Premarin Timeline 2014

Duavee enters the marketplace

Pfizer’s latest menopausal drug 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 FDA 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»

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

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? —Jane Allin.

Pfizer turns the sex talk toward 50-ish women with a menopause awareness push

Anyone who’s watched a Viagra commercial knows that Pfizer ($PFE) isn’t too embarrassed to talk about sex. Anyone who’s run across Pfizer’s “Get Old” campaign knows it doesn’t shy away from aging, either. Now, the drug giant is going equal opportunity on the sex-and-aging talk, and “Desperate Housewives” actress Brenda Strong has the dialogue.

With its latest menopause awareness campaign, Pfizer is taking a break from hot flashes and night sweats. Instead, it’s focusing on some lesser-known effects of menopause, namely painful intercourse and vaginal atrophy. They’re not terms tossed around at your average dinner party, and Pfizer’s campaign capitalizes on the uncomfortable.

Aptly titled “Let’s Talk About Change,” the campaign has launched with a YouTube video titled “The Other Talk.” In one scene, Strong’s character engages her daughter in the birds-and-bees conversation so often lampooned in Hollywood comedies. Predictably, said daughter closes the door in her mother’s face. But then the tables are turned. Strong’s character finds herself in an awkward conversation with her mother–about menopause and its effects on her mother’s sex life.

Pfizer’s point is that women need to talk to someone about these little-known effects of menopause. If not their mothers, then perhaps their partners–and most importantly for Pfizer, their doctors. “It’s our hope that ‘The Other Talk’ video will prompt new dialogue about the symptoms of post-menopause,” Strong says in a Pfizer release. “The video is funny, but has an important message–more women should be talking about these changes and taking action to help find relief. Women should not have to suffer in silence.”

If women did ask their doctors–and if the conversation goes as Pfizer might hope–women would not only hear about symptoms but also get information about the company’s products for those very symptoms.

To give a nudge, the “Let’s Talk” home page includes a link to Pfizer’s Estring brand website. A vaginal ring that releases estrogen over a 90-day period, Estring is approved specifically to treat any unpleasant menopausal changes in the vagina and is designed to act locally rather than systemically. Among its rivals is Osphena, approved in February 2013; Shionogi specifically touts it as a nonestrogen treatment for vaginal changes around menopause.

Estring is just one in Pfizer’s lineup of hormonal treatments for menopausal side effects. Its Premarin line of products, acquired along with Wyeth in 2009, still generates blockbuster-level sales, with $768 million for the first 9 months of 2014. Pfizer knows well about potential side effects of hormonal therapy in menopausal women; it paid $1.2 billion in 2012 to settle lawsuits over its Prempro drug and its links to breast cancer.

In October 2013, the company won approval for Duavee, which pairs estrogen with bazedoxifene, an ingredient designed to temper some of the safety risks that can accompany solo therapy with estrogen. Approved to treat hot flashes and to help prevent postmenopausal osteoporosis, the drug goes up against a new nonhormonal pill for hot flashes, Brisdelle, and a variety of hormone-based osteoporosis fighters, including Eli Lilly’s ($LLY) Evista. END

Source: FiercePharma »

Pfizer is stuck with a hot flash med that took years to get to market

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. END

Source: FierceBiotech »

The Horses

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

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