Ligand Enters Global License Agreement with CURx Pharmaceuticals, Inc. for Captisol-EnabledTM Topiramate Injection
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces it
has entered a global license agreement with CURx Pharmaceuticals, Inc.
for the development and commercialization of Ligand’s 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. Under the terms of the agreement,
Ligand will be eligible to receive more than $21 million in potential
net milestone payments and net royalties on future sales of 6.0% to 7.5%.
“This is another great deal for Ligand and our Captisol technology,
pairing our proven formulation agent with an approved medicine to create
a potentially novel, important and highly differentiated drug,”
commented John Higgins, President and Chief Executive Officer of Ligand.
“We are very pleased to be entering this agreement. CURx is highly
motivated to advance development with current plans calling for a Phase
II trial to commence in 2014. This deal represents our latest addition
to our growing pipeline of partnerships and another potentially
lucrative shot-on-goal.”
Dinu Sen, Chief Executive Officer and founder of CURx, said of this
transaction, “We are delighted to sign a licensing agreement with Ligand
and plan to bring Captisol-enabled Topiramate Injection to our patients
as soon as possible. In Phase I trials in healthy volunteers and
patients at the University of Minnesota, the product demonstrated a
faster onset of action than the orally administered drug. Our market
research indicates there to be a tremendous need for a product with
these characteristics.”
About Captisol-Enabled™ Topiramate Injection
The Captisol-enabled formulation of Topiramate Injection was designed
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 in 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 I clinical trials. In July 2013, the
U.S. Food and Drug Administration (FDA) granted orphan-drug designation
to Captisol-enabled Topiramate Injection.
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, Spectrum
Pharmaceuticals’ Captisol-enabled Melphalan and Rib-X's delafloxacin IV
program.
About CURx Pharmaceuticals, Inc.
CURx Pharmaceuticals, Inc. is a startup pharmaceutical company based in
San Diego, CA focused in the hospital marketplace. It was founded by
Dinu Sen, who has three decades of experience in the pharmaceutical
industry. Most recently, Mr. Sen was CEO of Avera Pharmaceuticals which
raised $90 million in venture financing and was eventually sold to
Maruishi Pharmaceuticals of Osaka, Japan.
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. and Spectrum Pharmaceuticals. 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
jcapuzelo@ligand.com
(858)
550-7584
or
LHA
Don Markley
dmarkley@lhai.com
(310)
691-7100
Source: Ligand Pharmaceuticals Incorporated
Released August 14, 2013