Ligand Partner Pfizer Receives European Marketing Authorization for DUAVIVE® (Conjugated Estrogens/Bazedoxifene) for Treatment of Estrogen Deficiency Symptoms in Postmenopausal Women with a Uterus
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that
its partner Pfizer has received EU marketing authorization for DUAVIVE®
(conjugated estrogens/bazedoxifene (BZA/CE)) from the European
Commission. In the EU, DUAVIVE™ is indicated for the treatment of
estrogen deficiency symptoms in postmenopausal women with a uterus (with
at least 12 months since the last menses) for whom treatment with
progestin-containing therapy is not appropriate. Ligand will be entitled
to a milestone payment following Pfizer obtaining pricing of DUAVIVE® in
a major European market.
DUAVIVE® was studied in a Phase 3 clinical development program (Selective
estrogens, Menopause And Response to Therapy
[SMART] trials), which included approximately 7,500 postmenopausal women
and assessed the safety and efficacy of DUAVIVE® for the treatment of
estrogen deficiency symptoms, such as moderate-to-severe hot flashes .
The most common adverse drug reactions observed in the SMART trials were
abdominal pain, vaginal yeast infection and muscle spasms.
About DUAVIVE®
DUAVIVE® is pairs conjugated estrogens (CE) with an estrogen
agonist/antagonist, also known as a selective estrogen receptor
modulator (SERM). DUAVIVE® uses bazedoxifene - instead of a progestin -
to help protect the uterine lining against hyperplasia that may result
from estrogen alone treatment.
DUAVIVE® should not be used in women who: have or had blood clots; are
allergic to any of its ingredients; have unusual vaginal bleeding; have
or had certain cancers (e.g. uterine or breast), liver problems, or
bleeding disorders; or are pregnant, may become pregnant or are
breastfeeding a baby.
About the Ligand/Pfizer Collaboration
DUAVIVE® was developed by Wyeth and was part of a broader research
collaboration with Ligand on SERMs. Pfizer acquired the rights to
DUAVIVE® when it acquired Wyeth. Under the terms of the agreement,
Ligand receives certain payments and royalties from Pfizer on
predetermined development and sales milestones.
About Menopause
Menopause is a normal, natural event—it marks the permanent end of
fertility and is usually confirmed when a woman has missed her period
for 12 consecutive months (in the absence of other obvious causes).
Menopause is associated with reduced functioning of the ovaries due to
aging, resulting in lower levels of estrogen and other hormones.
Declining levels of estrogens can lead to bothersome vasomotor symptoms
(VMS) in 60-85% of women undergoing the menopausal transition. With more
than 100 million women aged 50 and over in 2011, VMS may affect over 60
million women in the EU1.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to a lean corporate cost structure.
Ligand’s goal is to produce a bottom line that supports a sustainably
profitable business. By diversifying the portfolio of assets across
numerous technology types, therapeutic areas, drug targets, and industry
partners, we offer investors an opportunity to invest in the
increasingly complicated and unpredictable pharmaceutical industry. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies address the
unmet medical needs of patients for a broad spectrum of diseases
including diabetes, hepatitis, muscle wasting, dyslipidemia, anemia,
asthma and osteoporosis. Ligand’s Captisol platform technology is a
patent protected, chemically modified cyclodextrin with a structure
designed to optimize the solubility and stability of drugs. Ligand has
established multiple alliances with the world's leading pharmaceutical
companies including GlaxoSmithKline, Onyx Pharmaceuticals (a subsidiary
of Amgen Inc.), Merck, Pfizer Inc., Baxter International, Eli Lilly &
Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol. For more information on Ligand, please
visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
Caution Regarding Forward-Looking Statements
This news release contains forward looking statements by Ligand that
involve risks and uncertainties and reflect Ligand’s judgment as of the
date of this release. Actual events or results may differ from Ligand’s
expectations. For example, there can be no assurance that conjugated
estrogens/bazedoxifene or any product in the Ligand pipelines will be
successfully developed, that any of the milestone triggers will be
achieved, that regulatory approvals will be granted, that acceptable
pricing will be achieved in a timely manner, that patient and physician
acceptance of these products will be achieved, that final results of
human clinical trials will be consistent with any interim results, that
final results will be supportive of regulatory approvals required to
market products or that any revenue will be achieved from this partnered
program. Additional information concerning these and other risk factors
affecting Ligand’s business can be found in prior press releases
available via www.ligand.com
as well as in Ligand’s public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
1 Reference: S. Mirkin et al, Maturitas 2013 :77 (2014)
24– 31
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Erika
Luib, Investor Relations
(858) 550-7896
@Ligand_LGND
or
Lippert/Heilshorn
& Associates
Bruce Voss
(310) 691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: Ligand Pharmaceuticals Incorporated
Released December 19, 2014