Brand Development

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MERCK'S HYZAAR RECEIVES FDA APPROVAL TO REDUCE RISK OF STROKE IN PATIENTS WITH HYPERTENSION, LEFT VENTRICULAR HYPERTROPHY ------------------------------------------------------------------------------- Merck & Co. Inc. said the Food and Drug Administration expanded the approved indications for Hyzaar (losartan potassium/hydrochlorothiazide), a combination hypertension drug. Hyzaar is now indicated to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy (LVH), or enlarged left ventricles.

The FDA approved Merck's Cozaar (losartan potassium) for the same indication in March of 2003. Both drugs belong to a class of drugs known as angiotensin II receptor blockers. Hyzaar is a fixed-dose combination of Cozaar and hydrochlorothiazide, a diuretic.

Cozaar and Hyzaar have been shown to reduce the risk of stroke (both fatal and nonfatal) by 25 percent in patients with hypertension and LVH, as compared with an atenolol-based regimen, although there is evidence that suggests this benefit may not apply to black patients. According to Reuters, Merck said the findings regarding black patients may be attributed to "difficulties interpreting data from population subsets." -=-

FDA APPROVES BOSTON SCIENTIFIC'S LIBERTE CORONARY STENT SYSTEM ------------------------------------------------------------------------------- Boston Scientific Corp. received approval from the Food and Drug Administration for its Liberte bare-metal coronary stent system, which the company plans to launch in the United States immediately.

The bare-metal stent is the platform for the company's Taxus Liberte, a paclitaxel-eluting stent system currently in testing.

Boston Scientific launched the Taxus Liberte system in 18 international markets in January and plans to launch it in Europe later this year. The company expects to receive U.S. approval for Taxus Liberte in mid-2006.

"Approval of the Liberte coronary stent system is a significant development in the evolution of our coronary stent program," said Paul LaViolette, the company's chief operating officer. "This new state-of-the-art technology, featuring enhanced conformability and deliverability, is another step forward in helping clinicians treat coronary artery disease."

In separate news, Boston Scientific agreed to purchase the rest of Rubicon Corp. for approximately $71.7 million, although post-acquisition milestones could increase the cost an additional $83.7 million. Boston Scientific currently owns approximately 53.6 percent of Rubicon and will commence a cash tender offer for the remaining outstanding shares of common stock at a price of $1.50 per share. -=-

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

The resubmission was "solely to address formatting difficulties" with the electronic document originally submitted last October for the immediate-release capsules of indiplon, Neurocrine said, adding that the content was unaffected.

The company will address "similar formatting difficulties" when it resubmits an NDA during the second quarter for the tablet formulation of indiplon. Neurocrine said this resubmission will include new safety and efficacy data from a recently completed study. The original filing for the modified-release tablets of indiplon was made in November.

Neurocrine released data in February from a Phase III trial that showed treatment with indiplon 15 mg tablets demonstrated a highly statistically significant improvement in the primary endpoint of patient-reported Total Sleep Time as compared with placebo. The study showed that patients treated with indiplon tablets gained approximately one hour of sleep over baseline, Neurocrine said.

Gary Lyons, Neurocrine's chief executive officer, said in January that refiling the NDAs would have only a "modest impact" on anticipated approval and launch timelines. -=-

ENTREMED'S PANZEM RECEIVES ORPHAN DRUG STATUS FROM FDA ------------------------------------------------------------------------------- EntreMed Inc.'s lead compound, Panzem (methoxyestradiol), also known as 2ME2, was granted orphan drug designation by the Food and Drug Administration as a treatment for ovarian cancer.

The designation follows promising preclinical experiments, in vitro data and a Phase I trial in which an ovarian cancer patient exhibited a partial response to Panzem after three prior chemotherapy regimens proved unsuccessful.

Developed resistance to existing therapies is common among patients with ovarian cancer, according to EntreMed. The company hopes Panzem will be effective in overcoming such resistance, either as a single agent or in combination with other drugs.

"2ME2 inhibits the proliferation of ovarian carcinoma cell lines in vitro, has anti-angiogenic properties, and it binds to tubulin, properties that are important in the treatment of ovarian cancer. We look forward to initiating additional clinical studies to further evaluate 2ME2 alone and in combination with other chemotherapeutic agents in this patient population," said Dr. Carolyn Sidor, EntreMed's chief medical officer.

The FDA also granted Panzem orphan drug status for the treatment of multiple myeloma, a form of blood cancer; a Phase II trial is currently being conducted for this indication. -=-

UNITEDHEALTH REPORTS STRONG 2005 Q1 EARNINGS, REVENUE ------------------------------------------------------------------------------- UnitedHealth Group Inc. reported a rise in net earnings of 41 percent for the first quarter of 2005, attributing the increase to "strong and diverse growth and consistent operating performance" across all segments of the company.

Net earnings for the first quarter were $779 million, or $1.16 per diluted share, compared with $554 million, or $0.88 per diluted share, in the prior year's first quarter.

Analysts polled by Reuters Estimates on average expected earnings per share of $1.13.

Total revenue for the first quarter increased to $10.9 billion. By comparison, revenue for the first quarter of 2004 was $8.1 billion.

