Project name: conjugated estrogens/bazedoxifene
Disease: Moderate-to-severe vasomotor symptoms
Peak sales estimate: $200 million
Approved: Oct. 3
Companies: Pfizer and Ligand Pharmaceuticals
Pfizer ($PFE) already had treatments for menopausal women in its quiver when it got approval for Duavee, a drug it acquired in its buyout of Wyeth in 2009. In fact, what it refers to as its Premarin family of products, which also came with Wyeth, generated more than $1 billion in sales last year. But while many women would like to find something to treat hot flashes, they have been scared off by a decade of discussion over the risk of developing breast cancer after taking hormones for the symptoms.
Duavee is approved for moderate-to-severe hot flashes related to menopause in women who haven't had a hysterectomy as well as for prevention of postmenopausal osteoporosis. It differs from other hormonal treatments by being the first to combine estrogen with the estrogen agonist/antagonist bazedoxifene, which reduces the risk of endometrial hyperplasia. Some experts think the combo may mean it will have fewer of the increased cancer and other risks that have plagued earlier drugs in the category, including Prempro and Premarin. The company certainly understands the potential downside those risks pose; it has reported that litigation tied to these risks in its hormone products have cost it about $1.6 billion over the years.
Pfizer touts the drug as a hormone therapy with few of the side effects associated with similar treatments, but it has a risk history of its own. Originally known as Aprela, Wyeth started work on it in 1999, as part of a program with Ligand ($LGND). They had hoped for a 2007 approval, but FDA concerns over health risks kept pushing that opportunity further into the future. Still, some experts say Duavee may not carry the same safety concerns about long-term use of estrogen. Doctors who treat women with menopause know their patients are ready for a treatment option.
Duavee, however, is not the only alternative approved this year, and its competitor does not rely on hormones for its benefits. Brisdelle from Noven Therapeutics, a unit of Hisamitsu Pharmaceutical, is the first nonhormonal treatment for hot flashes. What it does contain is paroxetine, the same ingredient found in the popular antidepressant and antianxiety drug Paxil. Paroxetine carries a boxed warning about the risk of suicide associated with its use in children and young adults, and so the drug carries that as a boxed warning.
Pfizer could have given up on Duavee. Some analysts did, surmising it would never get to the market. That makes it difficult to gauge its potential earnings power. There have been forecasts that it could generate $200 million. But given that sales of the Premarin family of drugs top $1 billion and Eli Lilly's ($LLY) Evista for prevention of postmenopausal osteoporosis also reaches blockbuster status, it is hard to say. -- Eric Palmer (email | Twitter)
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