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			Package Design 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 Lilly expects 2006 earnings to be higher than expected Eli Lilly and Co. expects 2006 earnings to top Wall Street forecasts due to an increasing demand for its new drugs and growth of its product portfolio. The company expects 2006 earnings per share of $3.10 to $3.20, representing an 8 to 12 percent growth compared with expected 2005 adjusted earnings. "This growth rate is nearly double the average Wall Street consensus forecast for large-cap pharmaceutical companies," said Sidney Taurel, chief executive officer for Lilly. Reuters Estimates' analysts expected average earnings of $3.08 per share for next year. Nine new products--whose sales are up from 11 percent at the end of 2004 to 18 percent this year--account for an increasing percentage of Lilly's sales, said Charles Golden, Lilly's chief financial officer. He said such sales are expected to continue to rise from 7 to 9 percent next year, making up approximately 24 percent of revenue. However, Golden noted that continuing earnings growth is dependant upon increasing growth of its antidepressant Cymbalta (duloxetine hydrochloride), antipsychotic Zyprexa (olanzapine) and other new products. Such earnings growth is also contingent on the firm's ability to manage costs and increase productivity of resources, he added. "We are somewhat encouraged by Zyprexa's recent U.S. performance where the erosion of Zyprexa prescriptions slowed in recent months," John Lechleiter, chief operating officer for Lilly, explained. "Our goals are to further stabilize U.S. Zyprexa sales and sustain modest growth on a global basis. Also, despite an overall flat U.S. antidepressant market in 2005, Cymbalta has led all branded and promoted products in share-of-market growth during this period." Excluding a second quarter 2005 product liability charge and any potential fourth quarter unusual items, the company predicts fourth quarter adjusted earnings per share to be at the top of its guidance range of $0.73 to $0.79. It also expects its full-year 2005 adjusted earnings to be at the high end of the guidance range of $2.80 to $2.86 per share. These anticipated earnings reflect "strong operating results and the benefit of a lower-than-expected tax rate of 21 percent, " the company said. Reported earnings per share for 2005 should be at the top of the $1.90 to $1.96 range compared with reported 2004 earnings per share of $1.66. Separately, Lilly said it plans to submit a supplemental New Drug Application in 2006 to the Food and Drug Administration for Cymbalta for the treatment of generalized anxiety disorder. The company has completed two clinical trials that it believes will support the application. Package Design NEJM says publication of Merck-sponsored Vioxx study failed to include key data The New England Journal of Medicine said it has discovered that data regarding three patients who took Vioxx (rofecoxib) and experienced myocardial infarctions were not included in the publication of an important study sponsored by Merck & Co. Inc., giving the appearance that the painkiller was safer than it really was. The VIGOR study was designed to compare gastrointestinal events in patients with rheumatoid arthritis who were randomly administered Vioxx or F. Hoffmann-La Roche Ltd.'s Naprosyn (naproxen); researchers also collected data on cardiovascular events. Results were published in NEJM in 2000. But according to the "Expression of Concern" editorial posted Dec. 8 on the journal's Web site, the occurrence of three MIs in trial patients who received Vioxx was not submitted to NEJM when the study was published. When journal staff became aware of the events in 2001, they thought Merck had not known about the events in time for them to be included in the publication. But a memorandum obtained by subpoena in the current Vioxx litigation demonstrates that at least two of the study authors knew about the three events at least two weeks prior to submitting the first of two revisions and 4.5 months before publication, the editorial explained. "The fact that these three MIs were not included made certain calculations and conclusions in the article incorrect," NEJM stated. Specifically, exclusion of the three events resulted in an understatement of the difference in risk of an MI between the Vioxx and Naprosyn groups: When the data were excluded, there was a reduction in MI risk with naproxen, but when the data were included, the MI risk was increased with Vioxx. The editorial writers have asked the authors of the study to submit a correction to the journal. In a statement, Merck said the study "fairly and accurately" described the results of the trial. The company said the three omitted MIs, which "did not materially change any of the conclusions in the article," were not included in the submission for publication because they were reported "after a pre-specified cutoff date." The company believes it correctly expressed the benefits and possible risks of Vioxx, noting that it disclosed the additional MI events to the Food and Drug Administration in 2000 and 2001 and in subsequent press releases. Merck added that it only recently learned of the editorial in NEJM, so it did not have an opportunity to formally respond "given the timing of its publication." It plans to provide a more complete response. Some plaintiff's attorneys said they would use the disclosure about the withheld data to attack Merck's credibility in Vioxx trials, The Wall Street Journal reported. Package Design Switching from tamoxifen to Arimidex appears to reduce risk of death, analysis