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			Logo Designers 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 TARCEVA APPROVED FOR NSCLC IN SECOND-LINE; LABELING DISAPPOINTS INVESTORS ___________________________________________________________________________ The Food and Drug Administration approved lung cancer drug Tarceva (erlotinib), but shares of two of the drug's developers dropped Friday following the announcement. The drug, developed by Genentech Inc., OSI Pharmaceuticals Inc. and F. Hoffmann-La Roche Ltd., was approved for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one chemotherapy regimen. However, according to Piper Jaffray analyst Thomas Wei, the package insert for Tarceva contains unanticipated information that could limit the number of patients who are prescribed the drug, according to a Reuters report. Tarceva is an oral drug that inhibits the epidermal growth factor receptor (EGFR). The product's approved labeling unexpectedly describes subgroups of patients analyzed according to whether they genetically express EGFR. "Its inclusion in the label suggests that the FDA found the analysis important for physicians to consider," Wei said. "If physicians choose to limit their usage to EGFR-positive patients, our estimates for sales in lung cancer, which assume 55 percent penetration of the relapsed market at peak, may prove aggressive." The amount of revenue generated by Tarceva may also hinge largely on studies being conducted on AstraZeneca Plc's oral EGFR-inhibitor Iressa (gefitinib), according to a report from TheStreet.com. Iressa was approved based on studies that showed it reduced tumor size, while Tarceva's pivotal studies demonstrated the drug increased median survival from 4.7 months to 6.7 months. The survival data have encouraged investors that Tarceva may outsell Iressa, but data from survival studies of Iressa are due in early 2005, TheStreet.com said. Tarceva sales estimates for 2006 range from approximately $300 million to $600 million, according to TheStreet.com, while 2008 forecasts range from approximately $500 million to $1 billion (the 2008 estimates include assumptions that Tarceva may be used for other cancers as well). Shares of Genentech closed at $48.89, down $0.99, or approximately 2 percent, in moderate trading on the New York Stock Exchange. OSI shares closed at $58.16, down $6.09, or 9.5 percent, in heavy trading on the Nasdaq. ICAHN OFFERS TO PURCHASE MYLAN; PROPOSAL VALUES FIRM AT $5.4 BILLION ___________________________________________________________________________ Financier Carl Icahn offered Friday to purchase all outstanding shares of Mylan Laboratories Inc. for $20 per share, which would value the company at approximately $5.4 billion, according to The Wall Street Journal. News of the offer prompted a 10 percent rise in Mylan share value. Icahn currently owns 9.8 percent of Mylan shares, making him the firm's largest shareholder. The financier has been leading a proxy battle to stop the firm from completing its proposed $4 billion acquisition of King Pharmaceuticals Inc., which was announced in July. A letter sent to Mylan's board said that in order to show the sincerity of his proposal, Icahn would be willing to negotiate an agreement not to attempt to unseat Mylan Chief Executive Officer Robert Coury or the existing Mylan board, should they accept his $20-per-share offer. Additionally, the acquisition agreement would not include a breakup fee, allowing Mylan to seek alternative buyers, according to the Journal. "Frankly, I believe there would be better synergistic buyers than myself," Icahn noted. The letter added that Icahn believes there are at least three potential buyers who would have an interest in a "friendly" acquisition of Mylan. Mylan issued a press release late Friday, in which it promised to respond to the letter in due course. "This letter appears to be a standard Icahn tactic, containing factual misrepresentations, and is notable in its lack of detail and commitment," the Mylan statement asserted. "In addition, with regard to Mr. Icahn's threats against members of Mylan's board of directors, we can assure him that his attempts at corporate intimidation will not succeed." Mylan added that its position with respect to the King acquisition remains unchanged. Late last month, King released preliminary third-quarter results but cautioned the figures could be revised, pending an internal evaluation of its returns reserve. Any earnings restatement would give Mylan grounds to terminate the transaction, but Mylan said in October that it had made no decisions on the matter. Shares of Mylan closed at $18.88, up $1.72, in heavy trading on the New York Stock Exchange. Shares of King closed at $11.15, down $0.05, or 0.05 percent, also on Wall Street. EXUBERA EFFECTIVE, WELL TOLERATED AMONG PATIENTS WITH TYPE 1 DIABETES, DATA SHOW ___________________________________________________________________________ New data indicate Pfizer Inc. and the sanofi-aventis Group's Exubera (inhaled insulin) is effective, well tolerated and provides glycemic control comparable to that achieved with a conventional insulin regimen. In the trial, 335 patients were randomly assigned to receive either pre-meal Exubera