Upcoming FDA PDUFA: Oct 3 2013 - Ligand Pharmaceuticals and Pfizer - Aprela (Duavive) for menopause

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.

Date of FDA Decision (PDUFA): October 3, 2013
Company name: Ligand Pharmaceuticals and Pfizer
Stock ticker: LGND and PFE
Location: La Jolla, CA

Type of application: First NDA Submission; combination of an approved and an un-approved drug
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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