Generic Name

Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management

Guidant warns of problems with Insignia, Nexus implantable pacemakers Guidant Corp. issued a physician advisory for problems identified during a recent Food and Drug Administration inspection related to two of its implantable pacemakers.

The safety information pertains to the company's Insignia and Nexus pacemakers, which may demonstrate intermittent or permanent loss of pacing output without any warning, a malfunction that Guidant said can lead to serious health complications. Other reported failures include loss of telemetry and the appearance of a reset warning message.

The company said the FDA may label its notice as a recall.

No deaths have been reported as a result of these failure modes, although nine patients have required emergency hospitalization. Of 49,500 Insignia and Nexus pacemakers distributed worldwide, Guidant said it had confirmed the loss of pacing output in 36 devices as of Sept. 6. This included seven instances in which the problem was detected before implantation.

Guidant estimated the device failure rate to be .017 percent to .037 percent during the remaining device lifetime, or approximately seven to 15 additional failures.

The company noted that no failures have been observed in Insignia and Nexus devices shipped since March 2004, when a supplier made changes in the manufacturing of a timing component that was the apparent cause of the failures.

Guidant said a second type of problem, the cause of which has yet to be determined, resulted in a "no output condition" in 16 devices out of 341,000 devices distributed worldwide. In all 16 instances, the problem was detected at the time of the implant or during testing before the procedure. Additionally, Guidant received one report of a patient being resuscitated for cardiac arrest after a loss of pacing output during an elective procedure.

Earlier this summer, Guidant issued recalls on certain models of implantable cardiac defibrillators and other pacemakers. At that time, analysts speculated whether those actions would affect Johnson & Johnson's plans to acquire Guidant. J&J spokesman Jeffrey Leebaw said Thursday in a report by The Associated Press that the company continues to work with Guidant on the impact of the recall announcements and expects a decision on the merger by the Federal Trade Commission in October.

Regarding the earlier recalls, Guidant said the estimated failure rates for Contak Renewal and Contak Renewal 2 defibrillators have been revised and are nearly triple the previous estimates. The company said physicians have been notified of the revised rates.

Generic Name

FDA requests more information on Avanir's Neurodex NDA; delay likely Avanir Pharmaceuticals said the Food and Drug Administration requested more information for certain summary analyses in support of the company's New Drug Application for Neurodex (dextromethorphan/quinidine sulfate) for the treatment of pseudobulbar affect, a condition characterized by episodes of uncontrollable laughter or crying.

The company plans to meet with FDA officials in the next few weeks to discuss the agency's request, but it expects the FDA will reset the NDA filing date to coincide with the submission of the new data.

"This delay is unfortunate, but we are very appreciative that the FDA is willing to work closely with us to make our application as complete and reviewable as possible," said Eric Brandt, chief executive officer of Avanir.

Neurodex is in clinical trials for use in treating pseudobulbar affect and neuropathic pain. According to Avanir, as many as 1 million patients with neurological disorders such as amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer's disease and stroke experience the fits of laughter or crying associated with pseudobulbar affect. The FDA has not yet approved any drugs to treat this condition, the company added.

IriSys Inc. sublicensed Neurodex to Avanir in 2000.

Avanir shares closed at $3.06, down $0.24, or 7.3 percent, in heavy trading on the American Stock Exchange.

Generic Name

Risk of GI bleeding no different with COX-2 inhibitor, nonselective NSAID use, according to analysis Among patients of a managed care organization, use of COX-2 inhibitors did not reduce the risk of gastrointestinal bleeding when compared with use of nonselective nonsteroidal anti-inflammatory drugs.

Adult patients who began treatment with a nonselective NSAID or a COX-2 inhibitor between January 1999 and August 2002 were identified during a retrospective analysis of pharmacy and medical claims from a large managed care organization and a pharmacy benefits manager. Using propensity scoring, researchers matched patients from each treatment group based on age, sex, geographical state, comorbidity index, corticosteroid use, warfarin use, arthritis indication and history of GI bleeding.

The 35,007 pairs of COX-2 inhibitor and nonselective NSAID users were followed until they switched or discontinued their therapy, disenrolled from the health plan, developed a GI bleed or reached the end of the study's one-year follow-up period.