plus Eli Lilly and Co.'s Ultralente, administered subcutaneously at bedtime, or two to three injections of regular and NPH insulin for a period of 24 weeks. Researchers defined the trial's primary endpoint as the change in hemoglobin A1c levels, a measure of blood sugar. Secondary endpoints included changes in fasting plasma and 2-h postprandial glucose levels and percentage of subjects achieving HbA1c levels less than 7 percent at week 24. Results showed that mean decreases in HbA1c levels were comparable for the Exubera (8.1 percent to 7.9 percent) and conventional groups (8.1 percent to 7.7 percent). Patients who were administered Exubera achieved a greater reduction in fasting and postprandial plasma glucose levels (-25.17 mg/dL and -30.28 mg/dL, respectively) than those treated with conventional insulin. Mild to moderate cough was observed in 27 percent of Exubera-treated patients compared with 5 percent of conventional insulin recipients, although the prevalence of cough decreased during treatment. These data were presented in the November issue of Diabetes Care. ADDITION OF SINGULAIR TO SHORT-ACTING BETA2 AGONIST PROVIDES GREATER RESCUE BRONCHODILATION, PROTECTION AGAINST EXERCISE-INDUCED BRONCHOCONSTRICTION THAN DOES ADDITION OF SEREVENT, DATA INDICATE ___________________________________________________________________________ The addition of Merck & Co. Inc.'s Singulair (montelukast) to a short-acting beta2 agonist allows a greater and more rapid rescue bronchodilation than does the addition of GlaxoSmithKline Plc's Serevent (salmeterol) among patients whose asthma symptoms remain uncontrolled after using inhaled corticosteroids (ICS), study results demonstrated. The double-blind study was conducted at 16 centers in the United States among 122 patients with asthma whose symptoms were uncontrolled on low-dose inhaled fluticasone and who had a history of exercise-induced worsening of asthma. Study participants were randomized to receive oral Singulair (10 mg once daily), inhaled Serevent (50 mcg twice daily) or placebo for four weeks. At baseline and weeks one and four, the study authors performed standard spirometry after exercise challenge and beta2 agonist rescue. At four weeks, maximum achievable forced expiratory volume in 1 second (FEV1) percent predicted after rescue beta2-agonist improved in the Singulair and placebo groups (+1.5 percent and +1.2 percent, respectively), but declined in the Serevent group (-3.9 percent). Although pre-exercise FEV1 was greatest among those patients taking Serevent, those taking Singulair had significantly greater protection from an exercise-induced reduction in FEV1 as compared with those taking Serevent. Moreover, both the magnitude and rate of rescue bronchodilation were greater with Singulair compared with Serevent. Five minutes after the administration of rescue beta2-agonist, 92 percent of patients taking Singulair and 68 percent of patients taking placebo had recovered to pre-exercise levels, as compared with only 50 percent of those taking Serevent. "In patients whose asthma symptoms remain uncontrolled after using ICS, addition of [Singulair] permits a greater and more rapid rescue bronchodilation with a short-acting beta2 agonist than the addition of [Serevent] and provides consistent and clinically meaningful protection against exercise-induced bronchoconstriction," the study authors concluded. The study appeared in the November issue of Respiratory Medicine. HIV-POSITIVE PATIENTS ADMINISTERED TIPRANAVIR-BASED REGIMEN ACHIEVE GREATER TREATMENT RESPONSE THAN OTHER PROTEASE INHIBITOR REGIMENS ___________________________________________________________________________ HIV-positive patients administered a regimen including Boehringer Ingelheim GmbH's tipranavir achieved greater treatment response than patients on a regimen including one of several other marketed protease inhibitors (PIs), according to new data presented in Glasgow, Scotland, at the Seventh International Congress on Drug Therapy in HIV infection. In the study, 863 HIV-positive patients were randomized to receive a twice-daily dose of tipranavir 500 mg boosted with a 200 mg dose of Abbott Laboratories Norvir (ritonavir) or Norvir with a comparator PI. All patients combined their PI with an optimized background regimen of HIV therapies selected on the basis of treatment history and baseline genotypic resistance testing. Overall, patients examined in the trial were patients with advanced HIV who, on average, had received 12 antiretroviral therapies, were experiencing virologic failure and had documented resistance to PIs. Researchers defined treatment response as a 1 log 10 or greater decrease in viral load from baseline. Based on this criteria, 41 percent of tipranavir-treated patients achieved a treatment response compared with 14.9 percent of patients who received a comparator PI boosted with Norvir. Moreover, at 24 weeks, 33.6 percent of patients in the tipranavir group achieved a viral load of less than 400 copies/mL compared with 13.1 percent of patients on the non-tipranavir regimen. Patients who received tipranavir also experienced greater increases in CD4+ counts than those taking a comparator PI, with CD4+ increases of 31 cells/mm3 and 1 