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Repros Therapeutics Inc.

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April 15, 2015

Repros Announces November 30, 2015 PDUFA Goal Date for New Drug Application

THE WOODLANDS, Texas, April 15, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015, for substantive review of the Company's New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®. In addition, the FDA has informed the Company that the FDA is currently planning to hold an advisory committee meeting on the NDA during the review.
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Source: press release, 4/15/15. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=906763

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April 1, 2015

Repros Announces Acceptance for Filing of NDA

THE WOODLANDS, Texas, April 1, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®, has been accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. This investigational product, which is the Company's lead product candidate, is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The Company is developing this product candidate for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. The Company's product candidate is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism.
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Source: press release, 4/01/15. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=904588

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February 2, 2015

Repros Submits New Drug Application to FDA for Androxal (R)

THE WOODLANDS, Texas, Feb. 2, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported that it has electronically submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Androxal®, the Company's lead product candidate. Androxal® is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The Company is developing Androxal® for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Androxal® is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general.

The NDA for Androxal® includes a significant collection of data on safety and efficacy from over 20 studies. It is supported by four Phase 3 efficacy studies, two of which compared Androxal® to a leading FDA approved topical gel in addition to placebo. In the two active-comparative studies, Androxal® met the primary efficacy endpoints and demonstrated the reproducibility of the previous Phase 3 study results. Analyses found Androxal® to be superior to the topical gel in both co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24 hour average testosterone in the normal range with associated average sperm concentration ≥ 10 million/mL. Androxal® exhibited no negative effects on sperm concentration compared to placebo but exhibited highly significant effects on normalizing testosterone levels compared to placebo control.

Androxal® is an investigational product and has not been determined safe or efficacious.
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Source: press release, 2/02/15. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=894079

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December 29, 2014

Repros Updates Androxal(R) Global Regulatory Status

Full response to November meeting submitted to FDA

Repros believes all FDA questions positively addressed

Company expects contract organization to officially submit NDA to FDA during first quarter of 2015

Teleconference held with FDA to discuss Environmental Assessment requirements for NDA

Repros will conduct non-clinical environmental studies during the NDA review

Company believes there are no refuse to file issues for its NDA

Company contracts EU regulatory consultant to prepare European filings for Androxal®

THE WOODLANDS, Texas, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today updated the regulatory status for its drug, Androxal®. Androxal® is an oral therapy for the treatment of low testosterone due to secondary hypogonadism. Repros believes testosterone deficiency is linked to obesity in the majority of men that suffer from the disorder. In secondary hypogonadism associated with obesity, estrogen suppresses pituitary secretions of important hormones that are necessary for testosterone production by the testes. Androxal® is an anti-estrogen and acts centrally to restore pituitary secretions and, thereby, restores normal testosterone production in the body.

On November 5, 2014, the Company received guidance from the FDA regarding its NDA submission for Androxal®. During the second half of December the Company submitted a complete response to the guidance that the FDA provided. The Company believes it will have all documents to the contract organization assisting with the electronic filing of the NDA early in 2015 so that the dossier can be filed by the end of the first quarter 2015.

The Company had a follow-up discussion with the Agency regarding the Environmental Assessment requirements for the NDA. The FDA noted that commitment to perform the appropriate non-clinical experiments during the NDA review period would be considered sufficient for filing.

Overall, the Company believes there are no refuse to file issues for its NDA.

Lastly, the Company has engaged a European regulatory consultant, to convert the Company's Androxal® NDA to a suitable dossier for EU filing. Based on the current schedule provided by the consultant, the Company believes that the dossier will be submitted in the EU in the first quarter of 2016.

In all jurisdictions the Company is seeking a New Chemical Entity status for Androxal®.
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Source: press release, 12/29/14. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=889054

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November 6, 2014

Repros Holds Constructive Meeting With FDA Regarding Androxal(R) NDA Filing
No New Clinical Studies Requested
Environmental Impact Assessment Plan Will be Discussed With FDA Prior to NDA Submission
Company to Host Conference Call on Friday, November 7, 2014, at 9 AM Eastern
THE WOODLANDS, Texas, Nov. 6, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported the outcome from its meeting with the FDA to discuss the Company's expected NDA submission.

