Corporate Branding

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RISPERDAL DEEMED NOT APPROVABLE FOR PSYCHOSIS ASSOCIATED WITH ALZHEIMER'S DISEASE ------------------------------------------------------------------------------- Johnson & Johnson Pharmaceutical Research & Development LLC (J&JPRD) received a not approvable letter from the Food and Drug Administration for its supplemental New Drug Application for Risperdal (risperidone) as a treatment for psychosis in patients with Alzheimer's disease.

Noting that a great unmet need exists for this indication, the company said it will evaluate the FDA's letter and determine "appropriate" steps to take.

According to Reuters, Risperdal is one of Johnson & Johnson's biggest products, with annual sales of approximately $3 billion. The report added that other big-name pharmaceutical companies, such as AstraZeneca Plc, Bristol-Myers Squibb Co., Eli Lilly and Co. and Pfizer Inc., sell competing antipsychotics. Gaining approval for additional indications is a way to increase their share of the market.

J&JPRD recently received a not approvable letter for its sNDA for Risperdal as a treatment for autism as well.

Risperdal is approved to treat schizophrenia and as a short-term treatment for acute manic or mixed episodes associated with bipolar I disorder, both as monotherapy and in combination with lithium or valproate. The drug is marketed by Janssen Pharmaceutica Products LP, a division of J&J.

In separate news, J&J gave analysts a detailed look at its drug pipeline for the first time in four years, The Wall Street Journal reported.

J&J said it has 17 new drugs that are either awaiting regulatory approval or are in the advanced stages of testing, according to The Journal. The report noted that J&J had only two drugs in this stage of development as recently as 2001. "At a time when many companies in the industry are struggling with [research and development] productivity, we seem to be hitting our stride," said J&J Vice Chairman Christine Poon. -=-

MERREM APPROVED FOR TREATING COMPLICATED SKIN, SKIN STRUCTURE INFECTIONS ------------------------------------------------------------------------------- The Food and Drug Administration approved a new indication for AstraZeneca Plc's Merrem (meropenem) intravenous antibiotic for the treatment of complicated skin and skin structure infections in adults and children.

The approval was based on results from a Phase III, double-blind trial in which 1,037 hospitalized patients with complicated skin and skin structure infections were randomized to receive 500 mg of Merrem or an equivalent dose of Merck and Co. Inc.'s Primaxin (imipenem/cilastatin sodium) every eight hours. The primary efficacy endpoint was clinical outcome at follow-up in the clinically evaluable (CE) and modified intent-to-treat (MITT) study groups. MITT patients were those who met eligibility criteria and received at least one dose of the drug.

In the CE patients, 86 percent and 83 percent of the Merrem and Primaxin arms, respectively, achieved success. The rate of success was comparable between the treatment arms among MITT patients: 73 percent for Merrem versus 75 percent for Primaxin.

AstraZeneca underscored the results achieved by patients who were elderly or had diabetes mellitus. Among CE patients aged 65 years or older, 81 percent of those treated with Merrem showed a satisfactory clinical response at follow-up compared with 72 percent of patients treated with Primaxin. Among CE patients with diabetes, 86 percent of Merrem-treated patients and 72 percent of Primaxin-treated patients had a satisfactory clinical response.

Additionally, Merrem demonstrated an excellent success rate in patients infected with Gram-positive aerobes, Gram-negative aerobes and anaerobic pathogens.

Merrem, a broad-spectrum carbapenem injectable antibiotic, is already approved as a single agent for treating intra-abdominal infections in adults and for treating bacterial meningitis and intra-abdominal infections in pediatric patients aged at least 3 months. -=-

PHASE II STUDY OF ONO'S, MERCK'S ACUTE STROKE INJECTION HALTED ------------------------------------------------------------------------------- Ono Pharmaceutical Co. Ltd. plans to discontinue a Phase II study of an investigational acute stroke treatment it is codeveloping with Merck & Co. Inc. The decision was made after an independent data safety monitoring board determined that the drug's efficacy was unlikely to demonstrate statistical significance as compared with placebo.

Ono said it consulted with Merck before deciding to end the study of Proglia (2-propyloctanoic acid), formerly known as ONO-2506, which was currently under way in the United States and Canada.

The company also said it will share all study data with Merck, and the two companies will discuss future development plans for the drug outside Japan, Taiwan and Korea. Merck obtained rights last November to develop and market the drug worldwide, with the exception of those three countries.

Ono will continue a Phase II/III study that is currently under way in Japan. -=-

GSK SUBMITS BLA FOR FLUARIX INFLUENZA VACCINE ------------------------------------------------------------------------------- GlaxoSmithKline Plc submitted a Biologics License Application to the Food and Drug Administration for Fluarix (split virion, inactivated), an influenza vaccine.

If approved, Fluarix will be available to immunize adults against influenza virus types A and B. Dow Jones Newswires reported a GSK spokeswoman as saying the company would supply approximately 10 million doses of the vaccine for the upcoming flu season in the United States if the product is approved.