finds In postmenopausal women with hormone-sensitive early breast cancer, switching treatment to AstraZeneca Plc's Arimidex (anastrozole) after two years of tamoxifen resulted in a 29-percent reduced risk of death, according to an analysis of three trials presented at the San Antonio Breast Cancer Symposium. The three trials were similarly designed to assess whether replacing tamoxifen therapy with Arimidex after two years was more effective than staying on tamoxifen for a full five years of treatment. The results presented at the symposium came from patients who had been monitored for an average of 2.5 years, AstraZeneca said. In additional to the 29-percent reduced risk of death, Arimidex was associated with a 45-percent reduction in the risk of the disease returning and a 39-percent reduction in the risk of the cancer spreading to other parts of the body, the firm said. "For the first time, an aromatase inhibitor has shown a survival advantage over tamoxifen in early breast cancer," said Walter Jonat, the investigator who presented the new data. "These studies, along with others such as the ATAC trial, confirm that tamoxifen is no longer the best option we can offer our patients. Women who have taken two years of tamoxifen should be switched to [Arimidex] at the earliest opportunity to give them the best chance of surviving their disease." Last year at the symposium, ATAC data revealed that patients who took Arimidex for five years had a significantly reduced risk of disease recurrence as compared with patients who took tamoxifen for five years, AstraZeneca noted. Dr. Aman Buzdar, chair-elect of the ATAC trial, said that although these latest studies "help further define the clinical benefits of aromatase inhibitors," additional "data are needed to draw conclusive long-term overall survival results." "Optimal therapy for postmenopausal women with hormone receptor-positive early breast cancer should include an aromatase inhibitor," Dr. Buzdar said. Package Design Discontinuing Mirapex in patients with RLS leads to worsening symptoms, study finds Data from a withdrawal study of Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex (pramipexole dihydrochloride) showed that discontinuing the drug caused rapid worsening of restless legs syndrome in patients who previously responded well to Mirapex therapy. The randomized, placebo-controlled trial involved patients with RLS who had responded to Mirapex in a prior six-month, open-label treatment phase. These patients were then randomized to 12 weeks of blinded treatment with either Mirapex (n=78) or placebo (n=69). The study's primary endpoint was assessment of time to worsening of RLS symptoms, measured by the International RLS Rating Scale and the Clinical Global Impressions-Global Improvement scale, Boehringer said. Researchers found that, compared with those who were randomized to placebo, patients who were randomized to continue treatment with Mirapex experienced a significantly longer time before their symptoms worsened. While only 20.5 percent of patients in the blinded Mirapex group experienced worsening of their symptoms, 85.5 percent of those in the placebo group did. One week after they were randomized, more than 70 percent of the placebo-treated patients had worsened symptoms compared with 9 percent of Mirapex-treated patients, Boehringer noted. Furthermore, Mirapex significantly improved patients' disease-specific quality-of-life score to 90 percent; in the placebo group the score was 70 percent. Mirapex is currently approved for treatment of the signs and symptoms of idiopathic Parkinson's disease and is co-promoted in the United States for this indication by Boehringer and Pfizer Inc. Package Design Good adherence to drug regimen associated with lower risk of mortality in patients with CHF In patients with chronic heart failure, good adherence to a prescribed drug is associated with a lower risk of death than is poor adherence, regardless of treatment, according to a study published in the Dec. 10 issue of The Lancet. The double-blind, randomized, controlled CHARM trial compared the effects of Atacand (candesartan cilexetil) with placebo in 7,599 patients with CHF. Atacand is manufactured by AstraZeneca Plc under a license from Takeda Pharmaceutical Co. Ltd. A total of 187 patients were excluded because of missing information on adherence. Adherence to the study drug was recorded at each visit. Good adherence was defined as taking more than 80 percent of the study drug, while poor adherence was defined as taking 80 percent or less of the study drug. Overall, 89 percent (n=6,763) of patients were in the good adherence group, and 11 percent, (n=836) of patients were in the poor adherence group. After adjusting for predictive factors in the time-dependent Cox regression model, good adherence was associated with a 35-percent lower risk of all-cause mortality in patients with CHF. The adjusted hazard ratio for all-cause death with good adherence was similar in both the Atacand and placebo groups. "The finding that adherence to even placebo was strongly related to outcome suggests that adherent behavior itself is associated with outcome," the researchers concluded. "Since CHF is a major cause of death and disability, the need to improve adherence to effective treatments is obvious." Package Design Majority of large firms to maintain retiree drug coverage, accept Medicare subsidies in 2006, survey finds Four out of five large, private businesses that currently provide retiree health benefits will accept government subsidies for continuing to provide retiree drug coverage when the Medicare prescription drug benefit begins in January, according