Based on the data compiled to date, the FDA did not identify any additional clinical studies that would be required for filing the NDA. Although no specific request was made, the FDA stated that as a result of the recent Advisory Committee Meeting, cardiovascular risk is of particular interest and that additional safety studies could be required in the future.

The FDA advised that the Company's environmental assessment of Androxal® planned for the NDA should be discussed with appropriate Agency personnel prior to NDA submission. The Agency stated that due to their evolving interest in this class of chemicals this would be important to avoid late cycle approval delays, and the Company plans to engage in those discussions promptly.

Repros does not anticipate that an additional meeting will be held before submission of its NDA given the detailed guidance received and the subsequent response the Company will provide the Agency. Repros is confident that it will be able to address all concerns noted in the meeting and believes the discussions provided constructive guidance for the NDA filing. The Company will reassess submission timelines once it has discussed the environmental assessment requirements with appropriate Agency personnel.

Conference Call Details:

Time: Friday, November 7, 2014 - 9:00 AM Eastern
Participant Dial-In Number (Domestic): 877-407-8629; International: 201-493-6715
It is recommended that participants call in approximately 15 minutes prior to the start time of the conference call.

Replay Call Details:

Conference ID Number: 13595473
Replay Dial-In (Toll Free): 877-660-6853
Replay Dial-In (International): 201-612-7415

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Source: press release, 11/06/14. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=881340

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February 6, 2014

Repros Meets With FDA to Discuss Data Requirements for Androxal(R) in the Treatment of Secondary Hypogonadism
NDA submission remains anticipated by year end 2014

No additional long-term safety assessments currently planned before NDA submission and review

THE WOODLANDS, Texas, Feb. 6, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the outcome of its previously announced meeting with the FDA regarding the Androxal® Phase 3 data requirements for an NDA in the treatment of secondary hypogonadism. Repros expects to maintain its timeline for submitting an NDA prior to the end of 2014. This submission will include studies ZA-304 and ZA-305 which were initiated in January 2014. Following the meeting, the Company understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission. The FDA requested additional background information regarding the endpoints that the Company will use to confirm maintenance of fertility by semen assessments in studies ZA-304 and ZA-305. The Company plans to provide this information promptly to the FDA and while doing so to continue enrollment of ZA-304 and ZA-305 without interruption.
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Source: press release, 2/06/14. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=823675

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November 25, 2013

FDA Schedules Face to Face Meeting With Repros to Discuss Androxal(R) Efficacy

THE WOODLANDS, Texas, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported it has been granted a face to face meeting with the FDA to discuss the pivotal Androxal efficacy studies per the announcement of October 22, 2013. Prior to the meeting, the Agency will have had the final clinical study reports made available.

The meeting will also address the unmet medical need for therapy producing restoration of total testicular function, i.e. restoration of T levels without the characteristic suppression of spermatogenesis by marketed testosterone replacement products. To enhance this discussion, the Company has proposed attendance of two of its key opinion leaders, Wayne Hellstrom, M.D., F.A.C.S., Professor of Urology and Chief of Andrology, Tulane University and incoming President of ISSM and Edward Kim, Ph.D., Professor at University of Tennessee Graduate School of Medicine.

The Company will report the outcome of the meeting before the end of February 2014.
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Source: press release, 11/25/13. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=809285

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: III

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2015-11-30

Results:

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December 1, 2015
Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene
THE WOODLANDS, Texas, Dec. 1, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form.

In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.

Repros plans to work with the FDA to determine an appropriate path forward to address these comments. "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation," said Joseph Podolski, President and CEO of Repros. "We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
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Source: press release, 12/01/15. http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=944941

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