As a result, UnitedHealth strengthened its guidance for the year. The company now expects 2005 full-year earnings per share of $4.85 to $4.90, up from the $4.75 to $4.80 range it forecast in January, according to The Wall Street Journal.

In a conference call with investors, UnitedHealth's chief executive officer, Dr. William McGuire, said he expects revenue for 2005 to increase to $45 billion, compared with $37.22 billion in revenue reported in 2004, The Journal reported.

Shares of UnitedHealth closed at $93.91, down $2.05, or 2.1 percent, in heavy trading on the New York Stock Exchange. -=-

STUDY SHOWS PROVIGIL DOES NOT IMPROVE FATIGUE AMONG PATIENTS WITH MS ------------------------------------------------------------------------------- New findings show that Cephalon Inc.'s Provigil (modafinil), a wakefulness-promoting drug, does not appear to improve fatigue among individuals with multiple sclerosis.

A total of 115 patients with MS who experienced chronic fatigue for at least six months were enrolled in the five-week, double-blind trial. Of the total study population, 56 patients were randomized to receive Provigil and 59 to placebo.

Patients in the treatment group initially received 200 mg/day of Provigil for one week. Then, depending on their ability to tolerate the drug, the dose was increased weekly by 100 mg, up to 400 mg/d.

All patients were evaluated at baseline and at day 35 using the Modified Fatigue Impact Scale (MFIS) and two secondary scales.

MFIS scores improved for both groups between day 1 and day 35. At the end of five weeks, each group had an average fatigue score of 63. No significant between-group differences were observed.

Adverse events were reported by both groups, most commonly involving the nervous, gastrointestinal and psychiatric systems. Gastrointestinal complaints and insomnia were more frequent in the group treated with Provigil.

Researchers noted that despite previous research showing the benefits of Provigil on fatigue in patients with MS, "[t]his study did not detect a benefit of [Provigil] on fatigue."

Results of the study were published in the April issue of the journal Neurology. -=-

Brand Development
SEN. MICHAEL ENZI ------------------------------------------------------------------------------- Sen. Michael Enzi, R-Wyo., chairman of the Senate's Health, Education, Labor and Pensions committee, asked the Food and Drug Administration to investigate "unspecified accusations" made by an anonymous FDA employee against acting FDA commissioner Lester Crawford, The Wall Street Journal reported. The committee, which oversees the FDA, delayed Wednesday's vote on Crawford's nomination "to provide more time to address issues that have been raised on both sides of the aisle," Sen. Enzi said in a statement issued jointly with Sen. Edward Kennedy, D-Mass., who also serves on the committee. A primary concern is the FDA's delay in deciding whether to make Barr Pharmaceuticals Inc.'s "Plan B" emergency contraceptive (levonorgestrel, 0.75 mg) available over the counter, The Journal noted. "[W]e hope the matter gets resolved quickly, so the Senate can move forward on confirmation," a spokesman for the Department of Health and Human Services told The Journal. -=-

Brand Development
BARR LABORATORIES INC. ------------------------------------------------------------------------------- Barr Laboratories Inc. said the Food and Drug Administration granted final approval to its generic version of Aventis Pharmaceuticals Inc.'s Allegra-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride) 12 Hour extended-release tablets, a seasonal allergy treatment. Barr, which has been involved in patent litigation since its Abbreviated New Drug Application was accepted for review in November of 2001, said it was granted 180 days of sole exclusivity for the product. Allegra-D 12 Hour achieved sales of approximately $434 million during the 12-month period ended February 2005, according to IMS Health sales data. -=-

Brand Development
VENTIV HEALTH INC. ------------------------------------------------------------------------------- Ventiv Health Inc.'s Commercial Services group is partnering with Connectics Corp. to promote Connectics' principal dermatological products, Evoclin (clindamycin) foam 1%, Olux (clobetasol propionate) foam 0.05% and Luxiq (betamethasone valerate) foam 0.12%, to primary care physicians and pediatricians. Evoclin is indicated to treat acne vulgaris, Olux as a short-term treatment for mild to moderate plaque-type psoriasis and Luxiq to treat inflammatory and pruritic manifestations of corticosteroid-responsive scalp dermatoses. Connectics will use Ventiv's training, fleet, sales force automation and sample accountability services, as well as Ventiv's Promotech division to distribute materials and samples. -=-

Brand Development
CURIS INC. ------------------------------------------------------------------------------- Curis Inc. revised its agreement with Genentech Inc. to receive additional funding for a collaborative effort between the two companies. Curis will receive an additional $2 million from Genentech to support ongoing development of Curis' Hedgehog inhibition technologies, which are intended to treat solid tumor cancers. The original two-year agreement, which was scheduled to terminate in June, has been extended six months, with an option for a second six-month extension. -=-

Brand Development
U.S. DISTRICT JUDGE TENA CAMPBELL ------------------------------------------------------------------------------- U.S. District Judge Tena Campbell overturned the Food and Drug Administration's April 2004 ban on weight-loss aid ephedra, The Associated Press reported Thursday. Nutritional supplement manufacturer Nutraceutical International Corp. and its subsidiary, Solaray, had challenged the FDA's ban in a federal court. Campbell's ruling returns the issue to the FDA "for further rulemaking consistent with the court's opinion" and prevents the agency from taking enforcement action against the companies. -=-