Naming Business - Brand Institute, inc.



			Naming Business 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 SERONO REPORTS DISCONTINUATION OF TWO PHASE III CLINICAL TRIAL PROGRAMS ------------------------------------------------------------------------------- Serono SA said two Phase III clinical trial programs--onercept (recombinant tumor necrosis factor binding protein) for the treatment of moderate to severe psoriasis and Canvaxin, a vaccine for the treatment of Stage IV melanoma--are being discontinued. The move is based on recommendations from two separate independent data and safety monitoring boards (DSMB). According to Serono, the company initiated three Phase III trials of onercept for the treatment of moderate to severe psoriasis in 2004. Investigators recently reported that two patients were diagnosed with sepsis, a recognized potential risk for patients treated with anti-tumor necrosis factor therapies. One patient subsequently died. After reviewing data from the first 12 weeks of two placebo-controlled trials and an open-label trial, an independent DSMB found that "the efficacy response observed for onercept was less than that observed in the earlier Phase II trial and with other available treatments." Based on the treatment's unfavorable risk-benefit profile, the DSMB recommended the discontinuation of onercept's clinical development for moderate to severe psoriasis. Also, a Phase III clinical trial of Canvaxin for the treatment of Stage IV melanoma is being discontinued based upon the recommendation of an independent DSMB. Serono licensed Canvaxin from CancerVax Corp. and is CancerVax's worldwide development partner for the therapy. After completing a second, planned interim analysis of the data from this study, the DSMB decided that "the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo." "This news is disappointing," said David Hale, president of CancerVax. "Treatment of patients with Stage IV melanoma has proven to be very difficult and, as yet, no therapeutic agent has been shown to impact overall survival in these patients." "We support the recommendation of the two [DSMBs]," said Franck Latrille, Serono's senior executive vice president for corporate global product development. According to the companies, the DSMB recommended that a Phase III clinical trial of Canvaxin for the treatment of Stage III melanoma continue as planned based on a limited review of trial data. The companies added that they plan to continue this trial. In December of 2004, Serono and CancerVax signed an agreement to develop Canvaxin for the treatment of melanoma and other indications, the Associated Press reported. CancerVax received $25 million upfront and sold 1 million common shares to Serono for $12 million. According to the AP, CancerVax said at the time that it could receive up to $253 million in additional payments from development, regulatory and commercial milestones. CancerVax shares closed at $3.48, down $3.10, or 49.36 percent, in heavy trading on the Nasdaq. Serono shares closed at $17.90, down $0.14, or 0.78 percent, in heavy trading on the New York Stock Exchange. -=- FOREST LOWERS ESTIMATE FOR FISCAL 2005 Q4 EARNINGS PER SHARE ------------------------------------------------------------------------------- Forest Laboratories Inc. expects earnings for the fiscal year 2005 fourth quarter ended March 31, 2005, to be lower than expected and below current analysts' estimates. The company expects fourth-quarter diluted earnings per share before one-time charges of approximately $0.40. Including the charges, diluted earnings per share are expected to be approximately $0.15, compared to $0.38 per diluted share in the fourth quarter of fiscal 2004. Analysts polled by Reuters Estimates expected fourth quarter earnings of $0.52 per share. The company expects net sales of approximately $614 million for the fourth quarter. Analysts polled by Reuters Estimates expected quarterly sales of $720 million. Forest said that reduced inventory levels at wholesalers and chains negatively impacted reported quarterly sales of key products including its antidepressant Lexapro (escitalopram oxalate) and its Alzheimer's disease drug Namenda (memantine hydrochloride). Though it gained market share, Lexapro's sales are expected to total approximately $400 million in the fourth quarter, compared with $427 million in the third quarter. Fourth quarter sales of Namenda were approximately $93 million, compared with $100 million in the third quarter, despite an increase in the drug's total prescription volume. The company added that its antidepressant Celexa (citalopram hydrobromide) achieved sales of "only $6 million" as the drug lost market share to generic versions introduced in October 2004. Forest shares closed at $33.51, down $4.48, or 11.79 percent, in heavy trading on the New York Stock Exchange. -=- BOEHRINGER INGELHEIM SEES STRONG SALES, INCOME GROWTH IN 2004 ------------------------------------------------------------------------------- Boosted by the strength of the euro, Boehringer Ingelheim GmbH reported