received TNKase before the procedure died within 30 days, while 3.8 percent of those who receive placebo died, according to the AP. As previously reported, the study was stopped in July because of a higher death rate among those who received the drug. Experts believe the findings may prompt doctors to stop giving patients clot dissolvers prior to angioplasty, the AP said; however, in July, Dr. Frans Van de Werf, chair of the trial's steering committee, said the trial findings "have no impact on current guidelines." TNKase, the first "clot buster" that can be administered over five seconds in a single dose in the treatment of AMI, was approved by the Food and Drug Administration in June 2000. Tenecteplase is marketed by Boehringer Ingelheim GmbH as Metalyse in several countries worldwide, while Genentech markets the product as TNKase in the United States. Unique Company Names Norvasc-based regimen reduces rate of cardiovascular events, ASCOT results show Final results from the ASCOT trial indicate a regimen based on Pfizer Inc.'s Norvasc (amlodipine besylate) prevents more major cardiovascular events and induces less diabetes than a regimen based on atenolol, a beta blocker. A total of 19,257 patients (aged 40 to 79 years) with hypertension and at least three other cardiovascular risk factors were enrolled. They were randomized to receive the calcium channel blocker Norvasc plus CV Therapeutics Inc. and Solvay Pharmaceuticals Inc.'s Aceon (perindopril erbumine), as needed, or to receive atenolol plus bendroflumethiazide and potassium, as needed. After a median 5.5 years of follow-up, or 106,153 patient-years of observation, the study was stopped prematurely. Fewer patients receiving the Norvasc-based regimen rather than the atenolol-based regimen experienced stroke (23 percent reduction), cardiovascular events and procedures (16 percent reduction), cardiovascular death (24 percent reduction) and death from any cause (11 percent reduction). The Norvasc regimen also led to a 30 percent reduction in the incidence of diabetes when compared with the atenolol-based therapy. Additionally, the Norvasc-treated patients showed a 10 percent reduction in the primary endpoint of nonfatal myocardial infarction and fatal coronary heart disease, but this result was not significant. "We hope these results will be used to inform clinical practice in ways that should greatly reduce the burden of cardiovascular disease to which patients with hypertension are exposed," the investigators concluded. These results were presented in Stockholm, Sweden, at the annual meeting of the European Society of Cardiology and were published online Sept. 4 in The Lancet. Preliminary results were presented in March at the American College of Cardiology's Annual Scientific Session 2005. Unique Company Names Use of drug-eluting stents in all patients less cost effective than use in selected patients, study suggests The use of drug-eluting stents (DES) in all patients appears to be less cost effective than bare metal stents and could be restricted to use in high-risk patients, according to a study published online Sept. 6 in The Lancet. In the BASKET trial, 826 consecutive patients were treated with angioplasty and stenting for 1,281 de-novo lesions, "irrespective of indication for angioplasty," the study authors wrote. Patients were randomized to either Johnson & Johnson's sirolimus-eluting stent, Cypher (n=264); Boston Scientific Corp.'s paclitaxel-eluting stent, Taxus (n=281); or Guidant Corp.'s cobalt-chromium-based bare metal stent, Vision (n=281), and followed up for six months for incidence of major adverse cardiac events and costs. The primary endpoint was cost effectiveness after six months; effectiveness was defined as a reduction in adverse cardiac events. Results showed that cardiac death, myocardial infarction or target vessel revascularization occurred in 7.2 percent of the patients treated with one of the two DESs and 12.1 percent of patients treated with Vision stents. No significant differences between the DESs were observed, the authors noted. However, total costs at six months were higher with DESs (mean approximately $13,161) than with Vision (mean approximately $12,031), and the higher costs associated with DESs were not compensated for by lower follow-up costs. In addition, the incremental cost-effectiveness ratio of DESs compared with Vision to avoid one major event was approximately $22,856 and costs per quality-adjusted life year gained exceeded $62,409. The authors noted that subgroup analyses indicated that DESs were more cost effective for elderly patients in specific high-risk groups including those with three-vessel disease, treatment of multiple