Brand Design

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GENELABS' PRESTARA SHOWS NO SIGNIFICANT BENEFIT IN PHASE III LUPUS TRIAL; SHARES FALL ------------------------------------------------------------------------------- Genelabs Technologies Inc.'s shares fell more than 24 percent on news that its investigational treatment Prestara (prasterone), formerly known as GL701, failed to demonstrate a statistically significant benefit in patients with systemic lupus erythematosus (SLE, or lupus) in a preliminary analysis of a Phase III trial conducted by Genelab's licensee, Genovate Biotechnology Co. Ltd.

The nine-month, double-blind trial, which was not conducted under an Investigational New Drug application, tested the effect of Prestara on the bone mineral density of women with SLE who were receiving glucocorticoids, a standard treatment for SLE. Bone loss is one of the known side effects of glucocorticoid therapy.

Bone mineral density at the lumbar spine was the study's primary endpoint. Prestara did not demonstrate a significantly better effect than placebo.

"When the analysis of this study is complete, we plan to meet with the [Food and Drug Administration] and determine our course of action for Prestara . . . ," said James Smith, Genelab's chief executive officer.

Smith said that although the results for Prestara are disappointing, the company is enthusiastic about drugs it is developing to treat hepatitis C virus (HCV) infections. Genelabs is collaborating on one of its HCV programs with Gilead Sciences Inc.

Genelabs received an approvable letter for Prestara from the FDA in August of 2002.

Genelabs shares closed at $0.43, down $0.14, in heavy trading on the Nasdaq. -=-

MAJORITY OF PATIENTS TAKING DRUGS FOR EPILEPSY SUBJECTIVELY ATTRIBUTE SIDE EFFECTS TO TREATMENT, ACCORDING TO STUDY ------------------------------------------------------------------------------- The majority of patients who take antiepileptic drugs (AEDs) for epilepsy believe they experience side effects as a result of their treatment, suggest findings from a recent population-based survey conducted in the Netherlands.

Using databases from 17 outpatient pharmacies in the region, researchers identified 692 patients taking AEDs from a population of approximately 107,000 people aged more than 15 years. Questionnaires and checklists were mailed to all eligible subjects.

Of the 500 questionnaires returned, 101 patients were taking AEDs for indications other than epilepsy and an additional 53 patients either refused to or could not complete the questionnaire. As a result, 346 respondents were included in the final analysis.

Among these, 80.9 percent were taking a single AED, and 51 percent had been in seizure remission for more than two years.

Overall, 58 percent of respondents reported complaints probably due to side effects in at least three of eight general areas: general central nervous system complaints (68.2 percent), cognitive complaints (61.8 percent), gastrointestinal complaints (33.2 percent), motor problems (31.5 percent), mood and behavior complaints (22.3 percent), cosmetic complaints (20.4 percent), sleep problems (8.7 percent) and visual complaints (7.5 percent).

The highest prevalence of complaints were central nervous system complaints and cognitive complaints. The most frequently cited specific side effects in these two domains were memory problems (21.4 percent), fatigue (20.3 percent), tiredness (18.8 percent) and concentration difficulties (16.1 percent).

The most common AED regimens included valproic acid monotherapy (28.7 percent), carbamazepine monotherapy (24.7 percent), phenytoin monotherapy (15.7 percent) and AED polytherapy (19.1 percent). When the incidence of side effects was evaluated according to treatment regimen, researchers observed significantly different side effect profiles in each of these four groups.

Polytherapy was associated with significantly more side effects than was monotherapy in most domains. Phenytoin was associated with more concentration difficulties compared with valproic acid, while both phenytoin and valproic acid were associated with more weight gain compared with carbamazepine.

The authors acknowledged that the use of a checklist may have led patients to exaggerate the incidence of side effects or erroneously attribute their incidence to treatment.

"It has been shown, however, that subjective complaints, measured by similar checklists as used in this study, are important determinants of quality of life in epilepsy, and as such they seem clinically relevant," they added.

The study results were published in the April issue of the journal Seizure. -=-

STUDY FINDS THAT LILLY'S ZYPREXA PREVENTS LOSS OF GRAY MATTER IN SCHIZOPHRENIA PATIENTS, HALOPERIDOL DOES NOT ------------------------------------------------------------------------------- A recent study found that Eli Lilly and Co.'s atypical antipsychotic, Zyprexa (olanzapine), prevented the loss of gray matter in patients recently diagnosed with schizophrenia, while haloperidol, a conventional antipsychotic, did not.

