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			Product Brand 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 Safety of high-dose Lipitor confirmed in retrospective study Pfizer Inc.'s Lipitor (atorvastatin calcium) given at its highest dose may be safe for the long-term treatment of patients with multiple risk factors for coronary heart disease, a recently published retrospective analysis suggests. Using pooled data from 49 clinical trials, researchers assessed Lipitor's safety profile. The studies began in 1992 and were completed by Sept. 15, 2004. They involved a total of 14,236 patients with varying degrees of cardiovascular risk who were treated with Lipitor 10 mg (n=7,258), Lipitor 80 mg (n=4,798) or placebo (n=2,180) for an active treatment period that ranged from two weeks to 52 months. Overall, adverse events for the two Lipitor groups and the placebo group occurred at similar rates. Most frequently, patients experienced adverse events related to their digestive system; serious adverse events were uncommon, as was patient withdrawal from any of the treatment groups. The incidence of treatment-associated myalgia (muscle soreness or pain) occurred in 1.4 percent of the Lipitor 10 mg group, 1.5 percent of the Lipitor 80 mg group and 0.7 percent of the placebo group. The incidence of myopathy (muscle weakness or pain combined with a 10-fold increase in muscle enzymes) was rare, and no cases of rhabdomyolysis, a rare form of skeletal muscle breakdown, were reported among patients in the Lipitor groups. "[T]he results of this analysis show no evidence of a relation between the dose of [Lipitor] and the incidence of adverse muscle-related events," the authors concluded. The study was published in the Jan. 1 issue of the American Journal of Cardiology. Product Brand Priority review granted to Plavix application for acute ST-segment elevation MI indication The Food and Drug Administration granted priority review status to sanofi-aventis Group and Bristol-Myers Squibb Co.'s supplemental New Drug Application for antiplatelet drug Plavix (clopidogrel bisulfate) in a new indication. The companies filed the sNDA seeking approval for the drug to be used in treating patients with acute ST-segment elevation myocardial infarction (STEMI), a type of MI that results when an artery is completely blocked long enough to cause heart muscle damage. Plavix is currently approved to reduce the risk of various atherothrombotic events among at-risk patients. The sNDA is based on two clinical studies in which patients who had experienced STEMI were given Plavix on a background of standard therapy, the firms said. Patients in the trials were followed 28 to 30 days. Results of both studies were presented last March, prior to being published, at the 54th Annual Scientific Session of the American College of Cardiology. Sanofi-aventis and BMS also filed an application for the additional indication in the European Union. Product Brand FDA updates package insert format to promote safe, optimal drug use For the first time in more than 25 years, the Food and Drug Administration revised the format requirements for drug package inserts. "By improving the package insert to make it more useful for health care providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients," said Mike Leavitt, secretary of the Department of Health and Human Services. Approximately 300,000 preventable adverse events occur annually in U.S. hospitals, the FDA said, noting that many of these are the result of unclear medical information. "Research shows that prioritizing the warning information has a greater impact on reducing such events," the agency explained. "Therefore, the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians." New and recently approved products must adhere to the revised format, which includes a highlights section, a table of contents, the date of the drug's initial approval and contact information for reporting adverse events. According to the FDA, the new format is also more compatible for use with electronic information resources, including electronic prescribing tools. Although the requirements will be phased in gradually, the agency said it is encouraging pharmaceutical companies to comply with them before they are mandated. Complete details on the new package insert format are available on the FDA's Web site. Product Brand Novo Nordisk's NovoSeven may be linked to serious thrombotic complications, most commonly during off-label use, according to data Reports of serious thromboembolic adverse events, including death, following the use of Novo