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			Trademark 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 U.S. DRUG SALES UP 9 PERCENT IN YEAR THROUGH AUGUST, IMS REPORTS; GLOBAL SALES UP 8 PERCENT ___________________________________________________________________________ Pharmacy channel purchases from wholesalers and manufacturers in 13 key nations totaled $337.70 billion in the 12 months through August, including $170.69 billion in the United States, according to a report from IMS Health Inc. At constant exchange, global sales were up 8 percent over the period through August 2003 (when sales totaled $298.53 billion), while U.S. sales climbed 9 percent (from $156.37 billion). In the United States, the top-selling therapeutic category was central nervous system (CNS) drugs, with $39.80 billion in sales, up 14 percent year-over-year. Cardiovascular drugs ($30.56 billion, up 12 percent), alimentary/metabolism treatments ($23.79 billion, up 4 percent), respiratory therapies ($15.48 billion, up 3 percent) and anti-infectives ($13.74 billion, up 5 percent) rounded out the top five classes. Worldwide, cardiovascular drugs generated the greatest sales ($66.23 billion, up 8 percent), followed by CNS drugs ($62.65 billion, up 13 percent), alimentary/metabolism therapies ($48.52 billion, up 5 percent), respiratory treatments ($29.31 billion, up 4 percent) and anti-infectives ($27.67 billion, up 4 percent). Pfizer Inc.'s statin Lipitor (atorvastatin) was the world's top-selling drug, with $10.02 billion in revenue, followed by Merck & Co. Inc.'s statin Zocor (simvastatin), AstraZeneca Plc's ulcer drug Nexium (esomeprazole), Pfizer's calcium-channel blocker Norvasc (amlodipine besylate) and Bristol-Myers Squibb Co. and the sanofi-aventis Group's antiplatelet drug Plavix (clopidogrel bisulfate). Plavix had the greatest growth among top-selling drugs for the second straight year, with a 35 percent increase in sales. The five pharmaceutical firms with the greatest sales were unchanged from the previous year: Pfizer, GlaxoSmithKline Plc, Merck, AstraZeneca and Novartis AG. Overall sales in the top five European markets (Germany, France, Italy, the United Kingdom and Spain) totaled $83.41 billion during the 12-month period, up 7 percent, while Japanese sales climbed 3 percent to $56.11 billion. The top three Latin American markets (Mexico, Brazil and Argentina) generated $12.85 billion in sales, reflecting an increase of 20 percent, while sales in Australia and New Zealand were up 10 percent to $5.04 billion. Sales in Canada climbed 11 percent to nearly $9.60 billion. IMS said the 13 countries included in this analysis account for more than two-thirds of the world's drug sales. PFIZER REPORTS INCREASED THIRD-QUARTER INCOME, REVENUE ___________________________________________________________________________ Pfizer Inc. Wednesday reported third-quarter earnings that slightly exceeded Wall Street expectations and revenue that fell slightly short of expectations. The firm's net income, including special items, totaled $3.34 billion, or $0.44 per diluted share, up approximately 50 percent from $2.24 billion, or $0.29 per share, in the same period of last year. Excluding non-recurring items, Pfizer earned $4.16 billion, or $0.55 per share, compared with $3.68 billion, or $0.48 per share, last year. Analysts surveyed by Thomson First Call had anticipated earnings of $0.54 per share this year, excluding special items, CBS MarketWatch reported. Overall revenue in the quarter reached $12.83 billion, up 4 percent from $12.35 billion in the year-ago quarter. The company had been expected to generate approximately $13.23 billion in revenue, according to Thomson First Call. The firm's human pharmaceutical operations generated $11.29 billion in revenue, representing a 3 percent improvement from last year. The company's top-selling products in the quarter included the statin Lipitor (atorvastatin), with $2.74 billion (up 11 percent year-over-year); calcium-channel blocker Norvasc (amlodipine besylate), with $1.04 billion (down 6 percent); anxiety drug Zoloft (sertraline) and epilepsy drug Neurontin (gabapentin), with $802 million (down 3 percent) and $764 million (up 10 percent), respectively; COX-2 inhibitor Celebrex (celecoxib), with $797 million (up 14 percent); antibiotic Zithromax (azithromycin), with $339 million (down 4 percent); erectile dysfunction drug Viagra (sildenafil citrate), with $403 million (down 15 percent); and allergy drug Zyrtec (cetirizine), with $333 million (down 4 percent). Pfizer shares closed at $28.30, down $0.70, or 2.4 percent, in moderate trading on Wall Street. SIGNIFICANT PROPORTION OF HIGH-RISK ARTHRITIS PATIENTS WITH PRIOR ULCER BLEEDING EXPERIENCE