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USAN NameBrand 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 Cephalon's new formulation of modafinil deemed approvable for ADHD Cephalon Inc. received an approvable letter from the Food and Drug Administration for Sparlon (modafinil) tablets [C-IV], a potential treatment for attention-deficit/hyperactivity disorder in patients aged 6 to 17 years.The company submitted a supplemental New Drug Application for Sparlon in December 2004. Sparlon is a new formulation and proprietary dosage of modafinil, which Cephalon currently markets as Provigil, a treatment for sleep disorders. The firm expects to launch the new product, which will be co-promoted with McNeil Consumer & Specialty Pharmaceuticals, early next year, pending final regulatory approval. In its sNDA, Cephalon included data from three Phase III studies involving more than 600 children and adolescents with ADHD. The company said patients who received Sparlon showed "significant improvement" as early as the first week after initiating treatment when compared with those who received placebo. "Sparlon is distinct from all currently available ADHD therapies," said Dr. Paul Blake, Cephalon's executive vice president of worldwide medical and regulatory operations. "We are excited to offer physicians and families a potential new option in the treatment of ADHD and are working closely with the FDA to obtain final approval." USAN Name Antihypertensive drugs prevent significant proportion of headaches, researchers report Antihypertensive drugs from a variety of classes prevent a significant proportion of headaches, suggest findings from a new meta-analysis. "Cross-sectional studies have generally shown no association between blood pressure and headache, reinforcing the prevailing view that there is no link with headache or that, if there is, the headaches are attributable to anxiety and tension induced by being told one has 'hypertension,'" wrote investigators. "Recently, an editorial asked, 'Why does the hypertension headache myth persist?' Against this negative observational data, it is striking that published intervention studies have suggested that blood pressure-lowering drugs prevent headache." To evaluate whether blood pressure-lowering drugs affect headache, the investigators conducted a meta-analysis of 94 trials of four classes of therapies: thiazides, beta blockers, ACE inhibitors and angiotensin II receptor antagonists. The study included fixed-dose trials in which 17,641 patients were randomized to receive blood pressure-lowering drugs and 6,603 were randomized to receive placebo. On average, treatment lowered systolic blood pressure by 9.4 mm Hg and diastolic blood pressure by 5.5 mm Hg. Overall, one-third fewer patients in the treatment groups reported headache as compared with those who received placebo (8 percent vs. 12.4 percent, respectively). Highly statistically significant reductions in headache prevalence were noted for each of the four drug classes studied. The investigators calculated an average 3.5 percent absolute difference in the proportion of subjects who reported headache in the treated versus control groups, translating to the prevention of headache in approximately one person out of 30. "That this effect is seen with pharmacologically unrelated classes of drugs indicates that it is likely to be due to the reduction in blood pressure per se, the only recognized action that the drugs have in common," the researchers wrote. "This in turn indicates that high blood pressure is a cause of headache, but this conclusion is not supported by observational studies of blood pressure and headache. The uncertainty over whether high blood pressure causes headache does not, however, detract from the practical benefits of the use of blood pressure-lowering drugs in preventing headaches and cardiovascular disease." The study appeared in the Oct. 11 issue of the journal Circulation. USAN Name Atypical antipsychotics may be associated with slightly increased risk for death compared with placebo among dementia patients Data from a new meta-analysis found that the use of atypical antipsychotic drugs for periods of less than eight to 12 weeks was associated with a slightly increased risk for death compared with placebo among patients with dementia. To assess the evidence for increased mortality from atypical antipsychotic drug treatment for patients with dementia, researchers conducted a meta-analysis of atypical antipsychotic drug trials. The research team selected 15 trials, nine of which were unpublished. The trials generally lasted 10 to 12 weeks and included three trials of Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd.'s Abilify (aripiprazole), five of Eli Lilly and Co.'s Zyprexa (olanzapine), five of Johnson & Johnson's Risperdal (risperidone) and three of AstraZeneca Plc's Seroquel (quetiapine fumarate). One trial was counted both as a Risperdal trial and a Zyprexa trial. A total of 3,353 patients were randomized to receive the study drug and 1,757 to receive placebo. The meta-analysis found 118 deaths among patients who took the atypical antipsychotic drugs and 40 deaths among patients who received placebo. Overall, patients in the atypical antipsychotic drug groups were 1.54 times more likely to die than were controls. "These findings emphasize the need to consider certain changes in some clinical practices," the research team noted. "The fact that excess deaths and cerebrovascular adverse