its sales increased to approximately $10.56 billion in 2004. Operating income increased to approximately $1.8 billion. In addition, U.S. prescription drug sales grew in 2004, earning approximately $3.48 billion. IMS Health Inc. reported that Boehringer Ingelheim prescription drug sales grew 14.3 percent in 2004, which put the company in second place among the top 20 international pharmaceutical companies in terms of growth. The company increased its international market share by 0.2 percentage points, putting it in the 15th position in the market. Boehringer Ingelheim's best-selling drug in 2004 was Flomax (tamsulosin hydrochloride) for the treatment of benign prostatic hyperplasia, with sales of approximately $953.7 million. Mobic (meloxicam), used to treat rheumatoid arthritis, was the second best-selling drug at approximately $863.5 million in sales, followed by Micardis (telmisartan) for the management of high blood pressure, with sales of approximately $734.7 million. In 2004, Spiriva (tiotropium bromide monohydrate), used to treat chronic obstructive pulmonary disease, continued to grow in sales, reaching approximately $676.3 million. Spiriva is co-marketed worldwide with Pfizer Inc. -=- U.S. REVENUE OF SOME FIRMS MAY BE AFFECTED BY CMS' COST CONTROLS FOR PART B DRUGS, REPORT INDICATES ------------------------------------------------------------------------------- A large proportion of U.S. revenues for pharmaceutical and biotechnology companies may be at risk as the Centers for Medicare & Medicaid Services focuses more sharply on Medicare Part B drug costs, Wood Mackenzie said in a new report. The study, Medicare Insight, provides a four-year assessment of the top 500 pharmaceutical and biotechnological products launched in the United States before 2007. The firm used its Competitive Index and industry forecasting models to determine potential revenue impacts based on "each product's exposure to generic competition, uniqueness in the market, treatment costs among Medicare patient segments and outcomes superiority." The predictions were made within the framework of three possible Medicare scenarios, depending on whether manufacturers, supply chain or the government has control. The report shows that Part B drug prices have grown at double the rate of drugs that will be included in Part D. Part B drugs are administered in clinics rather than by the patients themselves and have recently made up the majority of the most expensive drugs introduced on the market. Part D drugs will be administered through the new Medicare prescription drug coverage plans. In 1995, Part B drug costs totaled $2 billion. Since then, the average increase in these costs has been 20 percent each year, as compared with the only 11 percent annual rise in Part D drug costs. As the federal government currently covers 75 percent of Part B drug costs, government coverage of Part B and Part D drugs could exceed $100 billion per year by 2010 if there are no cost controls, the study said. However, the Medicare Modernization Act gives CMS greater ability to implement Part B cost controls, which Wood Mackenzie believes will have an adverse effect on the revenue of companies who manufacture many Part B drugs. The report said Genentech Inc., Amgen Inc., F. Hoffmann-La Roche Ltd., Johnson & Johnson and Allergan Inc. derive more than 40 percent of their U.S. ethical pharmaceutical revenues from Part B drugs. "Because many Part B drugs are biologics and currently the [Food and Drug Administration] has no process to approve cheap generic versions, costs have remained high," said Mike Ratcliffe, U.S. research director at the firm. "We anticipate far greater scrutiny on these costs by CMS." Although companies like Pfizer Inc. and Merck & Co. Inc. do not largely rely on Part B drugs, a significant amount of their products may face competition with the introduction of Part D. -=- RITUXAN SIGNIFICANTLY IMPROVES RHEUMATOID ARTHRITIS SYMPTOMS DURING PHASE III STUDY ------------------------------------------------------------------------------- F. Hoffmann-La Roche Ltd.'s Rituxan (rituximab) met its primary endpoint in a recent Phase III rheumatoid arthritis (RA) trial. Roche markets the product as MabThera outside of the United States and Japan, while Genentech Inc. and Biogen Idec Inc. co-market the drug as Rituxan in the United States. Rituxan was approved by the Food and Drug Administration in 1997 and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma. The Randomized Evaluation of Long-term Efficacy of Rituximab in RA trial (REFLEX) enrolled patients with active RA but who had an inadequate response or were intolerant to at least one prior anti-tumor necrosis factor therapy. A total of 520 patients were randomized to receive 1,000 mg of intravenous Rituxan on days one and 15 or placebo. Additionally, they received a stable methotrexate dose and two-weeks of corticosteroids during the double-blinded study. At week 24, a greater proportion of the Rituxan group achieved 20 percent improvement on the American College of Rheumatology's