Bionovo: Challenges Ahead, But Poised to Move Higher

The Women’s Health Initiative ('WHI'), a study that demonstrated several lethal side-effects of hormone replacement therapy ('HRT'), has left many pharmaceutical companies scrambling to advance alternative therapies to meet the unique market demand created by the drop in hormone sales. Although several therapies have advanced to late-stage clinical studies, few represent a truly novel approach.

Pristiq, Wyeth’s (WYE) new treatment for depression and potentially –post menopausal hot flashes, is merely a metabolite of the multi-billion dollar blockbuster, Effexor. Aprella, Wyeth’s investigational combination product for the treatment of menopausal symptoms, repackages two commonly used classes of drugs; estrogens and selective estrogen receptor modulators. Instead of improvements in side-effects or enhanced efficacy, the pharmaceutical industry has employed a model where minor chemical alterations coupled with a profound marketing engine compensates for declining sales from products with patent expiration. It’s very seldom to find a pharmaceutical company that is developing a truly novel approach to therapeutics.