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			Qualitative Research 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 CONNETICS TO RESUME EXTINA DEVELOPMENT FOR TREATING SEBORRHEIC DERMATITIS ------------------------------------------------------------------------------- Connetics Corp. will resume clinical development of its investigational therapy Extina (ketoconazole 2%) for the treatment of seborrheic dermatitis via a new Phase III trial that is expected to begin in the third quarter of 2005. The company received a non-approvable letter from the Food and Drug Administration for Extina in November 2004 because of insufficient clinical data. However, after meetings with the regulatory agency regarding the requirements for Extina's New Drug Application, Connetics agreed to conduct a final Phase III trial intended to show the treatment's superiority to placebo foam for the seborrheic dermatitis indication. If the trial is initiated in the third quarter of 2005 as planned, Connetics would be in position to resubmit the NDA for Extina to the FDA by the end of 2006, with an anticipated review time of up to six months. "Returning Extina to our pipeline is an important decision that leverages our formulation and development achievements with the drug candidate and positions Connetics to potentially launch the product in 2007," said Thomas Wiggans, chief executive officer of Connetics. "We believe that the design of the proposed study will provide the data necessary to address the FDA's desire to see statistical superiority to placebo foam," he noted. -=- PHARMACEUTICAL COMPANIES CAN MARKET UNBRANDED VERSIONS OF THEIR OWN DRUGS, COURT RULES ------------------------------------------------------------------------------- Despite the effect on generic competition, pharmaceutical companies have the right to market unbranded versions of their own drugs, a U.S. appeals court ruled. According to court documents, Teva Pharmaceuticals Industries Ltd. sued to overturn the Food and Drug Administration's rejection of its "citizen petition" requesting that the FDA prohibit Pfizer Inc., maker of the epilepsy drug Neurontin (gabapentin), from selling that drug in "generic" form during Teva's 180-day exclusivity period. A district court and the FDA both previously concluded that the agency could not "prohibit [New Drug Application] holders from entering the market with [an authorized] generic drug during the exclusivity period," the U.S. Court of Appeals for the District of Columbia Circuit stated. Seeking a functional interpretation of the law, Teva argued that the purpose of the 180-day exclusivity period was "to encourage generic companies to file Paragraph IV challenges to brand-drug patents." The Israeli company held that "because the Congress could not have anticipated brand-generic competition during the exclusivity period, adhering to the 'literal' terms of the statute would lead to an absurd result, namely, that [the law] grants only a 'meaningless' exclusivity against subsequent [Abbreviated New Drug Application] filers rather than a 'commercially effective' exclusivity that runs against the NDA holder as well," according to the appeals court papers. "It does not follow, however, from the Congress having intended to create an incentive to challenge brand-drug patents--as it clearly did--that the incentive is without limitation," the court said in its decision, adding that the FDA cannot require supplemental NDAs "for reasons wholly unrelated to the safety or efficacy of the brand company's product." Pfizer has sold its "generic" gabapentin--which qualifies for "generic substitution" under state laws and third-party purchasing plans--at "substantially" lower prices than its brand-name equivalent, packaged the product in "generic" trade dress and used many of the same distribution channels as Teva, the court added. At the request of three U.S. senators, the Federal Trade Commission is examining whether authorized generics are anti-competitive, Bloomberg News reported. In April, Pfizer reported that first-quarter U.S. sales of Neurontin fell 90 percent to $56 million, compared with $570 million in the first quarter of 2004. -=- IMCLONE'S ERBITUX PLUS RADIATION MAY PREVENT SPREAD OF HEAD, NECK CANCER, STUDY SHOWS ------------------------------------------------------------------------------- ImClone Systems Inc.'s Erbitux (cetuximab) in combination with radiation as a first-line treatment of squamous cell carcinoma of the head and neck may be more effective than radiation alone in achieving locoregional control, or preventing the spread of cancer beyond the head and neck area, according to an independent clinical review committee analysis of data from a Phase III study. The trial involved 424 patients with advanced squamous cell carcinoma of the oropharynx, larynx or hypopharynx that had spread through the head and neck region. The Erbitux-radiation combination demonstrated a statistically significant improvement in locoregional control, ImClone said. Statistically significant