segments, long treated segments or small vessels. "[T]he use of DESs could be restricted to certain high-risk patient subgroups as defined in this study, at least until the prices of DESs are reduced," the authors concluded. Unique Company Names No link between FDA approval times, drug safety, analysis reveals There is no link between the Food and Drug Administration's approval times and drug safety, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD). "Given rising public concern over drug safety, and assertions by FDA critics that drug safety in the [United States] has deteriorated since the adoption of user fees in 1993, we wanted to investigate the matter," said Kenneth Kaitin, director of Tufts CSDD. The Prescription Drug User Fee Act (PDUFA), passed in 1992, allows the FDA to collect fees from drug firms to support the review process of a new drug or biologic. Findings indicate that 3.2 percent of all drugs approved for sale in the United States in the 1980s were subsequently taken off the market. In the 1990s, that rate grew to 3.5 percent, but it has since fallen to 1.6 percent, Tufts CSDD said. The analysis also found that the average time between the date of FDA approval and the date of safety withdrawal fell from 3.7 years in the 1980s to 1.4 years in the 1990s. That rate has fallen to 0.7 years during this decade, the report said. In addition, drugs withdrawn since 1980 had an average approval time of 2.14 years, more than the average approval time of 2.08 years for all approvals during that time. Lastly, the report noted that "[f]aster approval times also do not correlate with safety withdrawals within therapeutic class." "[I]t's important to understand if any aspects of the regulatory and approval process contribute to an imbalance in the benefit to risk ratio," Kaitin added. "We'll continue to study . . . the effects of PDUFA on new drug development." Unique Company Names Unique Company Names Merck & Co. Inc. Merck & Co. Inc. extended its collaboration with Celera Diagnostics to develop new treatments for Alzheimer's disease. The companies plan to combine their genetics research in order to "genetically validate and prioritize a series of genes targeted for drug development." Under the agreement, Celera will genotype specified gene-based mutations in four independent, case-control sample collections. Further terms of the agreement were not disclosed. The companies began identifying new targets for drug discovery and diagnostic markers related to Alzheimer's disease in July 2004. Unique Company Names Unique Company Names Novartis AG Novartis AG entered into a multi-year alliance with Alnylam Pharmaceuticals Inc. to discover therapeutics based on RNA interference, a natural mechanism for selective gene silencing and regulating found in cells. Novartis will make initial payments of $56.8 million to Alnylam, including up-front payments and the purchase of approximately 4.2 million Alnylam shares at $11.11 each. Novartis plans to hold an equity stake equal to 19.9 percent of Alnylam's outstanding common stock. The initial three-year agreement can be extended for two additional one-year terms. Excluding royalties, Alnylam could receive payments in excess of $700 million if the collaboration, which is subject to customary approvals, is successful and multiple products are developed and commercialized. Alnylam shares closed at $13.75, up $4.19, or 43.8 percent, in heavy trading on the Nasdaq, while Novartis shares closed at $49.35, up $0.07, or 0.1 percent, in light trading on the New York Stock Exchange. Unique Company Names Unique Company Names Wyeth Wyeth received a non-exclusive, worldwide license for Xoma Ltd.'s bacterial cell expression technology (BCE), an enabling technology used to discover, screen, develop and manufacture recombinant proteins and antibodies for commercial use. Under the agreement, Wyeth can use the BCE technology for the development and production of recombinant proteins. Additional terms of the agreement were not disclosed. Approximately 35 companies have been granted BCE licenses from Xoma. Unique Company Names Unique Company Names Novo Nordisk A/S Novo Nordisk A/S and Sangamo BioSciences Inc. entered into an agreement that will allow Novo access to Sangamo's zinc finger DNA-binding protein (ZFP) technology to see if it is useful in enhanced protein production. According to Sangamo, "ZFPs are the dominant class of naturally occurring transcription factors in organisms [and] . . . only zinc finger DNA-binding proteins are amenable to engineering and precise targeting to a particular gene or genes of interest." Unique Company Names Unique Company Names


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