2010 has already been a busy news year for the Premarin Industry. Here is what has happened so far.
PREMARIN TIMELINE 2010
- Further studies indicate higher risks of asthma, lung cancer, malignant melanoma, and reduced insulin resistance associated with HRT.
- Since 1976, Wyeth (now a Division of Pfizer) have been fighting on-going lawsuits related to the use of their Premarin® family of drugs. This number is estimated to be as many as 5000 cases primarily related to the incidence of breast cancer.
- Pfizer’s/Wyeth’s estimated sales figures suggest that Aprela will be available on the market in 2011.
- Pfizer Q4 2009 earnings from Biopharmaceutical were $14.6 billion, an increase of 30% compared with $11.2 billion in the year-ago quarter. Operationally, revenues increased $2.9 billion, or 26%, of which $2.5 billion, or 22%, was attributable to legacy Wyeth products, primarily Premarin® in the Primary Care unit.
- Pfizer/Wyeth’s projected sales for their HRT therapies (Premarin®, Aprela®) to exceed one billion USD by 2015.
- Pfizer Inc. re-affirms confidence in its (Wyeth) hormone therapy medicines (Premarin®) as important treatment options for symptoms of menopause and osteoporosis.
- Hormone replacement therapy makes a comeback in New York Times magazine article called “The Estrogen Dilemma”. One of the authors, Cynthia Gorney, spins a poignant tale about a psycho-socio-hormonal-spiritual breakdown that led her to hormone discipleship in midlife. Turns out that Gorney’s “sources” are the Wyeth funded Roberta Diaz Brinton, Thomas Clarkson-who worked with the Wyeth ghostwriting firm, DesignWrite-and Louann Brizendine and Claudio N. Soares who have served as actual paid Wyeth speakers.
- Pfizer Inc. announces closure of eight manufacturing plants, decreased production at six others and 6,000 job cuts since acquiring rival drug maker Wyeth. Plans are to cease operations at several plants in Ireland, Puerto Rico, Germany, Britain and the United States by late 2015. Pfizer manufactures three former Wyeth hormone-based medications in Rouses Point: Premarin®, Premarin® Vaginal Cream and Prempro® which will close in 2011. Manufacturing responsibility for these products is expected to be mostly shifted to other Pfizer sites once the company permanently pulls out.
- Due to increased risks of stroke and thromboembolic events, the FDA delays the approval of Bazedoxifene (Viviant®), the osteoporosis component of Aprela®. Once slated for release in 2011, Aprela is now subject to delay as well (possibly 2012 or later).
- Giant drug manufacturer Wyeth, a division of Pfizer, announces their intention to downsize the PMU industry through the cancellation of ranch contracts that will see their numbers dwindle from the current 64 to as few as 25. Herein lies a conundrum based on their projected sales for Premarin® and Aprela® of more than 1 billion USD by 2015.
- Pfizer, the world’s largest drug maker, announces the withdrawal of its new drug application (NDA) for Fablyn® a selective estrogen receptor modulator (“SERM”) for the treatment of both osteoporosis and selected consequences of menopause. As with other SERMs, Fablyn® has been shown to have significant side-effects which contraindicate widespread use. Of note is that Viviant®, the osteoporosis component of Aprela® , is also a SERM.
- The apparent ambiguity of the relationship of the decrease in North American PMU industry and projected sales of Premarin® and Aprela® is solved. According to an article in The Western Producer; “Wyeth plans to ramp up production of PMU facilities in China, Kazakhstan and Poland, out of the scrutiny of North American values. The byproduct of meat foals has a lucrative market, while Wyeth can continue to make statements relating to supply and demand to justify price of HRT”.
Compiled by JANE ALLIN
Research Analyst | Int’l Fund for Horses