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Genzyme suspends enrollment in cardiac cell therapy trial in patients with heart failure Genzyme Corp. halted enrollment in its Phase II cardiac cell therapy study, known as the MAGIC trial, on the recommendation of the study's Data Monitoring Committee.

The committee's planned review of preliminary efficacy and safety data showed that the study's hypothesis has been adequately tested and that it is unlikely the trial will result in the hypothesized improvements in heart function.

"Based on the preliminary results observed to date, we concur with the DMC that it is unlikely this trial will achieve success," said Dr. Richard Moscicki, Genzyme's chief medical officer. "Given this likely outcome, and the risks inherent in any clinical trial, we concluded that the most prudent action is to stop any new enrollment in the trial."

The MAGIC trial included patients with ischemic heart failure who were injected with one of two doses of autologous skeletal myoblasts or placebo during coronary artery bypass grafting. The trial was testing whether autologous skeletal myoblasts could safely halt a patient's progression of heart failure or reverse cardiac muscle damage caused by myocardial infarction.

Genzyme will continue to follow the 95 patients who were enrolled in the trial and will collect data throughout the trial's follow-up period. Afterward, Genzyme and the trial's steering committee will analyze and present the data.

Genzyme shares closed at $69.57, down $0.84, or 1.2 percent, in moderate trading on the Nasdaq.

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Berlex's sBLA for Betaseron accepted for FDA review Berlex Inc.'s supplemental Biologics License Application seeking to expand the indication for multiple sclerosis drug Betaseron (interferon beta-1b) was accepted by the Food and Drug Administration.

The application, which requests approval for the drug to be used to delay a second exacerbation in patients with MS who have had a first monofocal or multifocal clinical demyelinating event, was based on data from the BENEFIT study.

In the randomized trial, Betaseron was shown to reduce the risk of developing clinically definite MS by 50 percent compared with placebo. Betaseron-treated patients were also found to have twice the protection against developing MS, as defined by the McDonald diagnostic criteria, as compared with placebo-treated patients, Berlex said.

Betaseron is approved to treat relapsing forms of MS to reduce the frequency of clinical exacerbations.

Berlex expects the FDA to make a decision on the sBLA by the fourth quarter.

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OMRI's tolvaptan receives fast track designation The Food and Drug Administration granted fast track designation to tolvaptan, Otsuka Maryland Research Institute Inc. (OMRI)'s investigational treatment for autosomal dominant polycystic kidney disease (ADPKD), which results in progressive enlargement of focal cysts in the kidneys.

The FDA said there are no effective therapies approved for treating patients with ADPKD. Tolvaptan is being assessed as a prophylactic agent for increased renal size and for secondary complications, including hypertension, proteinuria and renal pain.

OMRI has completed Phase II clinical trials of the drug in patients with ADPKD and is preparing to initiate Phase III efficacy trials.

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Kos' Niaspan achieves endpoints in two separate studies; company announces Q4 results Kos Pharmaceuticals Inc. said a modified formulation of its Niaspan (niacin) extended-release tablets demonstrated the ability to reduce flushing in a recent study, and a separate trial investigating Niaspan as a combination therapy found that the drug may allow patients to lower their dosages of commonly used cholesterol treatments while improving their triglycerides and HDL cholesterol levels. The Niaspan MF study, a single-dose, double-blind, three-way crossover trial, included 156 patients who take Niaspan to increase their HDL cholesterol. Researchers evaluated the modified formulation's ability to reduce the severity and duration of a side effect referred to as flushing, a warm feeling accompanied by redness and itching or tingling of the skin that is a relatively common and usually transient among patients who take the marketed formulation of Niaspan.

Patients were randomized to receive a single dose of Niaspan MF 2,000 mg, regular Niaspan 2,000 mg or placebo. The modified formulation exhibited a 42 percent reduction in severity and a 43 percent reduction in duration of flushing compared with the original Niaspan formulation.

Kos noted that Niaspan MF achieved these reductions without the concomitant use of aspirin or nonsteroidal anti-inflammatory drugs, which physicians often recommend when patients begin Niaspan therapy to reduce the symptoms of flushing.

