© 2017 Evestra, Inc.

Development Pipeline

In conducting its research and development activities in support of its women’s health product initiatives, Evestra has, over its history, identified product opportunities deriving from its core platform technologies that appear to have significant potential but which are outside of the scope of its women’s health focus. 

The Company is seeking to license these potential products to partners which have important franchises in these therapeutic areas.

EVE112 is a vaginal ring product for fertility control which releases ethinylestradiol and etonogestrel. These are the same active ingredients as in NuvaRing®. Although EVE112 is not a generic equivalent product of NuvaRing® due to a different release profile, it will still compete in certain non-US territories with NuvaRing® and its generic equivalent product.

EVE119 is a fully generic product of NuvaRing® and will be commercialized in the US.

EVE116 is a vaginal ring product for fertility control containing trimegestone as progestin and the natural estrogen, estriol. Substituting ethinylestradiol for the natural estrogen, estriol, will reduce the rates of deep-vein thrombosis and will establish a new level of safety for contraceptive products.

EVE122 is an HRT vaginal ring product delivering the natural estrogen, estriol, for the treatment of climacteric complaints like hot flashes. It addresses the desire for longer acting products and will offer a better safety profile with regard to the incidence of deep-vein thrombosis without the danger of inciting breast tissue, which can lead to breast cancer.

EVE120 is a vaginal ring product that releases fesoterodine, an approved second generation anti-muscarinic agent for the treatment of over-active bladder. This product is designed to match plasma concentration of oral products over a 28 day period and will be approved via a 505(b)(2) regulatory pathway in the US.

Project Code

Classification

Target Disease

Phase/ Next Milestones

Dosage Form

Remarks

Fertility Control (FC) & Hormone Replacement Therapy (HRT)

EVE112

Vaginal ring releasing ethinyl-estradiol & etonogestrel

FC

Phase III clinical trial ongoing, NDA Q2/2018

VR

Innovative release profile

EVE119

Generic NuvaRing®

FC

Bioequivalence study 01/2018, ANDA 07/2018

VR

 

EVE116

Second generation NuvaRing®

FC

Phase II starts in Q1/2018

VR

Lower risk of deep-vein thrombosis

EVE122

Natural estrogen, estriol, vaginal ring

HRT

Phase II start in Q1/2018

VR

Lower risk of deep-vein thrombosis

Overactive bladder (OAB)

EVE120

Anti-muscarinic agent

OAB

IND Q3/2018

VR

Fast to market via 505(b)(2) strategy