Tuesday, November 9, 2004

IN BRIEF: SANKYO CO. LTD.

Sankyo Co. Ltd. said it plans to increase the staff at its U.S. subsidiary Sankyo Pharma Inc. from 535 to 615, Reuters reported. The increase is intended to enhance marketing of the angiotensin II receptor blocker Benicar (olmesartan medoxomil), with the goal of achieving approximately $950 million in annual sales, according to Reuters. The product reportedly generated $191 million in sales during the first half of this year.

Monday, August 23, 2004

DATA SUGGEST BENICAR IS EFFECTIVE IN REDUCING SYSTOLIC BLOOD PRESSURE, PULSE PRESSURE IN PATIENTS WITH HYPERTENSION

Sankyo Pharma Inc. and Forest Laboratories Inc.'s Benicar (olmesartan medoxomil) is an effective treatment for reducing systolic blood pressure (SBP) and pulse pressure (PP) in hypertensive patients, according to new results published in the August issue of the American Journal of Hypertension.

Researchers analyzed data from seven randomized, double-blind, 6- to 12-week trials that examined the efficacy of Benicar 20 mg/day and 40 mg/day. Changes in trough SBP and PP were analyzed among three groups: total group (n=1,777), subjects with a baseline PP measurement greater than 55 mm Hg ("wide PP") and a subgroup of patients with wide PP aged at least 65 years.

In the total group, Benicar 20 mg and 40 mg resulted in mean SBP reductions of 15.1 mm Hg and 17.6 mm Hg, respectively, as compared with placebo. Among patients with wide PP, those who received Benicar 20 mg or 40 mg achieved mean reductions in SBP of 17.7 mm Hg and 22.0 mm Hg, respectively. The respective mean PP reductions were 7.4 mm Hg and 8.8 mm Hg.

Furthermore, in patients with wide PP who were at least 65 years old, Benicar 20 mg and 40 mg treatment resulted in 21.8 mm Hg and 22.5 mm Hg reductions in SBP, respectively, while PP fell 6.7 mm Hg and 7.6 mm Hg as compared with placebo.

"[T]he treating physician should focus on SBP as the primary target for the management of hypertension and should accept that SBP is a reasonable approximation for PP," the researchers concluded.

FOREST REPORTS FISCAL Q1 RESULTS

Forest Laboratories Inc.'s first-quarter fiscal 2005 results beat analysts' expectations, even though Celexa (citalopram hydrobromide) sales were lower than in the first quarter of 2004.

Net income for the period ended June 30 rose 28 percent to approximately $230 million from nearly $180 million in the prior-year period. Earnings per diluted share increased 25 percent from $0.48 in the first quarter of last year to $0.60 in the recent quarter. Analysts polled by Reuters Estimates expected Forest to report earnings of $0.57 per share.

Net sales reached approximately $782 million, representing a 29 percent rise from approximately $606 million one year ago. According to CBS MarketWatch, analysts polled by Thomson First Call had estimated an average $753 million in revenue.

The firm's antidepressant franchise, which includes Lexapro (escitalopram oxalate) and Celexa, accounted for nearly $625 million in revenue. Lexapro sales, driven by higher prescription volume, reached nearly $364 million. However, Celexa sales of approximately $261 million were impacted by lower prescription volume, partially offset by a higher average selling price.

"Our three principal promoted products, Lexapro, Namenda and the angiotensin receptor blocker Benicar [olmesartan medoxomil], which we co-promote with Sankyo Pharma Inc., continued their strong performance during the quarter, increasing their respective market shares in response to continued growth in physician acceptance and patient response," said Forest Chief Executive Officer Howard Solomon. "Our strong financial performance this quarter will allow us to modify our earnings per share guidance for the fiscal year ending March 31, 2005, by increasing the lower end of our range from $2.35 to $2.40 while maintaining the upper end at $2.50."

The current analyst estimate is that the firm will post earnings of $2.46 per share for the fiscal year, according to The Associated Press.

Shares of Forest closed at $50.20, down $2.30, or 4.4 percent, in heavy trading on the New York Stock Exchange.

Wednesday, July 21, 2004

PRELIMINARY STUDY RESULTS SHOW ID BIOMEDICAL'S FLUINSURE VACCINE IS EFFECTIVE

ID Biomedical Corp.'s FluINsure, a non-living intranasally delivered influenza vaccine, is equally effective as live, cold-adapted influenza virus vaccines used in previously published studies, according to preliminary results from a new study.

The trial involved 1,349 healthy subjects aged 18 to 64 years who were randomized to receive one or two doses of FluINsure or placebo. The study period was from October 2003 to May 2004.

The one-dose regimen showed 67 percent efficacy against clinical illness, defined as a culture confirmed for influenza virus. "When using fever as a requirement for the definition of clinical illness, one dose of the FluINsure vaccine provided 100 percent efficacy," the company added in a press release.

"[W]e were also able to show that a one-dose regimen of the FluINsure vaccine was as efficacious as two doses. As a result, we will now focus our development efforts on a one-dose FluINsure vaccine product," said Dr. Anthony Holler, ID Biomedical's chief executive officer.

The company said it plans to conduct pivotal studies in North America before seeking approval for the vaccine. ID Biomedical also plans to seek approval from regulators to initiate a FluINsure vaccine trial in a pediatric population in 2005.

Shares of IB Medical closed at $10.35, up $2.51, or 32 percent, after heavy trading on the Nasdaq.

Tuesday, June 10, 2003

SANKYO'S HYPERTENSION TREATMENT BENICAR HCT APPROVED BY FDA

Sankyo Pharma Inc. announced that the Food and Drug Administration has approved its Benicar HCT (olmesartan and hydrochlorothiazide) as a second-line treatment for hypertension.

According to the company, the drug will be available in the second half of this year.

FDA officials examined Benicar HCT study data, which were presented at last month's American Society of Hypertension meeting, from 502 men and women who had received a diagnosis of mild to moderate hypertension.

Patients were randomized into 12 groups: monotherapy with Benicar in 10 mg, 20 mg or 40 mg doses; monotherapy with hydrochlorothiazide in 12.5 mg or 25 mg doses; all possible Benicar/hydrochlorothiazide combinations; or placebo.

Results showed that after eight weeks, combination treatment with Benicar and hydrochlorothiazide resulted in greater average reductions in systolic and diastolic blood pressure than did those treatments individually.

Sankyo said the results from the study are in accordance with new guidelines that "emphasize the need for more aggressive blood pressure lowering."