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			Brand Values 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 FDA advisory panel recommends black box warning for ADHD drugs The Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration voted 8-7 in favor of adding a black box warning to drugs used to treat attention-deficit/hyperactivity disorder, Reuters reported. The FDA advisory panel said the warning should advise patients that use of the drugs may increase the risk of heart problems. Although the drugs have been linked to reports of sudden death, myocardial infarction and other cardiovascular problems, FDA staff said prior to the vote that it was not clear whether the drugs contributed to these occurrences, Reuters noted. "The data [are] only suggestive at this point, but because of the gravity of the side effect, namely sudden death, physicians need to be made clearly aware of that concern," Dr. Peter Gross, panel chairman and head of internal medicine at New Jersey's Hackensack University Medical Center, said in a Reuters report. The committee members also voted to recommend that a guide be given out with the drugs explaining their potential side effects, the news service reported. According to an FDA report released before the meeting, 51 deaths in the United States prompted the agency to monitor for myocardial infarctions, high blood pressure and other health problems among patients taking ADHD drugs, Reuters noted. The FDA document said 24 deaths were reported through 2003 for patients who took Shire Pharmaceuticals Group Plc's Adderall (mixed amphetamine salts). Another 16 deaths were reported for patients who took Novartis AG's Ritalin (methylphenidate hydrochloride) and 11 deaths were reported for patients who took other drugs in the amphetamine class besides Adderall, Reuters said. Last February, the FDA said it would carefully evaluate reports of serious adverse events in patients being treated with Adderall XR, and related products, after Adderall XR was pulled from the Canadian market. The drug's suspension was based on 20 international reports of sudden death in patients taking Adderall or Adderall XR. At the time, Shire pointed out that these data were considered when the drug's label was updated in September 2004 to state that, in general, the drug should not be used in children or adults with structural cardiac abnormalities. Canada reinstated Adderall XR's marketing authorization last August. Brand Values FDA analyzes drug review process for efficiency The Food and Drug Administration analyzed its method of reviewing applications for drugs and biologics that have not previously been granted approval. The FDA commissioned a report called the Independent Evaluation of FDA's First Cycle Review Performance--Retrospective Analysis to examine the differences between applications that were approved in the first round of review (first-cycle) and those that required multiple reviews (multicycle). The analysis showed that "milestone" meetings between the drug sponsor and the FDA had a positive impact on the drug review process by improving the quality of the initial applications. Specifically, the results revealed that consultations prior to the final phase of human testing (end of Phase II) positively affected first-cycle approval rates. Of the companies that met with the FDA at the end of Phase II trials, 52 percent received approval during the first review cycle compared with 29 percent of companies that did not meet with the FDA at this stage. The agency noted that although milestone meetings can help identify problems in the application, they do not always prevent the need for multiple review cycles. The report said that many product sponsors did not adequately address issues discussed in the meeting before submitting the application; in 71 percent of applications in which the FDA had identified key issues during presubmission meetings, the issues were not adequately resolved by the time of first action. To further improve first-cycle approval rates, the report recommended that the FDA should be more proactive in the development process by working with the sponsor to identify and communicate issues and potential deficiencies earlier in the review process. In addition, the report suggested that the agency follow-up after its meetings with sponsors to make sure issues are being addressed sufficiently. Although the report recommended increased FDA participation during the review process, it noted that implementing these recommendations would significantly increase the agency's workload and staffing in the reviewing divisions. The FDA said the analysis found that most applications requiring multicycle reviews had major deficiencies in only one or two areas. Brand Values Use of SSRIs during late pregnancy linked to persistent pulmonary hypertension in newborns A case-control study revealed that women who use antidepressants known as selective serotonin-reuptake inhibitors late in the third trimester of pregnancy may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a dangerous and sometimes fatal condition in which blood continues to flow through an infant's heart the way it did in the womb, causing instability in the infant's body. In the study, researchers enrolled 337 women whose infants had PPHN and 836 matched controls between 1998 and 2003. Nurses who were blind to the study hypothesis interviewed the women regarding medication use during their pregnancy and potential confounders, including demographic factors and health history. Of the infants who were exposed to an SSRI after the 20th week of gestation, 14 had PPHN compared with six in the control group. The investigators found no association, however, between the use of SSRIs before the 20th week of gestation and an increased risk of PPHN. The results also showed that exposure to a non-SSRI antidepressant drug was not associated with an increased risk of PPHN. The trial investigators noted that further study is warranted and that women and their physicians should reconsider the use of SSRIs during pregnancy. The study was published in the Feb. 9 issue of The New England Journal of Medicine. Brand Values Reyataz therapy with, without Norvir appears effective in treatment-naive patients with HIV Among treatment-naïve patients with HIV, the response rates were similar for those who were treated with Bristol-Myers Squibb Co.'s HIV therapy Reyataz (atazanavir sulfate) alone and those who received Reyataz plus Abbott's antiviral Norvir (ritonavir), a new study found. Patients were randomized to once-daily treatment with 400 mg of Reyataz (the approved dose for this patient population; n=105) or 300 mg of Reyataz plus 100 mg of Norvir (n=95). Both treatment groups also received GlaxoSmithKline Plc's antiviral Epivir (lamivudine) and an investigational extended-release formulation of stavudine, BMS noted. The primary efficacy endpoint was