to results of a new survey. The survey, which was conducted by the Kaiser Family Foundation and Hewitt Associates LLC online between June 21 and Oct. 7, included 300 private-sector firms that employed at least 1,000 employees and offered retiree health benefits. For 2006, firms will have several options with regard to the Medicare drug benefit. They can continue to provide coverage that is at least as good as the Medicare drug benefit and receive tax-free subsidies equal to 28 percent of allowable drug costs between $250 and $5,000 per retiree, provide drug coverage that supplements Medicare coverage and not receive the subsidy, become a Medicare prescription drug plan or terminate drug and/or other medical retiree benefits entirely. Ten percent of survey respondents said that they will provide some drug coverage to supplement the new drug benefit, while 9 percent said they plan to no longer offer drug coverage to Medicare-eligible employees. Firms that plan to continue to offer benefits and accept the government subsidy are expected to save an average of $626 per individual retiree. Those that choose to supplement the Medicare drug benefit are expected to save an average of $826 per individual retiree. Survey results also indicated that while 56 percent of the employers surveyed who expect to accept the Medicare subsidy for their largest plan in 2006 said their retirees would be allowed to enroll or re-enroll in the employer plan at a future date if they sign up for a Medicare drug plan. The remaining 44 percent of employers indicated that their retired employees would not have this option. Nearly 30 percent of employers who will accept the government subsidy said that if a retiree signs up for a Medicare plan, that retiree will lose employer-sponsored medical and drug coverage, while 31 percent of such employers said retirees would lose drug coverage if they signed up for a Medicare plan. Forty-one percent of firms who accept the government subsidies said retirees would retain all employer-sponsored coverage. "Most employers are accepting government subsidies and taking a wait and see attitude on the drug law," said Drew Altman, chief executive officer of the Kaiser Family Foundation. "The widespread dropping of drug benefits that some had feared has been averted so far as businesses figure out what their longer-term response will be." "Seniors with retiree benefits should consider their options carefully before signing up for a new Medicare drug plan," said Tricia Neuman, a co-author of the study. "Most retiree plans offer more comprehensive benefits than Medicare, and retirees who drop employer-sponsored coverage may not be able to pick it up again later." Package Design Package Design Schering AG Schering AG said the Food and Drug Administration extended the review period of the New Drug Application for Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg), which was filed by Schering's U.S. affiliate, Berlex Inc. "We now expect a decision from the FDA in the first quarter of 2006," said Dr. Phil Smits, head of gynecology and andrology at Schering. Yaz is an oral contraceptive that is dosed in a regimen of 24 days of active pills followed by four days of placebo pills. Typical oral contraceptives are dosed in a regimen of 21 days of active pills followed by seven days of placebo pills, Schering noted. Package Design Package Design King Pharmaceuticals Inc. King Pharmaceuticals Inc. and Mutual Pharmaceutical Co. Inc. entered into a co-exclusive license agreement, under which the companies have granted each other worldwide licenses to certain intellectual property related to metaxalone, a muscle relaxant. "The intellectual property licensed to King relates to the potential for improved dosing and administration of metaxalone," King said, adding that it will make a $35 million up-front payment to Mutual. King will also pay royalties to Mutual on the net sales of products that contain the drug, which King currently distributes as Skelaxin through its wholly owned subsidiary Monarch Pharmaceuticals Inc. Package Design Package Design Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA Inc. entered into an agreement with Cephalon Inc. to resolve their pending patent infringement disputes related to Provigil (modafinil) tablets in both the United States and the United Kingdom. Cephalon will grant Teva a non-exclusive, royalty-bearing right to market and sell a generic version of Provigil, which will become effective in the United States in October 2011 unless a pediatric extension delays the entry date by six months. Comparable terms for the license effective date have been agreed upon in the United Kingdom, with an expected entry date of October 2012. The companies also agreed to other business arrangements related to modafinil, a wakefulness-promoting drug. Financial terms were not disclosed. Package Design Package Design Bedford Laboratories Bedford Laboratories, a division of Ben Venue Laboratories Inc., is voluntarily recalling one lot of its methotrexate injections (preservative free). The manufacturer of the drug's active substance informed Bedford Labs that the substance used in the recalled lot contained low levels of ethylene glycol. Humans cannot use these preservative-free methotrexate formulations for intrathecal administration if they contain ethylene glycol. Patients that have received this drug and have questions should contact their physicians. The company is working with the Food and Drug Administration on this recall and thus far, there have been no associated serious health or safety reports. Package Design


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