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Pozen's migraine drug needs to show more benefit to validate potential TD risk, FDA advisory committee says

The Food and Drug Administration's Peripheral & Central Nervous System Drugs Advisory Committee said that Pozen Inc.'s investigational migraine treatment, MT 100 (naproxen sodium/metoclopramide hydrochloride), needs to demonstrate "greater improvement" than it has in current studies, Reuters reported.

Pozen received a non-approvable letter for MT 100 in May 2004. In the letter, the FDA cited a lack of apparent superiority to naproxen for sustained pain relief in two component studies and a lack of statistically significant improvement on nausea, photophobia and phonophobia in one of the two studies. The agency also raised concerns about a potential risk of tardive dyskinesia (TD) and carcinogenicity.

"[G]iven the number of patients exposed to MT 100 for at least one year in your database (about 300), the absence of any detected cases is consistent with a true rate of TD of about 1 percent, an unacceptably high risk in the absence of any demonstrated advantage of the product," the FDA said in the non-approvable letter.

Background documents released ahead of Thursday's committee meeting said the group "reached consensus that the risk of [TD] with MT 100 use in the episodic, single-dose acute treatment of migraine is quite small [and should not approximate a risk of 1 percent]."

Pozen, which convened the panel, is currently deciding whether it should conduct an additional study to confirm MT 100's efficacy in patients with migraine without nausea, according to Reuters. The FDA reportedly said it would consider approving the drug for this indication if Pozen submitted additional research confirming a possible benefit for these patients.

John Plachetka, Pozen's chief executive officer, said he did not want to speculate as to what the company intends to do.

Pozen shares closed at $7.97, down $0.43, or 5.1 percent, in heavy trading on the Nasdaq.

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Rebif appears to be safe, tolerable long-term MS treatment, study finds

Serono Inc. and Pfizer Inc.'s Rebif (interferon beta-1a) appears to be a safe and tolerable multiple sclerosis treatment in both the 22 mcg and 44 mcg dosages, according to findings from a four-year study.

In the trial, 560 patients with relapsing-remitting MS received placebo or Rebif 22 mcg or 44 mcg injected subcutaneously three times per week for two years.

After this two-year period, patients in the placebo group were assigned to receive one of the two Rebif dosages, and subjects in the active treatment groups continued to receive their usual dosage of Rebif. This phase of the trial lasted two years.

Results showed that the most common adverse events for those who received the study drug during the first two years included injection-site inflammation (72 percent), headache (71 percent) and flu-like symptoms (69 percent). The authors noted that these adverse events were generally mild and occurred most frequently during the first month of treatment.

Adverse events over the entire four-year study period were similar to those occurring in the first phase of the study. The researchers noted that the adverse events between the two Rebif dosages were, "for the most part," similar.

No association was detected between Rebif and depression, suicide or attempted suicide.

"Therapy with subcutaneous [Rebif] three times weekly for up to four years was well tolerated without dose-limiting safety concerns," the authors concluded.

The study was published in the August issue of the European Journal of Neurology.

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Patients with type 2 diabetes receiving Exubera may achieve glycemic control faster than those receiving Avandia, study shows

Pfizer Inc. and sanofi-aventis Group's Exubera (human insulin), a rapid-acting, dry-powder insulin for inhalation, may be an effective therapy for patients with early type 2 diabetes who are unable to achieve control through diet and exercise alone, according to data from a recent study.

In the study, which was published in the August issue of the journal Diabetes Care, 134 patients with suboptimal control of their diabetes through diet and exercise were randomized to three months of treatment with either an individualized dose of Exubera before meals or GlaxoSmithKline Plc's Avandia (rosiglitazone maleate) 4 mg twice daily. All patients were instructed to maintain a diet and exercise regimen based on the American Diabetes Association guidelines.

The primary endpoint of the study was the percentage of patients achieving A1C levels of less than 8 percent at 12 weeks or at the time of discontinuation.

