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FDA APPROVES ATACAND TO TREAT PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION, WITH OR WITHOUT ACE INHIBITOR ------------------------------------------------------------------------------- AstraZeneca Plc received approval from the Food and Drug Administration for Atacand (candesartan cilexetil), an angiotensin receptor blocker, to treat heart failure in patients with left ventricular systolic dysfunction (defined as ejection fraction less than or equal to 40 percent).

The drug has been shown to reduce cardiovascular death and heart failure hospitalizations; according to AstraZeneca, when combined with an ACE inhibitor, Atacand has an even greater effect on these outcomes. "Atacand is now the first ARB proven to provide these benefits with or without an ACE inhibitor," the company said, adding that Atacand is also "the only ARB with proven benefit when used with conventional therapy that includes both an ACE inhibitor plus a beta-blocker."

The company said the approval was largely based on results from a trial comparing the efficacy of Atacand versus placebo in 2,548 patients with heart failure who were already receiving conventional therapy, including an ACE inhibitor. The trial showed the addition of Atacand provided a 15 percent relative-risk reduction in cardiovascular death or heart failure hospitalization.

The FDA approved Atacand in February to treat patients with heart failure. -=-

FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF BOEHRINGER'S HIV DRUG, APTIVUS; SEPARATE PANEL REQUESTS DETAILS ON FDA ACTIONS PRIOR TO DRUG WITHDRAWALS ------------------------------------------------------------------------------- Two separate Food and Drug Administration advisory committees made recommendations to the agency Thursday. The Antiviral Drugs Advisory Committee (ADAC) recommended approval of Boehringer Ingelheim Pharmaceuticals Inc.'s HIV drug, Aptivus (tipranavir), and the Drug Safety and Risk Management Advisory Committee "voted unanimously in favor of having the agency provide it with details on its actions leading up to a drug's withdrawal so that advisors could help identify areas for improvement," Reuters reported.

The ADAC based its recommendation on 24-week efficacy data from two Phase III trials that showed "evidence of the antiviral effect of [Aptivus] over currently available antiretroviral regimens in a population which are 'heavily pretreated,'" according to briefing documents on the FDA's Web site.

The committee did, however, ask for more long-term safety trials to be conducted on the drug, for which Boehringer is seeking accelerated approval as a combination therapy with Abbott Laboratories' Norvir (ritonavir), Reuters reported.

Committee members were concerned about reports of the drug causing rashes in women, as well as the drug's long-term effects on cholesterol levels and the liver, Reuters noted. However, most panelists believed the drug's risks were outweighed by its possible benefits and could be controlled through physician monitoring.

"[The risks] are manageable," Douglas Fish, a committee member and professor at New York's Albany Medical College, told Reuters. "These are the kinds of complications, especially in these highly pretreated patient populations, that have become a reality of HIV care in 2005."

In separate news, the Drug Safety and Risk Management Advisory Committee finished its two-day meeting on the FDA's risk assessment program and other safety-related issues pertaining to marketed drugs.

The committee said it wants to review the agency's previous drug recalls to identify areas in need of improvement, Reuters reported.

"I think it would be really helpful to have a transparent look back at where we think things could have been better," Arthur Levin, panelist and director of the Center for Medical Consumers, told Reuters.

Anne Trontell, deputy director of the FDA's Office of Drug Safety, said the agency will consider the committees' recommendations, and that officials have already been looking into safety issues, Reuters reported.

"It's already an area of active interest," said Trontell. -=-

GSK CREATES NEW DIVISION TO PROMOTE EXTERNALLY DISCOVERED DRUGS ------------------------------------------------------------------------------- GlaxoSmithKline Plc is creating a new division that will focus on developing new drugs discovered externally through partnerships with biotechnology companies, academic institutions and small- to medium-sized pharmaceutical companies.

Maxine Gowen, Ph.D., will lead the unit, called the Centre of Excellence for External Drug Discovery (CEEDD), as senior vice president. Previously, Gowen was managing partner and president of GSK's venture capital business, SR One.

"The CEEDD will leverage [research and development's] front-end capabilities, which are generating more targets and compounds than the organization has internal resource to develop, by sharing some of these assets for development by others," GSK said.

Gowen will work with a small internal management team that will have its own portfolio and budget. Unlike GSK's other R&D divisions, which are called Centres of Excellence for Drug Discovery, the company said the CEEDD will rely primarily on outside scientific resources.

A major goal of the new division is to deliver "compounds with proof of therapeutic concept" through its partnerships with other companies and organizations.

"The ultimate objective is to exploit the full potential of R&D assets and get more medicines to more patients faster," GSK said. -=-

ABLE LABS SUSPENDS SHIPMENT OF ALL PRODUCTS; CEO RESIGNS, SHARES PLUNGE ------------------------------------------------------------------------------- After conducting an internal evaluation prompted by several recent product recalls, generic drugmaker Able Laboratories Inc. is temporarily suspending shipment of its products until the company can be assured that each "product has been manufactured and tested in compliance with standard operating procedures and current good manufacturing practices."

The company also announced that its chief executive officer and chairman, Dhananjay Wadekar, is resigning. Robert Mauro, the company's president and chief operating officer, will act as interim CEO. Able expects that Wadekar will continue to serve the company as a consultant.

In the 10-Q report the company filed for the quarter ended March 31, Able stated that it had notified the Food and Drug Administration of its internal review, adding that it planned to "work proactively" with the agency, internal management and outside consultants. The product recalls leading to the review occurred as a result of "various improper laboratory practices and noncompliance with standard operating procedures."

