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FDA approves new indication, expands labeling for Diovan

Novartis AG's hypertension drug Diovan (valsartan) received expanded approval from the Food and Drug Administration to reduce cardiovascular mortality in patients who are at high risk--due to left ventricular failure or dysfunction--after myocardial infarction.

Additionally, the regulatory agency expanded Diovan's product labeling, allowing the angiotensin receptor blocker to be prescribed to a broader group of patients who have experienced heart failure, not just to those who are intolerant of ACE inhibitors.

The newest Diovan indication is based on results from the VALIANT trial, which compared Diovan with the ACE inhibitor captopril or a combination of the two in 14,703 patients who were at a high risk of death after an MI. While there were no differences in overall mortality between the treatment groups, the patients treated with Diovan showed improved survival and reduced cardiovascular events, including recurrent MI and hospitalizations for heart failure.

As a post-MI therapy designed to reduce cardiovascular death, Diovan should be dosed at 20 mg twice daily, Novartis said. This dose should be titrated to 40 mg twice daily and then titrated to a maintenance dose of 160 mg twice daily. Dose reductions can be considered if symptomatic hypotension or renal dysfunction occurs.

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Phase III trial of Eximias' cancer drug Thymitaq does not meet primary endpoint

Eximias Pharmaceutical Corp. said the pivotal Phase III trial of Thymitaq (nolatrexed) in patients with unresectable hepatocellular carcinoma (HCC), or inoperable primary liver cancer, failed to meet its primary endpoint of a survival benefit compared with doxorubicin hydrochloride.

The privately held firm said it will conduct additional analyses of the data from the ETHECC study, a two-arm, prospective, randomized trial designed to compare Thymitaq with doxorubicin in 446 patients with HCC and to confirm results of three completed Phase II trials that showed a survival benefit for Thymitaq-treated patients with liver cancer.

Eximias believes ETHECC is the largest Phase III trial completed with HCC patients, adding that there is no Food and Drug Administration-approved treatment for HCC.

In part because of its potential range of oncology applications, Thymitaq, a high-affinity antifolate that kills tumor cells by inhibiting thymidylate synthase and disrupting DNA replication, was named one of Pharmaceutical Executive's 25 Most Attention-Getting Investigational Compounds (MAGIC) in December 2004.

Thymitaq has been granted orphan drug and fast track status for HCC by the FDA, Eximias said.

Additionally, the company said it has a strong cash position and "is continuing to evaluate in-licensing, as well as other corporate opportunities."

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Pfizer's Inspra significantly reduces mortality after AMI in patients with damaged hearts, study results show

Recent study results show that Pfizer Inc.'s Inspra (eplerenone) significantly reduced all-cause mortality 30 days after randomization following acute myocardial infarction (AMI) in patients with left ventricular systolic dysfunction (LVSD) and heart failure.

Researchers used data from the double-blind EPHESUS trial that included 6,632 patients with AMI complicated by LVSD and clinical signs of heart failure. Patients were randomized to 25 mg of Inspra daily initiated three to 14 days following AMI (mean, 7.3 days) or placebo in addition to standard therapy. The trial demonstrated that Inspra reduced all-cause mortality by 15 percent during a mean follow-up of 16 months when used with standard therapy in this patient population.

The co-primary endpoints were time to death from any cause and the composite endpoint of time to death from cardiovascular causes or hospitalization from CV events after 30 days of therapy. Secondary endpoints included CV mortality, sudden cardiac death and fatal/nonfatal hospitalization for heart failure after 30 days of therapy.

Results of this analysis showed that 30 days after patients were randomized to Inspra or placebo, Inspra, a selective aldosterone blocker, reduced the risk of all-cause mortality by 31 percent and the risk of CV mortality/CV hospitalization by 13 percent as compared with placebo. In addition, Inspra reduced the risk of CV mortality by 32 percent and the risk of sudden cardiac death by 37 percent as compared with placebo.

"[Inspra] 25 mg/day significantly reduced all-cause mortality 30 days after randomization . . . in addition to conventional therapy in patients with [LVSD] and signs of heart failure," the study authors concluded. "Based on its early survival benefit, [Inspra] should be administered in the hospital after AMI."

This analysis was published in the Aug. 2 issue of the Journal of the American College of Cardiology.

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Eisai's Aciphex superior to placebo at preventing relapse of erosive, ulcerative GERD for five years, study shows

Maintenance therapy with Eisai Inc.'s Aciphex (rabeprazole sodium) for five years appears to prevent relapse of erosive or ulcerative gastroesophageal reflux disease, according to results of a new study. Aciphex is co-promoted in the United States by Eisai and Janssen Pharmaceutica Inc.

