OvaScience Says to Suspend Enrollment of AUGMENT in US, Will Plan for Enrollment Outside US Moving Forward
OvaScience^SM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today provided a regulatory, manufacturing and international strategy update on AUGMENT, the Company's product candidate designed to improve egg quality and increase the success of in vitro fertilization (IVF).
OvaScience has chosen to suspend enrollment of AUGMENT in the U.S. while moving forward with its plans for enrollment outside of the U.S. On September 6, 2013, the Company received an “untitled” letter from the Food and Drug Administration (FDA) questioning the status of AUGMENT as a 361 HCT/P and advising the Company to file an Investigational New Drug (IND) application. OvaScience anticipates having further discussions with the FDA to present details on AUGMENT and its qualifications as a 361 HCT/P, and to determine the appropriate path forward. OvaScience continues to believe that AUGMENT qualifies as a 361 HCT/P.
OvaScience plans to initiate sites for an AUGMENT study in select countries outside of the U.S. in 2014. In preparation for the launch of AUGMENT, OvaScience has expanded its manufacturing capabilities with a global supplier, which has extensive commercial experience in cell therapy manufacturing. This will enable OvaScience to increase capacity for the launch. The Company is making steady progress in preparation for the study and launch of AUGMENT.
OvaScience management will host a call regarding AUGMENT on Wednesday, September 11, 2013 at 8:30 am ET. The call can be accessed by dialing 877-703-6104 (U.S.) or 857-244-7303 (International) five minutes prior to the start of the call and providing the passcode 36060078. A replay will be available approximately two hours after completion of the call and can be accesses by dialing 888-286-8010 (U.S.) or 617-801-6888 (International) and providing the passcode 41313881. The replay will be available for two weeks from the date of the call. Additionally, the live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company's website at www.ovascience.com. A replay of the webcast will be archived on the Company's website for two weeks following the call.
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