S P E C I A L R E P O R T
March 17, 2014
How will this new drug impact profits and inevitably the PMU mares and their foals?
DUAVEE®, the Premarin® - bazedoxifene combination therapy for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone hysterectomy was FDA-approved in October 2013 amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval.
Pfizer anticipates that DUAVEE® will be available in the U.S. in the first quarter of 2014. This is the first approval of DUAVEE® in any country worldwide – an approval of a combination drug with the component bazedoxifene yet to receive FDA approval on its own – its approval is valid only in combination with Premarin®, at least in the US - a conundrum in itself and worthy of further debate.
Some market analysts estimate DUAVEE®’s peak sales to reach $200 million (USD)/annum. 
DUAVEE® will be sold as a combination of 0.45 mg CEEs / 20 mg bazedoxifene however no pricing information is available yet as Pfizer has yet to launch it. If it sells for the same average cost per dose as Premarin® - roughly $3.50 – the number of mares, in addition to those currently on the pee lines, can be approximated.
Number of doses
= Total Sales ($) / Cost per dose ($)
= $200,000,000 / $3.50/dose
= 57,142,857 doses
Total mg required
= 57,142,857 doses x 0.45 mg/dose
= 25,714,286 mg
Number of mares
= Total mg required / # of mg per mare
= 25,714,286 mg / 9466 mg/mare
= 2,716 mares
However all may not be lost on this new drug. Despite the fact that Pfizer re-labeled this combination formula as innovative with an improved safety profile over conventional HRT 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 anticipating a FDA approval in 2007 however it took 6 more years for the FDA to finally put its rubber stamp on it all the while citing concerns over health risks.
With the still lingering fear of developing cancers from CEE-derived HRT and the fact that there are other best-seller osteoporosis drugs currently on the market – for example Evista® from Eli Lily which generated $1 billion last year as well and its generic to be introduced within the month – DUAVEE® may not become the block-buster Wyeth/Pfizer once thought.
Particularly encouraging is that inside information reveals that even Pfizer is vacillating on the roll-out of this drug.
The veil of controversy over safety efficacy and its long and tortuous road to FDA approval seems to have cooled the hype associated with its introduction to the market. In fact speculation has it that Pfizer may never put this drug on the market – a Godsend to the horses and women alike.
Comments made by Pfizer employees on a public forum reveal a decidedly different picture from the one painted by Pfizer-proper. Here are a few interesting and illuminating remarks.
“Look into why this drug has taken so long throughout R&D phases. Wyeth Women's Health talked about this drug coming to market by 2005.”
“Just wait until the recall. This drug will make your uterus collapse.”
“It's the biggest joke at Pfizer. Enormous amounts of money being spent for what will be the biggest failed launch since Exubera.”
“Bingo! The cost to promote this DuaDog far exceeds the profitability for the first five years. Any CSO could sell this thing for a better ROI. It's not rocket science but simple math. Launch is seriously being questioned and could become a no go at any moment.”
“This product is a DOG! I hear that there is debate internally as to whether or not to even launch.”
Shareholders also understand and do not want to bear the brunt of more lawsuits, nor do the innocent women and their families. It is obvious that few have faith in the safety profile of this drug or its marketability – two risky drugs and limited clinical data makes for a bad recipe.
It is time to stop this madness.
Big Pharma – rotten to the core – deception, fraud, kickbacks, price-setting, bribery and illegal sales activities – anything to keep their profits rolling in. They will stop at nothing to expand their profit base, even if it means harming or killing countless innocents, humans and animals alike.
God bless the mares and their foals and whatever fate awaits them for they are undeniably the persecuted innocents – without voice or choice they suffer at the hands of greed and merciless degenerates with stilted vision who fail to comprehend the difference between right and wrong – a capitalist system where underlying principles are lost to a delinquent world that worships money.
"Where in this wide world can men find nobility without pride,
Friendship without envy, or beauty without vanity?
Here, where grace is laced with power and strength tempered by gentleness.
He serves without servility, he has force without enmity.
There is nothing so powerful, nothing less violent.
There is nothing so quick, nothing more patient.
Our pioneers were borne on his back,
Our history is his industry.
We are his heirs and he is our inheritance. . .
The horse."~ Robert Duncan