In the Compell study, a 12-week, open-label, dose-escalation, Phase IV efficacy trial that included 292 patients, researchers compared the efficacy of combination therapy with Niaspan (1,000 mg or 2,000 mg) plus low to moderate doses of Pfizer Inc.'s Lipitor (atorvastatin calcium) and AstraZeneca Plc's Crestor (rosuvastatin calcium) versus moderate- to high-dose Crestor and Merck & Co. Inc. and Schering-Plough Corp.'s Zetia and Merck's Zocor (a combination that Merck and Schering-Plough markets in a fixed-dose combination as Vytorin [ezetimibe/simvastatin]).

The results showed that all treatments were equally effective at lowering LDL cholesterol levels, achieving an approximate 50 percent or greater decrease at weeks 8 and 12. However, both Niaspan combinations significantly increased levels of HDL cholesterol (by 2.5 to 3.5 times) and significantly decreased triglyceride levels and lipoprotein (a) as compared with the other two treatment arms.

According to Kos, Niaspan is the only FDA-approved, once-daily, extended-release prescription formulation of niacin for the treatment of abnormal cholesterol levels.

In separate news, Kos reported financial results for the fourth quarter of 2005. Net income was $26.2 million, or $0.53 per diluted share, down substantially from the same period of 2004, when it recorded net income of $53 million, or $1.15 per share, which excludes interest expenses. Analysts were expecting the company to earn $0.80 per share, according to a report by The Associated Press.

Revenue for the quarter, however, increased 42 percent to $213.9 million, up from $150.7 million in the same quarter of 2004. Quarterly revenue from the company's cholesterol franchise increased 21 percent to $149.5 million, up from $123.2 million in the same quarter of 2004.

Kos shares closed at $41.39, down $8.38, or 16.8 percent, in heavy trading on the Nasdaq.

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Adolescents gain some benefit from Imitrex nasal spray; trial misses primary endpoints Although treatment with GlaxoSmithKline Plc's Imitrex (sumatriptan) nasal spray failed to achieve primary efficacy endpoints with statistical significance in a trial of adolescents, it did appear to benefit some patients.

The double-blind, parallel-group trial enrolled 888 patients aged 12 to 17 years who had at least a six-month history of migraine and who had experienced one to eight migraines of moderate to severe intensity within each of the two months preceding enrollment.

The patients were randomized to one of three treatment groups--placebo, Imitrex 5 mg nasal spray or Imitrex 20 mg nasal spray--and were instructed to take their assigned therapy within 30 minutes of the onset of a moderate to severe migraine. If the pain persisted or returned, a second dose of the assigned drug or another acute migraine drug could be taken two to 24 hours after the first dose.

The primary efficacy endpoints included headache relief at one hour and sustained relief from one to 24 hours after initial drug administration.

A total of 738 patients self-administered treatment. Of these, 731 provided at least one efficacy evaluation after baseline and were included in the intent-to-treat efficacy analyses.

Rates of headache relief were significantly higher with Imitrex 20 mg than with placebo, both 30 minutes (42 percent vs. 33 percent) and two hours (68 percent vs. 58 percent) postdose. However, the difference in headache relief between these two arms at the one-hour interval was not statistically significant (Imitrex 20 mg, 61 percent vs. placebo, 52 percent). The differences between the Imitrex 5 mg group and the placebo group were not statistically significant.

The proportions of patients in the Imitrex groups who achieved sustained relief one to 24 hours postdose were not significantly different from the proportion of patients in the placebo group who achieved sustained relief (Imitrex 20 mg, 41 percent and Imitrex 5 mg, 37 percent vs. placebo, 32 percent).

However, rates of sustained relief between two and 24 hours postdose were significantly higher in the Imitrex-treated groups (20 mg, 49 percent and 5 mg, 48 percent) as compared with the placebo arm (38 percent).

Results from analyses of the secondary efficacy endpoints also suggested a clinical benefit associated with the study drug: a significantly higher proportion of patients who received Imitrex 20 mg were pain free two hours postdose as compared with patients in the placebo group (44 percent vs. 30 percent).

The study appeared in the February issue of the journal Headache.

