Antares Pharma, Inc. (ATRS)

[H2R]

QST PDUFA: October 20, 2017

http://seekingalpha.com/pr/16753779-antares-pharma-announces-fda-acceptance-new-drug-application-quickshot-testosterone

EWING, N.J., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) today announced that the New Drug Application (NDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, has been accepted for standard review by the U.S Food and Drug Administration (FDA). QST was developed to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017, ten months from the official NDA submission. The PDUFA date is the target date for the FDA to complete its review of the NDA.

“The FDA’s acceptance of the QuickShot testosterone NDA is an important start to the review process and marks another significant milestone for our Company,” said Robert F. Apple, President and Chief Executive Officer. “We continue to believe QST could be an excellent treatment option for men with hypogonadism based upon the positive pharmacokinetic and safety data produced in the two phase three studies now on file with the FDA. In addition to virtually eliminating the risk of transference that exists with topical gel products and the uncomfortable deep intramuscular administration associated with current injectable therapies, we believe that the phase three studies demonstrated that weekly subcutaneous administration of testosterone using the QuickShot auto injector can provide patients with physiologically normal and steady levels of testosterone over the course of therapy. The study data also showed patients had a virtually painless treatment experience using the device. We will work closely with the FDA during the regulatory review process toward a potential approval.”