Ligand Receives Equity Milestone Payment from Retrophin
Retrophin Advancing Clinical Program for Rare Kidney Disease
SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated
RE-021 is in development for the treatment of focal segmental glomerulosclerosis (FSGS), a rare disease that attacks the kidney's filtering system (glomeruli), causing serious scarring, progressive kidney function degeneration and rapid loss of the kidneys. FSGS is one cause of a serious condition known as Nephrotic Syndrome. An estimated 50,000 patients in the United States suffer from FSGS, with most patients diagnosed as children or young adults. Ligand believes that Retrophin expects to begin enrollment in a Phase 2 clinical trial known as "FONT-3" during the first half of 2013.
"We are pleased to see our partner Retrophin meet this corporate milestone," commented John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "The leadership at Retrophin has shown tremendous passion and commitment to advance this important program, working with the FDA and raising additional capital. RE-021 has the potential to be a very significant therapy for serious diseases, and we are encouraged to see Retrophin position itself to advance this potential medicine to patients in need."
About RE-021 (DARA)
Ligand acquired DARA (currently known as RE-021) in its acquisition of Pharmacopeia in December 2008. The compound possesses two clinically validated mechanisms of action that selectively block two potent vasoconstrictor and mitogenic agents, angiotensin II and endothelin 1, at their respective receptors. In Phase 2b studies for hypertension completed in 2009, DARA was found to be safe and well tolerated, and demonstrated statistically significant greater reduction in blood pressure compared with placebo and with irbesartan.
The 261-patient, randomized, double-blind, placebo- and active-controlled study evaluated safety and efficacy at three different doses in subjects with Stage 1 and Stage 2 hypertension over 12 weeks of treatment. The high dose of DARA produced a statistically significantly greater reduction in blood pressure than the active comparator, irbesartan, which was tested at its highest approved dose.
Retrophin is a biotechnology company focused on discovering and developing treatments for rare and life-threatening diseases. Retrophin is currently developing treatments for FSGS, Pantothenate Kinase-Associated Neurodegeneration (PKAN), Duchenne Muscular Dystrophy and other catastrophic diseases. The company's lead compound, RE-021, formerly known as DARA, is scheduled to begin enrollment in a potentially pivotal Phase 2 clinical trial for FSGS in the first half of 2013.
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, Merck, Pfizer, Eli Lilly & Company, Baxter International, Bristol-Myers Squibb, Celgene, Onyx Pharmaceuticals, Lundbeck Inc. and The Medicines Company, among others. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand.
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This news release contains certain 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 continued development of RE-021. Actual events or results may differ from our expectations. There can be no assurance Retrophin will continue clinical development of RE-021; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack of negative impacts; that RE-021 will receive required regulatory approvals or that it will be a commercially successful therapy or be successfully marketed; or that any future milestone or royalty payments will be received. 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.
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