Researchers conducted a longitudinal, double-blind study of 263 patients with first-episode schizophrenia and 58 healthy volunteers for a two-year period. Patients were randomized to receive either haloperidol at doses ranging from 2 mg/day to 20 mg/d or Zyprexa at doses ranging from 5 mg/d to 20 mg/d.

Neurocognitive and magnetic resonance imaging assessments were performed at baseline and at weeks 12, 24, 52 and 104. Investigators used mixed-model analyses with time-dependent covariates to evaluate treatment effects on MRI endpoints.

The study's main outcome measure was the change in brain volume, as assessed by MRI. Investigators also looked at the relationship between MRI, psychopathologic and neurocognitive outcomes.

Researchers found that haloperidol-treated patients exhibited significant decreases in gray matter volume. Zyprexa-treated patients, however, did not show a significant decrease in gray matter volume. No change in gray matter volume was observed among the matched sample of healthy volunteers.

Researchers added, "Post hoc analyses suggested that treatment effects on brain volume and psychopathology of schizophrenia may be associated."

"This is a really big breakthrough," said the study's lead investigator, Dr. Jeffrey Lieberman, in a press release. "The drugs we have for schizophrenia can't cure people who've been sick for years, but this study shows that the newer atypical drugs, if started early, can prevent the illness from progressing."

The study was published in the April issue of the Archives of General Psychiatry. -=-

MERCK'S HPV VACCINE REDUCES INCIDENCE OF CERTAIN TYPES OF HPV INFECTION BY 90 PERCENT, STUDY FINDS ------------------------------------------------------------------------------- Merck & Co. Inc.'s Gardasil, an investigational human papillomavirus (HPV) vaccine, reduced the combined incidence of persistent HPV 6, 11, 16 or 18 infection and related disease by 90 percent in a Phase II study published in April's edition of The Lancet Oncology.

HPV types 16 and 18 are associated with 70 percent of all cases of cervical cancer, and HPV types 6 and 11 are associated with 90 percent of all cases of genital warts.

Researchers randomized 552 women, aged 16 to 23 years, to receive Gardasil or one of two placebo preparations at day one, month two and month six. Patients underwent regular gynecological examinations for 36 months.

The primary endpoint of the study was the combined incidence of infection with HPV 6, 11, 16 or 18 or external genital or cervical disease.

In the placebo group, researchers observed 36 cases of disease, persistent infection or HPV detection on the last recorded visit; in the Gardasil group, only four cases were observed. Merck reported that of the four cases, one was a persistent infection and the other three were cases in which HPV was detected on the last visit but not confirmed as a persistent infection.

"Although the study was not originally designed or powered to assess vaccine efficacy on the disease endpoints separately, efficacy of the investigational vaccine against cervical precancers caused by HPV types 16, 18, 6 and 11 was 100 percent," said Dr. Kevin Ault, one of the study's researchers.

Merck said Phase III studies of the vaccine involving more than 25,000 patients are currently under way. Data from these trials should be available later this year.

If approved, Gardasil is expected to become a blockbuster. According to Forbes.com, the vaccine could produce annual sales of $500 million to $1 billion.

The Wall Street Journal said Merck's target population for Gardasil is girls and women between the ages of 9 and 24 years. -=-

VIVITREX EFFECTIVE IN REDUCING HEAVY DRINKING AMONG PATIENTS WITH ALCOHOL DEPENDENCY, STUDY FINDS ------------------------------------------------------------------------------- Alkermes Inc.'s long-acting Vivitrex (naltrexone) injection effectively reduces heavy drinking in patients with alcohol dependency, according to a study published in the April 6 edition of JAMA.

The Phase III study included 624 adults with a current diagnosis of alcohol dependence defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Participants were randomized to receive once-monthly injections of Vivitrex 380 mg, Vivitrex 190 mg or placebo for six months. In addition, all three treatment groups received psychosocial counseling during the treatment period.

The current study differed from previous studies of orally administered naltrexone in that the majority of patients enrolled in this study were actively engaged in heavy drinking at the time of initiation. The earlier studies included only patients who were abstaining from alcohol use at the time of enrollment. Heavy drinking, for the purposes of this and previous naltrexone studies, was defined as five or more drinks per day on a regular basis for men and four or more drinks for women.

Patients receiving Vivitrex exhibited a reduction in the median number of heavy drinking days from 19 days per month to three days per month. Further, the drug's efficacy was observed during the first month of treatment and was maintained over the course of the study period.

Vivitrex was also found to be well tolerated, with predominantly mild adverse events that decreased over time.

