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POSSIBLE FOURTH PML CASE LINKED TO TYSABRI SENDS BIOGEN IDEC, ELAN SHARES DOWN ------------------------------------------------------------------------------- Biogen Idec Inc. and Elan Corp. Plc's shares fell Thursday after a report in The Boston Globe said Biogen Idec told the Food and Drug Administration that a fourth patient taking the companies' multiple sclerosis drug, Tysabri (natalizumab), may have developed progressive multifocal leukoencephalopathy (PML), a rare central nervous system disorder.

The FDA is "in communications with [Biogen Idec] on this case, as well as on the ongoing safety review," FDA spokeswoman Lenore Gelb told The Globe.

This fourth possible case of PML involves a 48-year-old woman who was taking the drug in combination with Biogen Idec's Avonex (interferon beta-1a). Two of the confirmed PML cases involved patients with MS who were participating in a Tysabri trial and who also were taking Avonex. The third case involved a patient in a Crohn's disease trial; this patient was not taking other MS drugs.

"The patient referenced in [The Globe] story is alive," Biogen Idec spokeswoman Amy Brockelman told Reuters, although she did not confirm whether the patient was suspected to have PML. "We are reviewing any and all suspected cases. It's an extensive evaluation. We hope to have findings by the end of the summer."

Brian McGlynn, a spokesman for Elan, said the company would refrain from commenting "on individual cases until the safety evaluation is completed."

Biogen Idec and Elan began their safety evaluation in February, when they suspended sales of Tysabri after the first patient developed, and died from, PML. In early March, the companies confirmed a second patient's diagnosis of the same disease. Later in March, the companies said they had determined that the December 2003 death of a patient in a Crohn's disease trial was caused by PML and not by malignant astrocytoma, a type of brain tumor, as was originally thought.

Richard Parkes, an analyst at ING Groep NV in London, told Reuters it is hard to know what impact this potential fourth PML case could have on the companies.

"If the story is true and the case is confirmed, it highlights two things--the possibility that we could still see further cases, and the risks in trying to get the product back on to the market," Parkes said.

Elan shares closed at $6.85, down $1.14, or 14.3 percent, in heavy trading on the New York Stock Exchange. Biogen Idec shares closed at $38.07, down $1.70, or 4.3 percent, in moderate trading on the Nasdaq. -=-

NOVADEL RECEIVES APPROVABLE LETTER FROM FDA FOR NITROMIST ------------------------------------------------------------------------------- NovaDel Pharma Inc. received an approvable letter from the Food and Drug Administration for NitroMist (nitroglycerin lingual aerosol), which is indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

The FDA said it will not require any additional clinical studies to approve the drug, and NovaDel believes final approval will be granted when the company completes "previously agreed-to manufacturing process validation commitments."

"We are already moving toward completion of the process-validation work required for approval and believe a complete response can be submitted to [the] FDA in an expeditious manner," said Dr. Gary Shangold, NovaDel's chief executive officer.

Par Pharmaceutical Companies Inc. has exclusive rights to market, sell and distribute NitroMist in the United States and Canada; in exchange for these rights, NovaDel will receive milestone and royalty payments. Inyx Inc. will manufacture the product. -=-

NOVARTIS, ANADYS PHARMACEUTICALS SIGN AGREEMENT FOR HEPATITIS DRUGS ------------------------------------------------------------------------------- Novartis AG entered into an exclusive agreement with Anadys Pharmaceuticals Inc. to develop, manufacture and market ANA975 and other toll-like receptor 7 (TLR7) prodrugs for the treatment of chronic hepatitis C virus and hepatitis B virus infections.

News of the agreement, which could be worth more than $570 million, sent Anadys' shares up nearly 24 percent.

Novartis will pay Anadys an initial license fee of $20 million and up to $550 million in milestone payments in connection with ANA975. Novartis will make a $10 million payment upon the successful submission of an Investigational New Drug application; Anadys expects to file the IND this summer.

