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BMS warns of blood sugar risks associated with Tequin; drug now contraindicated in patients with diabetes Bristol-Myers Squibb Co. issued a letter to health care providers advising them of labeling changes for the antibiotic Tequin (gatifloxacin), according to the Food and Drug Administration.

Tequin's prescription information is being updated following reports of serious cases of hyperglycemia and hypoglycemia in patients who have been treated with the drug.

The FDA noted that although the drug's warnings section was updated in 2002 to include information about the risks of hyperglycemia and hypoglycemia, the most recent update strengthens these warnings and adds a contraindication for the drug's use in patients with diabetes.

"Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug," the agency noted. "Most of these events were reversible when properly managed, but a few had fatal outcomes."

The updated label also contains information that identifies other risk factors for developing hyperglycemia and hypoglycemia, such as renal insufficiency, advanced age and the concomitant use of Tequin and glucose-altering drugs.

Tequin is indicated to treat bronchitis, pneumonia, uncomplicated gonorrhea and certain types of infections, including those of the kidneys, skin and urinary tract.

The FDA said it will keep monitoring the safety of the drug to make sure it has an acceptable benefit-to-risk ratio.

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BioSante submits NDA for transdermal estrogen gel BioSante Pharmaceuticals Inc. submitted a New Drug Application to the Food and Drug Administration for Bio-E-Gel (estradiol) transdermal gel for the treatment of moderate to severe hot flashes in women experiencing menopause.

The NDA includes data from four clinical trials, including a 12-week Phase III trial that involved 484 symptomatic menopausal women.

The randomized, double-blind study evaluated three dosage levels of Bio-E-Gel to establish the drug's lowest effective dose and optimal safety profile.

By week four, the middle and high doses of Bio-E-Gel yielded significant decreases in the number and severity of hot flashes when compared with placebo. This response was maintained through week 12, BioSante said.

By week five, the lowest dose of the topical gel also resulted in a significant decrease in the number and severity of hot flashes when compared with placebo. As with the higher dosages, this response was also maintained through the 12th week of the study.

"We believe the low dose of Bio-E-Gel, shown to be safe and effective in this trial, also may be the lowest dose of estrogen available on the market to treat hot flashes, if and when approved, and will be an attractive alternative to currently marketed estrogen therapies," said Stephen Simes, chief executive officer of BioSante.

The firm is seeking approval of the gel at all three dosages.

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Dr. Reddy's to acquire betapharm for approximately $570 million Dr. Reddy's Laboratories Ltd. and 3i Group, a private equity and venture capital company, entered into an agreement under which Dr. Reddy's will acquire betapharm Arzneimittel GmbH, which 3i controls, for approximately $570.2 million.

Dr. Reddy's outbid Ranbaxy Laboratories Ltd., India's largest pharmaceutical firm, to acquire betapharm, the fourth-largest generic pharmaceuticals company in Germany. With a focus on long-term therapies that have high prescription rates, betapharm has a market share of approximately 3.5 percent and a portfolio that includes approximately 145 products.

G.V. Prasad, chief executive officer of Dr. Reddy's, told Reuters that the acquisition will immediately increase the company's revenue by approximately $200 million. According to Prasad, the betapharm purchase will be financed through cash reserves and debt. He also noted that Dr. Reddy's may consider acquiring other European pharmaceutical concerns.

Dr. Reddy's conducts research in the areas of cancer, diabetes and cardiovascular, infectious and inflammatory diseases and markets its products worldwide, principally in India, the United States, Europe and Russia.

Additional financial terms of the agreement were not disclosed. The transaction is expected to be finalized the first week of March.

Dr. Reddy's shares closed at $27.80, up $1.45, or 5.5 percent, in heavy trading on the New York Stock Exchange.

