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Boston Scientific to implement Heart Rhythm Society's recommendations relating to implantable devices The Heart Rhythm Society released draft guidelines that relate to responding to pacemaker and implantable cardioverter defibrillator product malfunctions and recalls, and Boston Scientific Corp. issued a statement indicating that it plans to implement all the recommendations contained in the society's draft report.

In January, Boston Scientific received a warning letter from the Food and Drug Administration citing the medical device maker's "inadequate corporatewide corrective action plan" in response to "serious deficiencies" found at the firm's manufacturing facilities. The FDA said it would not approve any of Boston Scientific's Premarket Approval Applications until the firm resolved the issues raised.

The HRS recommendations--which according to The Wall Street Journal were developed in response to recalls announced last year of certain heart devices--urge device manufacturers to develop and use wireless and remote monitoring technology to identify device abnormalities as soon as possible and to reduce underreporting of device malfunctions. The society also said device manufacturers should establish independent committees of experts to analyze data regarding cardiac device performance.

The recommendations also suggest that the FDA eliminate the use of the term "recall" when referring to implanted devices, since actual replacement of the device is not always required and could be confusing to patients.

By implementing all of the recommendations contained in the HRS draft report, Boston Scientific hopes to "ensure timely and transparent clinician communication and patient safety." The firm acknowledged its need to "do better in this area." A statement issued by Medtronic Inc. indicated that the majority of the recommendations in the HRS proposal have been standard practice at the company.

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Novartis' NDA for blood pressure drug Exforge accepted by FDA The Food and Drug Administration accepted for review Novartis AG's New Drug Application for Exforge (amlodipine besylate/valsartan) as a treatment for high blood pressure.

The filing was based on a clinical trial program that involved more than 5,000 patients with hypertension. In five controlled trials in the program, more than 2,600 patients received Exforge once a day; the results of these trials showed that a single daily dose of Exforge significantly reduced blood pressure and was well tolerated.

Exforge combines two active ingredients that provide complementary mechanisms of action, according to Novartis. Amlodipine besylate is a calcium channel blocker, and valsartan, which Novartis markets as Diovan, is an angiotensin receptor blocker.

"Exforge has the added benefit of bringing together the efficacy of two proven mechanisms of action, resulting in significantly lower blood pressure," said Dr. James Shannon, head of development at Novartis Pharma AG.

The company noted that more than 65 million Americans are estimated to have high blood pressure, and that approximately half of those who are being treated for the condition have not achieved their treatment goal.

"With so many patients still uncontrolled, a real need exists for an agent that can help people reach and maintain their blood pressure goal," said Shannon.

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BMS, Gilead submit NDA for once-daily combined-regimen HIV tablet; BMS posts Q1 profit Bristol-Myers Squibb Co. and Gilead Sciences Inc. submitted a New Drug Application to the Food and Drug Administration for a once-daily tablet that combines BMS' Sustiva (efavirenz) and Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate) for the treatment of HIV-1 infection in adults.

The companies said if the FDA approves the new single-tablet regimen, it would be the first approved treatment to contain a complete highly active antiretroviral therapy regimen in a single, once-daily tablet; it could be administered alone as a complete HIV regimen or in combination with other antiretrovirals.

Upon receiving regulatory approval, the companies will share responsibility for U.S. commercialization of the product, with each entity receiving revenue from net sales at percentages relative to the contribution represented by their individual products that are in the new regimen. BMS and Gilead said the individual products that make up the new combined regimen--specifically Sustiva, Truvada, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), the latter two of which were combined to form Truvada--will continue to be sold separately.

In other news, BMS reported its financial results for the first quarter of 2006, which reflected net sales of $4.68 billion, an increase of 3 percent from the previous year's first-quarter net sales of $4.53 billion.

Net earnings for the quarter were $714 million, or $0.36 per diluted share, up from $533 million, or $0.27 per diluted share, for the same period last year. Excluding special items, net earnings were $637 million, or $0.32 cents per diluted share, compared with $670 million, or $0.34 per diluted share, in last year's first quarter.

U.S. pharmaceutical sales increased 17 percent to $2.1 billion in the first quarter of 2006 compared with the same period in 2005, driven in part by higher average net selling prices and by growth in sales of antiplatelet drug Plavix (clopidogrel bisulfate), which increased 26 percent to $850 million; hypertension treatments Avapro (irbesartan) and Avalide (hydrochlorothiazide/irbesartan), which increased 36 percent to $139 million; the antipsychotic Abilify (aripiprazole), which increased 43 percent to $231 million; HIV therapy Reyataz (atazanavir sulfate), which increased 29 percent to $119 million; and cancer treatment Erbitux (cetuximab), which posted an increase in sales of 56 percent to $136 million.

