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Repros Therapeutics Offers Update on EU Submission of Enclomiphene for Treatment of Secondary Hypogonadism, 3-Month Interim Results for Enclomiphene Study


Repros Therapeutics Inc.® (Nasdaq: RPRX) today announced that it remains on track for submission of a European centralized marketing authorization application (MAA) for enclomiphene for the treatment of secondary hypogonadism. To that end, the European Medicines Agency (EMA) has assigned France and the UK as rapporteurs for the application review. The Company expects to submit the application in Fall 2016. As part of the review process, the Company is scheduled to meet with British and French medical reviewers in June 2016.

Secondary hypogonadism is recognized in Europe. The epidemiology of the disorder, based on published evidence from the European Male Aging Study (EMAS), has been well reported and the Company believes that it is well understood amongst key European thought leaders.

US Development of Enclomiphene in the Treatment of Secondary Hypogonadism

The US FDA currently approves testosterone therapies for the treatment of "Classical Hypogonadism". The FDA defines this disorder as essentially a condition in which the testes are no longer functional (other than for old age) and/or the pituitary is defective. As required by the FDA, in order for any drug to be approved for treating men with secondary hypogonadism, a clinical benefit other than increasing testosterone must be determined in well controlled clinical studies. To that end, the Company is conducting the ongoing Phase 2 diet and exercise study evaluating numerous endpoints which could be deemed as clinically beneficial. There are two active arms dosing men with 12.5 and 25 mg of enclomiphene and one placebo group.

During the first six month phase of the study, men are provided a commercially available prepared diet along with enrollment in a health club with a personal trainer. Subjects are asked to attend the health club at least three times per week. At the end of the six month period the subjects will be assessed for changes in a variety of biochemical markers as well as anatomical markers such as waist circumference, lean body mass and BMI. Quality of life will also be assessed. The six month data should be available in Fall 2016.

During the second six month phase, men will continue treatment with enclomiphene or placebo but will no longer be provided the commercial diet. Exercise with the assigned trainer will continue during this period. A second assessment for changes previously monitored will be made and reported.

In the last three months of the study, the subjects will no longer receive treatment but will stay enrolled in the health club, though, without a trainer.

After three months of treatment, all groups lost weight. However, the weight loss exhibited in the placebo group did not yield increased levels of testosterone. The placebo group had an average testosterone level of 221 ng/dL at baseline. After three months of diet and exercise the average testosterone level dropped to 214 ng/dL. For the active arms, the mean baseline testosterone increased from 212 ng/dL to 399 ng/dL. The difference between the active and placebo group was highly significant, p<0.0001. Metabolic function was not assessed at the three month time point.

The Company plans to report metabolic and anatomical effects, including change in lean body mass, after the six month assessment.

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