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Gilead says fixed-dose combination of HIV drugs Truvada, BMS' Sustiva not bioequivalent to individual products dosed separately

Gilead Sciences Inc. said its second formulation of the fixed-dose combination of Truvada (emtricitabine/tenofovir disoproxil fumarate) and Bristol-Myers Squibb Co.'s Sustiva (efavirenz) did not demonstrate bioequivalence to the individual HIV drugs dosed separately.

Gilead said it is going ahead with the evaluation of as many as three new formulations of Truvada and Sustiva created using bi-layer technology, which involves individually formulated layers combined to form one tablet.

Bioequivalence studies in humans and stability studies of the new formulations will be initiated during the next several months, the firm added.

"Pending the results of the planned bioequivalence studies, Gilead and [BMS] anticipate filing a New Drug Application with the U.S. Food and Drug Administration in the first half of 2006," Gilead said.

In December 2004, Gilead and BMS established a joint venture to create a fixed-dose combination of Truvada and Sustiva, which, if approved, would be the first complete highly active antiretroviral therapy treatment regimen for HIV available in a fixed-dose combination taken once daily, according to Gilead.

Truvada, which combines Gilead's Emtriva and Viread, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Sustiva is also indicated to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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Biogen Idec, Elan's safety evaluation of Tysabri finds no new cases of deadly brain disease; shares rise

Biogen Idec Inc. and Elan Corp. Plc.'s shares rose after the companies said their safety evaluation of Tysabri (natalizumab) in patients with multiple sclerosis found no new confirmed cases of progressive multifocal leukoencephalopathy (PML), a rare central nervous system disorder.

Tysabri was voluntarily withdrawn from the market in February, and the companies have confirmed three cases of PML in patients taking the drug, two of which were fatal.

Ninety-one percent of the more than 2,000 eligible patients with MS who were treated with Tysabri participated in the safety evaluation, and none were found to have PML, according to the companies. As a result, Biogen Idec and Elan plan to take "preliminary steps to restart clinical trials in MS."

They also said the ongoing safety evaluation of Tysabri in the treatment of Crohn's disease and rheumatoid arthritis is expected to be completed by the end of the summer.

"Given the high unmet medical need in MS and the therapeutic benefit we have seen with Tysabri, we are encouraged by these safety findings," said Dr. Whaijen Soo, senior vice president of medical research at Biogen Idec.

Dow Jones Newswires reported that most analysts greeted the news with cautious optimism, foreseeing the return of Tysabri to the market in 2006. "Although sales would almost certainly not be as strong as first assumed, Tysabri might still become an important therapy for MS," Denise Anderson at Kepler Equities in Zurich told Reuters.

Biogen Idec shares closed at $41.24, up $2.82, or 7.3 percent, in heavy trading on the Nasdaq, while Elan shares closed at $9.09, up $1.09, or 13.6 percent, in heavy trading on the New York Stock Exchange.

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Reseachers find biomarker associated with resistance to Iressa

Researchers at Cedars-Sinai Medical Center found a protein called EMP-1 in the tumors of patients who do not respond to AstraZeneca Plc's lressa (gefitinib), a treatment for non-small cell lung cancer.

The findings, which were published online ahead of print in the journal Proceedings of the National Academy of Sciences, may help oncologists identify which patients would benefit from the drug.

The researchers identified the protein in Iressa-resistant tumors of mice infected with prostate cancer, which has similar properties as NSCLC, according to Reuters. They then examined tumor samples taken from human NSCLC patients and found those who had been resistant to Iressa had high levels of EMP-1.

"Our results show that the EMP-1 protein is a biomarker for resistance to treatment with [Iressa] and may enable us to identify patients who won't respond to the drug," said Dr. David Agus, senior author of the study and research director at Cedars-Sinai. "If we know who won't respond, we can explore other treatment options sooner and use [Iressa] when patients will benefit."

The ability to find which patients would benefit from treatment with Iressa might ease concerns about use of the drug, which produces dramatic results in a small percentage of NSCLC patients but fails to help the vast majority of them.

In December 2004, AstraZeneca released results from a trial showing that although Iressa did significantly shrink tumors, it did not improve survival in NSCLC patients. At that time, the company offered to stop promoting the drug. In April 2005, a Phase III trial of the drug was halted after a data monitoring committee found that Iressa was unlikely to improve overall or progression-free survival in patients with stable or responding NSCLC.