Nordisk Inc.'s NovoSeven Coagulation Factor VIIa (recombinant activated factor VII) are common, a new report indicates, especially when the product is administered for uses other than that for which it is approved. A team of researchers used the Food and Drug Administration's Adverse Event Reporting System to quantify thromboembolic events linked with NovoSeven from the date of its approval (March 25, 1999) through Dec. 31, 2004. The database includes required reports from product manufacturers, as well as reports submitted voluntarily by health care professionals and the public. NovoSeven is approved for the treatment of bleeding episodes among patients with hemophilia A or B and inhibitors to factor VIII or factor IX. However, use of NovoSeven among patients without hemophilia has grown substantially since the drug's approval. Last October, Novo Nordisk revised NovoSeven's package insert to include information regarding thromboembolic events among patients without hemophilia. In total, 431 adverse event reports for NovoSeven were identified. Of these, 168 reports involved 185 thromboembolic events. Most of the events (52 percent) took place within 24 hours of the last NovoSeven dose. Fifty-nine of the events (35 percent) involved patients enrolled in post-licensure trials. Although 17 events occurred among patients with hemophilia, off-label uses accounted for the majority (n=151) of the reports. According to the data, adverse events were broken down into 39 embolic/thrombotic cerebrovascular accidents, 34 acute myocardial infarctions, 26 other arterial thromboembolic events, 32 pulmonary emboli, 42 other venous thromboses and 10 clotted devices. In 36 of 50 reported deaths (72 percent), the thromboembolic event was listed as the probable cause of death. The researchers found that use of concomitant hemostatic agents was recorded in 64 of the reports (38 percent), with the most common concomitant therapy being platelets. Complete details of the analysis appeared in the Jan. 18 edition of JAMA. An addendum in the article noted that between Jan. 1, 2005, and Nov. 1, 2005, the FDA received 168 additional reports of adverse events involving NovoSeven, 52 of which were associated with 61 thromboembolic adverse events. Of the 52 reports, all but six involved off-label use of NovoSeven. In 17 of the 52 reports, the patient died. Product Brand Dynavax's hay fever treatment meets primary endpoint in Phase II/III trial Patients who received Dynavax Technologies Corp.'s Tolamba in a two-year trial showed a statistically significant reduction in total nasal symptom scores (TNSS) in the second year when compared with patients who received placebo. The Phase II/III trial involved 462 patients, aged 18 to 55 years, who had moderate to severe ragweed allergy, or hay fever. Patients received six weekly escalating doses of Tolamba, up to 30 mcg per dose, or placebo prior to the start of the 2004 ragweed season. Before the 2005 ragweed season began, half of the Tolamba-treated patients were given two additional booster shots. The other half of the Tolamba group and the entire placebo group were given placebo injections. In addition to reaching the primary endpoint of statistically significantly reducing TNSS, Tolamba was found to have a significant clinical benefit relative to ocular effects and composite hay fever symptoms, Dynavax said. Patients who were treated with Tolamba also showed a significant reduction in antihistamine use. Dynavax noted that these results were seen after one short course of therapy given before the 2004 ragweed season. Boosters given before the 2005 season were not required to reach clinical benefit. In fact, the group that received the boosters did not perform statistically significantly better than did the placebo group with regard to TNSS. Based on the trial's results, Dynavax said it plans to begin a large-scale pivotal Phase III trial of the immunotherapeutic agent in the first half of this year. Product Brand Generic blockbusters gaining acceptance, Medco analysis finds Health care professionals and consumers are accepting generic substitutions for blockbuster drugs at an accelerated pace, a Medco Health Solutions Inc. analysis of prescription claims revealed. The analysis found that, within 30 days of their availability, nonbranded versions of Pfizer Inc.'s Zithromax (azithromycin) and sanofi-aventis Group's Allegra (fexofenadine hydrochloride), Arava (leflunomide) and Amaryl (glimepiride) were dispensed at a rate of more than 87 percent. Medco noted that all four drugs lost patent protection within the last four