Overseas drug sales, by comparison, fell 10 percent to $1.6 billion, with the company citing generic competition in Europe for cancer drug Taxol (paclitaxel) and cholesterol fighter Pravachol (pravastatin sodium) as the primary reasons.

Plavix, Avapro and Avalide are part of BMS' alliance with Sanofi-Aventis Group.

BMS shares closed at $25.27, up $0.30, or 1.2 percent, in moderate trading on the New York Stock Exchange.

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Isis' investigational antisense agent lowers cholesterol, triglycerides in study patients Initial data from a Phase II trial of Isis Pharmaceuticals Inc.'s second-generation antisense agent, ISIS 301012, showed that the drug produced rapid, dose-dependent, prolonged reductions of apoB-100, which is a protein involved in the synthesis of LDL and very low density lipoprotein (VLDL) cholesterol, in patients with high cholesterol. The drug also reduced total cholesterol and triglyceride levels.

The researchers' objectives were to evaluate the safety and efficacy of weekly doses of ISIS 301012 as a single-agent in patients who were unable to control their cholesterol through diet and exercise.

In the double-blind, dose-escalation study, 30 patients were randomized to receive placebo or 50 mg, 100 mg or 200 mg per week of ISIS 301012. Patients in the 50 mg and 100 mg groups received a loading dose for the first two weeks.

After three months of treatment, patients experienced a median reduction in apoB-100 from baseline of 47 percent, 23 percent and 22 percent in the 200 mg, 100 mg and 50 mg groups, respectively.

Additionally, at the same timepoint, the 200 mg/week dose yielded a median reduction from baseline of 42 percent in LDL cholesterol, 34 percent in total cholesterol and 46 percent in triglycerides. The 100 mg/wk group experienced a median reduction from baseline of 22 percent in LDL cholesterol, 15 percent in total cholesterol and 22 percent in triglycerides. The 50 mg/wk group experienced a median reduction from baseline of 12 percent in LDL cholesterol, 12 percent in total cholesterol and 7 percent in triglycerides.

"The results of this initial Phase II study show that all three doses of ISIS 301012 produced attractive lowering of lipids and triglycerides, and were all well tolerated," said Dr. Mark Wedel, chief medical officer of Isis. "We have demonstrated that 50 mg/wk of ISIS 301012 effectively reduces LDL and that 200 mg/wk results in statin-like LDL reductions. In addition, we have shown that ISIS 301012 reduces triglycerides significantly."

Isis noted that it is developing ISIS 301012 in collaboration with Symphony GenIsis, an affiliate of Symphony Capital LLC, and that researchers are also assessing the drug at doses of 300 mg and 400 mg per week.

Shares of Isis closed at $8.64, up $1.08, or 14.3 percent, in heavy trading on the Nasdaq.

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GSK reports strong Q1 profit, sales GlaxoSmithKline Plc reported a 25 percent increase in 2006 first-quarter profit, which totaled $2.7 billion, driven by strong sales in its asthma, diabetes and vaccines product lines.

Sales for the quarter were $10.4 billion, an increase of 15 percent from the same period of the previous year, and earnings per share climbed 17 percent, from approximately $0.38 per share in 2005 to approximately $0.48 per share in 2006.

For asthma drug Advair (fluticasone propionate/salmeterol xinafoate), the company reported an 11 percent increase in U.S. sales, which totaled approximately $828.6 million for the quarter. U.S. sales of Avandia (rosiglitazone maleate) diabetes products rose 34 percent to approximately $477.3 million.

GSK's vaccine line exceeded analysts' expectations, according to The Associated Press. U.S. sales of the company's vaccines increased 41 percent to approximately $149.5 million, with the vaccines Infanrix (diphtheria and tetanus toxoids and acellular pertussis adsorbed [DTaP]) and Pediarix (DTaP/hepatitis b [recombinant]/inactivated poliovirus) posting an increase in sales of 32 percent to approximately $73.8 million. Hepatitis vaccine sales grew 27 percent in the United States to $66.6 million.

GSK reiterated a target of full-year earnings per share growth of 10 percent.

The company's shares closed at $55.45, up $2.38, or 4.5 percent, in heavy trading on the New York Stock Exchange.

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AstraZeneca's Q1 sales of key products increase; company to collaborate with Abraxis on tumor treatment AstraZeneca Plc reported positive financial results for the first quarter and raised its 2006 earnings forecast based on increased sales of key products.

The company reported a quarterly profit of $1.42 billion, or $0.90 per diluted share, compared with $1.04 billion, or $0.63 per diluted share, in the same period of 2005.