A significantly greater proportion of patients who received Exubera achieved A1C values of less than 8 percent as compared with patients in the Avandia group (83 percent vs. 58 percent), less than 7.0 percent (44 percent vs. 18 percent) and less than or equal to 6.5 percent (28 percent vs. 7.5 percent).

In addition, the absolute reduction in A1C levels at week 12 was greater among patients who received Exubera than among those treated with Avandia (-2.3 percent vs. -1.4 percent, respectively). Final mean A1C values were 7.2 percent and 8 percent for patients who received Exubera and Avandia, respectively.

"The study shows that [Exubera] monotherapy improves glycemic control more quickly than [Avandia]," which may take [at least] 18 weeks to achieve peak glucose lowering activity," the authors concluded.

Pfizer and sanofi-aventis filed a New Drug Application for Exubera with the Food and Drug Administration in March. Nektar Therapeutics provided the technology used in developing Exubera.

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Provigil provides modest wakefulness benefits to nighttime workers, study shows; study criticized for poor design

Treatment with Cephalon Inc.'s Provigil (modafinil) was shown to reduce the extreme sleepiness common among patients with shift-work sleep disorder and may result in a small but significant improvement in performance compared with placebo, researchers reported.

A three-month, double-blind trial that was published in Aug. 4 issue of The New England Journal of Medicine included 204 patients with shift-work sleep disorder. The patients were randomized to receive Provigil 200 mg/day or placebo before beginning their work shift. Researchers assessed the patients' nighttime sleep latency and their levels of alertness and sleepiness during night shifts. Patients also kept sleep diaries.

Treatment with Provigil resulted in a modest improvement in mean nighttime sleep latency, and more patients receiving Provigil exhibited improvements in clinical symptoms as compared with those receiving placebo. Patients in the Provigil group also experienced a reduction in the frequency and duration of lapses of attention during nighttime performance on the Psychomotor Vigilance Test, and proportionally fewer of these patients reported having accidents or near accidents while driving home.

The authors noted, however, that "[d]espite these benefits, patients treated with [Provigil] continued to have excessive sleepiness and impaired performance at night."

"Concern remains that even with treatment with 200 mg of [Provigil], the excessive sleepiness observed in this underrecognized population requires the development of yet more effective therapies," they concluded.

In an accompanying editorial, Dr. Robert Basner attacked the trial as being largely uninformative. According to Basner, the study was designed to investigate Provigil in a small group of subjects, with the design allowing "for the exclusion of other primary sleep disorders, such as obstructive sleep apnea."

He also noted that, compared with placebo, Provigil was associated with increased insomnia among study participants, "thus apparently worsening one of the defining criteria of shift-work sleep disorder even as it improved nighttime sleepiness and vigilance."

"[T]he current study does not adequately assess the clinical value of this particular drug in shift-work sleep disorder, nor does it justify writing more prescriptions for [Provigil]," Basner concluded. "Rather, it serves as a wake-up call for the design and implementation of further scientific studies to address in a cohesive manner the serious health and safety issues that surround us by virtue of our having become, to a large extent, a shift-working society."

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Addition of Rituxan to standard chemotherapy results in improved progression-free, overall survival in patients with lymphoma, study shows

The addition of Genentech Inc. and Biogen Idec Inc.'s Rituxan (rituximab) to chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) appears to lead to a dramatic improvement in outcome for patients with diffuse large B-cell lymphoma (DLBCL), according to data from a recent study.

The study, which was published in the Aug. 1 issue of the Journal of Clinical Oncology, consisted of a population-based retrospective analysis conducted in British Columbia that examined the outcomes for patients with advanced-stage DLBCL from September 1999 through August 2002 (18 months before and after the institution of a policy recommending the addition of Rituxan to CHOP). The goal of the study was to assess the impact of Rituxan on treatment outcomes.

