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Omnicare to acquire NeighborCare for approximately $1.8 billion

Omnicare Inc., a provider of pharmacy and pharmacy-related services to long-term care facilities, will acquire institutional pharmacy provider NeighborCare Inc. for approximately $1.8 billion.

More than a year after Omnicare first offered to buy NeighborCare, the firms signed a definitive merger agreement; the transaction was approved by the board of directors of both companies.

Omnicare will acquire all outstanding shares of NeighborCare common stock for $34.75 per share in cash. The transaction also includes approximately $245 million of NeighborCare's net debt, for a total value of approximately $1.8 billion.

The agreement, which is expected to close in the third quarter, has already cleared the waiting period required by the Hart-Scott-Rodino Antitrust Improvement Act, according to the companies.

Omnicare expects the acquisition to be "significantly accretive" to its diluted earnings per share beginning in 2006. Based on both firms' earnings for the quarter ended March 31, 2005, Omnicare anticipates the combined annualized revenue to be approximately $6 billion on a pro forma basis.

Upon completion of the merger, the combined company will have a pharmacy network serving long-care providers in 47 states and Washington, D.C.

"After careful consideration, our board has decided that Omnicare's revised offer is in the best interests of our shareholders," said John Arlotta, NeighborCare's chief executive officer. "Over the past year and a half as an independent company, our organization has made significant progress in achieving our business goals, and we are pleased that Omnicare has recognized the values inherent in our enterprise."

In May of 2004, Omnicare offered to assume $260 million of NeighborCare's debt and pay $30 per share of NeighborCare common stock. NeighborCare rejected the initial offer.

Shares of Omnicare closed at $47.22, up $1.19, or 2.6 percent, in heavy trading on the New York Stock Exchange while NeighborCare shares closed at $34.57, up $0.21, or 0.6 percent, in heavy trading on the Nasdaq.

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Galdermas MetroGel approved to treat rosacea lesions

Galderma Laboratories LP's MetroGel 1% (metronidazole) topical gel was approved by the Food and Drug Administration to treat inflammatory lesions associated with rosacea.

The product, which the company said will be available by the end of July, has a high concentration of metronidazole in a water-based formula containing no alcohol. The gel incorporates a combination of niacinamide, betadex and propylene glycol.

Unlike most other topical rosacea treatments, MetroGel 1% can be dosed once a day rather than twice a day, according to Galderma.

"Rosacea is the fourth most common diagnosis made by dermatologists, and we expect that MetroGel 1% will eventually become the No. 1 prescribed topical rosacea treatment," said Scott McCrea, product manager at Galderma.

The company noted that its MetroGel 0.75% currently leads the market among topical prescription treatments for rosacea.

Dow Pharmaceutical Sciences developed MetroGel 1% and Galderma will market the product.

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Lamictal appears to produce fewer cognitive, behavioral effects than Topamax, study finds

GlaxoSmithKline Plc's Lamictal (lamotrigine) appears to produce fewer unwanted cognitive and behavioral effects than Ortho-McNeil Neurologics Inc.'s Topamax (topiramate) when administered at a comparable dosage, according to results of a double-blind trial.

A total of 94 healthy volunteers were recruited to participate in the study, 19 of whom withdrew prior to randomization. The remaining 75 participants were randomized to receive Lamictal 300 mg/day or Topamax 300 mg/d during a 12-week treatment period, which included a seven-week titration phase, four weeks of maintenance therapy and one week in which medication was tapered off. This treatment phase was followed by a four-week washout period, after which participants began a similarly designed treatment phase with the other drug.

Participants completed a neuropsychological evaluation prior to treatment, at the end of each treatment period and after the washout period at the end of the study.

Among the 47 participants who completed both treatment phases of the trial, mean blood levels of Lamictal and Topamax during the maintenance phase of treatment were 4.7 mcg/mL and 9.3 mcg/mL, respectively.

Lamictal-treated patients outperformed Topamax-treated patients on 33 of 41 cognitive function and subjective behavioral effects variables; Topamax-treated patients did not outperform Lamictal-treated patients on any of the variables evaluated. Additionally, compared with average scores obtained pretreatment and post-washout, Lamictal-treated patients performed better on four of 41 variables and worse on seven.

