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			Naming Products 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 NOVARTIS BUYS RIGHTS TO VECTURA, ARAKIS' LUNG DISEASE DRUG FOR UP TO $375 MILLION ------------------------------------------------------------------------------- Novartis AG signed a global development and commercialization agreement with Vectura Group Plc and Arakis Ltd. for their investigational chronic obstructive pulmonary disease (COPD) treatment, AD 237. Novartis will be responsible for developing AD 237 as a monotherapy and in combination with its once-daily, long-acting beta2 agonist, QAB149, which is currently in Phase II trials for the treatment of asthma and COPD. Under the terms of the agreement, total Novartis payments could reach $375 million for both the monotherapy and combination product. Vectura and Arakis will each receive an initial payment of $15 million. Clinical, regulatory and commercialization payments to the two companies could total up to $172.5 million each based upon the achievement of pre-agreed targets. Novartis will also pay royalties on sales of the monotherapy and combination product. If Novartis develops another AD 237 combination product, the company will pay milestones and royalties on that product. Also in Phase II clinical development, AD 237 is a once-daily, long-acting and fast-acting inhaled muscarinic antagonist that is being studied as a treatment for COPD. Studies have shown the drug is well tolerated and effective over 24 hours after a single dose. "We believe that AD 237 will play a major role in the expansion of the COPD market, which is underserved today but set for dramatic growth over the coming decade," said Dr. Chris Blackwell, Vectura's chief executive. The COPD drug market, currently around $4 billion a year, could grow to $10 billion by 2010, the companies reported. According to Blackwell, the monotherapy could reach the market by 2010, The Wall Street Journal reported. Nomura analyst Sam Fazeli said in a note to investors that AD 237 could "generate at least $2 billion in annual sales," The Journal stated. The agreement is also an important step for Arakis as it seeks an initial public offering and full listing on the London Stock Exchange, The Journal added. COPD, an irreversible disease that is usually associated with smoking, is the world's fourth leading cause of death. -=- BARR, KOS TO CO-PROMOTE KOS' NIASPAN, ADVICOR CHOLESTEROL-LOWERING THERAPIES ------------------------------------------------------------------------------- Barr Pharmaceuticals Inc. and Kos Pharmaceuticals Inc. have signed co-promotion, licensing and manufacturing and settlement and license agreements relating to the resolution of patent litigation involving Kos' Niaspan (niacin) cholesterol-lowering products. Barr's subsidiary, Duramed Pharmaceuticals Inc., and Kos will co-promote current and future formulations of Niaspan and Advicor (lovastatin/niacin extended-release) cholesterol-lowering therapies to women's health professionals, including obstetricians and gynecologists, in the United States. As part of the seven-year agreement, Kos will train a 40-person Duramed specialty sales force that will start promoting the products in mid-2005. In return, Kos will pay Duramed royalties based on quarterly and yearly net sales of the products. The companies want to reach women's health professionals who are not currently aware of these products. The American Heart Association's February 2004 revised cardiovascular disease prevention guidelines for women "essentially tripled the number of women who are candidates for Niaspan and Advicor to about 28 million," the companies noted. As part of the settlement and license agreement, Barr is permitted to launch generic versions of current and future formulations of Niaspan and Advicor under an exclusive license that takes effect in September 2013, approximately four years before the last Kos patent expires. Barr will pay Kos royalties on product sales and has admitted that Kos' patents are valid and enforceable and that it has infringed on said patents. In a separate license and manufacturing agreement, Barr agreed to be prepared to supply Kos with quantities of 500 mg, 750 mg and 1000 mg of Niaspan extended-release tablets and 500 mg/20 mg, 750 mg/20 mg and 1000 mg/20 mg of Advicor extended-release tablets, pending approval of Barr's Abbreviated New Drug Applications. Barr will receive an initial license fee and quarterly payments to "stand ready" with these products. If Kos asks Barr to make these products, Kos will purchase them at a pre-arranged supply price. "We believe the agreements announced today provide an equitable way to resolve our Niaspan patent litigation that creates a benefit for consumers, as well as Barr's shareholders," said Bruce Downey, Barr's chief executive officer. "This agreement with Barr not only benefits both companies, but most importantly, it broadens the utility of our niacin-based pharmaceutical cholesterol products to a wider female patient population, thereby