Drug Branding

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FDA APPROVES ACCESS' ORADISC A CANKER SORE TREATMENT ___________________________________________________________________________ The Food and Drug Administration approved Access Pharmaceuticals Inc.'s New Drug Application for OraDisc A, an improved delivery system for amlexanox, which has previously been approved for treating canker sores.

Receipt of the approval permits the patch to be used for treating aphthous ulcers with amlexanox 2 mg in adults and adolescents aged 12 years or older with a normal immune system, the company said. The OraDisc A technology is a proprietary, mucoadhesive patch that gradually erodes and releases the active ingredient when applied inside of the mouth.

In its clinical program examining the safety and efficacy of OraDisc A, Access included pediatric patients aged 12 years or older in the trials. Such an inclusion permitted the company to expand the indication to adolescents aged 12 to 17 years of age, which is considered an important patient group for this indication.

Access' Chief Executive Kerry Gray said that the approval of the OraDisc A technology is a "landmark accomplishment" because the product was approved just four years after its conception.

"The approval of OraDisc A represents an important event for potential strategic partners," Gray noted.

CHIRON, GEN-PROBE SUBMIT BLA FOR PROCLEIX ULTRIO BLOOD SCREENING ASSAY ___________________________________________________________________________ Chiron Corp. and Gen-Probe Inc. submitted a Biologics License to the Food and Drug Administration for the Procleix Ultrio blood-screening assay.

The system is intended to simultaneously detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissue. Chiron and Gen-Probe are seeking approval to run the test on both the semi-automated Procleix System and on the fully automated Procleix Tigris system, according to a Chiron press release.

"Submitting the BLA for the Procleix Ultrio assay on time is another important milestone in our efforts to help safeguard the U.S. blood supply with the most sensitive nucleic acid testing technologies and the most sophisticated instrument platforms," said Henry Nordhoff, Gen-Probe's chief executive.

Chiron noted that approval of the Tigris system for the Procleix Ultrio assay would permit individual donor testing for HBV, which, in turn, could reduce the window period between infection and detection of hepatitis B by as much as 40 percent as compared with currently available tests.

LESCOL MAY LOWER RISK OF MAJOR CARDIAC EVENTS AFTER PERCUTANEOUS CORONARY INTERVENTION, RESEARCHERS SUGGEST ___________________________________________________________________________ Patients with unstable or stable angina following a first percutaneous coronary intervention may benefit from Novartis AG's Lescol (fluvastatin sodium) treatment, according to new evidence.

Investigators conducted a prespecified subgroup analysis from the Lescol Intervention Prevention Study (LIPS), in which 824 patients had unstable angina following percutaneous coronary intervention and 834 had stable angina. Within the unstable angina group, 417 were randomized to Lescol and 407 were assigned to placebo. In the stable angina group, 418 received Lescol and 416 received placebo. Median follow-up was 3.9 years.

Compared with placebo, Lescol lowered the risk of major adverse cardiac event by 28 percent among patients with unstable angina. The analysis revealed no difference between patients with stable or unstable angina.

Lescol also reduced coronary atherosclerotic events (major events excluding restenosis) by 36 percent in the unstable angina group and by 31 percent in the stable angina group.

Results also showed similar reductions in total cholesterol and LDL cholesterol with Lescol treatment among patients with stable or unstable angina.

The study was published in the October edition of Heart.

MEDICARE SPENDING ON DRUGS GREW BY ALMOST 72 PERCENT FROM 1997 TO 2001, NEW ANALYSIS REVEALS ___________________________________________________________________________ Between 1997 and 2001, outpatient drug spending by Medicare beneficiaries rose by approximately 72 percent, according to a new report. The elevated spending was mainly due to increased use of certain therapeutic drug classes.

Using data from the Medical Expenditure Panel Survey Household Component for 1997 and 2001, researchers estimated average annual drug use and spending among noninstitutionalized Medicare beneficiaries.

Aggregate drug spending increased 71.6 percent from $31.5 billion in 1997 to $54 billion in 2001. According to the results, the growth was driven by a 9.9 percent increase in the population with use, a 23.6 percent increase in prescriptions per user and a 26.3 percent rise in the average prescription price.

The analysis of spending patterns by treatment category showed great variation. Spending on cardiovascular drugs topped any other therapeutic class for both comparison years. During the study period, cardiovascular drug spending rose 55 percent due to a 21 percent increase in the population with use, a 15 percent increase in prescriptions per user and an 11 percent increase in the price per prescription, which was small because the number of generic prescriptions also rose.

Within this therapeutic category, antihyperlipidemic drugs appeared to be the most rapidly growing subclass, followed by ACE inhibitors, beta-blockers and antihypertensive combinations.

Spending for hormone therapies, which more than doubled during the study period, ranked second and spending for gastrointestinal agents ranked third. The analysis also revealed a large shift between GI subclasses; spending on proton-pump inhibitors rose by 175.5 percent, while spending on histamine-2 antagonists did not grow. Furthermore, there was a rise in the number of beneficiaries using PPIs while users of histamine-2 antagonists fell.

The researchers concluded that the study "points to the need for more information on the relative cost-effectiveness of drugs within clinically significant therapeutic categories."

