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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

Berlex receives FDA approval for Climara Pro patch to prevent postmenopausal bone loss The Food and Drug Administration approved Climara Pro (estradiol/levonorgestrel) transdermal system, the hormone therapy patch made by Schering AG's U.S. affiliate Berlex Inc., for the prevention of postmenopausal osteoporosis.

In 2003, Climara Pro received FDA approval to treat moderate to severe vasomotor symptoms that are related to menopause, such as hot flashes and night sweats. Results from a two-year, double-blind, randomized trial of 150 women indicated that Climara Pro is also safe and effective in the prevention of postmenopausal bone loss as compared with placebo.

Berlex noted that the FDA's approval makes Climara Pro the only combination once-weekly hormone therapy patch approved for both indications.

The therapy is delivered through a thin, translucent patch affixed to the skin and allows for week-long continuous delivery of hormones (estradiol 0.045 mg/day and levonorgestrel 0.015 mg/d).

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Vaprisol approved to treat euvolemic hyponatremia Astellas Pharma US Inc.'s Vaprisol (conivaptan hydrochloride) injection received approval from the Food and Drug Administration to treat euvolemic hyponatremia in patients who are hospitalized.

The FDA also sent an approvable letter for Vaprisol's use as a treatment for hypervolemic hyponatremia. Astellas plans to work with the regulatory agency to obtain approval for this additional indication.

Astellas said Vaprisol is the first drug specifically indicated for treating euvolemic hyponatremia, a potentially fatal condition that is associated with cancer, hypothyroidism and the use of certain drugs. It is characterized by the body's blood sodium level falling significantly below normal because total body water increases. As an arginine vasopressin antagonist, Vaprisol works by promoting "aquaresis," title="branding company" or increasing urine output without the loss of valuable electrolytes such as sodium and potassium.

Indeed, a double-blind, randomized, placebo-controlled trial of patients with mild to moderate euvolemic hyponatremia showed that 40 mg/day of Vaprisol administered for four days corrected the balance of sodium and water in the patients' bodies. Within the first day, the participants also demonstrated significant improvements in serum sodium levels.

In contrast, hypervolemic hyponatremia occurs when a decrease in total body water is accompanied by an even greater decrease in total body sodium.

An estimated 4 percent of hospitalized patients in the United States experience hyponatremia (plasma sodium concentration of less than 135 mmol/L) each year, Astellas said, with some showing no symptoms, but more severe cases possibly resulting in brain swelling, respiratory arrest and death.

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Statins do not appear to greatly reduce cancer risk, death, according to new studies Although previous studies have suggested that statins may reduce the risk of developing cancer, results from two newer studies indicate that statins have little to no effect on the risk of cancer or cancer death.

The first study, which appeared in the Jan. 4 issue of JAMA, consisted of a review of 26 randomized, controlled trials (n=86,936 participants) published through July 2005. All of these studies had an average follow-up of at least one year, enrolled at least 100 patients and reported data on either cancer incidence or cancer death.

The patients were monitored for a period of between 1.9 years and 10.4 years. A total of 6,662 incident cancers and 2,407 deaths from cancer occurred.

Statins did not reduce the incidence of cancer, including any of the prespecified subtypes, or the incidence of cancer deaths. When statins were evaluated by subtype (based on high or low lipophilicity or natural or synthetic origin), there was a null effect on cancer incidence.

In a second study, published in the Jan. 4 edition of the Journal of the National Cancer Institute, 132,136 patients participating in the Cancer Prevention Study II Nutrition Cohort were assessed for statin use and the incidence of colorectal cancer.

During the follow-up that lasted from 1997 to Aug. 31, 2001, 815 incident cases of colorectal cancer were identified.

Current use of cholesterol-lowering drugs and current use of such therapies for five years or more were not associated with the incidence of colorectal cancer.

"However, we cannot rule out a small reduction in risk or an effect associated with only specific types or doses of statins," title="branding company" the authors of the second study wrote.

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Salix's Xifaxan may prevent travelers' diarrhea, new findings show More patients who take Salix Pharmaceuticals Ltd.'s Xifaxan (rifaximin) versus placebo appear to remain free of travelers' diarrhea, according to results from a Phase III study.

In the trial, 106 patients who were traveling to Mexico were given three 200 mg tablet doses of the drug once daily for 14 days, while 104 other travelers were administered placebo. During the 14-day treatment period, researchers measured the relative risk of travelers' diarrhea for those treated with Xifaxan versus patients treated with placebo based on time to first unformed stool. The study was meant to replicate and confirm results of a previous investigator-initiated trial.

Results showed that 84 percent of the patients in the Xifaxan group compared with 50 percent of those in the placebo group remained free from travelers' diarrhea. Salix noted that the difference was highly statistically significant.

Salix said it will conduct a second trial during the first quarter of 2006 to explore Xifaxan as a preventative agent and a viable alternative to systemic antibiotics. Xifaxan is currently approved for the treatment of patients aged 12 years or older with travelers' diarrhea caused by noninvasive strains of Escherichia coli and is licensed from Alfa Wassermann SpA.

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Bayer acquires European business for blood pressure drug from GSK Bayer HealthCare purchased Boehringer Ingelheim GmbH's European telmisartan business, "an excellent strategic fit," from GlaxoSmithKline Plc for an undisclosed amount.

