Captisol® Licensee Lundbeck Announces FDA Acceptance of NDA Submission for Carbamazepine IV
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) Captisol®
licensee Lundbeck LLC today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review a New Drug Application
(NDA) for its investigational therapy intravenous carbamazepine, an
intravenous formulation of the anti-epileptic drug carbamazepine. An
action letter is anticipated before the end of 2014. Carbella™
(carbamazepine) Injection is the proposed U.S. trade name. With
acceptance of the NDA filing, Ligand earns a $200,000 milestone payment.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on maintaining and growing
its large portfolio of revenue generating assets through licensing and
acquisition with the goal to optimize and sustain cash-flow and
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 solubilize and stabilize active drug
ingredients. Ligand has established multiple alliances with the world's
leading pharmaceutical companies including GlaxoSmithKline, Onyx
Pharmaceuticals (a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter
International, Eli Lilly & Co. and Spectrum Pharmaceuticals. Please
visit www.captisol.com
for more information on Captisol or www.ligand.com
for more information on Ligand.
Follow Ligand on Twitter @Ligand_LGND.
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. These statements include those related to future
action by the FDA for the NDA recently accepted for review; future
regulatory approvals; increases in shareholder value; and future
milestone and royalty payments. Actual events or results may differ from
our expectations. There can be no assurance that any of our partners or
licensees will continue clinical development of any compound(s); that
clinical development will be successful; that future clinical trial data
will be favorable or that such trials will confirm any improvements over
other products or lack negative impacts; that drugs will receive
required regulatory approvals or that they will be commercially
successful, that any future milestone or royalty payments will be
received, or that if any future milestones or royalties are received
that they will not be subject to sharing obligations with any third
party. Our stock price could be harmed if any of these events or trends
fails to occur, is delayed or otherwise differs from expectations.
Additional information concerning these and other risk factors affecting
Ligand's business can be found in the company's prior press releases as
well as in Ligand’s public periodic filings with the Securities and
Exchange Commission, available 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.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
(858)
550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Don
Markley
(310) 691-7100
dmarkley@lhai.com
@LHA_IR_PR
Source: Ligand Pharmaceuticals Incorporated
Released March 10, 2014