saving more lives," said Adrian Adams, Kos' chief executive officer. Kos shares closed at $50.46, up $6.02, or 13.6 percent, in heavy trading on the Nasdaq. Barr shares closed at $50.55, down $1.11, or 2.2 percent, in heavy trading on the New York Stock Exchange. -=- RESULTS INDICATE LAMICTAL REDUCES NUMBER OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES ------------------------------------------------------------------------------- As adjunctive therapy, GlaxoSmithKline Plc's Lamictal (lamotrigine) tablets effectively reduce primary generalized tonic-clonic (PGTC) seizures in pediatric and adult patients with epilepsy, according to a new study. The double-blind trial enrolled 184 patients aged 2 years or older who had inadequately controlled PGTC seizures despite receiving a stable regimen of one or two antiepileptic drugs. Of those enrolled, 117 patients who had three of more PGTC seizures during an eight-week baseline period were randomized to add either Lamictal or placebo to their usual regimens. The escalation phase lasted between seven and 12 weeks; this was followed by a 12-week maintenance phase. At baseline, the Lamictal group experienced a median 2.4 PGTC seizures per month, and the placebo arm experienced a median 2.9 PGTC seizures per month. Throughout the entire treatment phase, the median number of PGTC seizures per month dropped to 0.8 and 2.0 for patients who received Lamictal and placebo, respectively. In other words, during the entire treatment period, there was a median 66 percent decrease in PGTC seizures from baseline for the Lamictal-treated patients as compared with a median 34 percent drop for the patients who received placebo. In a subgroup analysis of 45 pediatric and adolescent patients, the median PGTC seizure count was 0.4 per month with Lamictal and 2.5 per month with placebo throughout the study phase. Overall, this translated to a 77 percent reduction in the number of PGTC seizures for the Lamictal arm, but an only 40 percent reduction for the placebo group. "Despite the fact that PGTC seizures are a more serious form of epilepsy, few studies have focused on these types of seizures exclusively," said Dr. Victor Biton, director of the Arkansas Epilepsy Program and one of the study investigators. "These data offer promising news in our effort to understand how to best control these types of seizures where there are few therapies approved." As a seizure therapy, Lamictal is currently indicated as adjunctive treatment for partial seizures and for generalized seizures of Lennox-Gastaut syndrome. It is also approved for conversion to monotherapy in adults with partial seizures who are receiving certain single antiepileptic drugs. These results were presented in Miami Beach, Fla., at the annual meeting of the American Academy of Neurology. -=- EARLY ON, EISAI'S ARICEPT LINKED TO LOWER RATE OF PROGRESSION TO ALZHEIMER'S DISEASE, BUT EFFECT NOT SIGNIFICANT AFTER 3 YEARS, DATA SHOW ------------------------------------------------------------------------------- Eisai Inc.'s Aricept was associated with a lower rate of progression to Alzheimer's disease during the first 12 months of treatment, but after three years, the progression rate was no different between the patients who received placebo, Aricept or vitamin E during a recent study. Eisai manufactures Aricept, but the drug is co-marketed by both Eisai and Pfizer Inc. A total of 769 patients with amnestic mild cognitive impairment were enrolled in the trial and were randomized to 1,000 to 2,000 international units of vitamin E, 5 mg to 10 mg of Aricept or placebo each day. After three years, 212 patients developed possible or probable Alzheimer's disease, representing a 16 percent rate of progression per year. Based on the Cox analysis, the probability of progression to Alzheimer's disease was not significantly different between the vitamin E and placebo or Aricept and placebo arms. "However, since the effect of treatments varied during the three years of the trial and assumptions for the primary-analysis model were not met, prespecified group comparisons were carried out at each of the six-month evaluations," the researchers explained. The vitamin E and placebo groups demonstrated no significant differences in the rate of progression throughout the entire trial. During the first 12 months, 38 patients in the placebo arm and 33 patients in the vitamin E group progressed to Alzheimer's disease as compared with only 16 of the patients who were receiving Aricept. But by 36 months, the number of patients who had progressed was not significantly different between the three treatment arms. Among the patients who carried at least one apolipoprotein E epsilon4 allele (APOE-epsilon4), however, Aricept reduced the risk of progression to Alzheimer's disease by approximately one third. APOE-epsilon4 is the only known genetic risk factor for late-onset Alzheimer's disease. "The observed relative reduction in the risk of progression to Alzheimer's disease of 58 percent at one year and 36 percent at two years in the