ABOUT WYETH
WHO MAKES THESE DRUGS
Wyeth are the only US manufacturers of hormone replacement therapy drugs containing conjugated equine estrogen -- made from pregnant mare's urine. The most commonly known of them is Premarin.
The Premarin family of drugs are sold extensively in North America and Canada.
Pfizer Inc. is currently bidding to takeover, or merge, with Wyeth. Further information in the article below.
Will Pfizer-Wyeth merger cure the PMU horse blues?
What impact will the Pfizer-Wyeth merger have on the horses abused and killed by the PMU industry? If it goes through, probably nothing, except horse advocates will have an even larger foe to take on.
By VIVIAN GRANT
President, In'l Fund for Horses
Analysts are scratching their heads, and wondering why Pfizer are making the move. As far back as August, 2007, Fortune writer John Simons called a merger between Pfizer and Wyeth a “marriage of weakness,” adding “Pfizer needs blockbusters to overcome looming patent expirations and Wyeth has recently been failing to deliver.” --FiercePharma.com
Catherine Arnst reports on January 4, 2009:
Acquiring Wyeth might boost Pfizer’s fortunes in the short term, but it won’t solve the long-term problems that are roiling the major pharmaceutical makers. As many observers have noted, Pfizer and the rest of the drug industry suffer from a lack of promising new products to replace older ones going off patent. What is less widely understood is that Pfizer also will face an increasingly constrained marketing environment, even if it succeeds in bulking up with Wyeth.
The fact is, it’s getting a lot harder to market the products both companies have right now. Congress is widely expected to restrict direct-to-consumer advertising by drug companies this year, and much stricter limits were put in place last year on how the industry markets to doctors. Universities and hospitals also are toughening up existing constraints on how much money their researchers can accept from companies for promotional activities. -- Business Week
Arnst tells us in a subsequent article, dated January 26, 2009:
[Pfizer CEO] Kindler told a news conference that the Wyeth merger is not about “a single product or cost-cutting,” as with past deals. Instead, “it’s about creating a broad, diversified portfolio.” -- Business Week
None of the numerous articles we read for this report mentioned hormone replacement therapy drugs as high or even on the agenda for Pfizer’s takeover of Wyeth. Yet, Wyeth forecasts Aprela sales of $2 billion a year.
Let’s take a look anyway.
— Premarin, Prempro and Premhase.
Wyeth produces the Premarin family of drugs manufactured with CEE, or conjugated equine estrogen. Equine estrogen is derived from pregnant mare’s urine. There was a significant downturn in the sale of the Premarin drug group when the Women’s Health Initiative linked them to cancer, blood clots and cancer, among others. A rash of lawsuits followed. Premarin and Prempro are still widely prescribed, and obtainable on the internet without prescription. Physician’s notes for Premarin state that it also helps with osteoporosis that occurs during menopause.
— Enter Aprela.
Wyeth has a new drug in development also made with CEE called Aprela. Aprela is currently being scrutinized by the FDA for approval this Spring. Aprela will reportedly be marketed as an osteoporosis drug to women (and men) with the added attraction that it treats menopausal symptoms of women. -- Pharmalot
— Enter Fablyn.
Pfizer has had a drug in development awaiting FDA approval called Fablyn. Fablyn is an osteoporosis drug that also treats the menopausal symptoms of women. Called Ostoria in previous go rounds for FDA approval, it is said to be in the same class as Eli Lilly’s osteoporosis drug Evista.
Jared A. Favole tell us in a report filed January 8, 2008:
A panel of medical experts on Monday said Pfizer Inc.’s (PFE) proposed osteoporosis drug has benefits for post-menopausal women, but suggested the drug be restricted to women at high-risk of fracture or those who fail other treatments.
Pfizer is seeking U.S. Food and Drug Administration approval for the drug to treat osteoporosis, which generally leads to bone fractures, in post-menopausal women. Nine panel members said the benefits of Fablyn outweigh the risks, three said it didn’t and one member abstained.
and
It’s unclear whether the FDA will approve the drug, and if it will suggest restricting it to a certain population of women. The FDA will consider the panel’s advice in its decision.
The FDA has until sometime in October to make a decision. A rejection of Fablyn would be a setback for Pfizer as analysts estimate the drug could bring in peak sales of $1 billion. (emphasis added) -- Dow Jones Newswires
The panel voted 9 to 3 to approve Fablyn. However, the FDA has still not given the drug the go ahead.
John Carroll reports on January 20, 2009:
Pfizer has run into a roadblock at the FDA in its long-running quest to gain an approval for its experimental osteoporosis drug Fablyn. The pharma giant says the FDA has asked for more information on the drug.
Fablyn has had a long and troubled history. It was rejected as a treatment for osteoporosis almost four years ago after the agency had determined that it could cause cancer in the lining of a woman’s uterus. And it was rejected again in 2006 for vaginal atrophy. -- FierceBiotech.com
That sounds frighteningly familiar.
Will the Pfizer-Wyeth merger go through? The Greenlining Institute asked the Justice Department and Treasury Secretary Timothy Geithner to block the $64.6 billion transaction unless the companies lower consumer drug prices -- Bloomberg News
Will Fablyn or Aprela be approved?
Even if the answer to both those questions is no, thousands of foals will continue to lose their young lives, along with the mares when they can no longer become pregnant, so long as Premarin and Prempo are prescribed and sold. The approval by the FDA and sale of Aprela will simply add to the trail of blood, whatever pharma giant peddles it.
Source: Tuesday's Horse, A Weekly Publication of the Int'l Fund for Horses