events can be observed within 10 to 12 weeks of initiating medication, coupled with observations from individual clinical trials results that there is substantial improvement in both drug and placebo groups during the first one to four weeks of treatment, lead to the consideration that antipsychotic drugs should be prescribed and dosage adjusted with the expectation of clinical improvement within that time." The authors also recommended that clinicians consider discontinuing the medication if there is no observed improvement. In an accompanying editorial, Dr. Peter Rabins and Dr. Constantine Lyketsos outlined some recommendations when caring for a patient with dementia who develops psychotic symptoms or aggression. First, they suggested that clinicians consider etiologies other than dementia, such as untreated or undertreated medical illnesses, overmedication, environmental triggers, lack of engaging activities and misinterpretation of disease symptoms. Second, the risk/benefit ratio for each patient should be taken into account. And, if the decision is made to prescribe antipsychotic drugs, the two physicians noted that "careful assessment and documentation of the need for continued care is necessary." The study and editorial appeared in the Oct. 19 edition of JAMA. USAN Name Wyeth's Q3 net income falls on restructuring, tax charges Wyeth's net income fell 39 percent in the third quarter as the firm took restructuring and tax charges. The company reported third-quarter net income of $869.9 million, or $0.64 per diluted share, compared with $1.42 billion, or $1.05 per diluted share, for the third quarter of 2004. Income during the most recent quarter was affected by $95.8 million in net restructuring charges associated with the firm's productivity initiatives and a $170 million income tax charge related to Wyeth's decision to repatriate approximately $3.1 billion of foreign earnings. Net income during the third quarter of 2004 reflected a favorable income tax adjustment of $407.6 million, Wyeth noted. Excluding charges, Wyeth's third-quarter net income was $1.10 billion, or $0.81 per diluted share, in 2005 compared with $1.01 billion, or $0.75 per diluted share, in 2004. Analysts surveyed by Thomson First Call estimated earnings per share to average $0.76, The Wall Street Journal reported. The company's net revenue rose 5 percent from last year's third quarter, reaching approximately $4.72 billion in the third quarter of 2005. Worldwide pharmaceuticals revenue increased 7 percent for the quarter, led by strong sales of arthritis and psoriasis treatment Enbrel (etanercept), which is co-promoted with Amgen Inc. in North America but marketed exclusively by Wyeth outside of North America, and Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein]), which prevents invasive pneumococcal disease. For the full year, Wyeth expects to meet or exceed the upper end of its previous guidance of $2.80 to $2.90 per diluted share, excluding charges. Wyeth shares closed at $45.00, down $1.23, or 2.7 percent, in heavy trading on the New York Stock Exchange. USAN Name Boston Scientific's Taxus Express2 stent system reduces restenosis in patients with diabetes, data indicate Nine-month, sub-population data from Boston Scientific Corp.'s TAXUS V clinical study shows that Taxus Express2, a paclitaxel-eluting coronary stent system, significantly reduces restenosis in patients with diabetes, particularly in high-risk patients who require insulin. TAXUS V, an extension of the TAXUS IV trial, is investigating the most challenging lesions and highest-risk patients ever studied in a randomized, controlled clinical trial in the United States. The TAXUS V trial is designed to assess the safety and efficacy of the slow-release formulation paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions. The trial's sub-population data are consistent with positive results seen in other Taxus trials, according to Paul LaViolette, chief operating officer at Boston Scientific. In a sub-population analysis, patients with diabetes who received the Taxus paclitaxel-eluting system demonstrated significant improvements compared with those in the control group (patients who received a bare metal stent) in terms of nine-month target lesion revascularization (TLR) rate. In the medically treated patients with diabetes, the nine-month TLR rate was 9.6 percent with the Taxus stent versus 17.5 percent in the control group, demonstrating a 45 percent reduction that was comparable to the sub-population without diabetes. Additional improvements were observed among the higher-risk, insulin-requiring patients with diabetes, as Taxus led to a 52 percent reduction in the nine-month TLR rate. Moreover, the diabetes sub-population had an in-segment binary restenosis rate of 18.2 percent in the Taxus stent group compared with 38.4 percent in the control group, representing a reduction of 53 percent. In patients with diabetes who required insulin, the restenosis rate was 20.9 percent in the Taxus stent group compared with 46.7 percent in the control group, a reduction of 55 percent. Significant improvements were also noted in in-segment late loss in the diabetes sub-population of the Taxus stent group compared with the control group. Results were reported in Washington, D.C., at the annual Transcatheter Cardiovascular Therapeutics symposium. USAN Name Increased drug copayments may negatively affect consumers' usage, study finds An increase in prescription drug copayments resulting