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Sanofi-aventis' Acomplia yields modest but sustained weight loss in Phase III clinical trial Treatment with sanofi-aventis Group's obesity drug, Acomplia (rimonabant), a selective cannabinoid-1 receptor blocker, resulted in modest, but sustained, weight loss and favorable changes in cardiometabolic risk factors among patients in a Phase III trial.

In the double-blind, parallel-group study, 3,045 obese or overweight patients with hypertension or dyslipidemia were randomized to receive Acomplia 20 mg/day, Acomplia 5 mg/d or placebo for one year. Patients who received Acomplia were rerandomized to receive placebo or the same Acomplia dosage for the second year; those who received placebo continued to receive placebo. In addition, the patients were asked to reduce their caloric intake by approximately 600 kcal/d and to increase their physical activity.

Patients treated with Acomplia 20 mg during both years of the study experienced greater mean reductions in weight, waist circumference and triglyceride levels, along with a greater increase in HDL cholesterol levels, as compared with the placebo group.

Moreover, the trial investigators said the changes in HDL cholesterol and triglyceride levels were approximately double what would be expected from the achieved weight loss alone.

Patients who were switched from Acomplia 20 mg to placebo after year one gained back a "substantial amount" of the weight they had lost. Those continuing on Acomplia 20 mg during year two maintained their weight loss and favorable changes in cardiometabolic risk factors.

Acomplia was generally well tolerated; however, 11.2 percent of patients who received the 20 mg dosage experienced nausea compared with 5.8 percent of patients who received placebo.

The researchers said the trial was limited by a high dropout rate--approximately 50 percent among all treatment groups--and noted that further analysis is required to evaluate the drug's long-term effects.

The results of the trial were published in the Feb. 15 issue of JAMA.

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Prestwick's tetrabenazine shows some benefit in patients with Huntington's disease in new trial Titrated doses of up to 100 mg/day of Prestwick Pharmaceuticals Inc.'s tetrabenazine reduced symptoms of chorea and improved global outcome scores among patients with Huntington's disease in a Phase III study.

Ambulatory patients who had Huntington's disease and chorea were randomized to receive tetrabenazine (n=54) or placebo (n=30) for 12 weeks. During the first seven weeks, doses of tetrabenazine were titrated up to 100 mg/d until the desired antichoreic effect or intolerable adverse effects occurred. Patients remained on their optimal dose during the final five weeks unless intolerable adverse effects forced a dose reduction.

Between weeks nine and 12, the reduction in chorea severity was greater with tetrabenazine than with placebo (-5 units vs. -1.5 units on the Unified Huntington's Disease Rating Scale [UHDRS]). The effect was not related to age, sex of patient, sex of affected parent, baseline chorea score or baseline Clinical Global Impression (CGI) of severity.

The proportion of patients who achieved at least minimal global improvement on the CGI, defined as a score of three or less, was also greater with tetrabenazine than with placebo (69 percent vs. 24 percent).

On other measures, however, the tetrabenazine group did not show greater benefit. The trial investigators observed a trend toward an improvement on the UHDRS total motor score with tetrabenazine, but the improvement did not reach statistical significance. Further, the active drug had a negative impact on results for the UHDRS Functional Checklist and on Stroop word reading.

When treatment was stopped at the end of the study, chorea seemed to worsen in patients who had been treated with tetrabenazine when compared with those in the placebo group.

Overall, five withdrawals and five serious adverse events occurred in the tetrabenazine arm compared with one withdrawal and no serious adverse events in the placebo group.

These results appear in the Feb. 14 issue of Neurology.

Prestwick hopes to market tetrabenazine under the brand name Xenazine. The Food and Drug Administration is currently conducting a priority review of a New Drug Application for the product in Huntington's disease-associated chorea.

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Biogen Idec reports strong Q4, full-year results Biogen Idec Inc.'s 2005 fourth-quarter net income almost doubled from the previous year's same period as the firm benefited from drug sales led by multiple sclerosis treatment Avonex (interferon beta-1a).

