Ligand Earns Milestone Payment Triggered by EU Approval of Merck’s Captisol-enabled NOXAFIL® (posaconazole) Concentrate for Solution for Infusion
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that Merck,
known as MSD outside the United States and Canada, has received approval
for NOXAFIL® (posaconazole) 300 mg Concentrate for Solution for Infusion
from the European Medicines Agency (EMA). Ligand earns a $550,000
milestone payment as a result of the approval. Ligand will sell Captisol
to Merck for the product marketed in Europe under an existing commercial
supply agreement.
The EMA approval grants Merck centralized marketing authorization with
unified labeling that is valid in the 28 countries that are members of
the European Union, as well as European Economic Area members, Iceland,
Liechtenstein and Norway.
NOXAFIL is a novel triazole antifungal agent with demonstrated
broad-spectrum activity, covering both yeast and molds responsible for
serious invasive fungal infections. 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 also markets
oral suspension and tablet formulations of NOXAFIL.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr. Valentino Stella at the University of Kansas'
Higuchi Biosciences Center for specific use in drug development and
formulation. This unique technology has enabled six FDA-approved
products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter
International's Nexterone® and Merck’s Noxafil®
IV. There are currently more than 50 Captisol-enabled products in
development, including Lundbeck’s Carbella™, Spectrum Pharmaceuticals’
Captisol-enabled Melphalan and Melinta Therapeutics’ delafloxacin IV
program.
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
Bruce
Voss
(310) 691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: Ligand Pharmaceuticals Incorporated
Released September 26, 2014