entire cohort is likely to be clinically significant," the study authors concluded. "Although our findings do not provide support for a clear recommendation for the use of [Aricept] in persons with mild cognitive impairment, they could prompt a discussion between the clinician and the patient about this possibility." But in an accompanying editorial, Dr. Deborah Blacker said "a closer look at their data reveals no convincing evidence of a difference in treatment effect according to APOE-epsilon4 carrier status: the effect of [Aricept] was similar among APOE-epsilon4 carriers and noncarriers." She said the numbers suggest that the observed difference in significance may have been due to analogous differences in statistical power, as Alzheimer's disease developed in approximately twice as many APOE-epsilon4 carriers as noncarriers during the three years. Both the study and commentary were published online April 13 at The New England Journal of Medicine's Web site; these trial findings were also presented in Miami Beach, Fla., at the American Academy of Neurology's annual meeting. -=- GENENTECH, BIOGEN IDEC'S RITUXAN PLUS CHOP CHEMOTHERAPY MAY COST-EFFECTIVELY TREAT OLDER PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA, DATA SHOW ------------------------------------------------------------------------------- Genentech Inc. and Biogen Idec Inc.'s Rituxan (rituximab) combined with CHOP chemotherapy, or cyclophosphamide, doxorubicin, vincristine and prednisone, may be a cost-effective therapy for diffuse large B-cell non-Hodgkin's lymphoma in elderly patients, new model estimates demonstrate. Researchers based the cost utility analysis on findings from the Groupe d'Etude des Lymphomes Adultes LNH 98-5 study, which compared Rituxan and CHOP combination therapy with CHOP therapy alone among 399 patients aged 60 to 80 years with diffuse large B-cell non-Hodgkin's lymphoma and showed that Rituxan added to CHOP prolonged progression-free survival and overall survival. Using a Markov state-transition model to further assess the study's data, the research team found that during the five years following treatment initiation, Rituxan plus CHOP therapy compared with CHOP alone would prolong the mean event-free survival by 0.9 years and overall survival by 1.04 years. Standard-dose CHOP administered for six cycles cost a mean of $3,358 compared with $17,225 for six cycles of Rituxan combined with CHOP. Furthermore, the cost of post-treatment cancer surveillance was estimated to cost $3,950 for CHOP alone versus $5,202 for combined Rituxan and CHOP due to a higher response and survival rate. Overall, the investigators concluded that during a five-year time period, the incremental cost per quality-adjusted life year gained with combined Rituxan and CHOP compared with CHOP alone would be $19,297. The combination remained cost effective over a wide range of variables (i.e. costs of end-of-life care, costs of cancer surveillance) in sensitivity analyses. "[E]conomics should not be a basis for denying the appropriate use of [Rituxan plus CHOP] in the treatment of elderly patients with [diffuse large B-cell lymphoma]," the study researchers wrote. The results of the economic analysis can be found in the April 15 edition of Cancer. -=- NONSELECTIVE NSAIDS PLUS PPI PREFERABLE TO COXIB-BASED TREATMENT FOR MANAGING CHRONIC ARTHRITIS IN PATIENTS AT INCREASED RISK OF ADVERSE EVENTS, COST ANALYSIS SUGGESTS ------------------------------------------------------------------------------- For the management of chronic arthritis, generic nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) appear to be the most cost-effective strategy for patients at low risk for an adverse event, such as gastrointestinal (GI) complications, researchers reported. However, as both the GI and cardiovascular risk increase, the addition of a proton pump inhibitor (PPI) to a nonselective NSAID may be preferable to selective COX-2 inhibitor (coxib)-based strategies. "[C]oxibs are now widely used in clinical practice, and at least one professional society has endorsed coxibs as the drug class of choice for the initial management of moderate to severe arthritis pain," the study authors noted. "Despite the enthusiasm for coxibs, emerging data suggest that alternative therapies may be equally or more preferable, including the use of [a nonselective] NSAID alone or in combination with a PPI," they added. To further explore this issue, they conducted cost-effectiveness and cost-utility analyses of three separate strategies for the management of chronic arthritis using a decision model framework. In one therapeutic approach, a generic nonselective NSAID alone was used, and was modeled after naproxen 500 mg twice daily. In another, a generic nonselective NSAID plus a PPI was used, with the PPI modeled after TAP Pharmaceutical Products Inc.'s Prevacid (lansoprazole) 15 mg once daily. The third approach involved the use of a coxib alone, modeled after either Pfizer Inc.'s Celebrex (celecoxib) 200 mg once daily or Merck & Co. Inc.'s Vioxx (rofecoxib) 25 mg once daily. Costs were estimated from the perspective of a third-party payer, with only direct health care costs taken into consideration. The investigators determined incremental cost per ulcer complication avoided and incremental cost per quality-adjusted life year (QALY) gained. Varying patient GI risks were taken into account, and by assuming that a subset of the cohort required daily aspirin for cardiovascular prophylaxis, the model was stratified by both the strategy employed and the aspirin status of the patient. Among patients at average risk for an adverse event, the strategy of a nonselective NSAID plus PPI cost an incremental $45,350 per additional ulcer complication avoided and cost more than $300,000 per QALY gained as compared with the nonselective NSAID-alone strategy. Additionally, as compared with the nonselective NSAID plus PPI strategy, the coxib strategy was less effective and more expensive, the model revealed. Moreover, for patients at a high risk for an NSAID adverse event--that is, patients taking aspirin with at least one risk factor for a GI complication--the sensitivity analysis demonstrated that the nonselective NSAID plus PPI strategy was the dominant approach. "Our analysis indicates that the use of coxibs alone may not be cost-effective compared with the [nonselective] NSAID plus PPI strategy," the investigators concluded. They suggested that the cost-effectiveness of these competing strategies should be reappraised with additional prospective trials comparing the accrued cost and effectiveness across a range of risk profiles. The study is available in the April 15 issue of the journal Arthritis & Rheumatism. -=- Naming Products MERCK & CO. INC. ------------------------------------------------------------------------------- Merck & Co. Inc. expects first-quarter earnings per share of $0.62 and the company reaffirmed its previously announced 2005 full-year earnings per share guidance of between $2.42 and $2.52. The company previously expected to report first-quarter earnings per share of between $0.54 and $0.58. The company attributed the higher expectation to ongoing cost management, positive foreign exchange rates and overall revenue performance. The company said the guidance does not include establishment of any reserves for potential liability relating to litigation involving its COX-2 inhibitor Vioxx (rofecoxib). -=- Naming Products SCHERING-PLOUGH CORP. ------------------------------------------------------------------------------- Schering-Plough Corp. began preclinical development of a small-molecule drug candidate for inflammatory disease as part of its collaboration with Pharmacopeia Drug Discovery Inc. As a result of the advancement, Schering-Plough will make an undisclosed cash milestone payment to Pharmacopeia and will make additional payments upon further compound development, Pharmacopeia said. Pharmacopeia will also receive royalties on commercial sales of any resulting products. This inflammatory disease compound is the fifth development candidate to emerge from the companies' collaborations. -=- Naming Products DEPOMED INC. ------------------------------------------------------------------------------- Depomed Inc. and Biovail Corp. responded to the Food and Drug Administration's concerns regarding finalization of manufacturing specifications on a New Drug Application for their type 2 diabetes treatment, Glumetza, an extended-release formulation of once-daily metformin hydrochloride. The FDA said Glumetza was approvable last month, pending the resolution of its inquiry. On April 8, Depomed and Biovail filed the response with the agency, which they believe will carry a 60-day review period. Biovail will make a $25 million milestone payment to Depomed within 30 days of final approval. -=- Naming Products AUXILIUM PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Auxilium Pharmaceuticals Inc. signed a co-promotion agreement with Oscient Pharmaceuticals Corp. for Auxilium's Testim (testosterone) 1% gel for the treatment of hypogonadism. Under the agreement, Oscient will expand promotion of Testim to primary care physicians not previously covered by Auxilium's sales force, and Auxilium will continue promotion within the fields of urology, endocrinology and select primary care physicians. The companies will share profits from primary care sales above a preset baseline. The partnership will initially last for two years and may be extended for up to six years, depending on achievement of milestones. -=- Naming Products INSMED INC. ------------------------------------------------------------------------------- Insmed Inc. received priority review from the Food and Drug Administration for its New Drug Application for SomatoKine (mecasermin rinfabate), a treatment for growth hormone insensitivity syndrome. The FDA previously gave orphan drug designation to SomatoKine, which is an insulin-like growth factor-I therapy. The user fee goal date is set for July 3. -=- Naming Products


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