Barr Pharmaceuticals / Endeavor Pharmaceuticals

Menopausal vasomotor symptoms / hormone replacement therapy

Disease Overview

Menopausal vasomotor symptoms (hot flashes, night sweats) and atrophic vaginitis are treated with conjugated estrogens, with or without progestin co-therapy. The market in 2003-2004 was anchored by Wyeth's Premarin/Prempro franchise, which had been disrupted in 2002 when the Women's Health Initiative trial linked combined HRT to elevated cardiovascular and breast cancer risk and triggered a sharp prescribing decline.

Competitive Landscape

Endeavor Pharmaceuticals was formed in 1994 by aaiPharma and Schering Berlin Venture Corp to develop synthetic conjugated estrogens that could compete with Wyeth's Premarin without the equine-derived sourcing. The asset Barr acquired was the Enjuvia NDA, filed March 2002 — a plant-derived 10-component synthetic conjugated estrogen B mixture. CEO Forrest Waldon told Pharmaceutical Online in 2000 that prior funding 'allows us to continue our focus on hormone and female health drug development work' [pharmaceuticalonline.com]. Competing entrants in synthetic conjugated estrogens included Duramed's own Cenestin (synthetic conjugated estrogens A) and Solvay's Estratest. Note that the originally-cited Femcon FE / SEASONALE / SEASONIQUE lineage is NOT traceable to the Endeavor acquisition: SEASONALE was developed by Barr with Eastern Virginia Medical School and launched September 2003 [biospace.com]; Femcon Fe (chewable Ovcon 35) was a Warner Chilcott NDA approved November 2003 [pharsight.greyb.com]. Enjuvia received FDA approval May 10, 2004 in 0.625 mg and 1.25 mg doses, with 0.3 mg and 0.45 mg approved December 2004 [drugs.com].