A GI bleed--defined as an inpatient hospitalization for GI bleed or at least two medical claims with a primary diagnosis for GI bleed--occurred in 19.5 patients per 1,000 person-years in the COX-2 group and in 18 patients per 1,000 person-years in the NSAID group. Among those who experienced a GI bleed event, the average age was 75.1 years and 61 percent were female.

Data showed the risk of GI bleed was not significantly different for those who used COX-2 inhibitors as compared with those who used nonselective NSAIDs, although the time to a GI bleed event was shorter with NSAID use than with COX-2 use.

Even in high-risk patients--those who were older than 65 years of age, had a GI-bleed-related inpatient hospitalization within six months before beginning the therapy or had a pharmacy claim for warfarin or a corticosteroid--use of COX-2 inhibitors did not reduce the risk of a GI bleed, according to the findings.

"With the high direct-drug cost of COX-2 inhibitors and the uncertain risk of adverse cardiovascular events, further research is needed to re-evaluate the appropriate patient populations for cost-effective treatment with COX-2 inhibitors," the investigators concluded.

The study can be found in the September edition of the Journal of Managed Care Pharmacy.

In an accompanying editorial, the journal's editor-in-chief, Frederic Curtiss, said "the finding of no difference in the rate of GI bleed for COX-2 inhibitor users versus NSAID users seems stronger as a result of the coincident operation of a prior authorization program for COX-2 inhibitors in this managed care organization that may have led to selection bias in the group of COX-2 inhibitor users."

Generic Name

Phase II study of patients with mild Alzheimer's disease shows Myriad's Flurizan stabilizes cognitive decline Myriad Genetics Inc. said results of a Phase II follow-on study of Flurizan, an investigational treatment for Alzheimer's disease, showed that patients with mild AD who were treated with 800 mg of the drug twice a day appeared to stabilize and experience no further decline in cognitive function from months 12 to 15.

The three-month data included 81 percent of the participants of the 207-patient, year-long trial, which demonstrated a positive trend on all three of the trial's primary endpoints in patients who were treated with 800 mg of Flurizan twice a day.

During the three-month extension, patients who originally were randomized to receive placebo during the first 12 months were switched to 400 mg or 800 mg of Flurizan twice each day. Patients originally treated with Flurizan continued with the same regimen.

Patients treated with the twice-daily 800 mg dosage in the year-long study experienced additional improvement during the three-month follow-on period averaging 0.1 point on the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) subscale. Specifically, at month 12, these subjects had declined an average of 2.8 points on the ADAS-cog scale since the beginning of the trial, but after the three additional months on Flurizan, these patients had an average ADAS-cog decline of 2.7 points.

"These data indicate that patients did not decline further during this follow-on study and in fact demonstrated a small improvement," a Myriad press release stated.

Adrian Hobden, president of subsidiary Myriad Pharmaceuticals Inc., said the company is in the process of enrolling patients in a Phase III trial "to confirm these results in a larger population."

The data were presented at the Congress of the International Psychogeriatric Association in Stockholm, Sweden.

Generic Name

Flu vaccine most effective in long-term care setting, efficacy in community modest, research suggests While vaccination of the elderly against influenza is recommended worldwide, the results of a new investigation suggest that it is most effective against complications in long-term care settings and is only modestly effective in the community.

Researchers searched several electronic databases to identify studies of the efficacy and effectiveness of flu vaccines in individuals aged at least 65 years.

In the long-term care setting, the overall efficacy of flu vaccination against influenza-like illness was 23 percent, although efficacy for influenza in particular was not significant, the researchers reported. Well-matched vaccines effectively prevented pneumonia (vaccine efficacy, 46 percent) and hospital admission for influenza or pneumonia (45 percent), whereas those of poor or unknown match did not. One small study also found a significant effect of the vaccine on all-cause mortality (60 percent).

For elderly individuals in the community setting, however, vaccines were not significantly effective against influenza, influenza-like illness or pneumonia, although well-matched vaccines prevented hospital admission for influenza and pneumonia (vaccine efficacy, 26 percent) and all-cause mortality (42 percent).

