October 13, 2017
By Alex Keown, BioSpace.com Breaking News Staff
EWING, N.J. – During a drug review process, the U.S. Food and Drug Administration identified unnamed deficiencies in Antares Pharma’s New Drug Application for Xyosted that have halted discussion of labeling and postmarketing requirements.
The announcement sent share prices plunging this morning. Shares of Antares Pharma are down more than 40 percent this morning, trading at $2.20 as of 10 a.m. Antares shares closed at $3.78 on Thursday.
Xyosted, which was previously known as QuickShot Testosterone, is being developed as testosterone replacement therapy. Xyosted is designed to be injected at home, on a weekly basis by men who have been diagnosed with hypogonadism, a condition where the body does not produce enough testosterone. Phase III data showed that testosterone delivered subcutaneously using the auto-injector provided “rapid, steady, and reliable efficacy by restoring testosterone to pre-defined physiologic levels,” the company said when it filed the NDA with the FDA in December.
Antares said the letter it received from the FDA does not specify any deficiencies. Additionally, Antares said the FDA has not provided clarification of those deficiencies. The company said it should receive clarification from the FDA on or before the Prescription Drug User Fee Act (PDUFA) date of Oct. 20. Antares said it intends to work with the FDA to “understand the nature of the deficiencies once identified and resolve them as quickly as possible.”
Antares submitted its New Drug Application for Xyosted, a testosterone enanthate subcutaneous injection, on Dec. 20, 2016. Since the company submitted the NDA, Antares share prices have steadily climbed from $2.19 to a high of $3.96 on Oct. 10.
That high in share prices three days ago came after Antares inked a $14.5 million deal with Switzerland-based Ferring Pharmaceuticals for its Zomajet needle-free auto injector device. At the time of the deal, Antares Chief Executive Officer Robert F. Apple said the sale represents a milestone in the company’s long-term strategic plan. By selling a non-core asset, Apple said Antares will be better able to focus its resources on several key strategic objectives, which includes the potential launch of Xyosted.
There have been rumors that Antares could be the target of acquisition. A Seeking Alpha article noted that excitement may have been building among potential suitors due to the pending PDUFA for Xyosted. In addition to the testosterone therapy, the company is also looking at pending approval for AB-rated generic for Mylan ’s EpiPen autoinjector, as well as a generic form of the diabetes medication Byetta (exenatide).
