Ligand Pharmaceuticals (LGND) and Pfizer (PFE) are awaiting an FDA drug approval decision for Aprela - a novel combination drug of Bazedoxifene and Conjugated estrogens (Premarin) for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis in non-hysterectomized women.
Company name: Ligand Pharmaceuticals and Pfizer
Stock ticker: LGND and PFE
Location: La Jolla, CA
Name of drug: Aprela
Indication: moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis in non-hysterectomized women
Ligand Pharmaceuticals: 01 Oct 2013
Market Cap
|
$884.64 Mln
|
52-week range
|
14.75 – 50.85
|
Avg. volume
|
262,502
|
Q1 2013:
Net Income
|
$0.30 per share
|
Cash
|
$10.1 mln
|
Ligand is a biopharmaceutical
company that develops and acquires assets it believes will generate royalty
revenues and produce sustainable profitability. Ligand has a diverse asset
portfolio addressing the unmet medical needs of patients for a broad spectrum
of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis,
muscle wasting, dyslipidemia, anemia, and osteoporosis. Ligand has established
multiple alliances with the world's leading pharmaceutical companies including
GlaxoSmithKline, Merck, Pfizer, Eli Lilly & Company, Baxter
International, Bristol-Myers Squibb, Celgene, Onyx
Pharmaceuticals, Lundbeck Inc., and The Medicines Company, among
others.
As a result of a series of
successful licensing agreements, Ligand’s total revenue more than doubled in
recent years, with royalties up 90% on higher sales of GlaxoSmithKline’s
Promacta® and a contribution from Onyx Pharmaceuticals’ Kyprolis™, plus
increases of 131% and 125% in sales and licensing revenues of Ligand’s
proprietary patented drug delivery technology Captisol.
Aprela is a drug which combines Pfizer’s
as-of-yet-unapproved drug Viviant (bazedoxifene), initially developed by Ligand
and Wyeth (now Pfizer) in 1994 and Premarin, Pfizer’s conjugated estrogen
compound. Bazedoxifene is a selective estrogen receptor modulator, which is a
compound able to selectively act on estrogen receptors throughout the body.
Aprela belongs to the novel class of tissue-selective estrogen complexes
(TSECs), which pair SERM with conjugated estrogen (Premarin). So far, the
combination drug has demonstrated positive efficacy and safety results in a
series of Phase III clinical trials involving approximately 7,500 women.
The FDA accepted an NDA from
Pfizer and Ligand in December 2012. The agency will deliver its verdict on Oct
3, 2013, but complications are expected, in light of the fact that bazedoxifene
has been encountering obstacles with FDA approval since 2007.
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