improvement was also noted among secondary endpoints of overall survival and progression-free survival. "This independent review was a critical step toward the filing of a supplemental Biologics License Application for use of Erbitux in this tumor type," said Dr. Eric Rowinsky, ImClone's chief medical officer. Separately, investor Carl Icahn filed for clearance to acquire at least $100 million, but less than $500 million, of ImClone common stock, including the shares he already holds. Icahn currently owns approximately 5 million shares, or approximately 6 percent, of ImClone's outstanding shares, according to a Securities and Exchange Commission filing in April. Shares of ImClone closed at $35.27, up $5.11, or 16.9 percent, in heavy trading on the Nasdaq. -=- DEPAKOTE MAINTENANCE TREATMENT FOR BIPOLAR DISORDER MAY RESULT IN COMPARABLE MEDICAL COSTS, CLINICAL, QUALITY OF LIFE OUTCOMES RELATIVE TO LITHIUM, STUDY FINDS ------------------------------------------------------------------------------- Treatment of bipolar disorder with Abbott Laboratories' Depakote (divalproex sodium) resulted in comparable medical costs, clinical and quality-of-life (QOL) outcomes and fewer discontinuations due to lack of efficacy or adverse events as compared with lithium, a new study published in the June edition of the Journal of Affective Disorders found. Data from the study also suggested that patients remaining on any mood stabilizer therapy had substantially lower total medical costs and slightly better functional outcomes compared with those who discontinued therapy. The study included 201 adult patients hospitalized with bipolar I manic or mixed episodes. Patients were randomized to either Depakote or lithium, in addition to usual psychiatric care, and followed for a period of one year. Mania and depression symptoms were evaluated at baseline and again at hospital discharge. The researchers assessed manic and depressive symptoms, disability days as well as QOL at the beginning of maintenance therapy after one, three, six and nine months and at one year. In addition, medical resource use data were collected each month, and costs were estimated using national sources. Patients in the Depakote arm were less likely to discontinue study treatments for lack of efficacy or adverse effects than lithium-treated patients (12 percent vs. 23 percent, respectively), the researchers reported. No statistically significant between-group differences were noted during the one-year maintenance phase for clinical symptoms, QOL outcomes or disability days. Data revealed that mean estimated total medical costs were $28,911 for the Depakote arm compared with $30,666 for the lithium treatment group. The research team added that patients continuing mood stabilizer therapy at three months had slightly better health outcomes and substantially lower total medical costs than those who discontinued therapy ($10,091 vs. $34,432, respectively). "Clearly, treatment interventions that are effective at maintaining bipolar disorder patients on mood stabilizer therapy have significant financial implications for the mental health care system and potential benefits in patient functioning and well-being," the authors concluded. Depakote is indicated for the treatment of the manic episodes associated with bipolar disorder. Depakote is also indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Moreover, the drug is also indicated as a sole or adjunctive treatment for simple and complex absence seizures and for prophylaxis of migraine headaches. -=- LACK OF DRUG COMPLIANCE MAY INCREASE MEDICAL COSTS, RESEARCH SUGGESTS ------------------------------------------------------------------------------- Patients who exhibit non- or low adherence to recommended prescription drug therapy may incur higher costs due to hospitalization, according to the results of a new study. The study involved a sample of more than 137,000 patients aged less than 65 years with diabetes, high cholesterol, hypertension or congestive heart failure. Savings were estimated by comparing the costs of a less compliant group of patients with a more compliant group of patients. The study showed that every additional dollar spent on drugs saved an average of $7.00 in medical costs for patients with diabetes, $5.10 for patients with high cholesterol and $3.98 for patients with hypertension. Total costs were also higher among those with low compliance. For example, average combined drug and medical costs for the most compliant patients with diabetes was $4,570 and $8,867 for the least compliant patients. Similarly, patients with high cholesterol had average combined drug and medical costs of $3,924 in the most compliant group and $6,888 among the group with the least compliance. Risks of hospitalization also appeared to be higher among patients with low compliance. Specifically, patients with diabetes who exhibited low compliance had a 30 percent risk of hospitalization compared with a 13 percent risk among those with high compliance, the study showed. Reasons cited for non- or