The authors noted that, while the dosages of Lamictal and Topamax were comparable, mean blood levels were higher for Topamax, which may have influenced the results. To adjust for blood levels, researchers compared the drugs after excluding patients with Topamax levels greater than 8 mcg/mL. The remaining 15 patients had mean Topamax and Lamictal levels of 6.7 mcg/mL and 4.4 mcg/mL, respectively. Among these patients, those treated with Lamictal outperformed patients treated with Topamax on 19 of 41 variables; the Topamax group outperformed the Lamictal group on none.

This study appeared in the June 28 issue of the journal Neurology.

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Benefits of Xyotax demonstrated in Phase III trials of patients with advanced lung cancer

Cell Therapeutics Inc.'s Xyotax (paclitaxel poliglumex), a treatment for patients with advanced lung cancer, demonstrated comparable or superior efficacy, a significant reduction in most taxane-related side effects, a reduced need for transfusions and growth factors and more convenient administration as compared with controls in a series of Phase III tests known as the STELLAR trials.

Among the controls used in the trials were docetaxel, paclitaxel/carboplatin and gemcitabine or vinorelbine.

In the STELLAR 4 trial, which included 32 patients, the group who received Xyotax demonstrated superior survival as compared with patients who received vinorelbine. Additionally, among the 198 patients in the STELLAR 3 and STELLAR 4 trials, women with poor performance status who received Xyotax as a first-line therapy demonstrated a significant 60 percent increase in one-year survival.

"The survival advantage seen in women in the STELLAR 3 and 4 studies is worthy of note," said Scott Stromatt, senior vice president of clinical development and regulatory affairs at Cell Therapeutics. "The trials were stratified by gender, and survival by gender is pre-specified in the analysis plan. We plan to explore these results later this summer in our discussions with [the Food and Drug Administration] regarding the regulatory submission for Xyotax."

Results of the STELLAR trials were presented at the International Association for the Study of Lung Cancer's 11th World Conference on Lung Cancer.

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Bio-E-Gel shown safe, effective in Phase III testing

BioSante Pharmaceuticals Inc. revealed promising safety and efficacy results from Phase III tests of Bio-E-Gel (bioidentical estradiol), a transdermal gel developed to treat moderate to severe hot flashes in menopausal women.

The randomized, double-blind, Phase III study was conducted during a period of 12 weeks and included 484 symptomatic menopausal women. BioSante said the results showed a clear dose response in the reduction of the severity and number of hot flashes across the low, mid and high doses tested.

Furthermore, researchers found no significant differences in the safety profile of any dose of Bio-E-Gel compared with placebo.

"We believe the low dose of Bio-E-Gel shown to be safe and effective in this trial will be an attractive alternative to currently marketed estrogen therapies," said Dr. Leah Lehman, BioSante's vice president of product development.

The company said it will file a New Drug Application with the Food and Drug Administration after data analyses have been completed.

Stephen Simes, BioSante's chief executive officer, expects the product to be "well positioned to compete in the U.S. estrogen therapy market," which he estimates has annual sales of approximately $1.4 billion.

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Patients may experience complete heartburn relief after first dose of PPI therapy, recent analysis suggests

Approximately 30 percent of patients with heartburn who take a proton pump inhibitor experience complete 24-hour relief after the first dose, according to results of a recent meta-analysis.

Using data from 18 clinical trials, researchers conducted a systematic review of the efficacy of PPIs within the first one to two days of therapy. The analysis included more than 21,000 patients with heartburn and/or symptomatic gastroesophageal reflux disease at enrollment who were treated with one of the following PPIs as part of a study protocol: omeprazole 10 mg or 20 mg; AstraZeneca Plc's Nexium (esomeprazole magnesium) 20 mg or 40 mg; TAP Pharmaceutical Products Inc.'s Prevacid (lansoprazole) 15 mg or 30 mg; and Eisai Inc. and Janssen Pharmaceutica Inc.'s Aciphex (rabeprazole sodium) 10 mg or 20 mg. In all of the studies, antacids were permitted on an as-needed basis.

The primary outcome assessment, measured one day after the first dose of PPI therapy, was the proportion of patients who experienced overall, daytime and/or nighttime heartburn resolution during the prior 24-hour period.

