Ligand Earns $1 Million Milestone Payment Triggered by FDA Approval of Merck’s NOXAFIL® (posaconazole) Injection for Intravenous Use, a New Captisol-enabled Formulation
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that
it has earned a $1 million milestone payment as a result of the recent
U.S. Food and Drug Administration (FDA) approval of Merck’s NOXAFIL®
(posaconazole) injection (18 mg/mL). This is a new Captisol®-enabled
formulation of NOXAFIL for intravenous (IV) use. Ligand will
sell Captisol to Merck for this product under a commercial supply
agreement.
“We congratulate the project team at Merck on this important advancement
in the treatment of invasive fungal infections,” said John Higgins,
President and Chief Executive Officer of Ligand Pharmaceuticals.
“Ligand's business is thriving with the continued success of our
partners with late-stage clinical and regulatory events. This is the
second new product expected to be made available in 2014 following the
launch of Duavee® last month by Pfizer and three additional
Ligand-partnered programs are pending approvals in 2014,” continued
Higgins. “Captisol is a proven formulation that is garnering more
interest by prospective customers and partners given the
technology’s elevated profile.”
NOXAFIL injection for intravenous use is indicated for prophylaxis of
invasive Aspergillus and Candida infections in patients
who are at high risk of developing these infections due to being
severely immunocompromised, such as hematopoietic stem cell transplant
(HSCT) recipients with graft-versus-host disease (GVHD) or those with
hematologic malignancies with prolonged neutropenia (low white blood
cell counts) from chemotherapy. NOXAFIL injection is indicated in
patients 18 years of age and older.
The availability of a NOXAFIL formulation for intravenous administration
is particularly important for those patients who may benefit from or
require intravenous therapy, or who might not be able to take an oral
formulation. Merck’s antifungal agent is also marketed as NOXAFIL (100
mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension.
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, Alzheimer's disease,
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, 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.
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
potential future launch of products and product candidates; future
financial performance and other developments regarding Merck’s NOXAFIL
IV and statements regarding the potential for Ligand’s partnered and
un-partnered programs, including plans and market potential for such
programs and Merck’s NOXAFIL IV. Actual events or results may differ
from our expectations. There can be no assurance that Merck’s NOXAFIL IV
will achieve commercial success, that any of our partners 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 on the
company's prior press releases as well as in public periodic filings
with the Securities and Exchange Commission, available via www.ligand.com.
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 17, 2014