Last December, the FDA authorized use of the vaccine in the United States under an Investigational New Drug application after the shutdown of Chiron Corp.'s British manufacturing plant led to an influenza vaccine shortage. GSK was permitted to sell 4 million doses to alleviate the shortage.

"Right now, a limited number of companies supply injectable flu vaccine to the entire nation, making the system vulnerable when there are problems with supply, as we saw last flu season," said Christopher Viehbacher, president of GSK's U.S. pharmaceuticals division.

"We're happy to be once again working closely with the Department of Health and Human Services and the FDA to help fill this void in public health," he continued, "and with FDA approval, we're committed to making Fluarix available before the next flu season." -=-

NEUROCRINE REFILES NDA FOR INDIPLON TABLETS ------------------------------------------------------------------------------- Neurocrine Biosciences Inc. resubmitted its New Drug Application for indiplon tablets as a treatment for insomnia in adults and elderly patients.

The resubmission was to address formatting difficulties associated with an electronic NDA submitted in November.

The company resubmitted an NDA for indiplon capsules in April to correct similar formatting issues related to the electronic document originally submitted in October.

"The indiplon NDA submissions are supported by data from one of the most comprehensive clinical trial programs conducted in insomnia which showcased the consistency with which indiplon helps patients address sleep onset and sleep maintenance problems while improving overall sleep quality," said Gary Lyons, chief executive officer of Neurocrine.

"We believe that the flexibility of indiplon in treating the individual sleep needs of patients, coupled with the demonstrated long-term safety, make it an important advancement in the treatment of insomnia," Lyons added.

In January, Lyons said that refiling the NDAs would have a "modest impact" on anticipated approval and launch timelines for the non-narcotic, nonbenzodiazapine agent. -=-

CLINICAL-TRIAL AGREEMENT STANDARDS VARY, STUDY FINDS ------------------------------------------------------------------------------- Standards for industry-sponsored clinical-trial agreements vary greatly among academic medical institutions, according to the results of a structured, cross-sectional mail survey.

Researchers contacted administrators in charge of clinical-trial agreements at all 122 accredited U.S. medical schools, excluding those in Puerto Rico; 107 schools participated in the survey.

More than 85 percent of respondents said their office would not approve provisions allowing industry sponsors to revise manuscripts or decide whether to publish trial results.

However, the schools disagreed on whether it was acceptable to allow sponsors to add their own statistical analyses to manuscripts (24 percent allowed this, 47 percent did not allow it and 29 percent were unsure if it should be allowed).

Also, while 40 percent of respondents said they do not allow sponsors to draft manuscripts, 50 percent do allow this practice and 11 percent were unsure if it should be allowed.

The schools also varied on whether sponsors should be allowed to prohibit investigators from sharing data with third parties after a trial is complete; 41 percent said they do allow this, 34 percent said they do not allow this and 24 percent were unsure if it should be allowed.

"Further consensus-building among academic medical centers would help institutions structure research partnerships to be both ethical and productive," the authors concluded.

The study appeared in the May 26 issue of The New England Journal of Medicine. -=-

Corporate Branding
ARIAD PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Ariad Pharmaceuticals Inc. began enrolling patients in the first Phase 1b trial of an oral formulation of AP23573 in patients with relapsed and/or refractory cancer. The nonrandomized study, which will enroll as many as 150 patients in the United States, is intended to evaluate three different dosing regimens of the drug for safety, anticancer activity, pharmacokinetics and bioavailability. Ariad is currently testing an intravenous formulation of AP23573 in patients with hematologic malignancies and solid tumors. -=-

Corporate Branding
MYOGEN INC. ------------------------------------------------------------------------------- Myogen Inc. achieved three development milestones and expanded its research collaboration with Novartis AG relating to the discovery and development of drugs for heart muscle disease. The firms agreed to expand their previous agreement to include Myogen's histone deacetylase inhibitor program. The expansion will extend research funding for at least three years; it also includes undisclosed payments on sales of products that are marketed as a result of the collaboration. Myogen also has the option of co-promoting these products in specific markets, in exchange for certain considerations. -=-

Corporate Branding
CHROMOS MOLECULAR SYSTEMS INC. ------------------------------------------------------------------------------- Chromos Molecular Systems Inc. signed a letter of intent to acquire private biotechnology company Targeted Molecules Corp. Chromos will issue approximately 20.1 million common shares to Targeted Molecules' shareholders under the terms of the transaction, which is expected to close in July. Targeted Molecules' two lead drug candidates are antibody products intended to treat acute thrombosis and multiple sclerosis. -=-

Corporate Branding
HUMANA INC. ------------------------------------------------------------------------------- Humana Inc. and the University of Miami's Leonard M. Miller School of Medicine created the Health Services Research Center, which will explore new strategies for preventing disease and managing chronic illness. The center will integrate data from the medical school's records with Humana's claims and health benefits information toward its goal of keeping people healthy and reducing health care costs. The new research center will be located on the university's medical campus. -=-