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New treatment guidelines for HIV/AIDS include use of Roche, Trimeris' Fuzeon Updated guidelines for the treatment of HIV/AIDS, issued by the Department of Health and Human Services, support the use of F. Hoffmann-La Roche Ltd. and Trimeris Inc.'s Fuzeon (enfuvirtide) with an active boosted protease inhibitor in patients with virologic failure. The companies said Fuzeon, the "first and only fusion inhibitor available for the treatment of HIV," offers better and more prolonged virologic suppression.

While previous HHS guidelines focused on the preservation of immune function and the delay of clinical progression as the major treatment goals for patients with extensive prior treatment and drug resistance, the new guidelines represent a shift toward the suppression of viremia.

The new guidelines also include data from a study evaluating Fuzeon administration using Bioject Medical Technologies Inc.'s Biojector 2000, a needle-free injection device. Roche and Trimeris are seeking to add information about the device to the Fuzeon label and have filed a supplemental New Drug Application with the Food and Drug Administration regarding the label change.

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GSK's pertussis vaccine effective in adults, adolescents, study finds GlaxoSmithKline Plc's acellular pertussis vaccine was found to be more than 90 percent effective in a study of 2,781 healthy patients aged 15 to 65 years.

Researchers randomized 1,391 patients to receive the pertussis vaccine and 1,390 patients to receive GSK's Havrix hepatitis A vaccine as a control. The median follow-up duration was 22 months, with 94 percent of patients completing 12 to 17 months of follow-up and 80 percent completing 18 to 24 months of follow-up.

The pertussis vaccine was found to be immunogenic and safe, with an overall efficacy of 92 percent when adjusted for duration of illness and based on the primary pertussis case definition; and an overall efficacy of 89 percent when unadjusted for duration of illness.

In total, there were nine cases of pertussis in the control group that met the primary case definition of pertussis as compared with one case in the pertussis vaccine group.

"The acellular pertussis vaccine was protective among adolescents and adults, and its routine use might reduce the overall disease burden and transmission to children," the authors concluded.

GSK's acellular pertussis vaccine is only approved and available as part of a three-part booster shot, Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for patients aged 10 to 18 years. An editorial published along with the study addressed this fact.

"Of note, there is no acellular pertussis vaccine for adolescents and adults, such as the one used in the study by Ward et al., that is not combined with diptheria and tetanus toxoids," wrote Dr. Scott Halperin. "This fact could complicate the use of the vaccine, since a minimum interval of five years between doses of tetanus-containing vaccines is recommended."

The study and the editorial appeared in the Oct. 13 issue of The New England Journal of Medicine.

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Lamictal does not affect sexual function, reproductive hormone levels in men with epilepsy, according to new data GlaxoSmithKline Plc's Lamictal (lamotrigine) does not significantly affect sexual function or reproductive hormone levels among men with epilepsy, according to new data. However, findings also suggest that certain enzyme-inducing antiepileptic drugs, such as carbamazepine and phenytoin, diminish both sexual function and bioavailable testosterone in this patient population.

Investigators evaluated sexual function (measured with the S-score questionnaire, which assesses sexual interest and potency), hormone levels, hormone ratios and gonadal efficiency in 85 men with localization-related epilepsy and 25 controls. Among men with epilepsy, 25 were taking carbamazepine, 25 were taking phenytoin and 25 were taking Lamictal; the remaining 10 patients had not taken any AEDs for at least six months prior to the study.

Researchers observed significant differences between cases and controls, and between AED treatment groups, with respect to sexual function. Specifically, carbamazepine-treated patients and phenytoin-treated patients had significantly lower mean S-scores (16.5 and 16.6, respectively) than did Lamictal-treated patients (18.6) and controls (19).

Additionally, researchers observed several between-group differences with respect to mean levels of bioavailable testosterone. As compared with controls, men with epilepsy who were not taking an AED had lower levels of bioavailable testosterone (275 ng/dL vs. 245 ng/dL), as did men taking carbamazepine (182 ng/dL) and men taking phenytoin (216 ng/dL). Carbamazepine- and phenytoin-treated patients also had significantly lower levels of bioavailable testosterone than did Lamictal-treated patients (247 ng/dL).