criteria, or a 20 percent improvement in the number of swollen and tender joints and a 20 percent improvement in three of five disease-activity measures. According to this preliminary analysis, there were no unexpected safety signals, and the reported rate of serious adverse events was similar between the treatment arms. "The findings add to the growing body of evidence that selectively targeting B cells may provide an important new treatment approach for this debilitating disease," said Dr. Hal Barron, a senior vice president at Genentech. "While we are encouraged that the preliminary safety results are similar to previous studies, we recognize the importance of monitoring long-term safety in RA patients treated with Rituxan." Analysts said use of Rituxan in this difficult-to-treat form of RA will be relatively modest because competitors have also recently launched products, but sales to patients with RA could reach more than $831 million by 2010 if new indications are approved, Reuters reported. Zenyaku Kogyo Co. Ltd. co-markets the drug in Japan. -=- ENABLEX SIGNIFICANTLY INCREASES WARNING TIMES IN PATIENTS WITH URINARY URGENCY, RESEARCHERS REPORT ------------------------------------------------------------------------------- In the first study of its kind, treatment with Novartis AG's Enablex (darifenacin hydrobromide) was shown to significantly increase warning times in patients with urinary urgency. "When monitoring subjects with OAB [overactive bladder syndrome], urgency symptoms can be assessed by recording the frequency and severity of urgency episodes," wrote researchers. "However, each episode of urgency is also associated with a warning time, that is the time from the first sensation of urgency to the time of voluntary micturition or incontinence. Warning time may represent a meaningful measure of urgency to the subject, in addition to the number and severity of urgency episodes experienced." According to the investigators, warning time is rarely addressed in medical literature, and it has not been routinely used as an outcome measure in trials of pharmacological treatment for OAB. In the current study, the authors evaluated the effect of Enablex, an M3 selective receptor antagonist, on warning time associated with urinary urgency. The trial enrolled 72 patients with symptoms of urinary urgency, defined as a strong desire to void, for at least six months prior to study entry; subjects also must have had at least four episodes of urgency per 24 hours on at least five days of a 14-day run-in period. After a two-week washout period, patients were randomized to receive controlled-release Enablex 30 mg once daily or placebo for two weeks. The trial's primary efficacy endpoint was change in warning time; 67 patients (32 Enablex, 35 placebo) were included in this analysis. Results showed Enablex significantly increased mean warning time as compared with placebo, with a median treatment difference of 4.3 minutes. Furthermore, 47 percent of patients treated with Enablex achieved a 30 percent or greater increase in mean warning time compared with 20 percent of those treated with placebo. Enablex treatment also significantly increased warning times when evaluated using the median of each subject's urge-void cycles (median treatment difference, 4.3 minutes). In addition, minimum warning times, defined as the shortest time recorded by each subject from onset of urgency to micturition, were significantly greater with Enablex (median treatment difference, 1.9 minutes). "To our knowledge these data provide the first objective demonstration of an increase in warning time, which should confer a decrease in incontinence episodes and, thus, increase subject confidence," the researchers wrote. "Further studies are necessary to determine the degree of increase in mean, median and minimum warning times that would be required significantly to enhance quality of life in subjects with OAB." The results of the research can be found in the April edition of the Journal of Urology. -=- Naming Business NABI BIOPHARMACEUTICALS ------------------------------------------------------------------------------- Nabi Biopharmaceuticals updated its 2005 revenue guidance for WinRho SDF [Rho (D) immune globulin intravenous (human)] after customers did not fully replace products sold to patients during a transition period. Nabi's license and distribution agreement with Cangene Corp., WinRho's manufacturer, ended on March 24. For 2005, the company expects total biopharmaceutical sales to range between $88 million and $91 million, down from the original estimate of $93 million to $96 million. Total WinRho sales for the first quarter are expected to be approximately $6 million. Thomson Financial surveyed analysts who said they expect a loss of $1.01 per share on total revenue of $142 million, the Associated Press reported. -=- Naming Business NOVEN PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Noven Pharmaceuticals Inc. reported positive preliminary results from clinical trials of its methylphenidate transdermal system (MTS) patch, which