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			Trademark Search 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 MabThera shows sooner-than-expected positive results in relapsed indolent NHL; Phase III trial halted early The European Organization for Research and Treatment of Cancer (EORTC) stopped a Phase III study evaluating F. Hoffmann-La Roche Ltd.'s MabThera (rituximab) as a maintenance therapy in relapsed indolent non-Hodgkin's lymphoma (NHL) because the drug showed earlier-than-expected positive results. (In the United States, MabThera is known as Rituxan.) The randomized trial enrolled 465 patients with relapsed indolent NHL. Patients received either six cycles of MabThera in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy or CHOP chemotherapy alone. Patients who responded to the preliminary treatment were either randomized to MabThera maintenance therapy, one infusion every three months for two years, or received no additional treatment. In early 2004, the study was suspended because it reached its primary endpoints of being superior to CHOP therapy alone and improving progression-free survival. However, "the results were not mature enough to determine if MabThera maintenance therapy also prolongs progression-free survival for the subgroup therapy of patients who already had received MabThera plus CHOP as initial treatment." Therefore, the EORTC amended the study to measure this endpoint. Updated study analysis with approximately 18 months of additional follow-up data demonstrated that MabThera does have a significant benefit in this patient population. On the advice of an independent data monitoring committee, the EORTC halted the study and will report its results in December at the American Society of Hematology meeting in Atlanta. "Based on this new information, MabThera maintenance therapy could well become the new standard treatment in this disease," said Eduard Holdener, head of pharma development at Roche. Currently, Roche is preparing an application to request a label extension for maintenance therapy. They expect to submit this to European regulatory agencies in the fourth quarter of 2005. Genentech Inc. developed the drug and comarkets it as Rituxan in the United States with Biogen Idec Inc.; Roche markets the drug as MabThera in other countries except Japan, where it is comarketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd. Trademark Search Sankyo discontinues pactimibe trials Sankyo Co. Ltd. discontinued all ongoing clinical trials of pactimibe, its Acyl-coenzyme A: cholesterol acyltransferase inhibitor, which was formally known as CS-505. The company decided to stop the studies because in the coronary intravascular ultrasound study, ACTIVATE, pactimibe did not meet the primary endpoint of change in percent atheroma volume from baseline, as measured by coronary intravascular ultrasound, after 18 months. Evaluation of the secondary endpoints showed that pactimibe had a lower effect on atherosclerosis than standard care alone and did not reduce the frequency of cardiovascular events. The study, which was designed to assess the efficacy and safety of pactimibe in reducing the progression of coronary atherosclerosis in patients with existing coronary artery disease, included 534 patients. In addition to standard care including statin therapy, the patients were randomized to receive either 100 mg of pactimibe or placebo once daily. The company will provide additional information about the trial at the 2005 American Heart Association's Scientific Sessions on Nov. 15. Trademark Search Revenue rises, income falls for Biogen Idec in third quarter For the third quarter ended Sept. 30, 2005, Biogen Idec Inc. reported a 10 percent increase in revenue as net income dropped, but revenue and adjusted earnings per share missed analysts' projections. Total reported revenue was $596.2 million, up from $543.3 million in the third quarter of 2004. Global sales of Avonex (interferon beta-1a), a multiple sclerosis drug, increased 8 percent to $374.7 million. Revenue related to Biogen Idec's joint business arrangement with Genentech Inc. for Rituxan (rituximab), a treatment for certain B-cell Hodgkin's lymphomas, rose 14 percent to $182 million. Genentech reported that U.S. net sales of Rituxan reached $456 million this past quarter. However, net income fell from $36.8 million, or $0.10 per diluted share, in the third quarter of 2004 to $27.2 million, or $0.08 per diluted share, in this year's third quarter. Excluding charges, the company earned $0.36 per share. Analysts polled by Thomson First Call had estimated Biogen Idec would report $0.42 in adjusted earnings per share and revenue of $621 million, MarketWatch reported. Both net and adjusted earnings included charges of $25 million for impairments of non-Hodgkin's lymphoma drug Zevalin (ibritumomab tiuxetan), $50 million in payments to Protein Design Labs Inc. (PDL) and $5 million to write off certain investments. "We previously announced our strategic plan to reduce operating expenses to fund increased business development activities in order to accelerate long-term growth. During the quarter, we have progressed against these goals by signing the partnership with PDL to jointly develop and commercialize three Phase II antibodies," explained James Mullen, the firm's chief executive officer. The company projected that 2006 adjusted earnings