Ligand Earns Milestone from SAGE Therapeutics for SAGE-547
$150,000 payment triggered by start of Phase 1/2 clinical trial for treatment of super-refractory status epilepticus
SAN DIEGO-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that it has earned a $150,000 milestone payment from SAGE Therapeutics (SAGE) relating to the earlier commencement by SAGE of a Phase 1/2 clinical trial of SAGE-547 for the treatment of super-refractory status epilepticus (SRSE), a life-threatening seizure condition in which the brain is in a state of persistent seizure.
SAGE-547 is an intravenous agent in Phase 1/2 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of SRSE. SAGE utilizes Ligand’s Captisol® technology to develop SAGE-547 for status epilepticus (SE) and traumatic brain injury. In 2013, Ligand entered into a platform license agreement with SAGE for the development and commercialization of Captisol-enabled™ therapeutics for a broad range of debilitating central nervous system conditions. Elements of that agreement were also recently expanded to cover additional therapy areas for certain compounds.
“SAGE is a biopharmaceutical company committed to developing and commercializing novel medicines to treat life-threatening, rare central nervous system disorders. SAGE-547 is their lead product candidate. We commend the SAGE team on their progress with this important new therapy and also congratulate them on their recent receipt of U.S. Orphan Drug Designation for SAGE-547 for the treatment of SE,” said John Higgins, President and Chief Executive Officer of Ligand. “The treatment options for status epilepticus, a life-threatening disease, are inherently limited and there are no specifically approved therapies for SRSE. Our partnership with SAGE is but one example of Ligand’s science and technologies being utilized under licensing agreements to develop or improve treatments across a variety of medical conditions.”
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. The original form of 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 more than 30 Captisol-enabled products currently in clinical development.
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 seek to 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, 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.
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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 forward-looking statements include comments regarding SAGE-547 and other drug candidates, data analysis and evaluation of SAGE-547, utility or potential benefits to patients, the potential commercial market for SAGE-547 and plans for continued development and further studies of SAGE-547. Actual events or results may differ from Ligand’s expectations. For example, there can be no assurance that other trials or evaluations of SAGE-547 or other product candidates will be favorable or that they will confirm results of previous studies, that data evaluation will be completed or demonstrate any hypothesis or endpoint, that SAGE-547 or other product candidates will provide utility or benefits to certain patients, that any presentations will be favorably received, that SAGE-547 or other product candidates will be useful, that marketing applications will be filed or, if filed, approved, or that clinical or commercial development of these product candidates will be initiated, completed or successful or that our rights to SAGE-547 and other related product candidates will not be successfully challenged. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in 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 press release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Ligand Pharmaceuticals Incorporated
John L. Higgins, President and CEO
Bruce Voss, firstname.lastname@example.org
Source: Ligand Pharmaceuticals Incorporated
Released May 12, 2014