cell/mm3, respectively. Dr. Andrea Barner, vice chairman of the board of managing directors at Boehringer Ingelheim, noted the results from this study move the firm "one step closer to providing tipranavir to patients in need of new treatment options." NUMBER OF REGISTERED NURSES GROWING, BUT SHORTAGE STILL EXISTS, ANALYSIS SHOWS ___________________________________________________________________________ Researchers estimated nearly 119,000 registered nurses (RN) entered the U.S. workforce in 2003 following approximately 86,000 new RNs in 2002, but the country continues to face a shortage. The investigators used data from the U.S. Census Bureau's Current Population Survey to gather information on employment, hours worked and earnings, among other areas. The nationally representative survey includes more than 100,000 Americans, one-quarter of whom are polled each month. Results showed the U.S. workforce added approximately 118,698 full-time equivalent (FTE; the number of full-time RNs plus one-half the number of part-time RNs) RNs in 2003. In 2002, there was slightly more than 2 million FTE RNs overall. Among those who began working as an RN in 2003, approximately 98,764 were employed in a hospital, while 19,934 were employed elsewhere. The investigators found several factors that may have contributed to the increase in RNs, including greater inflation-adjusted earnings (1.8 percent increase in 2003 for hospital-based RNs and 1.2 percent increase for other RNs), higher overall unemployment in the United States (overall rate of 6.0 percent vs. 5.8 percent in 2002 and less than 5.0 percent from 1997 to 2001) and widespread private-sector initiatives. For the second straight year, more than 60,000 RNs aged 50 to 64 years entered the workforce. However, in 2003, that age group was outpaced by nurses aged 21 to 34 years, more than 87,000 of whom entered the workforce. In contrast, in 2002, the number of nurses aged 21 to 34 years dropped by more than 21,000, while the number of nurses aged 35 to 49 years grew by more than 43,000 (the number of nurses aged 35 to 49 years dropped by 34,000 in 2003). Furthermore, the number of foreign-born RNs in the United States grew by an average of 12.5 percent in 2002 and 2003, contributing a total of 66,000 RNs. During the years 1994 to 2001, the growth rate for foreign-born RNs was 6.0 percent, compared with 1.5 percent among all RNs in that period. "[D]espite the increase in employment of nearly 185,000 hospital RNs since 2001, there is no empirical evidence that the nurse shortage has ended," the researchers concluded. "To the contrary, national surveys of RNs and physicians conducted in 2004 found that a clear majority of RNs (82 percent) and doctors (81 percent) perceived shortages of RNs in the hospitals where they worked or admitted most of their patients." The study is available on the Web site of the journal Health Affairs. Logo Designers DYAX CORP. ___________________________________________________________________________ Dyax Corp. and Epix Pharmaceuticals entered into a collaboration for the discovery and development of peptides for use as imaging agents or therapeutics. The firms will attempt to identify peptides that bind specifically to an undisclosed Epix target. Epix will hold commercialization rights for any products derived from the collaboration. Logo Designers OXIGENE INC. ___________________________________________________________________________ Oxigene Inc. initiated a Phase II trial of its lead compound, Combretastatin A4 Prodrug. The open-label, dose-ranging study will assess the safety and efficacy of the drug in patients with active choroidal neovascularization associated with myopic macular degeneration (MMD). MMD is a progressively degenerative eye disease that can cause legal blindness and has been estimated to affect more than 300,000 individuals in the United States. Logo Designers CALIFORNIA ___________________________________________________________________________ California Insurance Commissioner John Garamendi filed suit against insurance companies Cigna Corp., MetLife Inc., Prudential Financial and UnumProvident Corp., claiming the firms secretly made deals with broker Universal Life Resources that paid ULR kickbacks for bringing them business, according to a Reuters report. ULR reportedly has pledged to fully help Garamendi's office in its investigation of the bid-rigging allegations in exchange for freedom from being required to pay fines or restitution. ULR remains open to other lawsuits, which may force it to return any "ill-gotten gains." Logo Designers ADVANCIS PHARMACEUTICAL CORP. ___________________________________________________________________________ Advancis Pharmaceutical Corp. eliminated 18 percent of its workforce, bringing its total number of employees to 87. The company said the reduction is part of an initiative that it believes will result in a 2005 net spending reduction of more than $20 million from previously planned levels. Advancis said its current funds and anticipated revenue should support its operations at least through the first quarter of 2006, even without the generation of new revenue sources. Logo Designers


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