Of the 292 patients evaluated (152 treated with Rituxan, 140 not treated with Rituxan), those receiving Rituxan demonstrated a significant improvement in both progression-free survival and overall survival. Even after controlling for age and International Prognostic Index score, a multivariate analysis showed that the addition of Rituxan remained a strong indicator of progression-free and overall survival.

"This study confirms the advantage of a combined chemotherapy-immunotherapy approach for the general population of patients with DLBCL and provides corroboration of the benefit predicted from randomized trials," the authors concluded.

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Caremark's Q2 EPS beat analysts' expectations, rise 57 percent

Caremark Rx Inc. raised its 2005 guidance as it reported a 57 percent increase in earnings per share for the second quarter.

The pharmacy benefit manager earned $212.8 million, or $0.47 per diluted share, for the second quarter compared with $139.2 million, or $0.30 per diluted share, in the same period last year.

Analysts had expected the company to earn $0.46 per share, according to Reuters Estimates.

Net revenue for the quarter increased to $8.24 billion, up 13 percent from $7.3 billion in the same quarter of 2004. Mail pharmacy revenue increased 34 percent to $2.8 billion, while retail revenue increased 4 percent to $5.3 billion.

Caremark now expects earnings before expenses to be between $1.95 to $1.97 per diluted share for the year, an increase from its previous expectations of $1.92 to $1.94 per diluted share. The revised forecast reflects anticipated growth in revenue at a rate of 28 percent to 30 percent. For the third quarter, the firm forecast earnings before expenses of $0.51 per diluted share.

On average, Reuters Estimates' analysts expect Caremark to earn $1.93 per share for the year and $0.50 per share for the third quarter.

Caremark shares closed at $46.96, up $2.30, or 5.2 percent, in heavy trading on the New York Stock Exchange.

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Genentech Inc.

Genentech Inc.'s Activase (alteplase), an expensive, clot-dissolving drug referred to as a recombinant tissue plasminogen activator, or rtPA, will be paid for by Medicare as a treatment for patients with ischemic stroke, The Wall Street Journal reported. The agency previously paid hospitals a flat rate of approximately $5,700 per case of stroke, regardless if Activase was used, according to The Journal. At a cost of $2,000 or more per dose, many hospitals were hesitant to use rtPA therapy. The Journal reported that Medicare's new base rate will be approximately $6,000 more per case if rtPA is used, noting that the change could represent a significant shift in how ischemic stroke is treated. Medicare said it will pay more than the actual cost of the drug to cover diagnostic tests and other therapies generally associated with the use of rtPA. This change in the guidelines for treating stroke will be published next week in the Federal Register and is expected to take effect Oct. 1.

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Par Pharmaceutical Cos. Inc.

Par Pharmaceutical Cos. Inc.'s subsidiary, Kali Laboratories Inc., received final approval for clonazepam orally disintegrating tablets, the generic equivalent of F. Hoffman-La Roche Ltd.'s anticonvulsant Klonopin Wafers. The branded drug has yearly U.S. sales of approximately $18 million, according to Par. Product shipment is to begin immediately.

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Advancis Pharmaceutical Corp.

Advancis Pharmaceutical Corp. and Par Pharmaceutical Cos. Inc. terminated their partnership agreement after Advancis' 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. By terminating the agreement, Par is no longer responsible for what would have been the company's last quarterly payment to Advancis of $4.75 million in the fourth quarter of 2005. Par will be reimbursed for as much as half of its development expenses, should Advancis succeed in developing and marketing any amoxicillin PULSYS product.

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Taro Pharmaceutical Industries Ltd.

Taro Pharmaceutical Industries Ltd.'s Abbreviated New Drug Application for the generic version of Ferndale Laboratories Inc.'s Locoid (hydrocortisone butyrate) 0.1% cream was approved by the Food and Drug Administration. Locoid, which is used to treat inflammatory skin conditions, had U.S. sales of approximately $8.2 million in 2004, according to Taro.

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