Wyeth-Ayerst To Take Annuelle Into Ph III
Wyeth-Ayerst is to begin a two-year Phase III study with its Annuelle (norethindrone) contraceptive implant following a 100% protection rate in a 90-person Phase II study.
Wyeth-Ayerst licensed the product from a company called Endocon in December 1992, along with the latter's Complimens subcutaneous delivery system. Under the agreement, Wyeth purchased 3% of Endocon and agreed to purchase a further 17%. Endocon received $4 million in upfront milestone payments for commencing Phase I and Phase II studies with the implant, and will receive additional payments at the completion of Phase III studies, submission of New Drug Applications and approval of products that employ the delivery system.
The procedure is performed in a doctors surgery through the use of a "preloaded, injector-like device" which can be set to last from one month to two years. Wyeth-Ayerst said that it expects to file an NDA for the contraceptive in January 1996.
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