Raptor Signs $50-Million Agreement With HealthCare Royalty Partners

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Raptor Pharmaceutical Corp. recently announced it has signed a $50-million loan agreement with HealthCare Royalty Partners to help fund the commercialization of PROCYSBI, the branded name of RP103 for the potential treatment of nephropathic cystinosis, and advance the company’s development programs.

Under the terms of the agreement, Raptor will receive $25 million at closing and an additional $25 million upon US FDA approval of PROCYSBI. The First Tranche and Second Tranche Loans, which mature on December 31, 2019, bear interest at an annual fixed rate of 10.75% and a Synthetic Royalty variable rate, tiered down, based on a percentage of future PROCYSBI sales. The loan is interest-only for the first 2 years.

“This loan agreement with HC Royalty further validates the growing value of PROCYSBI and Raptor’s pipeline. We believe that the proceeds of this financing will provide us with the necessary capital to fund our activities through FDA approval of PROCYSBI, based on our current assumptions for the timing of a potential FDA approval of PROCYSBI, as well as to fund our plans to launch PROCYSBI in the US, if approved by the FDA,” said Christopher Starr, Raptor’s CEO. “At closing of the first Tranche, we will have over $55 million in cash on our balance sheet, with an additional $25 million to be funded under the Second Tranche Loan upon FDA approval of PROCYSBI.”

“There is significant unmet market need for a more tolerable cystinosis treatment with a less burdensome dosing schedule, and we believe PROCYSBI will fill that need for patients once it is approved by the FDA,” added Clarke B. Futch, Founding Managing Director at HC Royalty. “We are pleased to partner with Raptor to help fund the commercialization of this important orphan drug.”

Cystinosis is a rare, life-threatening metabolic disorder that causes systemic toxic cystine accumulation. Toxic cystine accumulation leads to progressive and irreversible tissue damage and multi-organ failure including renal failure, blindness, CNS damage, respiratory deficiencies, muscle wasting, and premature death. Cystinosis is usually diagnosed in the first years of life and requires lifelong therapy. Left untreated, the disease is fatal by the end of the first decade of life. Daily cystine depletion is the primary treatment strategy for cystinosis. Despite a life-long requirement for cystine-depleting agent use to help preserve multi-organ function, a cumulative inability to maintain adequate cystine control results in the rapid deterioration of kidney function and ensuing need for kidney transplantation.

RP103 is an oral, delayed, and extended-release medication containing enteric-coated spheronized micro-beads of cysteamine bitartrate. PROCYSBI is the branded name of RP103 for the potential treatment of cystinosis. The New Drug Application and Marketing Authorization Application for RP103 for the potential treatment of nephropathic cystinosis have been submitted to the FDA and the European Medicines Agency, respectively, and the NDA has been assigned a PDUFA date of January 30, 2013.

RP103 is also in clinical development for the potential treatment of Huntington’s disease and non-alcoholic steatohepatitis (NASH). In cystinosis patients, RP103 may reduce cellular toxicity by continuously removing cystine from the lysosome. RP103, which can also cross the blood-brain barrier, was engineered specifically to allow release of cysteamine bitartrate micro-spheres in the duodenum for optimal absorption while simultaneously enabling administration every 12-hours for the potential treatment of cystinosis.

Raptor Pharmaceutical Corp. seeks to research, develop, and provide access to medicines that improve life for patients with severe and rare disorders. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, Non-alcoholic Steatohepatitis, Huntington’s Disease, and aldehyde dehydrogenase deficiency. For more information, visit www.raptorpharma.com.