SAN DIEGO & NEW YORK--(BUSINESS WIRE)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Pfizer
announced that the European Medicines Agency (EMA) accepted for review
the Marketing Authorization Application (MAA) for
bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for
postmenopausal women with a uterus for the treatment of estrogen
deficiency symptoms and treatment of osteoporosis in women at risk of
fracture. Pfizer expects a decision from the European Commission in 2013.
BZA/CE pairs the selective estrogen receptor modulator (SERM)
bazedoxifene with conjugated estrogens. BZA/CE has been studied in a
Phase III 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
BZA/CE for the treatment of estrogen deficiency symptoms, such as
moderate-to-severe hot flashes and vulvar and vaginal atrophy, as well
as postmenopausal osteoporosis. The most common adverse drug reactions
observed in the SMART trials were abdominal pain, vaginal yeast
infection and muscle spasms.
“We are encouraged by the progress Pfizer is making with
bazedoxifene/conjugated estrogens as it potentially offers another
option for the many women experiencing symptoms of menopause who are not
currently being treated,” said John Higgins, President and Chief
Executive Officer of Ligand. “Today’s announcement continues to
demonstrate the commercial potential of Ligand’s product portfolio,
which we believe is one of the strongest and deepest in the biotech
industry.”
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. In the
European Union, an estimated 67 million women are of menopausal age. Of
those, approximately 75% suffer from hot flashes.
About Osteoporosis
Osteoporosis is a disease of the bones that leads to an increased risk
of fracture. Decreased estrogen levels are associated with rapid bone
loss, making women more susceptible to osteoporosis. Osteoporosis is
estimated to affect up to a fifth of women in Europe between the ages of
50 and 79.
About the Ligand/Pfizer Collaboration
BZA/CE was developed by Wyeth and was part of a broader research
collaboration with Ligand on SERMs. Pfizer acquired the rights to BZA/CE
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 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, Merck, Pfizer, Eli Lilly & Company,
Baxter International, Bristol-Myers Squibb, Celgene, Onyx
Pharmaceuticals, Lundbeck Inc., The Medicines Company, Curis, Inc. and
Rib-X 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
or Pfizer’s expectations. For example, there can be no assurance that
bazedoxifene/conjugated estrogens or any product in the Ligand or Pfizer
pipelines will be successfully developed, that any of the milestone
triggers will be achieved, that regulatory approvals will be granted,
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.
Source: Ligand Pharmaceuticals Incorporated