will range between $1.95 and $2.10 per share, excluding the impact of stock option expensing. Trademark Search Chiron's net income rises, revenue falls in third quarter Chiron Corp. posted mixed financial results for the third quarter of 2005, as net income rose and net revenue fell. The firm said three factors influenced third-quarter results in both 2004 and 2005: a $91-million charge to cost of sales when Chiron's Fluvirin influenza virus vaccine inventory was written off in the third quarter of 2004; $46 million in royalty and license fee revenue one year ago related to a settlement with F. Hoffmann-L Roche Ltd. as compared with $8 million this past quarter; and no sales of the Begrivac influenza virus vaccine in the past quarter versus $41 million in Begrivac sales in the third quarter of 2004. Chiron achieved net income of $51.3 million, or $0.27 per diluted share, for the third quarter of 2005. After adjustments for an amortization expense and a $14.5-million impairment loss, the company earned $0.38 per share. Restated net income one year ago was $27 million, or $0.14 per share. Revenue fell 9 percent, from $529.5 million in the year-ago period to $479.6 million this past quarter, related mostly to recognition of funds for the Roche settlement, Chiron said. Overall product sales decreased to $367.2 million, down 2 percent from $375.6 million in the third quarter of 2004, due to the loss of Begrivac sales, which was partially offset by increased sales in other products. Analysts polled by Thomson First Call estimated adjusted earnings of $0.45 per share on revenue of $508 million, MarketWatch reported. Specifically, net vaccine product sales fell 12 percent to $153 million, while net biopharmaceutical product sales increased 4 percent to $137 million. "The third quarter marked a significant turning point for the company," said Howard Pien, Chiron's chief executive officer. "The work underpinning the Liverpool remediation came to culmination with the return of [the] Fluvirin vaccine to the U.S. market, and Chiron is now poised to provide possible solutions in the government's assessment of policy options to address influenza." Chiron shares closed at $43.38, down $0.71, or 1.6 percent, in moderate trading on the Nasdaq. Trademark Search Growth in pharmaceutical market to remain flat worldwide; drug companies need to implement new strategies, IMS Health suggests IMS Health Inc. forecasted the global pharmaceutical market will remain flat, showing growth of between 7 percent and 8 percent in 2005 and between 6 percent and 7 percent in 2006, totaling a market size of between $640 billion and $650 billion. Murray Aitken, senior vice president of IMS Health's corporate strategy, said several key market events are expected to shape the drug industry next year. "These include the introduction of the Medicare drug benefit in the United States, expected patent loss and generic introduction for six blockbuster products and continued efforts by local government to reduce drug spending and manage patient access to branded pharmaceuticals," he said. IMS projects the U.S. market will grow between 8 percent and 9 percent in 2006, an increase from the 6 percent to 7 percent growth expected in 2005. The initiation of Medicare Part D and a rebound from the COX-2 inhibitor product recalls and other safety issues will fuel this growth. In the five major European markets of France, German, Italy, Spain and the United Kingdom, growth is predicted to range from 4 percent to 5 percent next year, slightly lower than this year's growth. Of note, both Central and Eastern Europe should see double-digit growth next year as their health care systems are modernized and higher demand is funded by gross domestic product growth. While growth in Japan is expected to drop between 0 percent and 1 percent, market growth in China will remain robust at a range of 17 percent to 18 percent, reaching a market size of $13 billion to $14 billion next year. Finally, IMS estimated the oncology therapeutic drug class will grow the most--at a 17 percent to 18 percent rate worldwide--while the statin market will continue to rise at a rate of 7 percent to 8 percent. Drugs in the angiotensin-II, platelet aggregation inhibitor and osteoporosis classes are also projected to show above-average growth. "While some pharmaceutical companies are taking the necessary steps to address these areas, others must start planning now to ensure continued growth and success," Aitken recommended. He advised pharmaceutical firms to reassess sales and marketing spending levels and practice; accelerate safety surveillance efforts; invest in health outcomes and pharmacoeconomic studies that demonstrate drug value; and pursue growth in emerging markets, including China, Latin America and Eastern Europe. "Market conditions are changing, the governments' span of control is growing and future success will only be achieved by those manufacturers with innovative products, demonstrable cost effectiveness and productive, evidence-based sales and marketing approaches," Aitken said. Trademark Search Generic drug substitution could result in savings of more than $20 billion annually, study finds The substitution of generic drugs for their branded counterparts could have saved U.S. consumers more than $20 billion in 2004, according to data released by Express Scripts Inc. The generic drug usage report