Hormone ratios (bioavailable testosterone/bioavailable estradiol) were also significantly different among the groups, with the highest ratios observed among controls (123) and Lamictal-treated patients (123) and lower values observed among untreated patients (95), carbamazepine-treated patients (90) and phenytoin-treated patients (97).

Similarly, gonadal efficiency (measured with the bioactive testosterone/luteinizing hormone ratio) was significantly better among controls (71.9), untreated patients (69.4) and Lamictal-treated patients (58.9) than among carbamazepine-treated patients (35.6) and phenytoin-treated patients (49.8).

Moreover, levels of sex hormone binding globulin were significantly higher among carbamazepine-treated patients (1.19 mcg/dL) and phenytoin-treated patients (1.55 mcg/dL) versus controls (0.78 mcg/dL), untreated patients (0.90 mcg/dL) and Lamictal-treated patients (0.87 mcg/dL).

The study appeared in the Oct. 11 issue of the journal Neurology.

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Use of autoinjector with Rebif may improve incidence of injection site reactions, could improve long-term compliance in patients with MS Use of an autoinjector instead of manual injection to administer Serono Inc. and Pfizer Inc.'s Rebif (interferon beta-1a) results in fewer injection site reactions (ISRs) and could improve compliance in patients with relapsing-remitting multiple sclerosis, according to a study published in the October issue of the journal Multiple Sclerosis.

In the open-label study, 1,825 patients were randomized to receive subcutaneous Rebif injections, either manually or with an autoinjector. The primary endpoint of the study was the incidence of ISRs, a common side effect of the therapy.

Overall, 78.4 percent of patients who used manual injection completed the study compared with 80.3 percent of patients who used an autoinjector. While the proportion of patients who experienced moderate to severe ISRs was similar in the two groups, patients who used an autoinjector experienced significantly fewer ISRs, overall.

The method of administration did not appear to affect the course of disease-related neurological impairment, the authors noted.

"In long-term therapy, such as [Rebif], improved compliance may lead to improved therapeutic outcomes and, therefore, quality of life," the authors concluded, adding that the "use of an autoinjector allows reproducible technique and is an appealing option for patients with visual, cognitive or dexterity problems, or those who have difficulty self-administering the injection due to needle phobia."

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Report suggests Prograf superior to cyclosporin for preventing acute rejection of kidney transplants, but at expense of increased diabetes, certain side effects Data from a new review suggest Astellas US LLC's Prograf (tacrolimus) is superior to Novartis AG's Neoral (cyclosporine) solution and Sandimmune (cyclosporine) microemulsion for preventing acute rejection after kidney transplantation, but the improved early graft survival comes at the expense of increased diabetes and neurological and gastrointestinal side effects.

Investigators conducted a systematic review of controlled, randomized trials in which Prograf was compared with Neoral or Sandimmune as initial immunosuppressive therapy in patients who received kidney transplants. In total, 123 reports from 30 trials (4,102 patients) were included in the analysis.

Results showed graft loss was 44 percent lower at six months among recipients treated with Prograf as compared with those treated with Neoral or Sandimmune; this effect lasted up to three years. In meta-regression analysis, the relative reduction in graft loss with Prograf diminished at higher concentrations but did not vary with cyclosporine formulation or concentration.

After one year, treatment with Prograf led to 31 percent fewer patients who experienced acute rejection and 51 percent fewer patients who experienced steroid-resistant rejection. However, Prograf was also associated with a two to three times higher risk of developing diabetes that required insulin, and this risk rose with increased concentrations of Prograf.

Furthermore, Prograf-treated patients were significantly more likely to experience tremor, headache, diarrhea, dyspepsia, vomiting and hypomagnesemia; patients treated with Neoral or Sandimmune were more likely to experience constipation, hirsutism and gingival hyperplasia. No differences were observed between Prograf and the cyclosporine formulations in terms of infection or malignancy.

"In applying this evidence to patients, the choice of [tacrolimus or cyclosporine] for an individual patient is neither automatic nor straightforward, as risks of benefit and of drawbacks of each treatment must be balanced," the researchers remarked.

The study appeared in the Oct. 8 issue of the British Medical Journal.

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Diabetes, insomnia have strongest drug pipelines for 2006, according to Express Scripts executive Diabetes and insomnia are the drug pipelines to watch in 2006, according to Brian Kolling, senior director of emerging therapeutics at Express Scripts Inc., and a presenter at the Educational Conference of the Academy of Managed Care Pharmacy in Nashville, Tenn.

