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			Tagline 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 Schering, TAP stop dosing of asoprisnil in extension studies Schering AG and TAP Pharmaceutical Products Inc. plan to amend extension studies of asoprisnil, an investigational compound for the management of symptomatic uterine fibroids. Dosing has been discontinued in the extension studies, which patients could choose to participate in following Phase III controlled trials, due to endometrial changes that some patients experienced during the trial program. In most patients, these changes were reversible after they stopped therapy, but they resulted in additional invasive procedures. As part of ongoing extension studies, researchers will continue to follow-up with patients. "Based on Phase II and Phase III data, we believe that asoprisnil may be a promising therapy for the millions of women who suffer from uterine fibroids whose current options remain invasive procedures," said Dr. Phil Smits, head of the global business unit gynecology and andrology at Schering. The companies will continue to discuss submission plans with regulatory authorities in the United States and Europe, according to Schering. Asoprisnil is being tested as an agent to reduce uterine bleeding, shrink the fibroids and reduce pressure symptoms. Schering shares closed at $61.08, down $2.62, or 4.1 percent, in heavy trading on the New York Stock Exchange. Tagline Study shows Atacand reduces composite of cardiovascular death, nonfatal MI in optimally treated patients with heart failure AstraZeneca Plc's Atacand (candesartan cilexetil) significantly reduced the risk of the composite outcome of cardiovascular death or nonfatal myocardial infarction in patients with heart failure who are also receiving optimal therapy, according to results from the CHARM study, which was published in the Oct. 12 edition of JAMA. Overall, the study randomized 7,599 patients with heart failure and New York Heart Association class II to IV symptoms to receive up to 32 mg of Atacand or placebo once per day. More than one-half of these patients had previously experienced an MI, and nearly one-quarter had angina. Along with study drug, the patients received optimal therapy for heart failure, including 41 percent who received an ACE inhibitor; 55 percent, a beta-blocker; 42 percent, a lipid-lowering drug; 56 percent, aspirin; and 83 percent, a diuretic. During a median follow-up of 37.7 months, the primary composite outcome of cardiovascular death or nonfatal MI occurred at a significantly lower rate in the Atacand-treated arm than in the placebo arm (20.4 percent vs. 22.9 percent, respectively). The composite secondary outcome of fatal MI, sudden death or nonfatal MI was also significantly lower with Atacand compared with placebo (12.1 percent vs. 13.8 percent, respectively) as was nonfatal MI alone (3.1 percent vs. 3.9 percent). However, Atacand showed no impact on hospitalizations for unstable angina or coronary revascularization procedures. "[T]hat [Atacand] seemed to have a beneficial effect independent of ACE inhibition suggests that [the] non-ACE angiotensin II generation might be contributing to the continuing risk of MI in patients treated with an ACE inhibitor," the researchers concluded. Both the ONTARGET and TRANSCEND programs are currently under way to test this hypothesis. Tagline Javelin's Rylomine meets primary endpoint in Phase IIb trial Javelin Pharmaceuticals Inc.'s Rylomine (intranasal morphine) met its primary endpoint of a linear dose-response for pain relief in four hours, measured by the Visual Analog Scale, in a Phase IIb trial. The randomized, double-blind, placebo- and comparator-controlled study involved 187 post-bunionectomy patients with moderate to severe pain. Compared with patients who received placebo, patients treated with either a bolus intravenous injection of morphine 7.5 mg or one of four doses of Rylomine, ranging from 3.75 mg to 30 mg, had statistically significant pain relief over four hours. There were no serious adverse effects related to the drug and, for the highest intranasal doses, analgesic effects were similar to those seen with intravenous morphine. The ongoing analyses of the data will be submitted for presentation at an upcoming medical meeting. According to the company, "Rylomine is a patient-controlled nasal spray that delivers a single, metered dose of morphine, an opioid analgesic used for the treatment of moderate to severe pain." "For years, clinicians have relied upon injectable morphine to provide rapid and effective pain relief," said Dr. Daniel Carr, chief executive officer of Javelin. "Rylomine employs a proprietary morphine formulation that delivers rapid and clinically meaningful analgesia without the need for a needle or syringe, and is easy to administer. This study in an accepted model for postoperative pain confirms and extends Javelin's prior clinical trials with Rylomine and will be important for later approvals by both U.S. and European regulatory agencies." Tagline Lilly ICOS reports positive results from Phase II tadalafil trial in men with BPH Lilly ICOS LLC released positive results from a Phase II clinical trial of tadalafil in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. The double-blind, placebo-controlled, proof-of-concept study showed statistically significant and clinically meaningful improvement in the primary endpoint, the International Prostate Symptom Score (IPSS). The IPSS is a seven-item questionnaire that evaluates the severity of BPH symptoms and the patients' response to therapy. Tadalafil also demonstrated statistically significant improvements compared with placebo in most of the study's secondary endpoints. Patients treated with 5 mg tadalafil once a day, over a period of six weeks, had a mean 2.8-point improvement from baseline in IPSS; patients who received placebo experienced a mean 1.2-point improvement. After increasing the dosage of tadalafil to 20 mg and continuing therapy once a day for another six weeks, patients experienced a mean 3.8-point improvement from baseline in IPSS. Patients on placebo had a mean 1.7-point improvement. Further results from the 250-patient study will be presented at an upcoming medical congress. "Millions of men over the age of 45 suffer from lower urinary tract symptoms and BPH. The prospect of having an additional treatment option for these bothersome urinary symptoms is most welcome news for those physicians engaged in caring for the aging male," said Dr. Claus Roehrborn, professor and chair of urology at the University of Texas' Southwestern Medical Center in Dallas. Tadalafil, an inhibitor of the phosphodiesterase type 5, may cause relaxation of the