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Pharmaceutical NamesBrand 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 approves Exubera, new insulin delivery option The Food and Drug Administration granted approval to Pfizer Inc.'s Exubera, an inhaled powder form of recombinant human insulin (rDNA origin).Exubera was approved to treat adults with type 1 and type 2 diabetes and is the first new insulin delivery option to be approved since insulin was discovered more than 80 years ago. Nektar Therapeutics Inc. and Pfizer invented the insulin formulation and the inhaler device, which delivers insulin to the lungs. Industry analysts predict that Exubera will reach blockbuster status, earning more than $1 billion annually, Reuters reported. The inhaled insulin allows the blood sugar to be absorbed by cells as a source of fuel, therefore lowering blood sugar concentrations. Exubera is a substitute for some insulin shots; however, some users may still require the long-lasting effects of insulin injections. The short-acting effects of Exubera will allow those with diabetes to adjust their insulin levels before meals. The FDA cautioned that smokers, those who recently quit smoking or those with asthma, bronchitis or emphysema should not use Exubera. Pfizer has agreed to conduct additional studies to examine the product's safety and efficacy in those with underlying lung disease. Nektar Therapeutics will receive royalties on sales of the drug from Pfizer, Reuters noted. Pharmaceutical Names FDA issues broad warning to Boston Scientific The Food and Drug Administration sent a corporate warning letter to Boston Scientific Corp. citing the medical device maker's "inadequate corporate-wide corrective action plan" in response to "serious deficiencies" found at the firm's manufacturing facilities. According to numerous news sources, including Reuters and The Wall Street Journal, the agency's device center has only issued two such sweeping letters in the past. In the letter, the FDA cited three recent inspections of Boston Scientific plants in Massachusetts, Minnesota and Indiana, all of which revealed severe regulatory problems with the company's medical devices. These inspections came on the heels of three previous warning letters the agency sent to Boston Scientific warning of similar failures in other plants. Specifically, the agency noted that Boston Scientific failed to respond to and report quality control complaints in a timely fashion as required. The FDA acknowledged that it had received the company's prior responses to earlier warnings and had seen some general commitments to changes made in response to the serious violations, but added that the "responses continue to be specific spot fixes and have failed to achieve the necessary systemic approach to comprehensively address the violations." The FDA said it would not approve premarket submissions for class III devices related to the deficiencies until the violations had been fixed and warned that it also would not approve requests for Certificates to Foreign Governments. In a prepared statement, Boston Scientific said that the FDA sent a second communication stating that the company's facility in Galway, Ireland, had been reviewed by the agency and "concluded with no observations reported." "Although we are pleased with the result of the inspection of our largest plant, we have clearly not done enough to resolve the issues raised by the FDA last year," said Jim Tobin, chief executive officer of Boston Scientific. "We are confident we have addressed many of these issues, but others have not yet been fully resolved. We will work closely with the FDA to resolve these outstanding issues, and we believe we are on track to do so promptly." The company said it planned to meet with the FDA to discuss the letter. It was unclear what effect the letter would have, if any, on Boston Scientific's bid to acquire Guidant Corp. According to The Associated Press, the letter was sent several hours after Guidant had accepted Boston Scientific's $27 billion buyout offer. Boston Scientific shares closed at $21.63, down $1.52, or 6.6 percent, in heavy trading on the New York Stock Exchange. Pharmaceutical Names BMS, FDA issue warnings about blood disorder drug Bristol-Myers Squibb Co. notified health care providers about the potential for severe skin reactions in patients who have received Hydrea (hydroxyurea), a treatment for myeloproliferative disorders, and Droxia, which has the same active ingredient but is used to treat sickle cell anemia. The Food and Drug and Administration posted the warning letters on its Web site. Specifically, the letters addressed changes to the labels for both drugs, including "language regarding cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of, or currently receiving, interferon therapy." The warning sections for both drugs now recommend that use of the drug be stopped if cutaneous vasculitic uclerations occur and, in the case of Hydrea, that other cytoreductive agents should be started as indicated. In addition, a Geriatric Use subsection was added to the Hydrea label that notes elderly patients may be more susceptible to the effects of the drug and may need a lower dose regimen. In particular, the new label states that elderly patients are more likely to have impaired renal function, which may increase the risk of toxic reactions to the drug, and recommends that "it may be useful to monitor renal function" in