"The results of the Vivitrex study show how pharmacotherapy has the potential to advance the standard of care for alcohol dependence," Dr. James Garbutt, the lead researcher, said in a statement.

Alkermes recently filed a New Drug Application with the Food and Drug Administration for approval of the long-acting, injectable formulation of the drug. The oral form of naltrexone was approved in 1994 for the treatment of alcohol dependence. According to the study's authors, though, "adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited."

The authors also noted that "long-acting formulations [such as Vivitrex] may prove to be an important treatment strategy for a variety of addictive disorders." -=-

BIOGEN IDEC, FUMAPHARM'S BG-12 LESSENS SEVERITY OF PSORIASIS BETTER THAN PLACEBO, STUDY FINDS ------------------------------------------------------------------------------- Biogen Idec Inc. and Fumapharm AG said their investigational oral fumarate, BG-12, met its endpoint in a Phase III study, with patients demonstrating a lower median psoriasis severity score after 16 weeks of treatment.

The multicenter, double-blind, Phase III study included 175 patients with moderate to severe psoriasis who were randomized to receive 720 mg/day of BG-12 or placebo for 16 weeks. Patients were evaluated using the psoriasis area and severity index (PASI).

According to results released by the two companies, at the end of the treatment period the BG-12 group had a median PASI score of 5.8 compared with a score of 14.2 for the control group. The median reduction from baseline PASI was 68 percent and 10 percent, respectively, for the group treated with BG-12 and for those who received placebo.

Dr. Burt Adelman, Biogen Idec's executive vice president of development, said data from the trial will be used to file for market authorization in Germany, adding that "[a]dditional Phase III studies would need to be conducted for applications in the [United States] and the rest of Europe."

Biogen Idec said a Phase II study initiated last November is investigating BG-12 as a treatment for relapsing-remitting multiple sclerosis. The company licensed exclusive worldwide rights to develop and market BG-12 from Fumapharm AG, a private Swiss pharmaceutical company, in October of 2003 and is evaluating the drug for a range of diseases. -=-

Brand Design
ABBOTT LABORATORIES ------------------------------------------------------------------------------- Abbott Laboratories received conditional approval from the Food and Drug Administration regarding the Investigational Device Exemption application the company filed for its ZoMaxx drug-eluting stent. Consequently, Abbott said it will begin enrollment of the first 250 patients in a U.S. trial comparing ZoMaxx, which contains Abbott's immunosuppressant drug ABT-578, with Boston Scientific Corp.'s paclitaxel-eluting Taxus Express2 stent. According to Abbott, the trial will eventually include as many as 1,670 patients with coronary artery disease. The company is also enrolling patients in a similar but smaller trial being conducted outside the United States. Abbott expects to receive U.S. approval to market the ZoMaxx stent by the end of 2007. -=-

Brand Design
BIOMARIN PHARMACEUTICAL INC. ------------------------------------------------------------------------------- BioMarin Pharmaceutical Inc. initiated a Phase III trial of its oral, small-molecule therapy, Phenoptin (sapropterin hydrochloride), for the treatment of phenylketonuria (PKU), a genetic disorder caused by an enzyme deficiency. PKU can result in brain damage, mental illness, seizures and cognitive problems. According to BioMarin, the only current treatment for PKU is a restrictive medical food diet that is expensive and difficult to maintain. The trial will enroll approximately 100 patients with PKU, and BioMarin expects to release data from the trial before the end of the year. -=-

Brand Design
ONCOLYTICS BIOTECH INC. ------------------------------------------------------------------------------- Oncolytics Biotech Inc. received clearance from the Food and Drug Administration to begin a second clinical trial of the systemic delivery of Reolysin, a formulation of the human reovirus that may represent a treatment for advanced or metastatic solid tumors. The Phase I, open-label study will focus on determining the drug's maximum tolerated dose, dose-limiting toxicity and safety profile. Planned enrollment is up to 36 patients with advanced or metastatic tumors that are refractory to standard therapy or for which no current effective therapy is available. -=-

Brand Design
RITE AID CORP. ------------------------------------------------------------------------------- Rite Aid Corp.'s net income for the fourth quarter of fiscal-year 2005 increased to $228.6 million, or $0.35 per diluted share, up from $59.4 million, or $0.09 per diluted share, for the previous year's fourth quarter. The company attributed the improvement to an income tax benefit. Revenue for the quarter decreased 1.3 percent to $4.34 billion as compared with $4.40 billion in revenue during the previous year's fourth quarter. Same-store sales for the quarter decreased 0.9 percent when compared with the same period from a year earlier. -=-