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FDA expands indication of Novo Nordisk's diabetes therapy to include children Novo Nordisk Inc.'s supplemental New Drug Application for NovoLog (insulin aspart [rDNA origin]) injection to treat diabetes in children was approved by the Food and Drug Administration.

NovoLog, a rapid-acting insulin analog that can be taken immediately before meals, was found to be safe and effective in patients aged 2 to 18 years who have diabetes, according to Novo Nordisk.

"Approximately one in every 400 to 500 children and adolescents has type 1 diabetes," said Dr. Peter Aurup, the firm's vice president of clinical development, medical and regulatory affairs.

NovoLog was approved in the United States in 2000 for use by adults; it can be used in insulin pumps and is also available in prefilled NovoLog FlexPens. The latest approval was granted approximately four months before the agency's review deadline.

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FDA approves Abbott's new stent, embolic protection system for patients at risk for stroke Abbott received approval from the Food and Drug Administration for its minimally invasive Xact carotid stent for the treatment of carotid artery disease. Additionally, the FDA issued 510(k) clearance for Abbott's Emboshield Embolic Protection System to treat patients at risk for stroke who are not favorable candidates for surgery.

The Xact approval makes Abbott the second company to enter the U.S. carotid stent market, after Guidant Corp. According to Abbott, the self-expanding Xact stent has a closed-cell design that forms a tightly knit, flexible mesh. In doing so, the stent can help restore the inner diameters of diseased carotid arteries, promote smooth inner vessel surfaces and potentially reduce the release of emboli from diseased vessels during treatment, which can lead to stroke.

The Xact stent is designed for use with the Emboshield product, which uses proprietary Barewire technology to enable better control of stent placement. The Emboshield filter is intended to snare emboli that become detached during the stent procedure.

"Some patients may stand to benefit more from a minimally invasive procedure with a carotid artery stent and embolic protection that avoids the risk associated with general anesthesia, eliminates the risk of cranial nerve injury and neck scarring," said Dr. Gary Roubin of Lenox Hill Hospital in New York. "The Xact carotid stent and Emboshield Embolic Protection System provide a truly advanced, minimally invasive treatment alternative for these patients."

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Salvat's NDA for swimmer's ear treatment accepted by FDA Salvat's New Drug Application for Cetraxal Otic (ciprofloxacin) 0.2% solution, a drug developed to treat external otitis, or swimmer's ear, was accepted for review by the Food and Drug Administration.

If approved, Cetraxal Otic will be the only solution indicated for this condition that contains ciprofloxacin alone, Salvat said, noting that the drug provides "high efficacy and more convenience without the risk of steroids, aminoglycosides and preservatives."

Unnecessary ingredients can lead to adverse events, the company explained, especially in the pediatric population. Cetraxal Otic will be marketed in convenient, single-dispensing containers.

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Advancis to conduct additional Phase III noninferiority trial of Amoxicillin PULSYS drug candidate Advancis Pharmaceutical Corp. will conduct a new Phase III trial for Amoxicillin PULSYS in adults and adolescents with pharyngitis/tonsillitis resulting from Group A strep infections.

Upon extensive examination of data from earlier, unsuccessful trials, Advancis decided to extend the length of treatment with the drug from seven days to 10 days in the new trial.

"As a result of what we learned from our prior trials, we believe that our current once-a-day formulation dosed for 10 days has the potential to provide the efficacy required for product approval," said Edward Rudnic, the company's chief executive officer. "In addition, we believe this therapy may yield eradication rates that are competitive with the most efficacious treatments for strep throat."

Advancis plans to design the upcoming trial as a 600-patient, double-blind, double-dummy, noninferiority trial, with enrollment and initiation beginning as early as November. The company said it has the resources to fund the trial through its completion and the research operation into early 2007.

In August, Advancis and Par Pharmaceutical Cos. Inc. terminated their partnership agreement after Amoxicillin PULSYS failed to attain the desired microbiological and clinical endpoints in Phase III clinical trials. The partnership was established in 2004 with the goal of developing and marketing a novel formulation of the antibiotic amoxicillin, according to Par.

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Combination therapy with Imitrex, naproxen sodium may treat acute migraines more effectively than either drug as monotherapy New data suggest that the combination of GlaxoSmithKline Plc's Imitrex (sumatriptan) and naproxen sodium may offer a more effective treatment for acute migraines than does either drug alone.

As part of a double-blind, double-dummy study, researchers randomized 972 migraineurs to receive placebo (n=241), naproxen sodium 500 mg (n=250), Imitrex 50 mg (encapsulated; n=229) or Imitrex 50 mg plus naproxen sodium 500 mg (n=251). Participants were instructed to treat one migraine of moderate or severe intensity.

The primary endpoint of the study was a sustained pain response, defined as pain no greater than mild at two hours, no use of rescue medication for 24 hours and no recurrence of moderate or severe pain for 24 hours postdose.

In the combined treatment group, 46 percent achieved the primary endpoint compared with 29 percent in the Imitrex group, 25 percent in the naproxen sodium group and 17 percent in the placebo group.