In June, the Food and Drug Administration and AstraZeneca notified health care professionals that use of Iressa would be limited to patients who had previously benefited from or are currently benefiting from taking the drug.

The FDA approved Iressa in May 2003 for the treatment of NSCLC patients who had failed two or more courses of chemotherapy.

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Preliminary study results show Actelion's Tracleer significantly reduces new digital ulcers in systemic sclerosis patients

Actelion Ltd. reported preliminary Phase III trial results of Tracleer (bosentan) in patients with systemic sclerosis who have digital ulceration.

The preliminary analysis of the double-blind, placebo-controlled, 190-patient RAPIDS-2 trial showed that the primary endpoint of reduction in the occurrence of new digital ulcers during the six-month treatment period was statistically significant, Actelion said.

The firm added that these findings confirm the results of the 122-patient RAPIDS-1 trial, which demonstrated that the use of Tracleer led to a significant reduction in the occurrence of new digital ulcers among patients with systemic sclerosis and either a history of or active digital ulcerations at the time of enrollment compared with those who received placebo.

However, Actelion said the RAPIDS-2 trial demonstrated no difference in time to healing of existing digital ulceration between Tracleer-treated patients and those who received placebo.

"This program adds to our understanding of the role of vasculopathy in systemic sclerosis, a disease with multiple devastating manifestations, including pulmonary arterial hypertension, for which [Tracleer] is currently approved," said Dr. James Seibold, lead investigator for the RAPIDS-2 study.

In addition, Dr. Isaac Kobrin, head of Actelion's clinical development, said that by year-end, he expects results from a trial evaluating the safety and efficacy of Tracleer in pulmonary fibrosis, another major manifestation of systemic sclerosis.

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Appropriate length of Pegasys, Copegus therapy for patients with hepatitis C differs based on virus genotype, data indicate

Sixteen weeks of therapy with F. Hoffman-La Roche Ltd.'s Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) appears to be sufficient in patients with the hepatitis C virus genotype 2 or in those with the HCV genotype 3 and a low viral load, but patients with HCV genotype 3 and a high viral load may require longer therapy.

The Phase IIIb trial enrolled 153 treatment-naove patients who had chronic hepatitis C and were infected with genotypes HCV-2 (26 percent) or HCV-3 (74 percent). They all received 180 mcg of Pegasys once each week plus 800 mg to 1,200 mg of Copegus per day. At week four, the patients were tested for rapid virologic response, defined by serum HCV RNA of less than 600 IU/mL.

The 93 percent of patients who achieved rapid virologic response, plus one additional patient, were then randomized to receive treatment for a total of 16 weeks (group A, n=71) or 24 weeks (group B, n=71). Patients with HCV RNA levels of at least 600 IU/mL and one additional patient underwent a total of 24 weeks of therapy (group C, n=11).

Overall, 88 percent and 78 percent of the patients achieved intent-to-treat and sustained virologic response, respectively.

By group, the end-of-therapy response rates were 94 percent for group A and 85 percent for group B; sustained virologic response rates were 82 percent and 80 percent for groups A and B, respectively. However, the rate of sustained virologic response in group C was lower than that seen in group B, while the rate of end-of-therapy response in group C was only slightly lower than that seen in group B.

Based on genotype, those with the HCV-2 genotype had a higher rate of sustained virologic response than patients with the HCV-3 genotype (92 percent vs. 73 percent, respectively).

Furthermore, in patients with the HCV-3 genotype, those who had a baseline viremia of more than 800,000 IU/mL had a lower rate of sustained virologic response when compared with those who had a baseline viremia of no more than 800,00 IU/mL (59 percent vs. 85 percent). Also, the patients with HCV-3 genotype and a high baseline viremia showed a higher rate of sustained virologic response if they received 24 weeks of therapy rather than just 16 weeks (67 percent vs. 55 percent), but this result did not reach statistical significance.

"In conclusion, patients chronically infected with HCV-2 (independent from pretreatment viremia) and those infected with HCV-3 and a pretreatment HCV RNA level equal or below 800,000 IU/mL, who can achieve a rapid virologic response defined as HCV RNA below 600 IU/mL at week four, can be treated for only 16 weeks with [Pegasys] and [Copegus] without compromising the chances for a sustained virologic response. The data of the present study are less conclusive for HCV-3-infected patients with a pretreatment viremia above 800,000 IU/mL, who achieve a rapid virologic response as well as for those patients who cannot achieve a rapid virologic response," the researchers summarized.

