Strategic Pre-Clinical Collaborations

Orbis Biosciences, Inc.  - ORB-204 and ORB-214

In March 2018 we entered into an agreement with Orbis Biosciences, Inc. for the development of an injectable etonogestrel contraceptive with 6- and 12-month durations (ORB-204 and ORB-214, respectively). The collaboration represents our first partnership that leverages funds and development work supported to date by investment from a donor and non-profit development community devoted to improving options in women’s reproductive health, positioning Daré as a committed industry partner to advance innovation that addresses global gaps in therapeutic options.

The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360) through a grant from the Bill & Melinda Gates Foundation. Through its Contraceptive Technology Innovation (CTI) initiative, FHI 360 is developing new and strategically important contraceptives that are designed to fill gaps in the market, provide mid-to-long duration of action and have favorable usability profiles.

An injectable contraceptive is designed to provide discreet, non-implanted, protection over several months.  Limitations of the currently marketed injectable contraceptive is that it provides contraceptive protection for only three months, and can delay the ability to get pregnant for up to ten months after receiving the injection.  The target product profiles of ORB-204 and ORB-214 include prolonged duration (6 to 12 months), improved ease of use, with an improved side effect profile and predictable return to fertility.

Pre-clinical studies for the 6- and 12- month formulations have been completed to date, including establishing pharmacokinetics and pharmacodynamics profiles.  The collaboration with Orbis will continue to advance the program through formulation optimization with the goal of achieving sustained release over the target time period. 

The terms of the agreement with Orbis provide Daré with an option to enter into a license agreement for ORB-204 and ORB-214 should upcoming development efforts be successful.