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Repros Announces Acceptance of Dossier for Enclomiphene for Secondary Hypogonadism by European Authorities

THE WOODLANDS, Texas, Oct. 05, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received confirmation of acceptance of its September 12, 2016 filing for enclomiphene in the treatment of secondary hypogonadism in Europe.

Analogous to acceptance of an NDA by U.S. Food and Drug Administration
Responses expected by end of January 2017
The MAA was submitted to the European Medicines Agency (EMA) by Renable Pharma Limited, the UK subsidiary of Repros.

As has been described in previous communications, the typical time from submission to authorization of a medicinal product through the EMA's centralized procedure is 13-16 months and culminates in one authorization being obtained which is valid in all European Union and European Economic Area countries, i.e. 31 in total. The centralized procedure allows for a pan-EU review of the data, led by the Rapporteur's and Co-Rapporteur's assessment teams, and is governed by set timelines; therefore the review time is well defined. In this context, the Company expects to receive all questions relating to the application by the end of January 2017.

Dr. Michael Wyllie, Independent Director of Repros, commented: "The acceptance of the dossier by the EMA represents a key milestone toward the commercialization of enclomiphene and signals the acceptability and adequacy of the data for formal review. At a defined time point, ‘day 120', toward the end of January, we expect to get an initial reaction from the examiners."
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Source: press release, 10/05/16. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=992267

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Repros Announces Submission of MAA to the European Medicines Agency for Enclomiphene in the Treatment of Secondary Hypogonadism
UK designated as rapporteur and France as co-rapporteur
Average time to approval 13 - 16 months
THE WOODLANDS, Texas, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that, as anticipated, it has activated the process for obtaining a marketing authorization (MAA) for enclomiphene in the treatment of secondary hypogonadism in Europe.

The MAA has been submitted today to the European Medicines Agency (EMA) by Renable Pharma Limited, the U.K. subsidiary of Repros.

The typical time from submission to authorization of a medicinal product through the centralized procedure is 13-16 months and culminates in one authorization being obtained which is valid in all European Union and European Economic Area countries, i.e. 31 in total. The centralized procedure allows for a pan-EU review of the data, led by the Rapporteur's and Co-Rapporteur's assessment teams, and is governed by set timelines that establish a well-defined review time.

The EMA already recognizes secondary hypogonadism as a discrete disorder that requires medical intervention. This medical need is confirmed by Professor Fred Wu, Professor of Medicine and Endocrinology, University of Manchester and Principal Investigator in the European Male Aging Study (EMAS), who stated: "One of the most disabling but less recognized problems in obese men is low testosterone (secondary hypogonadism). With the increasing fattening of our society, there is a great need for effective medical treatment of secondary hypogonadism. Drugs, such as enclomiphene, that raise testosterone production in obese men, could be invaluable as part of the management of diabetic and obese patients."

Dr. Michael Wyllie, Independent Director of Repros, commented: "The submission for approval by the EMA represents a key milestone toward the commercialization of enclomiphene. Not only is the MAA timeline definable, but obtaining authorization would potentially allow access to a considerable patient population, with the EU adult male population being 165% of that in the US. The data from Professor Wu's EMAS study indicates that the prevalence of secondary hypogonadism is significantly greater than the occurrence of primary hypogonadism."
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Source: press release, 9/12/16. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=988758

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Repros Provides Update on EU Submission of Enclomiphene for the Treatment of Secondary Hypogonadism and 3 Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men

EU submission on track with anticipated registration decision expected Fall 2017

UK designated as rapporteur and France as co-rapporteur for the centralized review of the enclomiphene marketing application
3 month interim assessment of testosterone levels in obese men participating in Phase 2 diet and exercise study show statistically significant increases in testosterone in the active arms versus the placebo arm

THE WOODLANDS, Texas, June 01, 2016 (GLOBE NEWSWIRE) -- 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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Source: press release, 6/01/16. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=973829

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Repros Announces Initiation of Formal Approval Process by the European Medicines Agency

THE WOODLANDS, Texas, March 15, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has formally activated the process for obtaining marketing authorization for enclomiphene in the treatment of secondary hypogonadism by the European Medicines Agency (EMA).

Repros is seeking the enclomiphene marketing authorization for Europe through a central filing which is valid in all European Union and European Economic Area countries, i.e. 31 countries in total. The centralized procedure allows for a pan-EU review of the data, led by the Rapporteur's and Co-Rapporteur's assessment teams, and is governed by set timelines; therefore the review time is well defined. Based on these timelines, the Company believes authorization to market enclomiphene in the EU can be obtained by the fourth quarter of 2017. Importantly, EU approval would open potential marketing opportunities for enclomiphene to numerous non-US territories.

The EMA already recognizes secondary hypogonadism as a discrete disorder that requires medical intervention. This medical need is confirmed by Professor Fred Wu, Professor of Medicine and Endocrinology, University of Manchester and Principal Investigator in the European Male Aging Study who stated: "One of the most disabling but less recognized problems in obese men is low testosterone (secondary hypogonadism). With the increasing fattening of our society, there is a great need for effective medical treatment of secondary hypogonadism. Drugs, such as enclomiphene, that raise testosterone production in obese men, could be invaluable as part of the management of diabetic and obese patients."

Dr. John Dean, St. Peter's Andrology Centre and past President of the International Society for Sexual Medicine, commented: "The majority of men with secondary hypogonadism, the most prevalent form of hypogonadism, are poorly served. In addition, for many men receiving existing T replacement there can be a counterproductive reduction in fertility. For these reasons the approval of enclomiphene has the potential to represent a substantial step forward in the management of this area of high, and increasing, medical need. Fortunately, the EMA appears to recognize secondary hypogonadism as a disorder requiring medical intervention."
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Source: press release, 3/15/16. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=960764

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Enclomiphene citrateEndocrine and MetabolismInfertility maleEstrogen receptor antagonistEstrogen receptor

Mechanism of action: Enclomiphene citrate is an orally active non-steroidal estrogen receptor antagonist that restores normal pituitary response in men resulting in normalization of luteinizing hormone levels and gonadotropin-dependent testosterone secretion.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-11-10

Results: Pending