smooth muscle in the prostate, the company said. Tadalafil is the active ingredient in Lilly ICOS' Cialis, which is approved for the treatment of erectile dysfunction. Tagline OTC nasal decongestants may no longer tout relief of nasal congestion "associated with sinusitis" The Food and Drug Administration published final rules that prohibit use of the term "sinusitis" on over-the-counter nasal decongestants, Dow Jones Newswires reported. As a result, manufacturers must remove any wording on their labels that says the OTC nasal decongestant can temporarily relieve nasal congestion "associated with sinusitis." Most companies have 18 months to comply, but those with annual sales of less than $25,000 have 24 months. The new rules apply to an estimated 520 products such as Pfizer Inc.'s Sudafed (pseudoephedrine hydrochloride), Schering-Plough Corp.'s Afrin (oxymetazoline hydrochloride), Wyeth's Advil Cold and Sinus (ibuprofen/pseudoephedrine hydrochloride) and generic drugs. "Due to the current labeling, [the] FDA is concerned that consumers use OTC nasal decongestant drug products (both oral and topical) to treat symptoms associated with sinusitis, rather than seeking medical evaluation and definitive treatment. The delay in medical evaluation could also result in a lost opportunity for early diagnosis of another serious medical condition in patients who have symptoms similar to those of sinusitis," the regulatory agency said when it proposed the new rules in August 2004. The FDA went on to say that recent publications have found a lack of prospective studies that address the use of nasal decongestants to treat sinusitis. Additionally, "data on their use as an adjunct in the treatment of sinusitis are limited and controversial," although health care providers may recommend or prescribe their use as an adjunctive therapy for sinusitis "within a physician-patient relationship." Some preclinical evidence has even shown that topical nasal decongestants could negatively affect the resolution of sinusitis if they increase the degree of sinus inflammation, the FDA added. Phrases such as "temporarily relieves sinus congestion and pressure," "promotes nasal and/or sinus drainage" and "helps decongest sinus openings and passages" will not be affected by the new rules. Tagline Targeted education, rebates may increase PPI formulary compliance Targeted education about formularies, along with mail-in rebate incentives, may effectively encourage health care consumers to switch from a non-formulary agent to a formulary option, according to findings from a study evaluating proton pump inhibitor use among Blue Cross Blue Shield of Nebraska (BCBSNE) members. Researchers identified BCBSNE members who had filed at least one claim for a non-formulary PPI in the three-month period prior to Nov. 22, 2004. They mailed manufacturer mail-in rebates for Aciphex (rabeprazole sodium), which is co-promoted in the United States by Eisai Inc. and Janssen Pharmaceutica Inc., and Wyeth's Protonix (pantoprazole sodium) to 3,379 of these members (the intervention group). They also sent detailed information about the plan's formulary and the copayment differences among the PPIs. A total of 2,028 BCBSNE members served as the control group. Members that filed no claims in the follow-up period were excluded from the study, which left 2,433 members in the intervention group and 1,518 members in the control group. Three months after the letter was sent, 265 (11 percent) members in the intervention group had filed a claim for a generic or formulary PPI compared with 33 members (0.02 percent) in the control group. Throughout the follow-up period, 86 percent of these intervention group members maintained use of generic or formulary drugs. Among members who switched to a formulary product, the average copay decreased from $43 per month to $17 per month. This study was presented as poster PIP12 in Nashville, Tenn., at the Educational Conference of the Academy of Managed Care Pharmacy. Tagline Tagline The U.K. High Court of Justice The U.K. High Court of Justice ruled Wednesday that Pfizer Inc.'s patent for the calcium salt of atorvastatin, which expires in July 2010, was invalid, but upheld the exclusivity of Pfizer's main atorvastatin patent until November 2011. Ranbaxy Laboratories Ltd. has challenged the patents in both the United Kingdom and the United States. Pfizer plans to appeal the first decision, while Ranbaxy intends to appeal the second one. A ruling on the U.S. cases is expected by the end of the year. Atorvastatin is sold as cholesterol-lowering Lipitor. Tagline Tagline Barrier Therapeutics Inc. Barrier Therapeutics Inc. received notification from the Food and Drug Administration that its submission in response to the regulatory agency's not approvable letter for Zimycan (0.25% miconazole nitrate/15% zinc oxide/81.35% white petrolatum ointment) is considered to be a complete response. Barrier believes the submission provides the information necessary for the FDA to complete its review of the New Drug Application by early next year. The product, now with the approved brand name of Vusion, is intended to treat diaper dermatitis that is complicated by candidiasis. The FDA found the original NDA had insufficient information about the systemic exposure of miconazole in infants. Tagline Tagline Accellent Inc. Accellent Inc., which provides integrated contract manufacturing and design services for the medical device industry, has signed a merger agreement valued at approximately $1.27 billion with affiliates of Kohlberg Kravis Roberts & Co. (KKR). Members of Accellent management will retain a significant equity stake in the company by partnering with KKR. The acquisition is expected to be completed before the end of the year. Currently, Accellent is owned by a private investment group led by KRG Capital Partners LLC and DLJ Merchant Banking Partners, an affiliate of Credit Suisse First Boston. Tagline Tagline Immtech International Inc. Immtech International Inc. completed enrollment in its Phase IIb clinical trial of DB289 for the treatment of uncomplicated malaria. The company believes results from previous clinical and animal trials, which indicated low toxicity, support the use of DB289 as a treatment for malaria in pregnant and lactating women as well as in infants and young children. Currently, the company is enrolling pregnant and lactating women in clinical trials in Africa and also plans to test if DB289 could safely be used to prevent malaria during pregnancy. Also in progress are studies of DB289 as a malaria prophylaxis in travelers, a market that includes 80 million to 120 million people annually, the company said. Tagline Tagline


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