Because of the obesity epidemic and the aging population, there is an increased need for diabetes treatments, Kolling explained.

At Express Scripts, the increase in diabetes drug utilization in 2004 was almost three times the overall drug utilization increase for the year, he said. This drug class is thriving partly because it has a limited threat of generic exposure, he noted.

Several new diabetes drugs are expected to be approved in the coming years, Kolling said, adding that one drug with great potential for success is sanofi-aventis Group's Acomplia (rimonabant). Kolling believes this drug, which has been tested in obesity and smoking cessation, will be approved in the second quarter of 2006. He expects sanofi-aventis to market the drug as one that will prevent diabetes or cardiovascular problems but said payers will have to decide whether they will cover Acomplia since it might be viewed as a lifestyle drug.

Payers also face a potential dilemma in deciding whether to cover Pfizer Inc. and sanofi-aventis' Exubera (inhaled human insulin powder), which was recently recommended for approval by a Food and Drug Administration advisory committee. Because the inhaled insulin has not been shown to be any more effective than injected insulin, it may be considered a convenience product. Despite this concern, Kolling expects it to be one of the greatest new drug successes in 2006.

The insomnia drug class is also expected to grow considerably in 2006. Because of the recent influx of new products, such as Sepracor Inc.'s Lunesta (eszopiclone) and Takeda Pharmaceuticals North America Inc.'s Rozerem (ramelteon), Kolling expects an increase in direct-to-consumer advertising. In turn, he thinks the utilization of these drugs will continue to increase significantly.

Even though sanofi-aventis' Ambien (zolpidem tartrate), the market leader in insomnia, is expected to become generic in October 2006 or April 2007, Kolling expects the insomnia market to thrive. He pointed out that in its short time on the market, Lunesta is already getting approximately 15 percent of new insomnia prescriptions, many of which are being taken away from Ambien, he noted.

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Eli Lilly and Co. Eli Lilly and Co. and HistoRx Inc. entered into a collaboration to advance several Lilly pharmaceutical development programs using HistoRx's Aqua platform, an integrated, automated fluorescence-based imaging system that identifies tissue biomarkers. "The information afforded by the Aqua system allows greater insight into the role of protein expression in disease and how it will affect patient stratification and drug targeting, moving us closer to a new era of personalized, molecular medicine," said Robert Curtis, chief executive officer of HistoRx. Financial terms of the agreement were not disclosed.

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Baxter Healthcare Corp. Baxter Healthcare Corp. said the Food and Drug Administration seized approximately 6,000 of its Colleague volumetric infusion pumps and approximately 850 of its Syndeo PCA syringe pumps. Earlier this year, Baxter voluntarily placed shipments of these pumps on hold because of battery problems with the Colleague pumps and, according to Reuters, code and power button issues with the Syndeo pumps. Baxter said the seizure does not affect pumps currently owned by consumers, adding that the company has developed an "aggressive" plan to correct the problems and is discussing the situation with the FDA. Baxter shares closed at $37.42, down $0.69, or 1.8 percent, in heavy trading on the New York Stock Exchange.

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Chiron Corp. Chiron Corp. said three lots of its influenza vaccine, Fluvirin, have been approved by the Food and Drug Administration, bringing the vaccine one step closer to distribution. Chiron must still formulate and test the individual shots to be made from these bulk lots, but the FDA does not need to approve the final product. Chiron was unable to supply flu vaccines last year after British regulators shut down the company's manufacturing plant because of contamination problems, causing a temporary shortage. The FDA has also approved vaccine lots from sanofi pasteur, GlaxoSmithKline Plc and MedImmune Inc., according to Dow Jones Newswires.

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Genentech Inc. Genentech Inc. and Array BioPharma will extend and expand their collaboration for the discovery of targeted small molecule cancer drugs; the original agreement was established in January 2004. Under the revised agreement, Genentech may provide approximately $50 million in research funding to access Array's drug discovery platform throughout the next three years, with Genentech taking sole responsibility for the clinical development and commercialization of any resulting product. In return, Array would be entitled to milestone payments based on selection and progression of drug candidates, as well as royalties on net sales of resulting products. Other terms were not disclosed.

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