Product
Angeliq

Approval Date
September 28, 2005

Release Date

January 4, 2007

Company
Berlex

C
lass
Estrogen+ progestin
 
Indication

In women with an intact uterus: moderate to severe vasomotorsymptoms of menopause; moderate to severe vulvar and vaginal atrophy associatedwith menopause.
 
Active Ingredient

Estradiol 1mg, drospirenone 0.5mg; tabs.

Agency Roster

Y&R (consumer)
GSWNY(professional)
Wunderman (relationship)
RTC (relationship)
Ogilvy (PR)
 
Marketing Strategy/Execution

Angeliq,marketed by Bayer Women’s Health for treating moderate-to-severe vasomotorsymptoms associated with menopause, is the only hormone therapy to contain theprogestin drospirenone. As part of the launch, Bayer partnered with menopauseeducation organization Red Hot Mamas to sponsor the “Red Hot FlashbacksContest,” asking women to share funny or frustrating hot flash or night sweatstories. Bayer took control of Angeliq from Berlex, the US affiliate ofSchering AG which Bayer acquired in 2006.

The Market

Hormones, estrogen/progestin US sales ($000s) last 5 years
2006 $389,778
2005 $402,320
2004 $407,387
2003 $443,778
2002 $815,430
Source: IMS Health, Oct. 2007

Top 5 hormones, estrogen/progestin
  Jan.-July ’07 US sales ($000s) % sales growth over Jan.-July ‘06
PREMPRO LOW DOSE (Wyeth)  $80,434 7%
PREMPRO (Wyeth)  $49,304 -2%

FEMHRT (Warner Chilcott)

 $38,896 3%
ACTIVELLA (Novo Nordisk) $32,277 -2%
COMBIPATCH (Novartis)  $7,846 3%
Source: IMS Health, Oct. 2007

Physician Outlook
Study planned, 2008
 
Also in the Pipeline(courtesy of Adis R&D Insights)

Drug: Aprela
Manufacturer: Ligand/Wyeth
Indication: Postmenopausal osteoporosis prevention
Active ingredient: Conjugated estrogens/bazedoxifene
Phase: III

Drug: Angeliq
Manufacturer: Bayer Schering Pharma
Indication: Hypertension
Active ingredient: Estradiol/drospirenone
Phase: III
Source: Wolters Kluwer Health, Oct. 2007
 
Recent MM&MCoverage
ProductNews from the 10/07/05 News Brief
 
Pharmacology

Angeliq combines the estrogen, estradiol, with theprogestin, drospirenone, to treat moderate to severe symptoms of menopause. Ifthis product is being used solely for the symptoms of genital atrophy, the useof topical vaginal products should be considered.
 
Clinical Trials

Bioequivalency studies comparing the estrogen component of Angeliq to thatof a currently-marketed product, Estrace (estradiol tablets, from WarnerChilcott), were conducted in order to provide support for the treatment ofvasomotor symptoms and vaginal and vulvar atrophy. A multi-dose bioequivalencestudy evaluated the equivalence of estradiol from a tablet containingdrospirenone 2mg and estradiol 1mg relative to Estrace 1mg. The combinationproduct met the criteria for bioequivalence to Estrace.
Several large studies were conducted to establish the safety andefficacy of Angeliq in providing endometrial protection along with anacceptable bleeding profile. A one-year study involving 227 women given Angeliqand 226 women given estradiol 1mg yielded no diagnoses of endometrialhyperplasia in the Angeliq group.
 
Adverse Reactions

See literature. Increased risk of hyponatremia, gallbladderdisease, thromboembolic disorders, dementia, breast and ovarian cancer. GIupset/pain, irregular bleeding, headache, edema, hypertension, mastodynia,chloasma, others.
 
Adults

1 tab daily. Reevaluate periodically.
 
Children

Not applicable.
 
Contraindications

Breast or estrogen-dependent carcinoma. Thromboembolicdisorders. Undiagnosed abnormal genital bleeding. Renal or adrenal insufficiency.Liver dysfunction or disease. Other conditions that may predispose tohyperkalemia. Pregnancy (Cat.X).
 
Precautions

Use for shortest duration and lowest dose consistent withtreatment goals and risks. Endometrial hyperplasia. Gallbladder disease.Hypercoagulability. Hypocalcemia. Familial hypercholesterol-emia. Bone diseaseassociated with hypercalcemia. Do initial complete physical (include BP,mammogram, PAP smear) and repeat annually. Conditions aggravated by fluidretention. Discontinue if visual disturbances or jaundice occurs and duringimmobilization, or at least 2 weeks before surgery associated withthromboembolism. Manage risk factors for cardiovascular disease and venousthromboembolism appropriately. May aggravate asthma, diabetes, epilepsy,migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests(eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Nursing mothers.
 
Interactions

Consider monitoring serum potassium (esp during 1st cycle)with ACEIs, ARBs, NSAIDs, K+-sparing diuretics, K+-supplements, heparin, othersthat may cause hyperkalemia. Thyroid replacement therapy (may need doseadjustment). Estrogen may be antagonized by CYP3A4 inducers. Estrogen may bepotentiated by CYP3A4 inhibitors.