Additionally, a two-hour headache response was achieved by 65 percent of the combined therapy group, 49 percent of the Imitrex group, 46 percent of the naproxen sodium group and 27 percent of the placebo group.

Similar results were observed for a pain-free response at two hours and a sustained pain-free response at 24 hours.

Moreover, recurrent headache occurred less often in the combination therapy group (29 percent) than the other three groups (Imitrex, 41 percent; naproxen sodium, 47 percent; placebo, 38 percent). The authors noted that the low rate of recurrence in the placebo group "was likely due to the relatively small number of responders" in this group.

At two hours postdose, combination therapy also significantly reduced the incidence of photophobia and phonophobia as compared with placebo, Imitrex 50 mg and naproxen sodium 500 mg. The incidence of nausea was significantly lower in the combination therapy group as compared with the placebo and Imitrex 50 mg groups, but the difference between the combination therapy group and the naproxen sodium group was not significant.

The authors conceded that the use of encapsulated Imitrex (for blinding purposes) may have reduced the efficacy of both the Imitrex 50 mg arm and the combination therapy arm. As a result, they called for future research to evaluate the effects of combination therapy without encapsulating Imitrex "to better define the onset of efficacy of multimechanism therapy utilizing triptans and anti-inflammatory drugs in the acute treatment of migraine."

The study appeared in the September issue of the journal Headache.

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Risk of death inversely related to receipt of medication in patients with heart failure, study shows Patients who have heart failure and who are at the greatest risk of death are the least likely to receive proper prescriptions for their condition, according to data from a study published in the Sept. 14 issue of JAMA.

Researchers assessed 1,418 patients from the EFFECT study who had documented left ventricular ejection fraction of 40 percent or less and a low-, average- or high-predicted risk of death within one year. Their intent was to investigate patterns of drug therapy and underlying mortality risk in patients with heart failure. They evaluated the rates of drug administration for ACE inhibitors, angiotensin II receptor blockers and beta-adrenoreceptor antagonists, according to predicted baseline risk of death.

Compared with those at low risk, patients at medium and high risk for death were consistently and significantly less likely to receive prescriptions for any of the three types of treatments. This pattern was present immediately after discharge from the hospital and persisted for up to one year.

Controlling for differences in survival time and potential drug contraindications, low-risk patients were 1.61 times as likely to receive ACE inhibitors or ARBs as compared with high-risk patients, and 1.8 times as likely to receive beta-adrenoreceptor antagonists.

"[T]he predicted and observed risks of death in patients with heart failure were inversely associated with discharge and postdischarge administration of potentially life-saving drug therapies," the researchers summarized.

"Further study is needed to quantify the adverse consequences attributable to the mismatch between risk and treatment rates," they recommended, adding that such additional study could also "identify potential solutions to correct this undesirable phenomenon."

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Merck & Co. Inc. Merck & Co. Inc. and FoxHollow Technologies Inc. entered into a research collaboration in which Merck will have access to atherosclerotic plaque samples provided by FoxHollow from patients with cardiovascular disease who were treated with the SilverHawk Plaque Excision System. Merck will analyze the samples to identify biomarkers and profiling compounds. Under the agreement, Merck will initially pay FoxHollow $9 million in cash for the first year and up to $31 million if it chooses to continue the collaboration for another two years. Merck will also make milestone and royalty payments as FoxHollow achieves certain program objectives. "Our collaboration with FoxHollow has the potential to provide insight on cardiovascular disease and to accelerate development of novel drugs for this widespread health issue," said Dr. Richard Pasternak, vice president of clinical research at Merck.

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AstraZeneca Plc AstraZeneca Plc appointed Tony Zook, the company's senior vice president of U.S. commercial operations, to be executive vice president for North America. Zook will also assume the roles of president and chief executive officer of AstraZeneca U.S. and will succeed David Brennan, who was named in July to become chief executive of AstraZeneca Plc when Sir Tom McKillop retires at the end of the year.

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Novartis AG Novartis AG acquired exclusive worldwide rights to NM100060, a nail lacquer intended to treat onychomycosis, or nail fungus, from NexMed Inc. NexMed expects to receive as much as $51 million in up-front and milestone payments, including a $4 million initial cash payment when the agreement is signed. NexMed could also receive royalty payments. NM100060 combines the active ingredient in Novartis' antifungal drug Lamisil (terbinafine) with NexACT penetration enhancers and is currently in Phase I development.

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UCB Pharma Inc. UCB Pharma Inc. said a Phase III trial that compared antiepileptic drug Keppra (levetiracetam) with sustained-release carbamazepine in patients newly diagnosed with epilepsy with partial or generalized tonic-clonic seizures met its primary endpoint of noninferiority. The company will review trial data with the Food and Drug Administration and plans to file a marketing authorization application with the European Medicines Agency for use of Keppra as monotherapy in patients with epilepsy. The drug is already approved in the United States as adjunctive therapy to treat partial onset seizures in adults and children aged 4 years or older who have epilepsy. UCB hopes to gain EMEA approval by the end of 2006.

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