from changes in tiered benefit plans may prompt consumers to discontinue their use of prescription drugs within a specific therapeutic class or to switch to generic alternatives, new research suggests. In a retrospective prescription claims analysis, researchers assessed drug utilization patterns among members in four benefit plans. Between 1999 and 2001, three of the plans changed from a traditional two-tier design covering generic and formulary brand products to a three-tier design (varying copayments); the fourth plan, which served as the control, maintained a two-tier structure. Nine common drug classes--ACE inhibitors, calcium-channel blockers (CCBs), angiotensin-receptor blockers (ARBs), COX-2 inhibitors, nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors, tricyclic antidepressants, statins and triptans--used to treat five conditions (cardiovascular conditions, pain, depression, high cholesterol and migraines) were included in the analysis. Overall, those who experienced a tier change in their plan responded differently than did the control group. Medication possession ratios decreased for those whose benefit plans changed, while the ratios increased for the control group. Ratio changes varied by drug class. Lower-cost generic substitutions were available only for ACE inhibitors, CCBs, NSAIDs and tricyclic antidepressants. Researchers noted that in the case of CCBs, in the year after the tier change, substitution rates rose for cases but fell for controls. For ACE inhibitors, substitution rates increased among both cases and controls. Within-class switch rates rose for case members and fell for controls across all drug classes except CCBs. On average, case members switched products 1.5 times more after the plan change as compared with the pre-change period. Among those who switched within a specific drug class, a greater proportion of cases than controls switched to products with a lower copayment. For most of the drug classes, discontinuation rates among cases grew substantially during the first six months after the tier change compared with the same time frame in the previous year. The researchers observed that net changes in discontinuation rates were higher for cases than for controls in all classes except triptans. "Additional studies are needed to determine why patients make particular decisions regarding which products to pay more for and which to discontinue," the researchers wrote. "Additionally, the potential impact of discontinuation on health outcomes and health care utilization . . . needs to be quantified." The study results were published in the October issue of The American Journal of Managed Care. USAN Name USAN Name Pfizer Inc. Pfizer Inc. said it could take another one to three years to collect the necessary trial data for torcetrapib, a cholesterol-lowering treatment being tested in combination with Lipitor (atorvastatin calcium), also a Pfizer cholesterol drug. Torcetrapib raises HDL cholesterol levels, while Lipitor lowers LDL cholesterol. Investors are hopeful that Pfizer will launch a Lipitor/torcetrapib combination product before the U.S. patent for Lipitor expires in 2011. Reuters reported that a senior research official at Pfizer said it will take another year of study to determine whether less plaque is deposited in the coronary arteries of people taking the combination drug than in those treated only with Lipitor. The same company official noted that regulators could require additional trials to further demonstrate the product's effectiveness. According to Reuters, torcetrapib is Pfizer's most important experimental drug. USAN Name USAN Name GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals and the Aeras Global TB Vaccine Foundation entered into a partnership to develop GSK Biologicals' investigational tuberculosis vaccine, Mtb72F/AS02A. The companies said the product has shown promise in preclinical studies and will begin additional safety and immunogenicity trials in the next few months. The new vaccine will be tested in adults who have been infected with tuberculosis, as well as those who have been vaccinated with Bacillus Calmette-Guerin, an existing tuberculosis vaccine that reportedly fails to protect most people after childhood. USAN Name USAN Name Discovery Laboratories Inc. Discovery Laboratories Inc.'s response to an approvable letter for Surfaxin (lucinactant), which is intended to prevent respiratory distress syndrome in premature infants, has been accepted by the Food and Drug Administration. The company submitted additional data to the FDA on Oct. 5. and said the FDA plans to complete a review of the New Drug Application by April 2006. In August, Discovery's shares fell after the FDA deemed the company's previous response incomplete. Shares were up slightly more than 10 percent in heavy, late-afternoon trading on the Nasdaq. USAN Name USAN Name Syntonix Pharmaceuticals Inc. Syntonix Pharmaceuticals Inc. and Boehringer Ingelheim GmbH entered into a collaboration, valued as high as $63 million, to optimize certain Boehringer therapeutic peptides for inhalation using Syntonix's SynFusion and Transceptor technologies. As a result, Syntonix will receive an up-front payment and research support, as well as milestone and royalty payments on products developed and commercialized through the collaboration. Boehringer retains the option of developing and commercializing the peptide candidates. USAN Name USAN Name
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