The first phase of the study consisted of two identical one-year maintenance trials. A total of 497 patients were enrolled; all had been previously diagnosed with erosive or ulcerative GERD that had healed during an acute efficacy trial. During this study, the patients were randomized to receive 10 mg or 20 mg of Aciphex or placebo.

Overall, 261 of the patients successfully completed the one-year phase, defined as maintenance of esophageal healing that was confirmed by endoscopy. Then, 205 of these patients entered into a four-year extension phase during which they continued receiving the same therapy as in the first phase.

The primary outcome measure was relapse of the previously healed esophageal erosions or ulcerations, defined as a grade of more than one on the modified Hetzel-Dent grading scale (on the Hetzel-Dent grading scale, 0=no mucosal abnormalities, 4=deep ulceration in esophagus or confluent erosion).

After five years, the rates of relapse were significantly lower for the patients who were treated with 20 mg of Aciphex (11 percent) or 10 mg of Aciphex (23 percent) as compared with those who received placebo (63 percent). The difference between the relapse rates of the two Aciphex doses was also significant.

According to the Kaplan-Meier analysis, the probability that GERD erosions remained healed after five years also favored active treatment (87 percent for Aciphex 20 mg, 33 percent for Aciphex 10 mg and 20 percent for placebo).

Moreover, the relapse rates for daytime heartburn and heartburn frequency were also significantly lower for the Aciphex groups than for the placebo arm. The Aciphex-treated patients also scored significantly higher on overall well-being than the placebo-treated subjects.

Complete results can be found in the August issue of the journal Alimentary Pharmacology & Therapeutics.

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Cigna, Omnicare report increased 2005 Q2 income; shares rise

Citing better-than-expected results in its health and related benefits businesses and $430 million in tax-audit related benefits, Cigna Corp. posted a 43 percent increase in 2005 second-quarter income from $504 million, or $3.59 per diluted share, a year ago to $720 million, or $5.48 per diluted share.

For the second quarter ended June 30, the health insurer's adjusted income from operations was $1.98 per diluted share, $0.43 more than Reuters Estimates' average analyst forecast.

Cigna's total revenue fell to $4.11 billion, from $4.63 billion in the second quarter of 2004, as its total medical membership dropped by approximately 1 million to approximately 9 million; rate increases partially offset this loss, the firm said.

For the third quarter and full year 2005, Cigna expects consolidated adjusted income from operations to be in the range of $185 million to $215 million, or $1.40 to $1.60 per diluted share, and in the range of $920 million to $980 million, or $7.00 to $7.40 per diluted share, respectively. Analysts polled by Reuters Estimates expect the firm to achieve adjusted income from operations of $1.57 per share in the third quarter and $6.92 per share for the full year.

On the heels of its agreement to acquire NeighborCare Inc., Omnicare Inc. said its 2005 second-quarter net income rose as its institutional pharmacy business posted record revenues and productivity enhancement and cost reduction programs partially offset government reimbursement reductions.

The provider of pharmacy and pharmacy-related services to long-term care facilities achieved net income of $61.7 million, or $0.59 per diluted share, compared with $60.5 million, or $0.55 per diluted share, during the second quarter of 2004. Excluding items, the company earned $0.60 per share, which was in line with the forecast of analysts polled by Thomson Financial, The Associated Press reported.

Net sales increased from $1.01 billion in the previous-year period to $1.12 billion. The firm's institutional pharmacy business had sales of $1.07 billion, up from $976.8 million in last year's second quarter.

Last month, Omnicare said it was acquiring institutional pharmacy provider NeighborCare for approximately $1.8 billion.

Cigna shares closed at $115.57, up $7.17, or 6.6 percent, while Omnicare shares closed at $51.69, up $4.59, or 9.8 percent. Both stocks were heavily traded on the New York Stock Exchange.

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Mail-service pharmacies could save nearly $180 billion in U.S. prescription costs throughout next 10 years, report shows

Based on their estimated market penetration next year and potential future market penetration, mail-service pharmacies could save the U.S. health system up to $177.9 billion in prescription drug costs during the next 10 years, according to a study released by the Pharmaceutical Care Management Association (PCMA).

The Lewin Group, a health care policy consulting firm, conducted the study. Its calculations were based on data from the 2002 Medical Expenditure Panel Survey, IMS Health Inc., the Centers for Medicare & Medicaid's National Health Accounts projections for prescription drug spending, a Government Accountability Office report on pharmacy benefit managers and Takeda Pharmaceutical Co. Ltd.'s Prescription Drug Benefit Cost and Plan Design Survey Report.

The study noted that because mail-service pharmacies seem to have greater efficiency of automation and workflow as well as lower ingredient costs, prescription dispensing fees and administrative fees, these pharmacies are estimated to reduce costs by 10 percent when compared with their retail counterparts.