Analysts polled by Reuters expected the company to earn $0.82 per share.

Total sales for the quarter increased 12 percent to $6.18 billion from $5.74 billion in the same quarter of 2005.

Global sales of heartburn and acid reflux drug Nexium (esomeprazole magnesium) totaled $1.19 billion, up 16 percent from the first quarter of 2005. Sales of schizophrenia drug Seroquel (quetiapine fumarate) were $807 million, up 29 percent from the corresponding 2005 quarter.

AstraZeneca increased its 2006 earnings forecast to a range of $3.60 to $3.90. This includes approximately $0.33 of earnings relating to cardiovascular drug Toprol-XL (metoprolol succinate) for the rest of the year; Reuters noted that Toprol-XL may soon experience generic competition in the United States.

In separate news, AstraZeneca entered into an agreement with Abraxis BioScience Inc. to co-promote Abraxane (paclitaxel), an injectable, albumin-bound formulation of paclitaxel for the treatment of tumors.

In a Phase III study of women with metastatic breast cancer who had not responded to combination chemotherapy, the drug demonstrated a significantly higher response rate than standard paclitaxel did, according to AstraZeneca.

The company noted that Abraxane does not require premedication to avoid hypersensitivity reactions and requires a shorter infusion time than standard paclitaxel does. The drug is in development programs as a treatment for a variety of tumor types, including non-small cell lung, ovarian, prostate, adjuvant breast, melanoma, head and neck and upper gastrointestinal cancers.

Under the terms of the agreement, AstraZeneca will pay $200 million to Abraxis for co-promotion rights to the drug in the United States. AstraZeneca will also fund half of the drug's promotional and advertising program. Abraxis will receive milestone payments if new indications are approved within certain timelines. AstraZeneca will receive commissions on the drug's net sales within the United States.

In the first year of Abraxane's launch, Abraxis reported U.S. sales of $134 million.

AstraZeneca also agreed to sell to Abraxis its line of anesthetic and analgesic products. Abraxis will pay $350 million for the products and will enter into a five-year supply agreement. According to the company, combined sales for these products in 2005 were approximately $217 million.

AstraZeneca shares closed at $55.01, up $1.21, or 2.3 percent, in heavy trading on the New York Stock Exchange.

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Brand Institute
Bayer AG Bayer AG's net income decreased in the first quarter to approximately $752 million, or $1.03 per share, from approximately $817 million, or $1.12 per share, in the same period of 2005. The company attributed the decrease in large part to charges associated with U.S. arbitration involving the production of propylene oxide, a chemical compound. Quarterly net sales, however, increased nearly 12 percent to approximately $9.39 billion from approximately $8.4 billion in the same period of 2005. Bayer HealthCare sales increased to approximately $3.24 billion. The company confirmed its 2006 full-year outlook as a result of a "dynamic start" in the first quarter. Bayer shares closed at $45.00, up $1.30, or 3 percent, in moderate trading on the New York Stock Exchange.

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Brand Institute
Xoma Ltd. Xoma Ltd. and Aveo Pharmaceuticals Inc. entered into an agreement in which Xoma will use its patented Human Engineering technology to humanize AV-299, Aveo's hepatocyte growth factor monoclonal antibody. According to the companies, the agent has shown efficacy in preclinical cancer studies. Under the agreement, Aveo will pay Xoma an unspecified licensing fee, development milestones and royalties. Aveo will retain development and commercialization rights to AV-299. Additional financial terms of the agreement were not disclosed.

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Brand Institute
Anadys Pharmaceuticals Inc. Anadys Pharmaceuticals Inc. and LG Life Sciences Ltd. said results from a Phase II trial of ANA380 (LB80380) in 62 patients with hepatitis B virus infection and proven resistance to GlaxoSmithKline Plc's Epivir (lamivudine) demonstrated a substantial reduction in plasma HBV DNA at 12 weeks. Anadys also noted that preclinical studies have demonstrated activity of ANA380 against wild-type and resistant viral strains. "These Phase II data ... suggest that ANA380 may very well be the best-in-class among marketed HBV therapies and product candidates in development," said Anadys Chief Executive Officer Kleanthis Xanthopoulos.

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Brand Institute
Intracel Corp. Intracel Corp. reached an agreement with the Food and Drug Administration on the design of a pivotal Phase III trial of the company's colon cancer vaccine, OncoVax. The trial will assess the vaccine's effect in patients with stage II colon cancer who have already had surgery to remove cancerous tumors. The study is to include 560 patients in the United States and Europe. In addition to evaluating whether patients who receive the vaccine can remain cancer-free for a longer period of time, the investigators will assess the overall five-year survival rate and how long it takes tumors to recur.