Chemical Works of Gedeon Stock (OTC: GEDSF)

Latest news for Chemical Works of Gedeon (OTC:GEDSF) Stock

Chemical Works of Gedeon Richter PLC is a pharmaceutical company. The company focuses on the development and manufacture of gynaecological, cardiovascular, and central nervous system products. It manufactures medicines including original, generic and licensed products for treatment in the therapeutic area. The group is active in two business segments namely, the Pharma segment comprising Women's Healthcare, Neuropsychiatry, Biotechnology, General Medicine, and Other pharma; and the Others segment includes the remaining wholesale and retail business of the Group and all other activities. The company operates internationally.

GEDEON RICHTER LTD S/GDR by Gedeon Richter Ltd

Chemical Works of Gedeon Richter PLC

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Chemical Works of Gedeon

Allergan Plc (NYSE: <a class="ticker" href="/stock/agn#NYSE">AGN</a>) and Gedeon Richter Plc (OTC: <a class="ticker" href="/stock/gedsf#OTC">GEDSF</a>). today announced positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids. A new drug application filing for ulipristal acetate is planned for the second half of 2017.

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	The study included 432 U.S. patients with 162 and 157 patients randomized to ulipristal acetate 5 and 10 mg respectively, and 113 to placebo. The average age of patients enrolled was 41 years and 67 percent of enrolled patients were Black/African Americans. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p&lt;0.0001). The co-primary efficacy endpoints were percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding on treatment during Treatment Course One (12-week duration). Significantly more patients in the 10 mg group (54.8%) and the 5 mg group (42.0%) achieved absence of bleeding compared to placebo (0%).

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	The secondary efficacy endpoints were the percentage of patients with absence of uterine bleeding from Day 11 to end of the first treatment course; the percentage of patients with absence of uterine bleeding after the second treatment course; time to absence of uterine bleeding on treatment during treatment course two; and the change from baseline in the UFS-QOL revised Activities subscale at the end of the first treatment course.

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	More patients in the 10 mg group (55.4%) and the 5 mg group (34.6%) achieved absence of bleeding within 10 days after treatment initiation in Treatment Course One compared to placebo (0.0%). Significantly more patients in the 10 mg group (57.3%) and the 5 mg group (40.5%) achieved absence of bleeding compared to placebo (8.0%) in Treatment Course Two. The improvement from baseline in the UFS-QOL revised activities subscale was significantly greater in the 10 mg group (56.7%) and the 5 mg group (48.3%) compared to placebo (13.0%).

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	The UFS-QOL is a validated fibroid-specific symptom and health-related quality of life instrument. This questionnaire is an established instrument to assess disease impact on the well-being of women with uterine fibroids.

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	&quot;It is indeed very encouraging that we have another successful phase III study conducted in patients with uterine fibroid symptoms, which shows that ulipristal acetate could bring promising treatment for women suffering from this condition,&quot; added Dr Istv&aacute;n Greiner, Research Director of Gedeon Richter Plc. &quot;We remain committed to the development of female healthcare products aiming towards the improvement of the quality of life of women in all age groups.&quot;

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	The most common adverse events (&ge;5%) on ulipristal acetate treatment were hot flush, headache, fatigue, and nausea in the combined period of Treatment Course One and first off-treatment interval. The most common adverse event (&ge; 5%) on ulipristal acetate treatment was headache in the combined period of Treatment Course Two and second off-treatment interval.

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Allergan,and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in Treatment of Uterine Fibroids

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Chemical Works of Gedeon

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Latest news for Chemical Works of Gedeon (OTC:GEDSF) Stock

Tuesday, January 17, 2017

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