RECURRENCE WHEN TAKING CELEBREX, DICLOFENAC PLUS OMEPRAZOLE, STUDY FINDS ___________________________________________________________________________ In a study of patients with prior ulcer bleeding who require long-term regular use of nonsteroidal anti-inflammatory drugs, researchers found that treatment with Pfizer Inc.'s Celebrex (celecoxib) or with diclofenac plus omeprazole was associated with a high incidence of recurrent gastroduodenal ulcers. To investigate the gastric safety of COX-2 inhibitors and antisecretory therapy among patients at high risk of an ulcer but who require NSAID therapy, the investigators evaluated 287 patients with arthritis who had NSAID-associated ulcer bleeding. After their ulcer healed, all Helicobacter pylori-negative subjects were randomly assigned to receive Celebrex 200 mg twice daily plus placebo or diclofenac 75 mg twice daily plus omeprazole 20 mg once daily. The regimens were maintained for a six-month period. All of the subjects underwent subsequent endoscopy, either at the time of recurrent bleeding or at the end of the study. At the end of the treatment period, the probability of recurrent ulcers was 18.7 percent in the Celebrex group and 25.6 percent in the diclofenac-plus-omeprazole group. When the number of bleeding ulcers were combined with that for ulcers identified on endoscopy, the recurrent ulcer probabilities were 24.1 percent in the Celebrex group and 32.3 percent in the diclofenac group. The researchers found that factors that were independently predictive of ulcer recurrence included treatment-induced significant dyspepsia, being aged at least 75 years and comorbidity. "Current guidelines on the management of arthritis patients at high risk of ulcer complications need to be critically reconsidered," the study authors suggested. They added, however, that the study findings indicate that the rate of ulcers in high-risk patients who received Celebrex or diclofenac plus omeprazole was about three times more frequent than that of low-risk subjects. "Thus, prophylactic treatment with a [proton pump inhibitor] or substitution for a COX-2 inhibitor alone effectively prevents gastroduodenal ulcers in average-risk but not high-risk patients," the researchers remarked. The study was published in the October edition of the journal Gastroenterology. WYETH REPORTS IMPROVED THIRD-QUARTER RESULTS ___________________________________________________________________________ Wyeth reported that its net income and net revenue each increased substantially in the third quarter of 2004, driven by its core products Effexor XR (venlafaxine hydrochloride), Enbrel (etanercept), Prevnar (7-valent pneumococcal conjugate vaccine), Zosyn (piperacillin/tazobactam) and Rapamune (sirolimus). Net revenue in the quarter totaled $4.47 billion, up 10 percent from $4.08 billion in the same period of last year. Worldwide pharmaceutical sales climbed 13 percent to $3.62 billion. Net income reached $1.42 billion in this year's third quarter, compared with a net loss of $426.4 million in the prior-year period. These results include a $407.6 million favorable income tax adjustment this year and a $2.00 billion charge last year related to litigation for the diet drugs Redux (dexfenfluramine hydrochloride) and Pondimin (fenfluramine hydrochloride). Excluding non-recurring items, third-quarter net income climbed to $1.01 billion, or $0.76 per diluted share, versus $873.6 million, or $0.65 per share, in the same quarter of 2003. Analysts polled by Thomson First Call had predicted profit of $938 million, or $0.70 per share, on revenue of $4.43 billion, according to TheStreet.com. Chief Executive Officer Robert Essner said the firm's growth was driven by sales of the antidepressant Effexor (up 38 percent year-over-year to $893 million), pneumococcal vaccine Prevnar (up 32 percent to $321 million), intravenous antibiotic Zosyn (up 13 percent to $197 million), renal transplant drug Rapamune (up 76 percent to $68 million) and Enbrel, which is indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. According to Wyeth's North American marketing partner Amgen Inc., Enbrel generated $496 million in third-quarter sales, up 45 percent from the same quarter of last year. Outside of North America, where Wyeth holds exclusive marketing rights, Enbrel generated $173 million in sales, approximately twice last year's figure. Shares of Wyeth closed at $37.23, up $0.05, or 0.13 percent, in heavy Wall Street trading. MERCK REVISES COLLABORATION AGREEMENT WITH ARENA PHARMACEUTICALS ___________________________________________________________________________ Merck & Co. Inc. expanded and extended its research collaboration with Arena Pharmaceuticals Inc. and purchased $7.5 million worth of Arena common stock at a 70 percent premium to the stock's Tuesday closing price. The research collaboration was established in October 2002 and focuses on the development of cardiovascular drugs that target G protein-coupled receptors, or GPCRs. Under the amended agreement, the collaboration will continue until October 2007. Additionally, Merck increased to $5.7 million per year the amount of funding it will contribute to the collaboration. The new agreement also limits the circumstances under which Merck can terminate the research funding and improves for Arena the terms relating to royalties on products generated through the alliance. The Arena common shares acquired by Merck were purchased for $8.00 per share, compared to the Tuesday closing price of $4.61 on the Nasdaq. Arena shares closed Wednesday at $5.43, up $0.82, or 17.8 percent, in heavy Nasdaq trading. COPAXONE SAFE, EFFECTIVE IN REDUCING RELAPSE RATE, ACCUMULATING DISABILITY IN RELAPSING-REMITTING MS ___________________________________________________________________________ New research presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRMS) indicate Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer acetate injection) is both safe and effective in reducing relapse rates and accumulating disability among patients with MS after 10 years of treatment. Of the 251 patients originally enrolled in a long-term study of Copaxone, 232 patients were included in the 10-year follow-up. Disability at follow-up was measured with the Expanded Disability Status Scale (EDSS). An EDSS score of 6.0 indicated the need for intermittent or one-sided constant assistance with a device such as a cane, crutch or brace. Compared with 47 patients who withdrew from Copaxone therapy after an average of 4.5 years but returned for the 10-year follow-up, significantly fewer patients who had been taking Copaxone for an average of 10.1 years achieved an EDSS score of 6.0 (9 percent vs. 50 percent). Additionally, 38 percent of patients who continued taking Copaxone demonstrated a worsening of disability compared with 72 percent of patients who discontinued the therapy. "If one considers the natural long-term debilitating effects of MS, these data are quite remarkable, since patients had experienced, on average, seven years of MS when they entered the study. Now, after almost 20 years of the disease, they still are walking without assistance," said Dr. Kenneth Johnson, director of the Maryland Center for MS and lead investigator in the trial. The long-term follow-up represents the longest continuous assessment of therapy in MS patients, Teva said in a press release. The company also announced its intention to extend the observation period to 15 years. Trademark KOSAN BIOSCIENCES INC. ___________________________________________________________________________ Kosan Biosciences Inc. received an orphan drug designation from the Food and Drug Administration for its Phase I multiple myeloma drug KOS-953, a proprietary formulation of 17-allylamino-17-demethoxy-geldanamycin (17-AAG). Kosan is also evaluating 17-AAG in clinical trials of other cancers in collaboration with the National Cancer Institute. Trademark PDI INC. ___________________________________________________________________________ PDI Inc. signed a two-year contract to promote Shionogi USA Inc.'s Cedax (ceftibuten) in the United States. Cedax is a cephalosporin antibiotic indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, pharyngitis and tonsilitis. Financial terms of the agreement were not disclosed. Trademark CORCEPT THERAPEUTICS INC. ___________________________________________________________________________ Corcept Therapeutics Inc. initiated a second Phase IIII trial of Corlux (mifepristone) for the treatment of the psychotic features of psychotic major depression (PMD). The 440-patient placebo-controlled study will evaluate three different doses of Corlux over a seven-day treatment period. Results of both studies are expected in the first half of 2006. Corlux has been granted a fast track designation by the Food and Drug Administration for the treatment of PMD. Trademark MEDIMMUNE INC. ___________________________________________________________________________ MedImmune Inc. initiated a Phase III trial to compare its refrigerator-stable intranasal influenza vaccine with the injectable flu shot. The study will include approximately 7,000 children aged 6 months through 59 months and will evaluate the vaccines' efficacy during the upcoming flu season. MedImmune has also initiated a study to compare its refrigerator-stable vaccine with its currently marketed frozen formulation, FluMist. Trademark


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