U.S. Food and Drug Administration (FDA) Accepts New Drug Application For Bazedoxifene/Conjugated Estrogens, An Investigational

  U.S. Food and Drug Administration (FDA) Accepts New Drug Application For
  Bazedoxifene/Conjugated Estrogens, An Investigational Treatment For Symptoms
  Associated With Menopause And Prevention of Osteoporosis

Business Wire

NEW YORK & SAN DIEGO -- December 13, 2012

Pfizer Inc. (NYSE: PFE) and Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
today announced that the United States Food and Drug Administration (FDA)
accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated
estrogens (BZA/CE), a potential new medicine for non-hysterectomized women 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. The FDA Prescription Drug User Fee Act (PDUFA)
date is October 3, 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
moderate-to-severe VMS and VVA associated with menopause, as well as the
prevention of postmenopausal osteoporosis. The most common adverse drug
reactions observed in the SMART trials were abdominal pain, vaginal yeast
infection and muscle spasms.

“Pfizer is dedicated to advancing treatments that may help improve health and
well-being at each stage of life,” said Gail Cawkwell, M.D., Ph.D., vice
president, Pfizer’s Medical Affairs. “BZA/CE was developed for
non-hysterectomized women with moderate-to-severe menopausal symptoms. This
milestone moves us one step closer towards potentially providing the first new
treatment option in the U.S. in years for the treatment of these women’s
menopausal symptoms.”

BZA/CE was developed by Wyeth Pharmaceuticals and was part of a broader
research collaboration with Ligand on SERMs. Pfizer acquired the rights to
BZA/CE when it acquired Wyeth.

“Pfizer continues to make good progress with this program, with this NDA
submission shortly following the European Marketing Authorization Application
submission earlier this year,” said John Higgins, president and chief
executive officer, Ligand. “This is an important therapeutic need, and we
commend Pfizer for its continued strong commitment to the program.”

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. Menopause is associated with reduced functioning of the ovaries due to
aging, resulting in lower levels of estrogens and other hormones. It is
estimated that approximately 43 million women in the United States are of
menopausal age, i.e. between the ages of 40 and 59. Of these women, 17 million
experience vasomotor symptoms and 9 million experience moderate-to-severe
symptoms. The majority of menopausal women experiencing moderate-to-severe
vasomotor symptoms are not currently treating their symptoms.

About Osteoporosis

Osteoporosis is a disease of the bones that leads to an increased risk of
fracture. Decreased estrogen levels at the time of menopause are associated
with rapid bone loss, making women more susceptible to osteoporosis. About 60
percent of women 50 years of age or older have low bone mass or osteoporosis.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines, as well
as many of the world’s best-known consumer products. Every day, Pfizer
colleagues work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases of
our time. Consistent with our responsibility as the world’s leading
biopharmaceutical company, we also collaborate with health care providers,
governments and local communities to support and expand access to reliable,
affordable health care around the world. For more than 150 years, Pfizer has
worked to make a difference for all who rely on us. To learn more about our
commitments, please visit us at www.pfizer.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company that develops and acquires assets it
believes will generate royalty revenues and, under its lean corporate cost
structure, 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’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., and The Medicines Company, among others.
Please visit www.captisol.com for more information on Captisol. For more
information on Ligand, please visit www.ligand.com.

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of
December 13, 2012. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.

This release contains forward-looking information that involves substantial
risks and uncertainties about an investigational therapy,
bazedoxifene/conjugated estrogens (BZA/CE), including its potential benefits,
that is under review by regulatory authorities in the U.S. and the EU. Such
risks and uncertainties include, among other things, the uncertainties
inherent in research and development; whether and when regulatory authorities
in the U.S. and the EU will approve our applications for BZA/CE as well as
their decisions regarding labeling and other matters that could affect its
availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in
its reports on Form 10-Q and Form 8-K.

LIGAND DISCLOSURE NOTICE: This news release contains certain forward-looking
statements by Ligand that involve risks and uncertainties and reflect Ligand's
judgment as of the date of this release. These statements include those
related to the investigational therapy, including its potential benefits, that
is under review by regulatory authorities in the United States (US). 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. The failure to meet expectations with respect to
any of the foregoing matters may reduce Ligand's stock price. 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.

Contact:

Pfizer Media Contact:
MacKay Jimeson
mackay.jimeson@pfizer.com
(212) 733-2324
or
Pfizer Investor Contact:
Suzanne Harnett
suzanne.harnett@pfizer.com
(212) 733-8009
or
Ligand Media Contact:
LHA
Don Markley
dmarkley@lhai.com
(310) 691-7100
or
Ligand Investor Contact:
Jennifer Capuzelo
jcapuzelo@ligand.com
(858) 550-7584
 
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