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Merck's Q1 earnings increase on strong drug sales Merck & Co. Inc.'s first-quarter net income rose 11 percent from the previous year's same period on sales that increased 1 percent.

The firm earned $1.52 billion, or $0.69 per diluted share, in the first quarter of 2006 compared with $1.37 billion, or $0.62 per diluted share, in the first quarter of 2005.

Excluding restructuring charges, Merck earned $0.78 per share, which beat the average analyst forecast of $0.73, according to Reuters Estimates. First-quarter sales increased from $5.36 billion in 2005 to $5.41 billion in 2006, led by strong performances of cholesterol-lowering drug Zocor (simvastatin) and asthma and allergy treatment Singulair (montelukast sodium).

In the United States, Zocor sales increased 13 percent from 2005's first quarter, but globally, the drug's sales fell 4 percent to $1.1 billion.

Singulair sales increased 17 percent in the United States and 9 percent worldwide, reaching $801 million for the first quarter of 2006.

For the full year, Merck expects to report earnings per share of $2.02 to $2.16 and adjusted earnings per share of $2.32 to $2.40.

Merck shares closed at $35.00, up $0.60, or 1.7 percent, in moderate trading on the New York Stock Exchange.

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FDA to review Novartis' NDA for aliskiren as potential treatment for hypertension Novartis Pharmaceuticals Corp.'s New Drug Application for aliskiren as a treatment for hypertension has been accepted for review by the Food and Drug Administration.

Novartis is seeking approval of the drug, which has the proposed brand name of Rasilez, as a monotherapy and in combination with other treatments for hypertension.

"As a renin inhibitor, Rasilez would represent the first new treatment approach for people with high blood pressure in more than a decade," Novartis said.

The NDA includes data from 34 trials that involved more than 6,000 patients. In the trials, aliskiren monotherapy produced significant reductions in blood pressure, which were sustained during 24 hours. When the drug was used in combination with ACE inhibitors, diuretics or calcium channel blockers, it caused additional reductions in blood pressure, Novartis said.

"This innovative medicine has the potential to redefine future treatment standards, and studies are now under way to evaluate potential long-term benefits beyond blood pressure control," said Dr. James Shannon, head of development at Novartis Pharma AG.

Speedel Pharmaceuticals Inc. licensed aliskiren from Novartis in 1999 and developed the drug through Phase II trials. In 2002, Novartis exercised its license-back option.

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Roche files BLA for investigational anemia agent CERA Roche submitted a Biologics License Application to the Food and Drug Administration to market its continuous erythropoietin receptor activator, CERA, as a treatment for anemia associated with chronic kidney disease in patients who are on dialysis and those who are not.

According to Roche, CERA is the first and only drug in this class. The company said CERA's activity is different from that of erythropoietin at receptor sites that play a role in stimulating red blood cell production, and this "distinct molecular interaction" may help provide targeted, stable and sustained control of anemia.

Roche noted that CERA is the only anemia drug that has been studied at extended dosing intervals up to once every four weeks for its initial filing.

"CERA's unique ability to provide up to once-monthly dosing may potentially offer a convenient and efficacious treatment option for patients with anemia in all stages of chronic kidney disease," said Richard Hinson, vice president of operations at Roche.

The BLA is based on a program that included 10 clinical trials involving more than 2,700 patients and includes results from six Phase III trials in which CERA was administered both intravenously and subcutaneously.

Four of the six Phase III trials were maintenance studies conducted in patients on dialysis and on stable maintenance treatment of anemia with Amgen Inc.'s Epogen (epoetin alfa) or Aranesp (darbepoetin alfa). Patients were randomized to continue with their usual treatment or to switch to CERA, which was administered once every two or four weeks.

The other two Phase III trials, which Roche recently completed, were correction studies in patients with CKD.

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FDA issues nonapprovable letter to PhotoCure for Hexvix to detect bladder cancer PhotoCure ASA, a Norwegian company, received a nonapprovable letter from the Food and Drug Administration regarding a New Drug Application for Hexvix (hexaminolevulinate), a diagnostic imaging product developed to detect bladder cancer.

The FDA requested "additional analyses and information." PhotoCure said it plans to meet with the agency to clarify what it must do to move forward with the approval process.

PhotoCure is conducting a Phase III study in Europe and the United States. Data from this study were not included in the initial NDA. The study is expected to conclude in 2007 and "may provide useful supplementary clinical data," according to the company.

Based on photodynamic technology, Hexvix combines hexaminolevulinate, which is a photosensitizing drug, with a light source that activates the drug to aid in detection of the disease. It has been approved for this indication in 27 European countries.

"Hexvix Imaging is an innovative and effective diagnostic method that can be used for all types of bladder cancer," PhotoCure said, adding that it is especially useful in diagnosing carcinoma in situ, a malignant form of the disease that can be difficult to detect using standard methods.

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Lilly's results increase in Q1 Eli Lilly and Co. reported positive results for the first quarter of 2006, with a 13 percent increase in net income from the first quarter of 2005.