was based on a random sample of approximately 3 million individuals and estimated the generic opportunity or targets based on therapeutic and chemically equivalent generic substitution across six therapy classes: gastrointestinals, antihyperlipidemics, calcium channel blockers, antihypertensives, nonsteroidal anti-inflammatory drugs and antidepressants. The generic fill rate targets used in the study were based on an evaluation of clinical efficacy and market dynamics of branded and generic drugs. Results showed the greatest savings potential was in the gastrointestinal therapy class. Reaching a target of 95 percent generic prescribing in this class would save employers, state governments and consumers $5.4 billion per year. The current dispensing rate for generic gastrointestinal drugs is only 31 percent nationwide, the report noted. A savings of $5.1 billion per year could also be realized in the antihyperlipidemic therapy class if the overall generic fill rate were to increase to the target of 70 percent. Currently, the national generic fill rate for this class of drugs is 7 percent. The highest generic fill rates for 2004 were in Oregon, Massachusetts and New Mexico (56 percent in all three states), while the lowest generic fill rate was in New Jersey (41 percent). California, Texas, Florida, New York, Ohio and Pennsylvania were identified as the states with the largest savings opportunity. According to the findings, generic substitution could save each of these states at least $1 billion per year. The report noted that the savings opportunity from the increased use of generic drugs has never been greater and will continue to grow as more than $50 billion worth of branded drugs are expected to lose patent exclusivity during the next five years. In response to the study findings, the Generic Pharmaceutical Association (GPhA) ssued a statement suggesting that lawmakers looking for ways to reduce Medicaid spending consider increased use of generic drugs as a means of achieving significant savings while maintaining the same quality of care. "Just a 1 percent increase in generic utilization in Medicaid would save states $475 million," stated Kathleen Jaeger, GPhA's chief executive officer. "Generic medicines provide the same medicine and the same results, but at a significantly lower price than their brand counterparts." Trademark Search Trademark Search F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. suspended sales of its antiviral Tamiflu (oseltamivir phosphate) in Canada following an increase in demand, which is attributed to a panic over a possible H5N1 avian flu pandemic, Reuters reported. Paul Brown, Roche Canada's vice president of sales and marketing, said the company needs to "actively manage" its Tamiflu inventory, adding that there was more demand for the drug from retailers on a single day last week than in the whole flu season last year. Roche said it can fill current levels of demand for a normal flu season and can supply governments' stockpiling orders, according to Reuters. However, the World Health Organization said there are not enough supplies of Tamiflu and other antivirals, such as GlaxoSmithKline Plc's Relenza (zanamivir). Trademark Search Trademark Search Ortho-McNeil Pharmaceutical Inc. Ortho-McNeil Pharmaceutical Inc. and Bayer HealthCare AG entered into a development and marketing agreement for BAY 59-7939 (Factor Xa inhibitor) for the treatment and prevention of thrombosis. Phase III trials for the prevention of venous thromboembolism after major orthopedic surgery are expected to begin in the next few weeks, with a submission for marketing approval in this indication planned for the end of 2007. Ortho-McNeil will have exclusive marketing rights to the U.S. cardiology, primary care and hospital markets, while Bayer will retain the option to copromote the product in the hospital and specialty markets and will have sole marketing rights outside the United States. Bayer also gained rights to copromote Ortho-McNeil's Elmiron (pentosan polysulfate sodium), which relieves certain bladder pain, to the U.S. urology audience. Trademark Search Trademark Search Insmed Inc. Insmed Inc.'s submission in reply to a Food and Drug Administration approvable letter for iPlex (mecasermin rinfibate [rDNA origin] injection) has been deemed a complete, class 1 response by the agency. The firm needed to submit additional information mostly for the chemistry, manufacturing and controls section of the New Drug Application in order for iPlex to be approved as a treatment for severe primary insulin-like growth factor-1 deficiency in children. The FDA set Dec. 12 as its target date for completing its review of the NDA but has not yet determined whether the approval and granting of orphan exclusivity to Tercica Inc.'s Increlex (mecasermin [rDNA]) in the same indication will block iPlex's approval. Trademark Search Trademark Search Alba Therapeutics Corp. Alba Therapeutics Corp.'s drug candidate, AT-1001, received fast track designation from the Food and Drug Administration for the treatment of celiac disease. Additionally, the company has successfully completed its first Phase I trial for the drug. Within the next few months, Alba will begin a proof-of-concept study designed to demonstrate the efficacy of AT-1001 in patients with celiac disease. Trademark Search


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