Biogen Idec earned $55.6 million, or $0.16 per diluted share, in the fourth quarter of 2005 compared with $28.7 million, or $0.08 per diluted share, in the fourth quarter of 2004.

On an adjusted basis, the company earned $0.48 per share, which beat analysts' average expectations by $0.01, according to Reuters Estimates.

The firm reported fourth-quarter revenue of $632.9 million in 2005, an increase of 8 percent from 2004's fourth-quarter revenue of $587.8 million.

Biogen Idec attributed the increased revenue to higher sales of Avonex and to increased revenue received from its joint business venture with Genentech Inc. for Rituxan (rituximab), a treatment for certain types of B-cell Hodgkin's lymphoma. Avonex sales increased 12 percent from 2004's fourth quarter to $413 million in the fourth quarter of 2005, while revenue received from the Rituxan business arrangement was up 6 percent to $182 million.

For the full year, Biogen Idec reported net income of $160.7 million, or $0.47 per diluted share, in 2005 compared with $25.1 million, or $0.07 per diluted share, in 2004.

Full-year revenue rose from $2.21 billion in 2004 to $2.42 billion in 2005.

For 2006, Biogen Idec expects adjusted earnings per share of $1.95 to $2.10.

Biogen Idec also said it expects the Food and Drug Administration to make a decision on its supplemental Biologics License Application for Tysabri (natalizumab), which the company co-promotes with Elan Corp. Plc, by late March. An FDA advisory committee is scheduled to review the application on March 7; earlier this week, the agency lifted its clinical hold on the drug for treating MS.

Biogen Idec shares closed at $47.33, up $1.61, or 3.5 percent, in heavy trading on the Nasdaq.

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Merck & Co. Inc. Merck & Co. Inc. initiated Phase I clinical studies of NGD-8243, a potential treatment for pain. The drug is being developed through an alliance between Merck and Neurogen Corp. Merck agreed to pay Neurogen $2 million as a milestone payment upon the initiation of these trials. The two companies are collaborating on next-generation oral therapies that target the type 1 vanilloid receptor, which plays a role in how the central nervous system processes certain types of pain signals. In the randomized, double-blind, placebo-controlled study Merck is conducting in Europe, researchers will evaluate the safety and pharmacokinetics of single ascending oral doses of NGD-8243 in healthy subjects.

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Novartis AG Novartis AG licensed global rights from Kyorin Pharmaceutical Co. Ltd. to develop and market KRP-203, an immunosuppressant agent. Under the agreement, Novartis will develop and commercialize the drug worldwide for use in organ transplantation. The agreement also gives Novartis the right to develop and market the drug worldwide for other indications, except for inflammatory bowel disease and related diseases, and excluding Japan, the Republic of Korea, China and Taiwan. In exchange, Kyorin will receive an undisclosed payment up front, as well as milestone payments and royalties.

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Bayer Pharmaceuticals Corp. Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. initiated a Phase III clinical trial for Nexavar (sorafenib), an investigational treatment for non-small cell lung cancer. The trial will evaluate Nexavar in combination with chemotherapeutic agents carboplatin and paclitaxel versus the chemotherapy alone. The companies expect to enroll approximately 900 patients in the trial, which will assess overall survival, progression-free survival, tumor response and safety. Nexavar is an oral multikinase inhibitor that targets both the tumor cell and the tumor vasculature. The drug is currently approved for treating advanced kidney cancer and is being tested in other trials for liver and skin cancers.

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King Pharmaceuticals Inc. King Pharmaceuticals Inc. and Pain Therapeutics Inc. are beginning a pivotal Phase III trial for Remoxy, a long-acting, abuse-resistant formulation of oxycodone. The firms intend to enroll 400 patients with moderate to severe osteoarthritic pain in the double-blind trial. Patients will be titrated and then randomized to receive a daily dosage of 10 mg to 80 mg of Remoxy or placebo for 12 weeks. The trial's primary endpoint is reduction in pain scores during three months compared with baseline.