NOVATO, Calif., June 20, 2012 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq:RPTP), today announced that the Company has acquired exclusive rights to intellectual property related to cysteamine and related compounds in the potential treatment of Parkinson's Disease from Université Laval ("Laval"), Quebec, Canada.
Raptor's agreement with Laval provides exclusive rights to technology related to the use of cysteamine and related compounds to potentially modify the progression of Parkinson's Disease. Researchers at Laval reported that administration of cystamine (an oxidized form of cysteamine) in an animal model of Parkinson's Disease showed signs of preventing neuron loss and rescuing neurons undergoing a degenerative process. Signs of restoration and partial reversal of behavioral impairments were also observed.
Dr. Patrice P. Rioux, Raptor's Chief Medical Officer, stated, "The agreement with Laval extends our existing portfolio in neurodegenerative diseases. We are currently conducting a Phase 2/3 clinical trial in France of Delayed-release Cysteamine Bitartrate capsules (RP103), for the potential treatment of Huntington's Disease. The researchers at Laval have compiled a solid preclinical foundation which, when combined with the existing safety profile of cysteamine, may enable us to more rapidly advance this program for the potential treatment of Parkinson's Disease in to a Phase 2 clinical trial. We plan to seek grant support to help fund the clinical development of RP103 in Parkinson's, as we have done with our Huntington's and NASH programs."
Dr. Francesca Cicchetti, Professor at the Faculty of Medicine at Université Laval, said, "Treatments for Parkinson's Disease that provide neuroprotective/neurorestorative effects remain an urgent unmet clinical need. Our preclinical results obtained in various animal models of parkinsonism substantiate the need for more research with cysteamine for this indication. We hope to see the study of this potential cysteamine treatment move to clinical trial."
About Cysteamine and RP103
RP103 is Raptor's proprietary delayed release oral medication currently being investigated in several indications. RP103 is an enteric coated, microbead formulation of cysteamine bitartrate.
In December 2007, Raptor obtained an exclusive, worldwide license from the University of California, San Diego for the development of RP103 and other forms of cysteamine for the potential treatment of Huntington's Disease currently in a Phase 2/3 clinical trial in France, non-alcoholic steatohepatitis ("NASH") currently in a Phase 2b clinical trial in the U.S. and for the development of RP103 for the potential treatment of nephropathic cystinosis which Raptor has recently filed for marketing approval in the U.S. and E.U. The U.S. Food and Drug Administration ("FDA") has accepted for filing Raptor's New Drug Application ("NDA") for RP103 for the potential treatment of nephropathic cystinosis and assigned the user fee goal date of January 30, 2013. Raptor's E.U. marketing application of RP103 for the potential treatment of nephropathic cystinosis is under review by the EMA, and Raptor expects a decision in the first half of calendar 2013. Raptor has licensed issued patents related to the potential treatment of Huntington's Disease and other neurodegenerative diseases with cysteamine and related compounds from Niigata University and Weizmann Institute and patent applications for the potential treatment of malaria and other parasitic diseases from McGill University. Raptor has been granted orphan product designation for RP103 for the potential treatment of nephropathic cystinosis by the European Medicines Agency and FDA and for the potential treatment of Huntington's Disease by the FDA.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) ("Raptor") seeks to research, produce, and deliver medicines that improve life for patients with severe, rare disorders. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, Non-alcoholic Steatohepatitis ("NASH"), Huntington's Disease ("HD"), aldehyde dehydrogenase deficiency ("ALDH2"), and thrombotic disorder.
Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein and related proteins that are designed to target cancer and infectious diseases.
For additional information, please visit www.raptorpharma.com.
The Raptor Pharmaceutical Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7180
About Université Laval
Located in Quebec City, Université Laval is the first French-language university in North America. It is one of Canada's leading universities, ranking 7th among the country's 95 university-level institutions in terms of research funding, with more than $300 million devoted to research last year. Université Laval's 1,300 professors-researchers share their knowledge with some 44,000 students, 10,000 of whom are enrolled in graduate-level programs.
For additional information, please visit www.ulaval.ca.
FORWARD LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: that cysteamine and related compounds could potentially modify the progression of Parkinson's Disease or provide restorative benefits; that Raptor can rapidly advance the Parkinson's program to a Phase 2 clinical trial; that Raptor can attract grant funding to help fund the clinical development of RP103 in Parkinson's; that Raptor will continue its collaboration with the researchers at Laval, as well as other clinical thought leaders in Parkinson's Disease; that the FDA and EMA will deliver a decision regarding marketing approval of RP103 for the potential treatment of nephropathic cystinosis on January 30, 2013 or the first half of calendar 2013, respectively; and that Raptor will be able to successfully develop RP103 or any of its other product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent the Company's forward looking statements from fruition include: that Raptor may be unsuccessful in developing any products or acquiring products; that Raptor's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; that Raptor is unable to retain or attract key employees whose knowledge is essential to the development of its products; that unforeseen scientific difficulties develop with the Company's process; that Raptor's patents are not sufficient to protect essential aspects of its technology; that competitors may invent better technology; that Raptor's products may not work as well as hoped or worse, that the Company's products may harm recipients; and that Raptor may not be able to raise sufficient funds for development or working capital. As well, Raptor's products may never develop into useful products and even if they do, they may not be approved for sale to the public. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the Securities and Exchange Commission (the "SEC"), which Raptor strongly urges you to read and consider, including: Raptor's annual report on Form 10-K, as amended by Form10-K/A, filed with the SEC on November 11, 2011 and December 19, 2011, respectively; and Raptor's quarterly report on Form 10-Q filed with the SEC on April 9, 2012; all of which are available free of charge on the SEC's web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor's reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements.