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Trademark SearchingBrand 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 ASTRAZENECA AFFIRMS 2004 EPS GUIDANCE, BUT PUSHES FILING DATE FOR GALIDA FORWARD ___________________________________________________________________________ AstraZeneca Plc said for the full-year 2004, earnings per share would be in the middle of the previously projected $2.00 to $2.15 range, even as it extended its regulatory filing date for Galida, a potential type 2 diabetes treatment. Analysts surveyed by Thomson First Call expect earnings of $2.08 per share, according to CBS MarketWatch.AstraZeneca said dyslipidemia drug Crestor (rosuvastatin), gastrointestinal drug Nexium (esomeprazole), antipsychotic Seroquel (quetiapine), asthma inhaler Symbicort (budesonide/formoterol) and cancer drug Iressa (gefitinib) will drive sales and earnings growth in the near term, Reuters reported. However, the company pushed the filing date for Galida from 2006 to 2007 after agreeing to extend long-term follow-up clinical studies to two years. This follows a global regulatory review of the safety and toxicology of the drug class to which Galida belongs-- peroxisome proliferation activated receptor agonists. AstraZeneca reported in the press release that the Phase III programs for both Galida and Cerovive are progressing well. Cerovive, also known as NXY-059, is being evaluated to determine its effect on disability and neurological recovery in patients who have experienced acute ischemic stroke. This news comes after a Food and Drug Administration advisory committee recommended last month that the FDA not approve the company's Exanta (ximelagatran). The drug is intended to prevent blood clots, stroke and other clot-induced complications among certain patients. The panel said Exanta's benefits do not outweigh the long-term risk of liver damage and the potential short-term risk of heart attacks in some patients, The Wall Street Journal reported. AstraZeneca said in the press release that it is in discussions with the agency, and the 10-month deadline is Oct. 23. "With $10 billion in annual sales of newer products growing strongly, good progress across the development portfolio and success in emerging markets, AstraZeneca is well-positioned to overcome the recent disappointment of Exanta and to meet the wider challenges facing the industry," said Sir Tom McKillop, chief executive officer. The firm added that another 28 New Molecular Entity projects are in Phase I and II development, representing 60 percent more than those in Phase II studies one year ago. Shares of AstraZeneca closed at $39.64, down 2.3 percent, or $0.94, in heavy trading on the New York Stock Exchange. FDA GRANTS PRIORITY REVIEW TO ROCHE'S SBLA FOR PEGASYS, COPEGUS COMBINATION TO TREAT HCV IN HIV PATIENTS ___________________________________________________________________________ The Food and Drug Administration granted six-month priority review status to Hoffmann-La Roche Inc.'s supplemental Biologics License Application for its Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) combination therapy to be used as a treatment for chronic hepatitis C in patients co-infected with HIV. In August, Roche submitted the sBLA, which included results from what Roche identified as the largest study to date evaluating chronic hepatitis C treatment in HIV patients. Results of that trial showed that 40 percent of patients treated with Pegasys and Copegus achieved a sustained virological response (SVR). SVR refers to a patient's continued undetectable hepatitis C virus levels in the blood 24 weeks following treatment. "There are currently no approved treatments for the approximately 300,000 people in the United States with HIV who are infected with hepatitis C," said Dr. Juan Carlos Lopez-Talavera, senior medical director at Roche. GENENTECH POSTS HIGHER SALES, NET INCOME FOR THIRD QUARTER, INCREASES GUIDANCE ___________________________________________________________________________ Genentech Inc. increased its 2004 non-Generally Accepted Principles earnings guidance after posting a more than 50 percent increase in both product sales and net income in the third quarter of 2004 compared with last year. The company now expects earnings per share to be in the range of $0.80 and $0.83, up from the previously estimated range of between $0.75 and $0.80. This past quarter, product sales reached $1 billion for the first time in the firm's history, representing a 54 percent rise from $654.9 million in product sales one year ago. Operating revenue climbed 47 percent to $1.2 billion. Colorectal cancer drug Avastin (bevacizumab) and non-Hodgkin's lymphoma drug Rituxan (rituximab) lead sales, achieving $183 million and $437.7 million, respectively. Sales of breast cancer drug Herceptin (trastuzumab) increased 17 percent to $126 million while sales of asthma therapy Xolair (omalizumab) rose from $6.8 million a year ago to $53.9 million this past quarter. Excluding recurring charges related to a previous Roche redemption of Genentech's stock, special litigation items and the 2003 change in accounting principle, net income increased 80 percent to $259.6 million, or 71 percent to $0.24 per share. GAAP net income rose 52 percent from $152 million in last year's third quarter to $230.9 million; GAAP earnings per share increased 50 percent from $0.14 to $0.21. Earlier this week, Genentech said it had received a subpoena from the assistant U.S. Attorney's Office for the Eastern District of Pennsylvania requesting documents related to the promotion of Rituxan. The firm said it is cooperating with the investigation. Shares of Genentech closed at $50.52, down $0.88, or 1.7 percent in heavy trading on the New York Stock Exchange. BIOGEN IDEC LICENSES TECHNOLOGY WITH ANTIBODIES FROM IMMUNOGEN; SHARES OF IMMUNOGEN RISE ___________________________________________________________________________ ImmunoGen Inc. announced that Biogen Idec Inc. licensed exclusive rights to its Tumor-Activated Prodrug (TAP) technology with antibodies for an upfront $1 million payment, pushing shares of ImmunoGen up by 5.1 percent. If certain predetermined milestones are met, ImmunoGen could receive an additional $42 million as well as royalties on sales from resulting products. The firm will also be compensated for research done on Biogen Idec's behalf and production of preclinical and initial clinical materials. In exchange, Biogen Idec has exclusive worldwide rights to develop and commercialize anticancer therapeutics that contain a maytansinoid cell-killing agent developed by ImmunoGen and an antibody developed by Biogen Idec to an undisclosed tumor cell target. Biogen Idec will be responsible for researching, developing, manufacturing and marketing any resulting products. "We are delighted that Biogen Idec has recognized the value of our TAP technology as a way to create antibody-based anticancer compounds that have the potential to provide much better efficacy and tolerability than traditional anticancer drugs," said Mitchel Sayare, chief executive officer of ImmunoGen. The TAP technology is designed to provide tumor-targeting antibodies with significant anticancer activity. ImmunoGen shares closed at $5.60, up $0.27, in heavy trading on the Nasdaq. MEDAREX'S ANTIBODY RECEIVES ORPHAN DRUG STATUS FOR TREATING HODGKIN'S DISEASE ___________________________________________________________________________ Medarex Inc.'s fully human anti-CD30 antibody, MDX-060, received an orphan drug designation from the Food and Drug Administration for the treatment of Hodgkin's disease. The New Jersey-based company is currently conducting an expanded dose-ranging Phase II study with the antibody in patients with CD30-positive lymphomas. MDX-060 targets CD30, a molecule that is over-expressed in several lymphoproliferative disorders and is present on malignant cells in Hodgkin's disease, anaplastic large cell lymphoma and other CD30-positive lymphomas. The American Cancer Society estimates that approximately 7,880 new cases of Hodgkin's disease will be diagnosed in the United States this year, while 1,320 patients will die of the condition. This new designation was announced just one day after Medarex said the FDA granted fast track status to its fully human antibody MDX-010, in combination with melanoma vaccine MDX-1379, for the treatment of previously treated stage III and IV metastatic melanoma that is unresectable. The product had already received orphan drug designation for the treatment of high-risk stage II, III and IV melanoma. DATA REVIEW INDICATES BEXTRA HAS SIMILAR EFFICACY, FEWER ADVERSE EVENTS THAN NSAIDS IN TREATMENT OF OA, RA ___________________________________________________________________________ Findings from a review of randomized trials indicate Pfizer Inc.'s COX-2 inhibitor Bextra (valdecoxib) has similar efficacy compared with maximum doses of comparator nonsteroidal anti-inflammatory drugs (NSAID), but with fewer adverse events. Researchers conducted a systematic review of randomized, double-blind Phase II/III trials that compared Bextra with placebo or NSAIDs in patients with active osteoarthritis or rheumatoid arthritis. In total, the authors analyzed data from nine trials (five in OA, four in RA) that enrolled a total of 5,726 patients and lasted six to 26 weeks. Bextra was dosed at 10 mg or 20 mg once daily; the most common NSAID comparators were naproxen 1,000 mg/day (six trials) and sustained-release diclofenac 150 mg/day (two trials). Paracetamol and low-dose aspirin were allowed for reasons not associated with arthritis. The overall findings were consistent, showing Bextra 10 mg and 20 mg were significantly more efficacious than placebo and equivalent in efficacy to maximum daily doses of NSAIDs. Discontinuations because of lower gastrointestinal-related adverse events were 4 percent among patients treated with Bextra compared with 8 percent among those treated with NSAIDs. The rate of endoscopic ulcers 3 mm or greater was also lower with Bextra than with NSAIDs (5 vs. 13 percent, respectively). Clinically significant upper GI events occurred in 0.1 percent of patients treated with Bextra (two of 2,733) compared with 0.4 percent of those treated with NSAIDs (eight of 1,846). Clinically significant renal events occurred at the same rate with Bextra (2.3 percent) as with NSAIDs (2.7 percent). Peripheral edema occurred in 2 percent of patients treated with Bextra or NSAIDs, with no significant difference between therapies. Myocardial infarction occurred in 14 patients: three of 2,733 treated with Bextra (0.1 percent) versus 11 of 1,846 treated with NSAIDs (0.6 percent). "This was statistically significant, but not robust because of the small number of events," the authors noted. "In chronic disorders where the gain is small and the adverse events can be catastrophic, drugs like [Bextra], though a small step forward, are still part of work in progress," the researchers concluded. "Ongoing reviews of all useful clinical data should form part of evaluating that work." The findings were found in the October issue of Pain. Trademark Searching BAYER AG ___________________________________________________________________________ Bayer AG plans to spin off its chemicals and polymers business Lanxess at the beginning of next year. The plan requires approval from an extraordinary shareholders' meeting on Nov. 17 and would give Bayer stockholders one share in Lanxess for every 10 Bayer shares they own. Bayer said it expects one-time charges of approximately $94 million this year for spinning off the busines. The two companies will continue to trade with each other as well as jointly operate chemical park sites, Bayer said. Trademark Searching MERCK & CO. INC. ___________________________________________________________________________ Merck & Co. Inc. signed a license agreement with Norak Biosciences Inc. whereby Merck was granted the right to use Norak's Transfluor technology for G protein-coupled receptor drug (GPCR) discovery. Under the agreement, Merck will internalize Transfluor for use broadly with GPCR targets of interest. Financial terms of the agreement were not disclosed. Trademark Searching CVS CORP. ___________________________________________________________________________ CVS Corp. suspended further flu clinics in its stores after Chiron Corp. announced that it will be unable to supply the United States with any flu vaccine, Reuters reported. The drug store said its flu clinic program is administered by various health care companies that acquire vaccine from different sources, including Chiron. The company said it is evaluating its remaining vaccine supply in order to determine how to best distribute it. To date, none of the vaccinations administered in any of their clinics were manufactured by Chiron, CVS noted. Trademark Searching BARR LABORATORIES INC. ___________________________________________________________________________ Barr Laboratories Inc. received tentative approval from the Food and Drug Administration for its generic version of Warner Chilcott's Femhrt (norethindrone acetate and ethinyl estradiol) 1 mg/0.005 mg tablets. The product is indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of osteoporosis. The company expects final approval and launch in November 2009. Barr said it plans to market the drug as Nevis. Trademark Searching
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