elderly patients. Finally, language was added to the Dosing and Administration sections of both drugs emphasizing the need to wear impervious gloves when handling the capsules. The letters concluded with contact information for reporting adverse events either directly to BMS or to the FDA's MedWatch Reporting System. The labels for both drugs already included strict warnings about possible complications, including a potential increased risk of secondary cancers. Pharmaceutical Names Bayer disagrees with journal report associating Trasylol with serious risks Bayer Healthcare issued a statement refuting recently published evidence on Trasylol (aprotinin) that challenged the product's safety. Trasylol is approved as a prophylactic to reduce perioperative blood loss and the need for blood transfusions in patients undergoing heart bypass surgery. The prospective, observational study in question, which was published in the Jan. 26 issue of The New England Journal of Medicine, included 4,374 patients scheduled for coronary-artery bypass surgery with cardiopulmonary bypass. In total, 1,295 patients were given Trasylol, 883 were administered aminocaproic acid, 822 were administered Pfizer Inc.'s Cyklokapron (tranexamic acid) and 1,374 no agent (control). All three medications reduced blood loss as compared with the control group. However, the study authors noted that the use of Trasylol was linked with a higher risk of renal, cardiac and cerebral events when compared with the two other products or no therapy. In propensity-adjusted, multivariable logistic regression analysis, Trasylol more than doubled the odds of renal failure requiring dialysis than did the control group among patients undergoing complex coronary-artery surgery or primary surgery. Furthermore, Trasylol increased the odds of myocardial infarction or heart failure by 55 percent and the odds of stroke or encephalopathy by 181 percent as compared with the control for patients undergoing primary surgery. Based on the research, the study authors suggested that Trasylol's "continued use is not prudent." "[O]ur findings indicate that reconsideration of the safety of [Trasylol] among patients undergoing cardiac surgery is warranted and indicate replacement of [Trasylol] with either aminocaproic acid or [Cyklokapron]," they added. In response, Bayer said in its statement that the conclusions of the NEJM report "are not consistent with the more than 15 years of clinical data and experience Bayer has amassed on Trasylol." Bayer said it has studied Trasylol in a series of prospective, randomized, placebo-controlled trials with more than 6,500 open heart surgery patients and did not find any increases in renal failure, MI, congestive heart failure and stroke or encephalopathy among the Trasylol-treated patients (n=3,817). The company plans to contact the study authors to question the data, study methodology and analysis. Pharmaceutical Names Guidant reports decreased earnings, sales for Q4, FY 2005 Guidant Corp. announced a decrease in fourth-quarter and full-year sales and net income for 2005 as a result of product recalls that took place during the year among some of the firm's cardiac devices. Fourth-quarter earnings declined to $78.9 million, or $0.23 per diluted share, from $104.5 million, or $0.32 per diluted share, in the same period of 2004. Income from continuing operations totaled $85.4 million in the 2005 period compared with $123.7 million in 2004. Quarterly sales reached $828.2 million, a 14 percent decrease from $968.2 million achieved in the year-ago quarter. A Thomson First Call survey indicated that analysts estimated Guidant would earn $0.34 per share in the quarter on revenue of $851 million, according to The Wall Street Journal. Full-year net income totaled $413.9 million, or $1.24 per diluted share, versus $524 million, or $1.63 per diluted share, in 2004. The medical device maker earned $443.6 million, or $1.33 per diluted share, in continuing operations during 2005 compared with $573 million, or $1.78 per diluted share, in 2004. Sales for 2005 decreased 6 percent to $3.55 billion from $3.77 billion in 2004. Guidant said the weak results reflect the impact of decreased sales for its implantable defibrillator products and coronary stents. As previously reported, the company recalled some models of its implantable defibrillators after their use was linked to patient deaths. Worldwide sales for the defibrillators fell 19 percent in the fourth quarter from 2004 while U.S. sales fell 23 percent compared with the year-ago period. In the full year, worldwide and U.S. sales fell 6 percent and 12 percent, respectively. The company stood by its previously disclosed guidance for 2006, which ranges between $3.8 billion and $4 billion in revenue and earnings of between $1.48 and $1.58 per share. Last week, Guidant agreed to be acquired by Boston Scientific Corp. for $27 billion. Guidant shares closed at $73.72, down $1.54, or 2.1 percent, in moderate trading on the New York Stock Exchange. Pharmaceutical Names Use of hypertension drugs, hypertension polytherapy increased during past decade, but disparities in use by sociodemographics remain The use of hypertension medication and multiple hypertension medications increased during the past decade among U.S. adults with hypertension, but there are still disparities in hypertension treatment use related to demographic factors, new study results indicate. To assess current medication