months of last year. As of the first week in January, the antibiotic Zithromax, the largest and most recent of the drugs to lose its patent protection, had a generic dispensing rate at retail pharmacies of more than 90 percent, Medco said. "Medco regularly achieves a near-95 percent substitution rate within the first week for new generic chronic-care medications dispensed through our mail-order pharmacies; however, the fact that an acute-care medication like Zithromax is now showing a 90 percent substitution rate at retail is extraordinary, and speaks volumes about the acceptance of physicians to prescribe, pharmacists to dispense and patients to use generic medications when clinically appropriate," said Dr. Glen Stettin, senior vice president of clinical products at Medco. The pharmacy benefit manager said its clients and their members could save an estimated $130 million per year by taking advantage of the generic availability of Zithromax, allergy treatment Allegra, diabetes treatment Amaryl and rheumatoid arthritis treatment Arava. Within the next five years, almost 70 branded drugs--19 of which are blockbusters--will go off patent, Medco said, noting that these drugs account for more than $45 billion in U.S. sales. Product Brand Product Brand Eli Lilly and Co. Eli Lilly and Co. was granted a nonexclusive license to Xencor Inc.'s ImmunoFilter technology, which Lilly will use in assessing the immunogenicity of its therapeutic proteins. Financial terms of the agreement, under which Lilly has a multiyear license to ImmunoFilter data and software, were not disclosed. "Using ImmunoFilter technology, we and our partners are able to identify potential 'hot spots' on protein drug candidates very early in the development process, and to potentially minimize the future risk of immunogenicity using protein engineering and other technologies," said Bassil Dahiyat, chief executive officer of Xencor. Product Brand Product Brand AstraZeneca Plc AstraZeneca Plc's compound and composition patents for Toprol-XL (metoprolol succinate) extended-release tablets were ruled invalid by the U.S. District Court for the Eastern District of Missouri. AstraZeneca said it will appeal the court's decision, which also asserted that the patents, due to expire in September 2007, are unenforceable. News of the decision caused shares of AstraZeneca to fall 4.5 percent, or $2.23, to close at $47.14 in heavy trading on the New York Stock Exchange; shares of Andrx Corp. and KV Pharmaceutical Co., two of the defendants in the litigation, closed at $18.00, up $1.41, or 8.5 percent, in heavy trading on the Nasdaq and $24.03, up $2.03, or 9.3 percent, in heavy trading on the New York Stock Exchange, respectively. Andrx, KV Pharmaceutical and Novartis AG's Eon Labs have filed Abbreviated New Drug Applications for metoprolol succinate extended-release tablets. Last year, U.S. sales for Toprol-XL reached $1.29 billion. Product Brand Product Brand Boehringer Ingelheim GmbH Boehringer Ingelheim GmbH and Evotec AG expanded the scope of the drug discovery collaboration they began in September 2004, and they extended the termination date from August 2007 to the end of 2008. Originally, the companies were exclusively targeting therapeutics that acted on G-protein coupled receptors. With the expansion, they will now also target classes such as ion channels and enzymes. Boehringer is responsible for all development, manufacturing and commercialization of compounds identified as a result of the collaboration, and Evotec will continue to receive research payments from Boehringer. Boehringer will also pay Evotec for milestones achieved and royalties on product sales associated with drugs discovered through the collaboration. Product Brand Product Brand Ligand Pharmaceuticals Inc. Ligand Pharmaceuticals Inc. and Organon USA Inc. terminated their co-promotion agreement for Avinza (morphine sulfate) extended-release capsules. As a result, rights to the pain drug revert to Ligand. Although the termination agreement took effect Jan. 1, the firms will "cooperate" during a transition period scheduled to end Sept. 30. The companies said they have resolved their dispute over previous co-promotion fees; accordingly, Ligand will pay Organon $14.8 million by Jan. 30 and $37.8 million by Oct. 15. If Organon makes sufficient sales calls, Ligand will pay an additional $10 million on or before Jan. 15 of next year. Organon will also receive quarterly royalty payments until Avinza's patent expires, which is slated for November 2017. Product Brand


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