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March 12, 2014
07:02 EDTATRSAntares Pharma receives second milestone payment from LEO Pharma
Antares Pharma announced the receipt of a second milestone payment of $5M from LEO Pharma. The milestone payment was received in connection with the launch of OTREXUP and the achievement of a specific percentage of patient lives covered by managed care organizations. To date, Antares has received $10M in milestone payments from LEO Pharma. On November 14, 2013, the company announced an exclusive license and promotion agreement with LEO Pharma for detailing OTREXUP to dermatologists for symptomatic control of severe recalcitrant psoriasis in adults. Under the terms of the agreement, Antares may receive up to a total of $20M in milestone payments. LEO Pharma will be responsible for all promotion and marketing costs in dermatology. Antares Pharma will record all product revenue associated with future dermatology prescriptions and pay LEO Pharma a percentage of OTREXUP net sales generated in dermatology.
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February 25, 2015
07:12 EDTATRSAntares Pharma announces QuickShot testosterone study met primary endpoint
Antares Pharma announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the company’s ongoing, multi-center, phase 3 clinical study evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males. In the study, 150 adult males with hypogonadism low testosterone and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate once weekly for six weeks. Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic profiles were obtained during the 12th week of treatment. One hundred fifty patients have received at least one dose of study drug and to date, there have been no reported deaths and one serious adverse event of hospitalization for worsening depression. This patient received a single dose of QS T, and the SAE was not considered to be related to study drug. Thus far, there have been no reported adverse events consistent with urticaria. The FDA has recommended that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months.

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