Net income for the first quarter of 2006 was $834.8 million, or $0.77 per diluted share, compared with $736.6 million, or $0.68 per diluted share, in the first quarter of last year. Analysts with Reuters Estimates had forecast 2006 first-quarter earnings per share of $0.75.

Net sales increased by 6 percent to $3.71 billion in the first quarter compared with $3.5 billion in the corresponding quarter of 2005.

Global sales of the antipsychotic Zyprexa (olanzapine) dropped 3 percent from the first quarter of 2005, to $1 billion. The company noted that lower demand and higher prices affected U.S. sales, while the impact of foreign exchange rates negatively affected international sales.

Lilly's treatment for major depressive disorder and diabetic peripheral neuropathic pain, Cymbalta (duloxetine hydrochloride), which was launched in the third quarter of 2004, achieved worldwide sales of $233.3 million, reflecting an increase of 118 percent compared with the previous year's first quarter. The company plans to seek an additional approval later this year to market Cymbalta as a treatment for general anxiety.

For the second quarter of 2006, Lilly expects earnings per share of $0.74 to $0.76. Reuters Estimates said the average second-quarter forecast by analysts is $0.77 per share.

For the full year, Lilly expects earnings per share of $3.10 to $3.20 and sales growth of 7 percent to 9 percent.

Additionally, the Food and Drug Administration granted priority review to the company's New Drug Application for ruboxistaurin mesylate for the treatment of diabetic retinopathy. The proposed brand name for the drug is Arxxant.

Lilly shares closed at $53.62, down $1.03, or 1.9 percent, in heavy trading on the New York Stock Exchange.

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Schering-Plough posts strong Q1 results Schering-Plough Corp.'s first-quarter net income nearly tripled in 2006 compared with the same period in 2005.

For the first quarter, the firm earned $372 million, or $0.24 per diluted share, compared with $127 million, or $0.07 per share, in 2005.

Excluding accounting-related gains, Schering-Plough earned $0.22 per share, which still beat the average analyst forecast of $0.14, according to Reuters Estimates.

First-quarter net sales were $2.55 billion compared with $2.37 billion in 2005.

The firm's pharmaceuticals division had sales of $2.03 billion in the first quarter of 2006, representing a 10 percent increase over the $1.85 billion sold in the previous year's first quarter.

Leading the growth in sales was Remicade (infliximab), a treatment for immune-mediated inflammatory disorders that recorded sales of $278 million. Centocor Inc. markets the drug in the United States, and Schering-Plough markets it in most other countries.

Nasonex (mometasone furoate monohydrate), a nasal spray for allergies, and Temodar (temozolomide), a treatment for brain cancer, were also cited as strong performers for the quarter, with sales of $229 million and $163 million, respectively.

Schering-Plough shares closed at $19.40, up $0.51, or 2.7 percent, in heavy trading on the New York Stock Exchange.

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Food and Drug Administration The Food and Drug Administration will incorporate a standard computerized medical vocabulary system to make sharing drug information easier for health care professionals. The move is intended to advance the government's effort to create electronic health records. According to the FDA, the Systematized Nomenclature of Medicine, or SNOMED, will electronically code important terms in prescription drug labels and will "improve the domestic exchange of product information in FDA-approved package inserts."

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Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services said more than 30 million Medicare beneficiaries are now receiving Medicare prescription drug coverage. "With a month to go, we've passed our projections of 28 [million] to 30 million enrollees in the first year, and we are intensifying our local outreach efforts to get more seniors signed up before the May 15 deadline," said Mike Leavitt, secretary of the U.S. Department of Health and Human Services. During March, more than 93 million prescriptions were filled for these beneficiaries, CMS said, noting that this averages 3 million prescriptions filled each day.

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Serono SA Serono SA reported strong 2006 first-quarter results. Net income for the quarter was $180 million, or $0.30 per diluted American Depositary Share (ADS), compared with a loss of $567.2 million, or $0.97 per diluted ADS, in the first quarter of 2005. Total revenue increased 11 percent to $667.5 million from $601.4 million in the same quarter of 2005. Product sales were up 7.9 percent to $594.9 million from $551.4 million in the first quarter of 2005. The company noted that sales of Rebif (interferon beta-1a), a treatment for multiple sclerosis co-marketed with Pfizer Inc., contributed to its strong first-quarter results; worldwide sales of Rebif increased to $327 million from $292.8 million in the previous year's first quarter. Serono shares closed at $16.32, up $0.02, or 0.1 percent, in moderate trading on the New York Stock Exchange.

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Mission Pharmacal Co. Mission Pharmacal Co. acquired from Presutti Laboratories LLC the rights to manufacture and commercialize Tindamax (tinidazole) tablets in the United States. The drug is indicated to treat trichomoniasis, giardiasis, intestinal amebiasis and amebic liver abscess. Trichomoniasis is the most common curable nonviral sexually transmitted disease in the United States, according to the Centers for Disease Control and Prevention. "This acquisition strengthens our portfolio of prescription brands with an effective, well-tolerated and easily dosed therapy that will play a key role in the control of potentially serious conditions such as trichomoniasis, which can increase susceptibility to and transmission of HIV," said Neill Walsdorf Jr., president of Mission Pharmacal.