They added, "Such information should be readily available to both consumers and physicians."

The study was published in the September/October issue of Health Affairs.

NEW MODEL ESTIMATES HIGHER COSTS WITH ZYPREXA VERSUS RISPERDAL FOR TREATMENT OF SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS ___________________________________________________________________________ Among patients with chronic schizophrenia or schizoaffective disorders, treatment with Johnson & Johnson's Risperdal (risperidone) may result in a lower discontinuation rate and medical costs than treatment with Eli Lilly and Co.'s Zyprexa (olanzapine), a new study shows.

Researchers developed a Markov model to estimate the outcomes and costs when patients with chronic schizophrenia or schizoaffective disorders were treated with either Risperdal or Zyprexa for one year.

The incidence of extrapyramidal symptoms and symptomatic prolactin-related disorders was slightly higher for Risperdal compared with Zyprexa, according to the model. However, the incidence of diabetes was slightly higher among Zyprexa users.

More patients (25 percent) in the Zyprexa group were projected to experience an increase in body weight (7 percent or more) compared with patients in the Risperdal group (4 percent).

At the end of one year, 76.9 percent of patients remained on initial Risperdal therapy while 45.6 percent of patients remained on initial Zyprexa therapy.

Overall mean costs of care were higher for Zyprexa ($2,316 per month) than for Risperdal ($2,163 per month).

Complete study details appeared in the September/October issue of Value in Health.

POOLED DATA ANALYSIS REVEALS COST-EFFECTIVENESS OF EXTENDED-RELEASE EFFEXOR ___________________________________________________________________________ Outpatient treatment of major depressive disorder with extended-release (ER) Wyeth's Effexor (venlafaxine hydrochloride) may be cost-effective as compared with selective serotonin reuptake inhibitors, new evidence shows.

Researchers retrospectively assessed pooled data from eight randomized, double-blind trials. The studies, lasting eight weeks each, included 851 patients treated with Effexor or Effexor ER for major depressive disorder and 748 patients treated with Eli Lilly & Co.'s Prozac (fluoxetine hydrochloride), GlaxoSmithKline Plc's Paxil (paroxetine hydrochloride) or Solvay Pharma Inc.'s Luvox (fluvoxamine maleate). The remaining four studies included 446 patients treated with placebo. A decision modeling method was used to identify the cost and effectiveness ratios.

Results of the analysis showed a higher number of depression-free days for the Effexor ER group (22.8 days) versus the SSRI group (18.6 days). The decision model also indicated that 22.06 productive days and between 4.56 and 9.36 quality-adjusted days would be achieved in the Effexor group compared with the anticipated 19.34 days and between 3.72 to 7.63 days, respectively, in the SSRI group. Approximately 26 percent of patients were expected to achieve full activity in the Effexor group compared with 19.6 percent in the SSRI group.

Use of Effexor was expected to yield a cost of $1,303.94 per patient achieving remission of symptoms versus a cost of $1,514.96 per SSRI-treated patient achieving symptom remission. The cost per depression-free day was also lower in the Effexor group compared with the SSRI group.

The research results can be found in the October edition of the Journal of Clinical Psychopharmacology.

Drug Branding
OSI PHARMACEUTICALS INC. ___________________________________________________________________________ OSI Pharmaceuticals Inc., Genentech Inc. and F. Hoffman-La Roche Ltd.'s New Drug Application for Tarceva (erlotinib hydrochloride) was accepted for priority review by the Food and Drug Administration. The treatment is being investigated as a monotherapy for patients with advanced non-small-cell lung cancer for whom chemotherapy has previously failed. The regulatory agency established an action date of Jan. 30, 2005, for the NDA.

Drug Branding
GILEAD SCIENCES INC. ___________________________________________________________________________ Gilead Sciences Inc. and Genelabs Technologies Inc. entered an agreement to collaborate on the research, development and commercialization of novel compounds for treating infection caused by the hepatitis C virus (HCV). Genelabs will lead all research initiatives associated with the agreement, while Gilead will head the development and marketing efforts for novel nucleoside inhibitors of HCV polymerase. Gilead will pay $8 million up front and could pay Genelabs up to $38 million for each compound developed in the collaboration, the companies said.

Drug Branding
MIRAVANT MEDICAL TECHNOLOGIES ___________________________________________________________________________ Miravant Medical Technologies received an approvable letter from the Food and Drug Administration for its proprietary therapy SnET2 PDT, a drug-and-light procedure being developed to slow the progression of wet age-related macular degeneration. In the letter, the FDA requested that the firm conduct an additional confirmatory clinical trial for SnET2. Miravant is a pharmaceutical development firm specializing in photodynamic therapy.

Drug Branding
ACAMBIS INC. ___________________________________________________________________________ Acambis Inc., a subsidiary of Acambis Plc, was awarded a contract from the National Institute of Allergy and Infectious Disease for the manufacture and development of a Modified Vaccinia Ankara (MVA) vaccine. MVA is a weakened form of smallpox vaccine being developed for patients for whom the traditional smallpox vaccine is contraindicated. The vaccine is being developed in conjunction with Baxter Healthcare SA.

Drug Branding