Currently, mail service accounts for just 17.3 percent of expenditures on outpatient prescriptions, but if their growing use continues, the group estimated that mail-service pharmacies could encompass approximately 50 percent of expenditures on outpatient drugs.

Indeed, while mail-service pharmacies are projected to account for 18.5 percent of drug expenditures in 2006, these pharmacies will save the health care system $5 billion in 2006 and $78.9 billion between 2006 and 2015. The latter figure includes $44.3 billion in savings for the Medicare population and $34.6 billion in savings for the commercial sector.

However, if all appropriate prescriptions for chronic conditions were filled through mail-service pharmacies, the health care system would save an additional $6.2 billion next year and would see a further cost reduction of $99 billion ($42.2 billion for Medicare patients and $56.8 billion for the commercial sector) throughout the next 10 years.

"Mail-service pharmacy is a 'win-win' scenario for seniors and policymakers looking to improve Medicare and put it on a more sound fiscal footing," said Mark Merritt, president of PCMA. "Some of the reasons that seniors with chronic conditions don't yet use mail is because they are unfamiliar with it, don't understand how it could help them and don't know how to access it. To the degree the mail-service pharmacy option can be more aggressively promoted and accepted, the better off seniors will be and better off the Medicare program will be."

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Eli Lilly and Co.

Eli Lilly and Co. will increase its debt by approximately $2 billion for the rest of the year, according to documents filed with the Securities and Exchange Commission. As of the end of last quarter, total debt was $4.68 billion, reflecting repayment of approximately $1.8 billion in debt during the first half of this year. However, business needs, the schizophrenia drug Zyprexa (olanzapine) product liability settlement and a resolution with the Internal Revenue Service for the tax years of 1998 to 2000 led to the increased debt, which Lilly expects to repay by the end of 2006.

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Biogen Idec Inc.

Biogen Idec Inc. and Protein Design Labs Inc. (PDL) entered into a collaboration to develop, manufacture and commercialize daclizumab in multiple sclerosis and any indications other than respiratory and transplant diseases. The drug is currently in Phase II trials for MS. The agreement also allows for M200 (volociximab), which targets tumor growth, and Huzaf (fontolizumab), which is designed to treat autoimmune diseases, to be developed and commercialized for all indications. PDL will receive an up-front payment of $40 million, and Biogen Idec will purchase $100 million of common stock from the company. PDL could receive milestone payments totaling up to $660 million if the products are developed for multiple indications and all milestones are reached. PDL shares closed at $26.24, up $2.94, or 12.6 percent, in heavy trading while Biogen Idec shares closed at $40.69, down $0.15, or 0.3 percent, in light trading. Both stocks are traded on the Nasdaq.

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Takeda Pharmaceutical Co. Ltd.

Takeda Pharmaceutical Co. Ltd. and Santhera Pharmaceuticals AG will collaborate on the development and commercialization of Idebenone, formerly known as SNT-MC17, a small molecule drug intended to treat Friedreich's ataxia, a hereditary and disabling neuromuscular disorder. Idebenone has been shown to "improve mitochondrial function and/or reduce oxidative stress in muscle cells, heart cells and neurons." Currently, the drug, which is about to begin Phase III studies, has orphan drug designation. Santhera will receive up-front payments of approximately $6.1 million, milestone payments and royalties from Takeda. Further financial terms were not disclosed. Santhera plans to market Idebenone on its own in the United States but will supply the drug to Takeda for Europe.

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Altana AG

Altana AG's specialty chemicals division, Altana Chemie AG, agreed to acquire the chemicals firm Eckart GmbH & Co. KG for approximately $777.1 million. Altana expects the acquisition to have a positive impact on its earnings starting in the second full year of business after the transaction. Following the completion of the acquisition, Altana plans to establish Altana Chemie as an independently operating and separately listed company. In addition, Altana said it has more than approximately $1.23 billion to strengthen its pharmaceuticals division, Altana Pharma AG, through product development, acquisitions, cooperations and alliances; the firm said it also expects to spin off this division "in the future." Altana shares closed at $56.00, up $2.51, or 4.7 percent, in moderate trading on the New York Stock Exchange.

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Auxilium Pharmaceuticals Inc.

Auxilium Pharmaceuticals Inc. and Cobra Biomanufacturing Plc entered into an agreement for the production and supply of AA4500, a protein biopharmaceutical. Cobra will supply scale up and current Good Manufacturing Practices services and provide the drug for Phase II/III trials. AA4500, which has been granted orphan drug status by the Food and Drug Administration, is being developed by Auxilium as a potential treatment for Peyronie's disease and Dupuytren's disease. The agreement is valued at more than $3.3 million for process development and clinical lot production through 2006.

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