low compliance include costs, side effects, forgetfulness and lack of noticeable symptoms, particularly among patients with high cholesterol or hypertension. "Increased medication compliance for chronic conditions can significantly cut medical costs and keep patients out of the hospital," said Dr. Robert Epstein, co-author of the study and chief medical officer of Medco Health Solutions Inc., which conducted the study. "Health care professionals . . . can play an important role in encouraging medication compliance." The study was published in the June issue of the journal Medical Care. -=- BROAD SUBSTITUTION OF GENERIC DRUGS COULD RESULT IN SUBSTANTIAL ABSOLUTE SAVINGS, STUDY SUGGESTS ------------------------------------------------------------------------------- New research suggests that broad substitution of generic drugs could result in substantial absolute savings even though only a modest percentage of drug expenditures would be affected. To estimate the potential savings related to broad substitution of generic drugs, researchers analyzed data from the 1997-2000 Medical Expenditure Panel Survey Household Component. The survey--which involved a cross-sectional, nationally representative sample of non-institutionalized U.S. adults--was conducted by the Agency for Healthcare Research and Quality. Researchers found that 56 percent of all outpatient drugs were multisource products (that is, a drug available in a brand name and at least one generic formulation). Multisource drugs accounted for 41 percent of total drug expenditures; 61 percent of multisource drugs were dispensed as a generic. Had generic drugs replaced all corresponding brand-name outpatient drugs in 2000, researchers found that the median annual savings in drug spending would have been $5.9 billion for adults aged less than 65 years, or $45.89 per person, and $2.9 billion for adults 65 years and older, or $78.05 per person. The $8.8 billion total represents approximately 11 percent of all drug expenditures, researchers added. "Interventions to stimulate competition in the generic market, to reduce the approval times for generic drugs by the U.S. Food and Drug Administration and to limit opportunities to extend the patent life of brand-name drugs could increase the potential savings," the study authors stated. The study was published in the June 7 issue of the Annals of Internal Medicine. -=- Qualitative Research MERCK & CO. INC. ------------------------------------------------------------------------------- Merck & Co. Inc. exercised options under an agreement with Vical Inc. to obtain rights to Vical's nonviral gene delivery technology for use in cancer vaccine applications. In addition to potential milestone and royalty payments, "Vical will receive payments of $3 million," Vical said, adding that it also holds certain co-promotion rights for therapeutic products that result from the agreement. -=- Qualitative Research ELI LILLY AND CO. ------------------------------------------------------------------------------- Eli Lilly and Co. will scale back a proposed 600,000-square-foot, insulin-producing plant in Prince William County, Va., to a single, 300,000-square-foot building and intends to hire half of the approximately 700 workers originally planned, The Washington Post reported. Lilly will now invest $325 million in the project, $100 million less than initially expected. The Post cited analysts as saying lackluster demand for Lilly's insulin products and increased competition may have played a role in this decision. Citing rising material costs, the firm had already pushed back the start of construction on the project, which is anchored by millions of dollars in public subsidies and is currently two years behind schedule, The Post added. -=- Qualitative Research CELL THERAPEUTICS INC. ------------------------------------------------------------------------------- Cell Therapeutics Inc. said it will likely terminate 75 employees as part of a work-force reduction plan. The firm will record approximately $1.4 million in severance-related expenses in the third quarter. In a filing with the Securities and Exchange Commission, Cell Therapeutics said this action is part its overall plan to decrease operating costs "and focus on the development of its late-stage product pipeline and early-stage opportunities that have the highest potential value. . . ." The company expects the job cuts to be completed by August. -=- Qualitative Research US ONCOLOGY INC. ------------------------------------------------------------------------------- US Oncology Inc., a health service network focused on cancer therapies, will start a pharmaceutical distribution business this fall. The company will integrate the purchasing, storage and distribution of nearly $1.6 billion in pharmaceuticals for the network's 470 service sites. The move is expected to reduce costs by improving waste tracking, inventory management and operational efficiencies, the company said. -=- Qualitative Research


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