Telmisartan, an angiotensin II receptor blocker that controls blood pressure, had an annual European turnover of approximately $78.6 million in 2005, Bayer said. The drug is marketed on its own or in combination with hydrochlorothiazide. The firm added that drugs in the ARB class have a growth rate of approximately 15 percent.

As a result of this transaction, Bayer will gain marketing rights to the drug in Italy, Spain, France, Greece and Portugal, along with 22 smaller European markets. Under a 2002 co-marketing agreement with Boehringer Ingelheim, Bayer already markets telmisartan as Kinzalmono in certain European markets, such as Germany, Belgium, the Netherlands, Switzerland and Finland.

Boehringer Ingelheim discovered and developed telmisartan, which it markets as Micardis in 84 countries throughout the world, including the United States (co-promoted with Abbott), Japan (in cooperation with Astellas Pharma Inc.) and certain European countries.

In March 1998, Boehringer Ingelheim licensed telmisartan to GSK; a co-marketing agreement between the two companies allows GSK to continue to promote the product as Pritor in five countries.

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Medicare drug benefit may be cheaper option than buying drugs from Canadian pharmacies, AARP concludes A new AARP Bulletin investigation suggests that in some cases, the new Medicare Part D drug benefit may incur lower total prescription costs than importing prescription drugs from Canada.

While taking into account all out-of-pocket costs (premiums, deductibles and copayments), AARP evaluated the total cost of real combinations of drugs taken by Americans when received through the least expensive Medicare drug plans' 90-day mail-order option or from an online Canadian pharmacy.

AARP noted that previous comparison calculations relied on the basic Medicare drug benefit designed by Congress in 2003, but now private plans offer less expensive options in each geographic area.

In one case analyzed by AARP, a woman from California would pay $2,323.68 during the year for her six drugs (five brand-name therapies and one generic) when enrolled in the least expensive Medicare plan in her area. However, using a low-cost Canadian pharmacy to obtain her drugs would cost her almost $1,400 more ($3,718). This is because the least expensive Medicare plan choice in her area offers high monthly premiums, but does not charge a deductible and would give her continuous coverage for all her drugs, AARP noted.

Even if the woman chose a plan that did not fill in the coverage gap, she would still be paying slightly less than the Canadian cost, the report said.

For one woman in Pennsylvania taking three brand-name drugs and one generic, the estimated total annual cost in 2006 under the least costly Medicare drug plan (high monthly premium, no deductible and full coverage in the gap) would be $1,752, which is $582 less than the current annual costs for the same drugs from Canadian pharmacies ($2,334).

There are, however, some cases in which eligible beneficiaries would be better off financially by using Canadian pharmacies instead of a Medicare drug plan, according to AARP.

"The unexpected results of the Bulletin analysis do not apply to everybody, but are widespread enough to underscore the importance of carefully doing the math--especially looking at the copays--when choosing among Medicare plans or comparing them with the cost of drugs from Canada," the AARP Bulletin report said.

AARP noted that every state except Alaska, Hawaii, Maine and New Hampshire offers at least one plan that covers brand-name and generic drugs in the coverage gap. Furthermore, all states have at least five plans that cover only generic drugs in the gap.

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AstraZeneca Plc AstraZeneca Plc and Avanir Pharmaceuticals initiated a Phase I study of AZD2479. The compound is being developed as a reverse cholesterol transport enhancer to treat dyslipidemia. As a result of the Food and Drug Administration's approval of the Investigational New Drug application, AstraZeneca will pay a $5 million milestone payment to Avanir according to terms of the research collaboration and license agreement they entered into in July.

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Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. completed submission of a supplemental Biologics License Application to the Food and Drug Administration regarding Orencia (abatacept). The sBLA involves the licensure of a third-party manufacturing facility "to increase production capacity and meet expected long-term demand" title="branding company" for Orencia, which was recently approved to reduce the signs and symptoms of rheumatoid arthritis.

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Wyeth Pharmaceuticals Wyeth Pharmaceuticals and Trubion Pharmaceuticals Inc. formed an alliance for the discovery, development and commercialization of biopharmaceutical products to treat inflammatory disease and cancer using Trubion's proprietary Small Modular Immunopharmaceutical (SMIP) technology. Wyeth said SMIPs are a class of immunotherapeutics that has enhanced drug properties over monoclonal and recombinant antibodies. Wyeth made an initial payment of $40 million to Trubion through the agreement, and if all milestones are achieved, the total payments to Trubion could exceed $800 million, excluding royalties and co-promotion fees.

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GW Pharmaceuticals Plc GW Pharmaceuticals Plc received permission from the Food and Drug Administration to move forward with Phase III clinical trials on Sativex, a cannabis-derived, oro-mucosal spray composed primarily of tetrahydrocannabinol and cannabidiol, a nonpsychoactive cannabinoid, for the treatment of pain in patients who have advanced cancer and whose pain has not been adequately relieved by opioid drugs. The company said it received written guidance from the FDA to conduct a double-blind, randomized, placebo-controlled study involving 250 patients. A previous Phase III study showed statistically significant improvement in pain relief among patients with advanced cancer through the use of Sativex.

 

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