After conducting its evaluation, the company said it identified "apparent departures from standard operating procedures with respect to certain laboratory testing practices."

Able said the review will lead to additional product recalls; since the company cannot yet identify which products will be affected, it has temporarily suspended shipment of them all.

Noting that the suspension will have a "material effect" on its ability to meet established sales and operating goals, Able is withdrawing its previous financial guidance.

Able shares closed at $6.26, down $18.37, or 74.6 percent, in heavy trading on the Nasdaq. -=-

CYBERONICS' SHARES FALL ON NEWS OF SENATE FINANCE COMMITTEE PROBE ------------------------------------------------------------------------------- Cyberonics Inc. received notification from the Senate Finance Committee that the committee is "examining the [Food and Drug Administration's] handling" of Cyberonics' application for approval of its Vagus Nerve Stimulation (VNS) Therapy System as a treatment for chronic and recurrent treatment-resistant depression.

Cyberonics' shares fell sharply on the news, even though Robert Cummins, the company's chief executive officer, said the company and its advisors do not expect the committee's examination to affect the FDA's decision regarding the device's new indication.

Currently, VNS Therapy is approved as an adjunct treatment for adults and adolescents with treatment-refractory epilepsy.

Despite an approval recommendation from an advisory committee, the FDA informed Cyberonics in August 2004 that the device was not approvable for the treatment of refractory depression. In February, however, the FDA reversed its position and issued a conditional approval letter to Cyberonics for the device to treat chronic treatment-resistant depression.

In a conference call on Thursday, Cummins said the informal inquiry focuses on the FDA's review of VNS, adding that there is no subpoena, TheStreet.com reported.

Cummins said he felt "compelled" to issue a press release and conduct a conference call after receiving a call from a Wall Street Journal reporter Wednesday afternoon. According to TheStreet.com, the reporter told him The Journal would be running a story on the investigation the following day. Cummins said he told the reporter the information supplied by an unidentified source was "false and misleading."

According to a Wall Street Journal report, Cyberonics hoped to receive final FDA approval for VNS' new indication as early as this week.

Cyberonics shares closed at $34.18, down $4.69, or 12.1 percent, in heavy trading on the Nasdaq. -=-

MERCK'S GARDASIL CERVICAL CANCER VACCINE PRODUCES HIGH ANTI-HPV IMMUNE RESPONSE IN ADOLESCENTS, DATA SHOW ------------------------------------------------------------------------------- Merck & Co. Inc.'s investigational quadrivalent human papillomavirus (HPV) vaccine, Gardasil, produced a higher anti-HPV immune response among adolescent males and females as compared with young adult women, based on data from a recent Phase III study. The trial was the first to evaluate the immune responses and tolerability among adolescents aged 10 to 15 years.

In addition to preventing infection from the sexually transmitted HPV, the vaccine is also intended to prevent HPV-related cervical cancer and genital warts.

The trial evaluated the immune response to the vaccine in 1,529 patients who were divided into groups by age and sex. The adolescent group included male and female patients; the older group (aged 16 to 23 years) included women only.

Each patient received three injections of the vaccine during a six-month period. Patients were then retested to see if they exhibited an immune response against the four strains of HPV contained in the vaccine--types 6, 11, 16 and 18.

Researchers found significantly higher levels of antibodies among the adolescent groups as compared with the older group. The vaccine was well tolerated, with fever being the most common adverse event, the company said.

According to Merck, Gardasil is being evaluated in worldwide Phase III clinical trials enrolling more than 25,000 participants. Merck expects results from these trials to be available later this year. -=-

Corporate Brand
THE FOOD AND DRUG ADMINISTRATION ------------------------------------------------------------------------------- The Food and Drug Administration updated its advice to health care providers regarding the administration of albumin to critically ill patients. According to the FDA, the SAFE study, published in The New England Journal of Medicine last May, resolves safety concerns raised by the earlier Cochrane Injuries Group study. The SAFE study found that critically ill patients treated with albumin had a similar mortality rate when compared with critically ill patients given saline. The FDA cautioned that the relative safety of albumin treatment in patients with burns, traumatic brain injuries or septic shock has not been evaluated. -=-

Corporate Brand
CHIRON CORP. ------------------------------------------------------------------------------- Chiron Corp. and Enanta Pharmaceuticals Inc. signed an agreement to develop and market Chiron's hepatitis C virus protease inhibitor portfolio. The agreement gives Enanta exclusive rights to develop and market the portfolio; in exchange, Chiron will receive milestone payments and royalties on commercial sales. Chiron retains certain co-development and commercialization opt-in rights, except in Asia, the companies said. -=-

Corporate Brand
SCIOS INC. ------------------------------------------------------------------------------- Scios Inc. issued a letter to health care providers on May 6 notifying them of labeling revisions for Natrecor (nesiritide), an injectable heart failure drug, the Food and Drug Administration's MedWatch said Thursday. As reported in April, the revised label includes a section regarding a possible increased risk of death associated with the treatment. According to the label's new section, titled "Effect on Mortality," pooled results from seven studies involving 1,717 patients showed that 5.3 percent of Natrecor-treated patients died within 30 days after treatment compared with 4.3 percent of control patients. -=-

Corporate Brand
ZIOPHARM INC. ------------------------------------------------------------------------------- Ziopharm Inc. initiated dosing in a Phase I study of its proprietary small molecule organic arsenic, ZIO-101. The study, starting just nine months after Ziopharm licensed ZIO-101 from the University of Texas, will enroll as many as 40 patients with diverse blood and bone marrow cancers. Safety and dosing of the drug will be tested further in a second Phase I study involving solid cancers; the company plans to begin the second study in June. -=-