The proportion of patients who achieved complete heartburn relief during the first day following an initial dose of PPI therapy was 0.31 compared with 0.09 among placebo-treated patients. Those who received placebo were 41 percent as likely as those who received any PPI to achieve complete relief at day one.

The proportion of patients who achieved daytime or nighttime heartburn relief at day one was 0.49 and 0.55, respectively. The authors noted that these proportions dropped to 0.42 and 0.48, respectively, when results from one large, uncontrolled trial were excluded from the analysis.

Using data from six trials, investigators determined that 21 percent of patients experienced sustained heartburn relief after the first PPI dose, defined as complete relief achieved on day one and maintained for at least seven days.

In the meta-analysis, for complete 24-hour heartburn relief at day one, omeprazole 20 mg was inferior to the combined group of PPIs, to Prevacid 30 mg and to Nexium 40 mg. Prevacid 30 mg achieved similar rates of heartburn relief at day one as Nexium 40 mg. Similar results were observed for sustained heartburn relief; omeprazole was inferior to the combined group of PPIs as well as Nexium 40 mg.

The authors attributed the apparent inferiority of omeprazole 20 mg to the lower dosage and to pharmacokinetic differences between the three drugs.

In two studies comparing single-dose and double-dose PPI therapy (omeprazole 10 mg vs. 20 mg and Nexium 20 mg vs. 40 mg), a single PPI dose was significantly less effective at achieving complete heartburn relief at day one than was double-dose therapy.

The authors conceded that their analysis was limited in that none of the studies provided information regarding the proportion of patients with heartburn on the day preceding treatment. As a result, they could not determine the proportion of symptom relief attributable to drug therapy versus that attributable to the natural fluctuation of symptoms. Additionally, they acknowledged that complete relief of heartburn during the first 24 to 48 hours of treatment was not a primary endpoint in any of the original studies.

The study results appear in the June issue of the journal Clinical Gastroenterology and Hepatology.

Omeprazole is available in generic formulations and as AstraZeneca's Prilosec.

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Merck & Co. Inc.

Merck & Co. Inc. entered into an agreement with ParAllele BioScience Inc. to research genetic variations that may affect a person's "susceptibility, prognosis or response to therapy in cancer." Merck will fund a study in which ParAllele will use its single nucleotide polymorphism genotyping technology to characterize genetic changes in tumor samples. Additional terms of the agreement were not disclosed.

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GlaxoSmithKline Plc

GlaxoSmithKline Plc exercised its option to jointly develop and commercialize LymphoStat-B (belimumab), a potential treatment for rheumatoid arthritis and systemic lupus erythematosus, with Human Genome Sciences Inc. As part of an agreement made between the companies in 1996, GSK was granted a 50/50 promotion and development option for certain Human Genome Sciences products that successfully complete Phase IIa trials. The companies will equally share development costs for Phase III/IV trials, sales and marketing expenses and profits. Additional terms of the agreement are being negotiated. LymphoStat-B was created through a collaboration between Human Genome Sciences and Cambridge Antibody Technology Group Plc.

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Canadian advisory panel

A Canadian advisory panel voted 12-1 to allow Merck & Co. Inc.'s Vioxx (rofecoxib) back on the market, Reuters reported Thursday. The panel, which met last month at the government's request to evaluate the risks of Vioxx and Pfizer Inc.'s Bextra (valdecoxib) and Celebrex (celecoxib), unanimously said Celebrex should continue to be sold. However, the panel voted 8-5 that Bextra, which was withdrawn from the Canadian market in April, should not be made available. According to Reuters, the panel voted against allowing Bextra to be sold because of the drug's association with a rare skin disorder and because of insufficient information about drug. The panel did recommend that warnings of the potential cardiovascular risks be added to patient information for Vioxx and Celebrex.

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ViroLogic Inc.

ViroLogic Inc. signed a $4.8 million service agreement with Schering-Plough Research Institute that will enable Schering-Plough to support its drug discovery and development programs through the use of ViroLogic's HIV resistance testing technology. Schering-Plough will use ViroLogic's assays for the clinical development of vicriviroc, a CCR5 receptor antagonist that belongs to a class of drugs known as HIV entry inhibitors. ViroLogic's PhenoSense HIV Co-receptor Tropism assay will be used to identify and monitor patients during the Phase III program for vicriviroc, which is expected to begin this year.

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