Under the agreement, Anadys is also eligible for potential royalties and a co-promotion option in the United States. Should Anadys decide to contribute 35 percent of U.S. marketing costs, it will receive 35 percent of U.S. profits. If it chooses not to exercise this option, Anadys will still receive royalties on net product sales.

ANA975, a small molecule agonist, is a prodrug of isatoribine. Anadys believes isatoribine interacts with TLR7, which is found on certain cells in the immune system, thereby helping to regulate the body's innate immune responses against the hepatitis viruses.

Results from clinical trials of patients with HCV have shown statistically significant reductions in viral loads after one week of treatment with ANA975, according to Anadys.

Novartis and Anadys will also collaborate on other possible indications for the drugs.

Anadys shares closed at $8.37, up $1.61, in heavy trading on the Nasdaq. Novartis shares closed at $49.53, up $0.42, or 0.9 percent, in heavy trading on the New York Stock Exchange. -=-

TAXOTERE SIGNIFICANTLY IMPROVES DISEASE-FREE, OVERALL SURVIVAL OVER FLUOROURACIL AS ADJUVANT THERAPY FOR BREAST CANCER, DATA SHOW ------------------------------------------------------------------------------- Sanofi-aventis Group said results from a Phase III study of an adjuvant Taxotere (docetaxel) injection concentrate-based regimen showed a 28 percent reduction in risk of relapse and a 30 percent reduction in risk of death in women with operable, node-positive breast cancer after a median follow-up of 55 months.

In the study, investigators randomly assigned 1,491 patients to receive six cycles of treatment with one of two drug combinations following surgery: doxorubicin and cyclophosphamide plus Taxotere (TAC) or doxorubicin and cyclophosphamide plus 5-fluorouracil (FAC).

In addition to the previously mentioned benefits, patients treated with the combination treatment including Taxotere exhibited a lower rate of recurrence: 25 percent versus 32 percent for those treated with fluorouracil combination therapy.

"What is particularly important about the Taxotere findings is that the risk of relapse is reduced in both hormone receptor positive and hormone receptor negative patients and is irrespective of the number of positive lymph nodes, which means that all women with operable, node-positive breast cancer may potentially benefit from the TAC therapy," said Dr. Miguel Martin, a member of the Breast Cancer International Research Group, which conducted the study.

While the authors of the study noted increased toxicity with the Taxotere-based regimen, they said the treatment resulted in "only a transient reduction in quality-of-life scores, which subsequently returned to pretreatment baseline values." Furthermore, the Taxotere-based regimen was associated with significantly less nausea and vomiting compared with the fluorouracil-based regimen.

The benefit of the combination therapy that included Taxotere "was so large and so striking, it's turned a lot of heads," John Mackey, one of the study's authors, told Reuters. "It's a high water mark for chemotherapy. It has catapulted the (docetaxel) regimen into being a standard of care," he added.

The study appears in the June 2 issue of The New England Journal of Medicine. -=-

MERCK'S INVESTIGATIONAL VACCINE CUTS INCIDENCE OF SHINGLES MORE THAN 50 PERCENT IN OLDER ADULTS, STUDY FINDS ------------------------------------------------------------------------------- Merck & Co. Inc.'s investigational vaccine, Zostavax (zoster vaccine live), reduces morbidity from herpes zoster (also known as shingles), and postherpetic neuralgia (PHN), in adults aged at least 60 years, according to a study appearing in the June 1 issue of The New England Journal of Medicine.

Researchers enrolled 38,546 adults aged 60 years or older; more than 95 percent completed the study. Patients were randomized to receive a subcutaneous 0.5 mL injection of Zostavax or placebo.

After a median 3.12 years of surveillance (range, one day to 4.9 years), researchers confirmed 315 cases of shingles in Zostavax recipients, 642 cases of shingles in placebo recipients, 27 cases of PHN in Zostavax recipients and 80 cases of PHN in placebo recipients.

The vaccine was found to reduce the burden of illness due to shingles by 61.1 percent, the incidence of shingles by 51.3 percent and the incidence of PHN by 66.5 percent.