This study appeared in the August issue of Gastroenterology.

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Two osteoporosis treatments effective but in opposite ways, research shows

Two osteoporosis treatments--Eli Lilly and Co.'s Forteo (teriparatide [rDNA origin]) and Merck & Co. Inc.'s Fosamax (alendronate sodium)--increase bone mineral density (BMD) among postmenopausal women, but do so in different ways and to varying degrees, according to new research.

In an 18-month, double-blind study, investigators assessed markers of bone turnover and areal BMD in 203 postmenopausal women with osteoporosis; volumetric BMD was assessed in a subset of patients.

Patients were randomized to either 20 mcg Forteo plus oral placebo (n=102) or 10 mg Fosamax plus injectable placebo (n=101).

At six months, results showed that Forteo, an anabolic agent, significantly increased markers of bone turnover while Fosamax, an antiresorptive agent, significantly decreased the markers.

At 18 months, patients who received Forteo had significantly higher areal and volumetric spine BMDs than those in the Fosamax group. However, cortical bone density increased by 7.7 percent in patients who received Fosamax and decreased by 1.2 percent among those who received Forteo.

In addition, both treatments led to a significantly higher areal femoral neck BMD than at baseline and there were no significant differences in trabecular femoral neck BMD between the treatment groups.

Researchers noted that significantly fewer Forteo-treated patients reported back pain compared with Fosamax-treated patients.

"The availability of two distinct treatment options for the management of osteoporosis provides the opportunity to select the optimal treatment strategy for a given patient based on different clinical and pathophysiological characteristics," the study authors concluded. "The challenge facing clinicians and clinical investigators is to identify those attributes in an individual patient that would determine whether an antiresorptive agent or an anabolic agent would be most appropriate."

This study was published in the Aug. 8/22 issue of the Archives of Internal Medicine.

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Merck & Co. Inc.

Merck & Co. Inc. and DOV Pharmaceutical Inc. amended their 2004 license agreement regarding the clinical development of the triple reuptake inhibitors DOV 21,947 and DOV 216,303. As part of the amendment, DOV will now conduct additional studies of DOV 21,947, including a Phase Ib trial of the drug in normal volunteers and two Phase II trials in patients with depression. If the Phase II trials are successful, DOV will be reimbursed by Merck for pre-agreed expenses and will receive a success premium. The amendment also allows the collaboration to be expanded to include an additional triple uptake inhibitor from DOV's pipeline. All other milestones, royalties and business terms of the original agreement remain intact.

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Bayer HealthCare AG

Bayer HealthCare AG received a collection of potential novel therapeutic targets from Cenix BioScience GmbH. The targets were identified through an RNAi-based discovery collaboration in which cell-based assays originally developed by Bayer were adapted and optimized by Cenix to be run as high throughput RNAi screens, Cenix said. "The method of identification . . . conveys upon these targets a significantly stronger pathophysiological relevance than that typically seen for targets identified by less probative 'first wave' genomics methodologies of recent years," Cenix added. Under a 2003 agreement, Bayer has the first option to secure all rights to new target-related intellectual property developed through the project.

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Progen Industries Ltd.

Progen Industries Ltd. said it was expanding the Phase II clinical trial program of its lead cancer product, PI-88, into prostate cancer. PI-88 is currently in Phase II trials as a treatment for lung cancer, liver cancer, multiple myeloma and melanoma. The new trial, which will include 82 patients with androgen-independent prostate cancer, will combine PI-88 with sanofi-aventis Group's Taxotere (docetaxel) chemotherapy. The study will examine the efficacy and safety of the drug in these patients whose condition has worsened despite having received hormone therapy. One of the study's goals is to determine whether the addition of PI-88 to Taxotere will improve efficacy versus monotherapy with Taxotere. The company said it expects recruitment to be rapid because of a lack of available and approved treatments for patients with this type of prostate cancer.

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Novavax Inc.

Novavax Inc. appointed Dr. Rahul Singhvi as president and chief executive officer effective immediately. Singhvi was also elected a director of the specialty biopharmaceutical company. He replaces the retiring Nelson Sims. Prior to joining the firm in 2004, Singhvi had 11 years of experience in the pharmaceutical industry, including serving as a director within Merck & Co. Inc.'s manufacturing division.

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