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Post Menopause

September 26, 2011

Pfizer reported results from a phase III trial of bazedoxifene/conjugated estrogens (BZA/CE) for menopausal symptoms. This double-blind, placebo-controlled study, SMART-5 (Selective estrogens, Menopause, And Response to Therapy), enrolled 1,843 postmenopausal women who had not had a hysterectomy. The subjects received BZA/CE, CE/ medroxyprogesterone acetate (MPA), and BZA monotherapy or placebo in the following daily oral doses: BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, BZA 20 mg, CE 0.45 mg/MPA 1.5 mg or placebo. One of the key primary endpoints was the incidence of endometrial hyperplasia at the end of one year of treatment. Results indicated that BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg demonstrated less than one percent incidence of endometrial hyperplasia over 12 months. A second key primary endpoint, the prevention of postmenopausal osteoporosis was also reached, as were the secondary endpoints of bone mineral density, breast density, sleep parameters and health-related quality of life.

October 11, 2004

Amgen has issued positive results from a phase II study of AMG 162, their investigational monoclonal antibody for the treatment of low bone mineral density (BMD). Interim results indicated that an injection of the drug administered twice during the first year of the study produce significant increases in total hip BMD compared to placebo, the trial’s primary endpoint. Data also demonstrated that the increases in total hip BMD at all trial doses were comparable or superior to those observed with standard weekly administration of Fosamax, an approved low-BMD therapy, the trial’s secondary endpoint; this effect was statistically significant (p<0.001) at a dose of 60 mg AMG 162 twice yearly. This ongoing, multi-center, dose-ranging study randomized a total of 411 postmenopausal women with low lumbar spine BMD to receive one of three doses AMG 162 every three months (6 mg, 14 mg, or 30 mg), one of four doses every six months (14 mg, 60 mg, 100 mg or 210 mg), standard therapy with Fosamax (70 mg weekly), or placebo. Amgen announced that these results would help support their recently initiated pivotal phase III study.

September 13, 2004

Cellegy Pharmaceuticals reported second interim analysis from a phase II trial investigating Tostrelle (testosterone gel) .5% for the treatment of sexual dysfunction in low-testosterone postmenopausal women. Results demonstrated the gel produced testosterone levels that were within the normal range of young women (p<0.001) and produced a 65% improvement in the number of satisfying sexual events, a 30% increase over placebo. The randomized, placebo-controlled study enrolled 103 postmenopausal women with low testosterone levels who were distressed by symptoms of sexual dysfunction. The study was designed to determine testosterone blood levels and the efficacy of topical gel administered daily. Full results will be reported at the International Society for the Study of Women's Sexual Health (ISSWSH) during their annual meeting in Atlanta on October 28-31, 2004. The company has now begun preparations for phase III trials.

Novo Nordisk has announced positive results of a phase II study of liraglutide, the company’s GLP-1analog, for the treatment of type 2 diabetes. The study found that liraglutide was significantly efficacious in promoting glycemic control and weight loss, especially in combination with metformin. Further, the combination of metformin and liraglutide produced significantly better glycemic control and weight loss than the combination of metformin and glimepiride (an approved therapy), and was the only study regimen to reduce HbA1c levels by greater than 1%. The randomized, double-blind study enrolled a total of 144 subjects with type 2 diabetes. Novo Nordisk announced plans to initiate phase III trials by the end of 2004, based upon these results.

March 5, 2002

Phase II trial results suggest that Novartis' intravenous zoledronic acid is as effective in increasing bone mineral density as oral daily or weekly bisphosphonates. The placebo-controlled trial, which was conducted at 25 centers, included 351 women with postmenopausal osteoporosis. In the zoledronic acid groups, subjects received 0.25 mg, 0.5 mg or 1.0 mg every three months, 2.0 mg at study onset and six months, or 4 mg only at study onset. At 12 months, bone mineral density was significantly increased from baseline in all dosing groups.

December 17, 2001

Phase III trial results indicate that first-line therapy with Novartis' Femara (letrozole) improves survival of postmenopausal women with locally advanced or metastatic breast cancer compared to tamoxifen. The randomized, double-blind trial consisted of 907 postmenopausal women, with 453 receiving Femara and 454 receiving tamoxifen. At one and two years, data demonstrated that Femara produced a statistically significant survival advantage compared to tamoxifen. Additionally, in comparison to subjects receiving tamoxifen, those on Femara had a 78% greater chance of responding to treatment. In terms of disease progression, Femara was shown to delay progression for a median of 9.4 months compared to 6.0 months for tamoxifen.