"We believe that the observed efficacy of [Zostavax] reflects its ability to boost immunity to [varicella-zoster virus] in vaccinated subjects--an issue that will require further study," the investigators said.

Initial infection by the varicella-zoster typically results in chickenpox. The virus then becomes dormant, often for decades. Shingles occurs when the virus is reactivated.

Merck filed a Biologics License Application for Zostavax in April. -=-

CONSUMERS VIEW INTERNET MOST TRUSTWORTHY MEDIUM FOR HEALTH CARE INFORMATION, STUDY FINDS ------------------------------------------------------------------------------- Consumers trust health care information found on the Internet more than information delivered via other media, according to a survey sponsored by Medical Broadcasting Company (MBC) and fielded by Nielsen/NetRatings.

The survey was conducted over a 30-day period in the first quarter of this year and involved 991 respondents who had visited "the 20 most highly trafficked health Web sites," according to MBC, an interactive health care marketing agency.

Researchers found that 42 percent of respondents trust health information on the Internet, versus 16 percent who said they trust information found in other media.

The study also revealed that more than 65 percent of respondents research important health topics on the Internet before and after visiting their physician and that almost one-third of respondents visit pharmaceutical companies' Web sites to get prescription drug information.

More than 85 percent of those polled said they view at least two Web sites when searching for health information.

"These health care consumers are online, they trust the medium more than other media, we can segment them more efficiently than we can in other media and with the advent of rich media, the online experience takes on some of the more impactful attributes of television," said Larry Mickelberg, a senior vice president at MBC.

"Given the current environment of pressure and constraints on [direct-to-consumer] television advertising, we're surprised that spending on Internet marketing still lags so far behind actual use," said Linda Holliday, president of MBC.

Holliday said MBC created the survey to show its clients "how powerful and truly exceptional the Internet is for their marketing needs." -=-

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CHIRON CORP. ------------------------------------------------------------------------------- Chiron Corp., in conjunction with the Multiple Myeloma Research Consortium (MMRC), initiated a Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic and pharmacodynamic profiles of CHIR-258 in patients with multiple myeloma. This marks the third Phase I trial of the drug--a tyrosine kinase inhibitor developed by Chiron. The drug is also being tested as a treatment for mixed solid tumors and acute myeloid leukemia, according to Chiron. It is the first drug candidate to undergo clinical study through the MMRC. -=-

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INSPIRE PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Inspire Pharmaceuticals Inc. submitted an amendment to its New Drug Application to the Food and Drug Administration for approval to market diquafosol tetrasodium as a treatment for dry eye disease. The company completed two additional Phase III trials of the compound after receiving an approvable letter from the FDA in December 2003. According to Inspire, the amendment focuses on multiple analyses of ocular surface staining. -=-

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CVS CORP. ------------------------------------------------------------------------------- CVS Corp. raised its second-quarter and full-year guidance for 2005 as a result of the company's strong performance year-to-date, the acquisition of Eckerd stores and increased generic drug utilization. For the second quarter, CVS now expects to earn $0.61 to $0.63 per diluted share, up from previous estimates of $0.59 to $0.61 per diluted share. For the year, the company expects diluted earnings per share of $2.70 to $2.75 compared with a previous guidance of $2.66 to $2.72 per diluted share. CVS reported total sales of $2.85 billion for the four-week period ended May 28, representing an increase of 31.5 percent from the same period in 2004. Same-store sales increased 5.8 percent. CVS shares closed at $57.25, up $2.17, or 3.9 percent, in heavy trading on the New York Stock Exchange. -=-

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GROPEP LTD. ------------------------------------------------------------------------------- GroPep Ltd. said the Food and Drug Administration approved a biopharmaceutical product containing a key raw material GroPep supplies. The product is the seventh drug made with the company's cell culture products to gain regulatory approval. GroPep said it was unable to divulge the name of the product or the name of the company that produces it due to confidentiality agreements, adding that an application has been filed to market the product in the European Union. The FDA approval is not expected to substantially increase GroPep's revenue, but the company's chief executive officer, Bob Finder, said it does underscore "growing international recognition" for GroPep's cell culture products. -=-