Before the Women’s Health Initiative (‘WHI’), women were effectively treating their menopausal symptoms with hormone replacement therapy (‘HRT’), such as Premarin, Prempro and others. But since then, the medical community has carefully examined the toxicity of these hormones and is now more cautious of their usage. The prescriptions for hormones for menopausal symptoms have been cut in half since WHI. This presents an opportunity for the next safe and effective treatment option.
It seems that the consumer has been more vigorous in avoiding hormones than physicians. Most gynecologists still recommend the use of hormones because there are few other FDA approved options, but patients are seeking alternatives. Gynecologists estimate that 1/3 of women seeking treatment for menopausal symptoms are on conventional prescription hormones ('HRT'), despite a greater risk for heart disease, cancer, stroke, breast cancer and blood clotting. Another 1/3 of women are taking prescription or OTC bio-identical hormones. The advertisements for these treatments often tout that it is a “natural alternative”, yet evidence from medical literature shows that bio-identical hormones have the same safety concerns as HRT. The final 1/3 of women are seeking alternative therapies like Black Cohosh, acupuncture or topical creams, despite the lack of clinical trials proving efficacy or FDA oversight regulating quality control.
Stuck between a rock and a hard place, women have a lack of treatment options to safely and effectively treat menopausal symptoms. So, just how big is the opportunity to fill this treatment void? Depends on who you ask:
According to Claudia Steward, senior manager of Biomedical Licensing at University of Rochester, the market potential is in the billions. "With regard to market penetration, we think that a non-hormonal drug for hot flashes will be very successful. We estimate that $1 billion of the retail market [for menopausal hot flashes] could be captured by a drug with existing approvals for other indications", Steward was referring to a class of drugs that includes Pfizer’s (NYSE:PFE) Lyrica and Depomed’s (NASDAQ:DEPO) Serada. Pfizer has since stopped pursuing the ‘hot flash’ indication for Lyrica and Depomed should report top-line Phase III trial results for Serada in October.
Another contender for this segment is Wyeth’s (WYE) antidepressant Pristiq. In January of 2007, Wyeth’s CEO Robert Essner believed that, “sales for Pristiq may top $2 billion [if Pristiq is approved for the ‘hot flash’ indication]". In July 2007, the FDA asked Wyeth to produce a more comprehensive safety profile for Pristiq for the indication of ‘hot flashes’. Wyeth immediately began the additional trial and should report top line results in December 2009. Pristiq is currently approved and marketed ONLY for depression, with annual sales below $200 million dollars, well below the $2 Billion that Essner was hoping for.
According to BioSante (BPAX), “the estrogen market for the treatment of hot flashes was a $1.3 billion market in 2006 and is expected to grow based on the aging of the baby-boom generation." BioSante is currently marketing Elestrin, which is the lowest (and safest) dose of hormone approved by the FDA for the treatment of hot flashes.
BioNovo (OTC:BNVI) believes the hot flash market is "$8 billion dollars at branded prices." BioNovo is conducting a phase III trial for Menerba, a novel selective estrogen receptor beta ('ERβ') agonist. The trial is headed by Dr. Wulf Utian, the Founder and Executive Director of The North American Menopause Society ('NAMS'). He believes that “Menerba has exciting preclinical and clinical safety data, and the efficacy is encouraging.”
Noven (NOVN-OLD) believes that “this market could exceed $3 billion annually, and that their product Mesafem could achieve sales in 2012 in excess of $400 million, with the potential for significant continued growth thereafter."
Recently, DataMonitor published a report about new, potential treatments for Hot Flashes. According to Datamonitor, "Non-hormonal treatments have the potential to capture, at least, $535m in the US and EU."
So you tell me: How big is this problem and what’s the opportunity.
Disclosure: Author holds a long position in DEPO and BNVI.