use patterns among adults with hypertension in the United States, a team of investigators compared data from the 1988-1994 National Health and Nutrition Examination Surveys (NHANES III) with that of NHANES 1999-2002. Survey respondents aged 18 years and older were identified as having hypertension if they had a mean systolic blood pressure of 140 mm Hg or more, a mean diastolic blood pressure of 90 mm Hg or more or were currently being treated for hypertension with a prescription medication. The researchers found that the prevalence of hypertension medication use among U.S. adults increased significantly between the two time periods evaluated: from 57.3 percent in 1988-1994 to 62.9 percent in 1999-2002. The greatest increase in the prevalence of hypertension medication was among men: from 47.5 percent in 1988-1994 to 57.9 percent in 1999-2002. During both time periods studied, use of hypertension medication was lower among men than among women, lower among younger subjects as compared with older subjects and lower among Mexican-American subjects as compared with non-Hispanic white and black subjects. In both surveys, diuretics were the most common class of hypertension drugs used (27.8 percent in NHANES III and 28.7 percent in NHANES 1999-2002). Use remained stable for most hypertension drug classes, with the exception of ACE inhibitors, which grew from 15.2 percent in NHANES III to 23.8 percent in NHANES 1999-2002. Use of hypertension polytherapy also increased significantly--from 29.1 percent in 1988-1994 to 35.8 percent in 1999-2002. Specifically, the use of polytherapies containing a calcium-channel blocker increased 30 percent, the use of polytherapies containing a beta blocker increased 42 percent and the use of polytherapies containing an ACE inhibitor increased 68 percent. Between these same time periods, monotherapy use of a diuretic or a beta blocker decreased (from 4.9 percent to 2.7 percent and from 7.1 percent to 5.1 percent, respectively). Among hypertensive adults with diabetes, congestive heart failure or prior myocardial infarction, utilization patterns were consistent with Sixth Joint National Committee guideline recommendations. "Continued efforts are needed to improve antihypertensive medication use, especially among younger hypertensives and racial and ethnic minorities in certain gender and age groups," the researchers wrote. The study was published in the Jan. 17 issue of the journal Circulation. Pharmaceutical Names Pharmaceutical Names Sandoz GmbH Sandoz GmbH's investigational growth hormone, Omnitrope, received the first positive opinion for a "similar biological medicinal product" from the European Medicines Agency. Omnitrope contains somatropin, a recombinant-DNA growth hormone, intended to treat growth disturbance and growth hormone deficiency in children and adults. The EMEA's Committee for Medicinal Products for Human Use found that Omnitrope demonstrated similar quality, safety and efficacy when compared with Pfizer Inc.'s Genotropin (somatropin [rDNA origin]). Sandoz filed for approval of Omnitrope in the United States in July 2003. The Food and Drug Administration has yet to make a decision on the application. Pharmaceutical Names Pharmaceutical Names Chiron Corp. Chiron Corp. entered into a non-exclusive licensing agreement with AVI BioPharma Inc. The agreement grants AVI the rights to the patents and patent applications for the research, development and commercialization of antisense therapeutics intended to treat hepatitis C virus. AVI is currently evaluating its lead Neugene antisense compound for HCV, AVI-4065, in an exploratory safety and efficacy clinical trial. Chiron will receive shares of AVI common stock as an initial license fee payment. Other financial terms were not disclosed. Pharmaceutical Names Pharmaceutical Names Millennium Pharmaceuticals Inc. Millennium Pharmaceuticals Inc. informed ImmunoGen Inc. that it will discontinue the development of its MLN2704 compound, an investigational prostate cancer treatment. Millennium decided to stop the development "as part of its ongoing portfolio management process and based on the evaluation of recent clinical data in the context of other opportunities in its pipeline," according to ImmunoGen's filing with the Securities and Exchange Commission. Millennium provided the antibody to the prostate-specific membrane antigen (PSMA) contained in MLN2704, while ImmunoGen contributed the DM1 component, a cancer-killing agent. Millennium was developing MLN2704 under a 2001 agreement between the companies. Millennium will retain the rights to use ImmunoGen's maytansinoid tumor-activated prodrug technology with antibodies targeting PSMA. Pharmaceutical Names Pharmaceutical Names Clinical Data Inc. Clinical Data Inc.'s investigational antidepressant, vilazodone, a dual serotonergic treatment, will be evaluated in a Phase III clinical trial. Results of the double-blind, placebo-controlled trial are expected to be available by mid-2007. Researchers will investigate the efficacy and safety of vilazodone in approximately 400 patients with major depressive disorder, as well as analyze genetic markers of treatment response associated with the drug. Detecting genetic markers could help predict a patient's likelihood of a response to a given antidepressant and minimize trial-by-error pharmacological inefficiencies, Clinical Data said. Pharmaceutical Names
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