"[I]nvestment in the development of better vaccines than available at present should be linked to better knowledge of the causes and patterns of influenza-like illnesses in different communities," the investigators concluded.

The study was published online Sept. 22 ahead of the print edition of The Lancet.

Generic Name

Boston Scientific to pay Medinol $750 million to settle legal dispute Boston Scientific Corp. agreed to pay Israel-based Medinol Ltd. $750 million to settle a long-standing legal dispute regarding a contract signed in 1995 stipulating that Medinol would exclusively produce Boston Scientific's stents until October 2005.

While the $750 million payment is "sizable," an analyst cited by The Wall Street Journal said it is in line with investors' expectations based on Medinol's claim that it was entitled to a portion of Boston Scientific's stent revenue through 2005. So far, revenue from the stents has exceeded $5 billion.

Under the new agreement, all previous agreements between the companies will be terminated and Boston Scientific will relinquish its 20 percent stake in Medinol. The settlement includes an assurance that Medinol will not challenge Boston Scientific's Express and Taxus Express stents in a patent-infringement suit.

However, the settlement also includes a provision for future disputes that will permit arbitration on intellectual-property claims, although Medinol has agreed not to seek an injunction of Boston Scientific's stents and to limit claims to "reasonable" royalties, The Journal reported.

"We're pleased to close this chapter and put this matter behind us," Paul Donovan, a spokesperson for Boston Scientific, told The Journal. This settlement represents the largest sum Boston Scientific has ever paid another company in a legal dispute.

Medinol first sued Boston Scientific in 2001 for breach of contract and for stealing its technology after Boston Scientific acknowledged that it had surreptitiously set up a facility to copy Medinol's stents.

Generic Name

Generic Name
The U.S. Senate The U.S. Senate unanimously passed an amendment to force the Food and Drug Administration to disclose to the public any conflicts of interest members of its advisory committees may have. Under the amendment, which was attached to the agriculture appropriations bill, the FDA must disclose, 15 days before a panel meeting, any conflicts of interest that require a waiver. This information was previously available only through a Freedom of Information Act request. The advisory committees make recommendations as to whether the agency should approve drugs and sometimes include medical experts who have been involved in research for drug companies.

Generic Name

Generic Name
Serono AG Serono AG expects to finalize a settlement regarding a federal and state investigation into the company's marketing of AIDS drug Serostim (somatropin recombinant), The Wall Street Journal reported. Unidentified sources "familiar with the agreement" said Serono would likely admit wrongdoing and pay fines of approximately $700 million. The sources said the settlement would probably allow Serono to continue being paid for its drugs under Medicaid. Normally, admissions of criminal wrongdoing are grounds to disqualify health care providers from getting reimbursed by government health insurers, the newspaper explained. The Journal noted that in criminal cases against former Serono employees, charges were in connection with an "aggressive" campaign the company launched to increase prescriptions for the high-dollar AIDS treatment. In this campaign, the company allegedly offered kickbacks to physicians and marketed an unapproved medical device for diagnosing AIDS wasting, a condition in which patients experience rapid weight loss.

Generic Name

Generic Name
Barrier Therapeutics Inc. Barrier Therapeutics Inc. will retain global rights for all licensed indications to Hyphanox (itraconazole), its once-daily, 200 mg oral antifungal product candidate. Janssen Pharmaceutica Products LP held a region-by-region option for rights to the drug but declined the opportunity to exercise the option, which, according to Barrier, was triggered after results from a recently completed Phase III clinical trial showed the drug's clinical efficacy was not inferior to fluconazole in patients with vaginal candidiasis. The trial did not reach the primary regulatory endpoint of therapeutic cure.

Generic Name

Generic Name
Neurogen Corp. Neurogen Corp. reported that its leading drug candidate for insomnia, NG2-73, was safe and well tolerated across a broad dose range, based on data from a Phase I escalating dose study. Although it was not an endpoint of the trial, an apparent effect of the drug was that it induced sleep in treated subjects, consistent with the results of Neurogen's preclinical studies. The company said preclinical studies also suggested that NG2-73 is "pharmacologically distinct" from other agents intended to treat insomnia, both those currently available and those under development.

Generic Name

Generic Name