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Corautus expects completed enrollment in Phase IIb trial of VEGF-2 in cardiovascular disease to be delayed Corautus Genetics Inc. expects the completion of enrollment in its Phase IIb GENASIS trial to be pushed back, although an interim analysis suggests that the trial already has more than 90 percent power to yield statistical significance in terms of the primary endpoint.

Because of a decrease in the rate of enrollment, Corautus expects enrollment to be completed around June 30, rather than by March 31, as was originally expected.

The trial is testing the safety and efficacy of vascular endothelial growth factor-2 (VEGF-2) as a treatment for severe angina resulting from cardiovascular disease. In November, the product was granted fast track status for this indication.

Corautus said a blinded interim variability analysis based on the first 171 patients to be treated showed that fewer patients than originally planned may be needed to reach statistical significance. Nevertheless, the company said it still plans to enroll 404 patients, as specified when the trial was designed. So far, 276 patients have been treated.

"Notwithstanding the fact that the trial may be oversized based on this recent analysis, we will continue with our plan to treat 404 patients in the GENASIS trial, as it will strengthen the reliability of the results of the trial and possibly provide a basis for a smaller Phase III trial than the GENASIS trial," Corautus Chief Executive Officer Richard Otto said.

The firm noted that the Food and Drug Administration has indicated a "heightened interest" in longer-term safety and efficacy data for VEGF-2, which could result in the primary efficacy measurements of a subsequent trial being changed from 90 days to six or 12 months.

"We have made a significant investment in the GENASIS trial, and we are taking the appropriate steps to protect the integrity of the trial data and to maximize the results from GENASIS in our overall clinical development strategy" said Otto.

He added that the firm is focused on "implementing the most expeditious pathway to Biologics License Application submission and approval."

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The Food and Drug Administration The Food and Drug Administration will not delay the starting date of its new distribution program for Roche's acne treatment, Accutane (isotretinoin), and generic formulations of the drug. The program is intended to prevent use of isotretinoin during pregnancy because it has been shown to cause miscarriages and serious birth defects. Earlier this month, an FDA advisory committee heard from physicians who said the new process being used to register patients is "time-consuming and cumbersome." The FDA decided, however, that it will implement the program on March 1, as planned.

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The New England Journal of Medicine The New England Journal of Medicine released two letters from the authors of a well-publicized Vioxx (rofecoxib) study and will publish them in its March 16 issue. In the letters, the authors defend the information included in their manuscript of the VIGOR study, point by point, and state that the article "does not require a correction." In December, The NEJM accused the 13 authors of minimizing the risks associated with Merck & Co. Inc.'s Vioxx by withholding information related to cardiovascular events in three patients and deleting certain information from a draft of the study. In response, the authors claim that they did not know about the events because they occurred after the predetermined cutoff date for reporting such events, and that the "deleted" information was moved from a table into the text of the final manuscript.

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AstraZeneca Plc AstraZeneca Plc and BioSystems International (BSI) will collaborate in the discovery of biomarkers, with BSI conducting processes using its proprietary technologies along with AstraZeneca's funding and clinical samples. BSI retains the rights to its diagnostic applications and will receive income derived from their use. AstraZenenca receives nonexclusive license to use the results from BSI's processes for its own research and development activities, including exclusive rights to new targets developed through the collaboration. In addition, BSI will provide AstraZeneca with detection kits and reagents.

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Par Pharmaceutical Cos. Inc. Par Pharmaceutical Cos. Inc. and Spectrum Pharmaceuticals Inc. will collaborate on developing and marketing generic versions of injectable and ophthalmic drugs. Under the agreement, Spectrum will be responsible for product development and Par will have exclusive rights to promote, market, sell and distribute the products in the United States. Spectrum will receive milestone payments and the firms will share profits. Par said it will make an equity investment in Spectrum in the next two years but did not disclose a specific amount. Spectrum's generic version of GlaxoSmithKline Plc's Imitrex (sumatriptan succinate) injection, a migraine treatment, is included in the agreement. Spectrum and GSK are currently involved in patent litigation over the product; Par will assume responsibility for any additional expenses regarding this litigation.