the proportion of patients who responded to treatment, defined as those who achieved HIV RNA levels of less than 400 copies/mL through week 48. An intent-to-treat analysis found that 86 percent of patients who received the combination of Reyataz and Norvir responded to treatment compared with 85 percent of patients in the Reyataz-only arm. Researchers also found that 75 percent of patients in the Reyataz/Norvir arm achieved HIV RNA levels of less than 50 copies/mL, as did 70 percent of those in the Reyataz arm. These data are based on an analysis performed 48 weeks after the last patient was randomized, BMS said. To assess the long-term safety and virological response of the treatment regimens, researchers will conduct a final analysis 96 weeks after the last patient is randomized. The interim results were presented at the 13th Annual Conference on Retroviruses and Opportunistic Infections in Denver. Brand Values Merck's investigational HIV drug suppresses virus better than placebo, study finds Merck & Co. Inc.'s MK-0518 plus optimized background therapy provides greater viral suppression than does placebo plus optimized background therapy, according to interim results from a Phase II trial involving patients with HIV. Researchers randomized 167 patients with highly resistant HIV who had failed multiple therapies to receive optimized background therapy plus placebo or oral MK-0518 (200 mg, 400 mg or 600 mg) twice daily. The background therapy was chosen based on HIV-resistance testing and previous treatment history. After 16 weeks, patients treated with MK-0518 at any dosage level were found to have greater antiretroviral activity than did patients treated with placebo, according to Merck. Interim results showed that, depending on the dosage, 64 percent to 84 percent of patients who received MK-0518 achieved HIV RNA of less than 400 copies/mL at week 16 versus 22 percent of placebo-treated patients who achieved this response. Furthermore, 56 percent to 72 percent of those treated with MK-0518 achieved HIV RNA of less than 50 copies/mL compared with 19 percent of placebo-treated patients who did so. MK-0518, which belongs to a new class of antiretroviral therapies called integrase inhibitors, prevents HIV viral DNA from being inserted into the human DNA genome, Merck explained, which keeps the virus from replicating and infecting new cells. "The efficacy of MK-0518 provides additional evidence that demonstrates the antiviral activity of HIV integrase inhibitors as a new and promising class of antiretroviral agents," said Dr. Bach-Yen Nguyen, senior director of infectious diseases and clinical research at Merck Research Laboratories. These data were presented at the 13th Annual Conference on Retroviruses and Opportunistic Infections in Denver. Brand Values Aetna posts strong Q4 results, raises guidance Aetna Inc. reported substantial increases in earnings and revenue for the fourth quarter of 2005 and raised its 2006 guidance. The health insurer earned $423 million, or $1.42 per share, in the fourth quarter of 2005, a 41 percent increase from the same period of the previous year, in which the firm earned $300.7 million, or $0.98 per share. Excluding reserve development, the firm earned $1.26 per share, which was higher than the average of $1.23 per share that analysts at Thomson/First Call had anticipated. Revenue for the fourth quarter increased 14 percent, from $5.17 billion in 2004 to $5.87 billion in 2005. For the full year, net income fell in 2005, with earnings of $1.63 billion. In 2004, the firm earned $2.25 billion, which included favorable tax adjustments and a tax refund. On a per share basis, Aetna earned $5.40 in 2005 compared with $7.15 in 2004. Full-year revenue increased, rising 13 percent from $19.9 billion in 2004 to $22.49 billion in 2005. Specifically, Aetna's health care division posted annual revenue of $19.62 billion in 2005, up from $17.2 billion in 2004. Net income for the division rose from $1.1 billion in 2004 to $1.49 billion in 2005. For 2006, the firm now expects to report operating earnings of $5.57 to $5.63 per share; the previous forecast had been $5.45 to $5.50 per share. Aetna shares closed at $99.27, up $3.15, or 3.3 percent, in heavy trading on the New York Stock Exchange. Brand Values Brand Values Pfizer Inc. Pfizer Inc. filed a citizen's petition with the Food and Drug Administration, claiming that Teva Pharmaceutical Industries Ltd. and Sandoz's azithromycin products "appear to be misbranded because their labels do not accurately describe the drugs' active ingredients." Pfizer alleges that the products contain "significant" amounts of azithromycin sesquihydrate instead of azithromycin monohydrate, as stated on their labels. Pfizer also claims that the products, which are generic versions of Pfizer's Zithromax, an antibiotic, violate a recently issued patent. Accordingly, Pfizer has brought legal actions against the two companies and is seeking injunctions to prohibit further sales. Teva said the allegations are "baseless" and refuted the claim that its product label is inaccurate. Brand Values Brand Values Bausch & Lomb Inc. Bausch & Lomb Inc. is collaborating with Novartis Ophthalmics to co-promote Bausch & Lomb's patented orphan drug, Retisert (fluocinolone acetonide) 0.59 mg intravitreal implant, in the United States. The drug is indicated to treat chronic, noninfectious, posterior-segment uveitis. Under terms of the agreement, Novartis' retinal sales team will promote Retisert to retinal specialists within its network. Bausch & Lomb will continue to be responsible for the marketing and product strategy of Retisert. Brand Values Brand Values Baxter International Inc. Baxter International Inc. is selling its transfusion therapies unit, by way of an auction, and is in the second round of considering offers from private equity firms, according to Reuters, which cited "sources familiar with the deal." The unit manufactures blood-collection systems, filters and containers and generated $547 million in sales last year. The unidentified sources said that investment bankers have circulated proprietary financial information pertaining to the business and that bidders are performing due diligence. Brand Values Brand Values NeoPharm Inc. NeoPharm Inc. received a request from the Food and Drug Administration for additional data to support a New Drug Application for LEP-ETU, a new, "easy-to-use" formulation of liposomal paclitaxel, which is commonly used in treating cancer. The additional data are required to establish bioequivalence between LEP-ETU and Bristol-Myers Squibb Co.'s Taxol (paclitaxel). NeoPharm intends to submit the data and meet with agency officials in the second quarter. Provided the FDA's concerns are resolved, NeoPharm said it will initiate a proposed clinical trial comparing the efficacy of the two drugs. Brand Values


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