Ligand Receives Orphan Designation for Captisol-EnabledTM Topiramate Injection
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that
the U.S. Food and Drug Administration (FDA) has granted orphan-drug
designation for its proprietary Captisol-enabled™ Topiramate Injection
for the treatment of partial onset or primary generalized tonic-clonic
seizures in hospitalized epilepsy patients who are unable to take oral
topiramate.
“The granting of orphan designation for Ligand’s Captisol-enabled
Topiramate program is an important step in the future of this
potentially life-saving therapeutic, and should provide an additional
layer of market exclusivity for the program,” commented Matthew W.
Foehr, Executive Vice President and Chief Operating Officer of Ligand.
“In Phase 1 trials in healthy volunteers and patients at the University
of Minnesota, this product demonstrated a faster onset of action than
the orally administered drug. Our goal is to find a committed partner to
further progress the clinical development of this asset and add to our
portfolio of fully-funded programs.”
“An injectable formulation of Topiramate will provide patients and
clinicians with an important new product that ensures continuity of
therapy and offers the potential for use in acute management of several
neurological disorders,” declared Jim Cloyd, Pharm.D., Lawrence C.
Weaver Endowed Chair in Orphan Drug Development, Professor of
Experimental and Clinical Pharmacology and Director of the Center for
Orphan Drug Research at the University of Minnesota-College of Pharmacy.
Orphan-drug designation is granted to drugs and biologics defined as
those intended for the safe and effective treatment, diagnosis or
prevention of rare diseases/disorders that affect fewer than 200,000
people in the U.S., or that affect more than 200,000 persons but are not
expected to recover the costs of developing and marketing a treatment
drug.
About Captisol-Enabled™ Topiramate Injection
Ligand is developing a proprietary Captisol-enabled formulation of
Topiramate injection for the treatment of partial onset or primary
generalized tonic-clonic seizures in hospitalized epilepsy patients who
are unable to take oral topiramate. The formulation was initially
developed at, and is exclusively licensed from, the University of
Minnesota. Topiramate is sold by Janssen Pharmaceuticals, Inc. under the
trade name Topamax® and is currently only available as oral
formulations. The Captisol-enabled Topiramate Injection formulation is
designed to provide an intravenous or intramuscular option for
hospitalized epilepsy patients unable to use oral topiramate.
Captisol-enabled Topiramate Injection has been studied in Phase 1
clinical trials.
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 Pfizer's Vfend® IV. There are currently
more than 30 Captisol-enabled products in development, including
Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and
Rib-X's delafloxacin IV program.
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, Onyx Pharmaceuticals, Merck,
Pfizer, Baxter International, Bristol-Myers Squibb, Lundbeck Inc., Eli
Lilly & Co., Spectrum Pharmaceuticals and The Medicines Company. Please
visit www.captisol.com
for more information on Captisol and 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 include statements regarding clinical
development of Captisol-enabled Topiramate Injection, market size and
possibility of commercial success, efficacy, potency, competitiveness
and the strength of Ligand's product portfolio. Actual events or results
may differ from our expectations. For example, there can be no assurance
that Captisol-enabled Topiramate Injection will progress through
clinical development or receive required regulatory approvals within the
expected timelines or at all, that further clinical trials will confirm
any safety or other characteristics or profile, that there will be a
market of any size for Captisol-enabled Topiramate Injection or that
Captisol-enabled Topiramate Injection will be beneficial to patients or
successfully marketed. The failure to meet expectations with respect to
any of the foregoing matters may have a negative effect on 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.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Jennifer
Capuzelo, Investor Relations
858-550-7584
jcapuzelo@ligand.com
or
LHA
Don
Markley
310-691-7100
dmarkley@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released July 26, 2013