it is developing with Shire Pharmaceuticals Group Plc. The company said the MTS patch met study endpoints in children aged 6 to 12 years with attention deficit hyperactivity disorder. Noven and Shire expect to use this data to amend their New Drug Application for the patch, which is currently under review by the Food and Drug Administration. The FDA had initial concerns when it reviewed the NDA in April 2003, but said it will review the amendment within six months. Shire said it will release additional trial data in May. -=- Naming Business HALOZYME THERAPEUTICS INC. ------------------------------------------------------------------------------- Halozyme Therapeutics Inc. received priority review of its New Drug Application for Enhanze SC drug dispersion product, pending the Food and Drug Administration's formal acceptance of its filing. Enhanze SC is a form of a naturally occurring human enzyme that is intended to aid absorption of drugs or fluids. Halozyme submitted the NDA on March 23 and said the FDA might complete its review by the end of the third quarter this year. -=- Naming Business OSCIENT PHARMACEUTICALS CORP. ------------------------------------------------------------------------------- Oscient Pharmaceuticals Corp. amended its license and option agreement with LG Life Sciences Ltd. for Oscient's Factive (gemifloxacin mesylate) tablets for the treatment of community-acquired pneumonia and chronic bronchitis. As a result of the amendment, Oscient will reduce royalties payable to LG Life Sciences at certain revenue levels. Oscient will pay a one-time cash payment of $2 million recorded in the first quarter of 2005 and will increase milestone payments by $8 million. Oscient expects to record, also in the first quarter, $5 million from orders shipped and approximately $500,000 in revenue from 2004 shipments previously recorded as deferred product revenue. -=- PFIZER PULLS BEXTRA FROM MARKET; FDA ASKS ALL NSAIDS TO UPDATE WARNINGS ON CARDIOVASCULAR, GASTROINTESTINAL RISKS ___________________________________________________________________________ Pfizer Inc. voluntarily suspended sales of its COX-2 inhibitor Bextra (valdecoxib) in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The FDA asked Pfizer to pull the painkiller from the market late Wednesday afternoon "because the overall risk versus benefit profile for the drug is unfavorable," the agency said in statement. Though Pfizer said it "respectfully disagrees" with the agency's position, it agreed to suspend sales "pending further discussions with the FDA." According to Pfizer, the FDA concluded that Bextra's cardiovascular risk is no different than the risk in other nonsteroidal anti-inflammatory drugs (NSAIDs), but "that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market." Pfizer said it will explore its options with the FDA to see under what conditions it might be able to resume marketing the drug. Until then, however, patients should no longer take the drug and should contact their physicians for alternative treatment options. The FDA also asked Pfizer to add a boxed warning to Celebrex's (celecoxib) label to highlight "the potential for increased risk of cardiovascular events and gastrointestinal bleeding associated with [its] use." The FDA asked all manufacturers of prescription NSAIDs to add this same boxed warning to their drugs. Additionally, all manufacturers of over-the-counter NSAIDs were asked to update their labels "to include more specific information about the potential [cardiovascular] and [gastrointestinal] risks, and information to assist consumers in the safe use of the drugs," the FDA said. OTC NSAIDs should also include a warning about possible skin reactions associated with their use, the FDA said; prescription NSAIDs already include this warning on their labels. "[The] FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks," said Dr. Steven Galson, acting director of the agency's Center for Drug Evaluation and Research (CDER). In making this decision on NSAIDs, CDER reviewed regulatory histories and New Drug Application databases on the drug class. It also considered background documents, data, presentations and votes from the advisory committee meeting held Feb. 16 through Feb. 18. At the advisory committee meeting, the panel voted 17 to 13 in favor of keeping Bextra on the market (with two abstentions), but they unanimously stated that Bextra, Celebrex and Merck & Co. Inc.'s Vioxx (rofecoxib) do present potential heart risks and suggested placing black box warnings on each drug's label. The FDA's re-examination of the cardiovascular and gastrointestinal risks associated with NSAIDs began after Merck voluntarily withdrew Vioxx in September 2004 when an increased relative risk of cardiovascular events was observed in some users. The FDA said it will "carefully review any proposal from Merck for resumption of marketing of Vioxx." Pfizer shares fell $0.41, or 1.5 percent, to $26.45 in midday trading on the New York Stock Exchange. Naming Business


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