Duavee, the combination menopausal-osteoporosis drug, comprised of conjugated equine estrogens (Premarin) and bazedoxifene (Selective Estrogen-Receptor Modulator) was approved by the FDA on Oct 3 2013 and was available to the marketplace in the first quarter of 2014.
However the NDA approval was not without provisions. Due to the heightened risk of endometrial hyperplasia, potentially a precursor to endometrial cancer, Wyeth/Pfizer is required to conduct a post marketing pharmacokinetic trial to evaluate the effect of conjugated equine estrogens and bazedoxifene on imminent changes in endometrial tissues within the selected cohort of non-obese and obese postmenopausal women. See http://goo.gl/mFpmON
In effect the FDA has granted them permission to sell this concoction to unsuspecting women despite the undeniable concern that there is an increased risk of endometrial cancer. The final report from Wyeth/Pfizer is to be submitted by 04/2015 – an entire year and a half after its approval.
Pfizer had a lackluster first quarter, and the continued profit decline, accompanied by a lack of groundbreaking drugs on the horizon, disappointed investors. Despite the fact that Duavee took years to get to market along with biased studies, inexcusable side effects, questionable data and the fact that the FDA has yet to approve bazedoxifene as a stand-alone drug, Pfizer is pinning its hopes on Duavee to pick up the slack.
Pre-and post-market availability of Duavee, Pfizer ramped up an aggressive direct to consumer campaign and boosted its marketing efforts that continued throughout the year, not only for its new drug but also Premarin tablets and vaginal cream. Similarly medical doctors were plied with the benefits of Premarin and Duavee and encouraged to prescribe it to their patients – particularly Duavee – the so-called “safer” of the two drugs.
In late May 2013, Pfizer followed several other pharmaceutical companies in their quest to extend the period of their New Chemical Entity (NCE) exclusivity for their Fixed-Dose Combination drug Duavee to 5-years from the 3 years they were granted when it was approved on October 2013. To date the FDA has denied all petitions. The reasons for Pfizer’s fight for a 2-year extension are unclear – bazedoxifene has yet to be granted approval by the FDA nor is there a generic version of Premarin on the market.
Pfizer continues to fight its legal battles in the courtroom over the carcinogenic effects of the Premarin family of drugs. Of note is a class action lawsuit pending in Canada that has the potential of proving this to be true in a high number of cases, revealing important facts and figures previously uncovered - the body of evidence to date overwhelmingly points to a causal connection between the use of Premplus and the development of invasive breast cancer in women.
In a Canadian study conducted by the Canadian Cancer Society, its top epidemiologist alleges that popular menopause drugs made in part from estrogen found in the urine of pregnant horses have caused breast cancer in thousands of Canadian women. Wyeth, now wholly owned by Pfizer continues to deny this of course.
A blow to horse advocates and those opposed to the use of CEE-containing hormone therapies came in October of this year with the news that Kim Cattrall, star of Sex and the City, teamed up with Pfizer to promote Duavee in a campaign called “Tune into Menopause”. This, despite the fact that Cattrall is not a Duavee patient, has the potential to influence and encourage many women to take this drug.
On October 27, 2014 the combination conjugated equine estrogen/bazedoxifene venom, to be sold under the name of Duavive, was recommended for approval by the European Medicines Agency (EMA) so it is only a matter of time before it is available in Europe.
After the launch of Duavee in the first quarter of the year Pfizer reports that the sales of their combo drug have grown to more than 5,000 prescriptions per month. Sales projection for 2014 is approximately 100 million USD, estimated to double by the year 2020. See http://consensus.druganalyst.com/Pfizer/Duavee/#
Last but by no means least, the horses. In North America the NAERIC (North American Equine Information Council) website lists the number of mares on the PMU farms as 2,000.
NOTE: It is well known however that the primary production of CEEs for the manufacture of the Premarin family of drugs now takes place overseas in Asian locations (China, possibly India). As for the exact number of farms and mares on the pee lines this has yet to be confirmed. Needless to say, they must far out-number those left here in North America. How long will it be before the ranches here disappear?