Patents Claim Covers Composition and Methods of Use
NOVATO, Calif., July 6, 2011 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq:RPTP), today announced that the United States Patent and Trademark Office ("USPTO") has issued Notices of Allowance for two patents covering the Company's delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine"), as well as other formulations of cystamine and cysteamine, as outlined below:
|U.S. Patent Application No.:||11/990,869|
|Issued Notice of Allowance:||June 27, 2011|
|Patent Title:||"Enterically Coated Cystamine, Cysteamine and|
|Expected to Cover:||Methods of administering DR Cysteamine to|
|patients for any clinical indication, including|
|nephropathic cystinosis, non-alcoholic|
|steatohepatitis ("NASH"), and Huntington's Disease|
|Expected Initial Term:||20 years plus 239 days of patent term adjustment;|
|expiring September 22, 2027|
|U.S. Patent Application No.:||12/745,504|
|Issued Notice of Allowance:||June 24, 2011|
|Patent Title:||"Methods of Treating Non-Alcoholic|
|Steatohepatitis ("NASH") Using Cysteamine|
|Expected to Cover:||Methods of treating NASH by administering|
|cysteamine or cystamine|
|Expected Initial Term:||20 years; expiring November 22, 2028|
Raptor holds exclusive, worldwide licenses to these patent applications, which are owned by the Regents of the University of California, and are based on work performed at the University of California, San Diego ("UCSD"). Both patent applications are expected to issue before the end of 2011.
"In addition to the market exclusivity we may receive in the US and the European Union for our orphan designated programs, we believe that the claims in these patent applications will provide significant additional market protection for our expanding portfolio of orphan and non-orphan cysteamine clinical indications," commented Christopher M. Starr, Ph.D., ceo of Raptor. "These allowances testify to the innovative and novel work performed by the medical researchers at UCSD, who had the scientific vision and dedication to the cystinosis patient community to perform the pivotal proof-of-concept work that we believe will lead us to an improved therapy for nephropathic cystinosis and support our expanding list of additional indications."
Patent application 11/990,869 covers the use of any composition of cysteamine or cystamine, regardless of the specific formulation, that provides increased delivery to the small intestine with pharmacokinetic benefits that allow for less than 4 times daily dosing. The Company believes that its proprietary formulation of cyteamine may provide significant therapeutic and compliance advantages compared to the presently marketed, immediate-release cysteamine bitartrate for the treatment of nephropathic cystinosis. Data analysis is underway for the Phase 3 clinical trial of DR Cysteamine in patients with nephropathic cystinosis following the completion of the last patient visit in early June 2011. The Company expects to report top-line data from this clinical trial by the end of July 2011.
Patent application 12/745,504 covers the use of cysteamine or cystamine, in any formulation, for the treatment of Non-alcoholic Steatohepatitis ("NASH"). In 2010, the Company released results of its Phase 2a clinical trial of a prototype formulation of DR Cysteamine in NASH, which was conducted in collaboration with UCSD. Raptor plans to test a solid caplet formulation of DR Cysteamine in a Phase 2b clinical trial in NASH in 2012.
Raptor is also investigating DR Cysteamine's potential to treat neurodegenerative diseases. The Company is collaborating with CHU d'Angers on a Phase 2/3 clinical trial of DR Cysteamine in Huntington's Disease, a rare, inherited neurological disorder. In addition to claims related to the treatment of neurodegenerative diseases in UCSD patent application 11/990,869, the Company holds an exclusive worldwide license to two issued patents related to the treatment of a variety of neurodegenerative diseases, including Huntington's Disease, from the Weizmann Institute of Science in Israel and the Niigata University in Japan.
Other Recent Raptor News
Through June 22, 2011, Raptor received total aggregate proceeds of approximately $5.2 million relating to the exercise of warrants issued in connection with its registered direct offering completed December 2009. Raptor's cash balance as of June 22, 2011 was approximately $15.7 million with approximately 34.6 million shares outstanding.
On June 24, 2011, Raptor was added to the Russell Global, the Russell 3000®, and Russell 2000® Indices based on the Russell Investment Group's annual reconstitution of its family of U.S. indices. Raptor's renewable membership in these new Russell Indices remains in place for one year.
About Cysteamine and DR Cysteamine
DR Cysteamine is Raptor's proprietary enteric-coated, microbead oral formulation of cysteamine bitartrate designed to reduce dosing frequency and reduce gastrointestinal side effects associated with immediate-release cysteamine bitartrate, which is approved for sale by the US Food and Drug Administration and the European Medicines Agency to treat nephropathic cystinosis.
In December 2007, Raptor obtained an exclusive, worldwide license from the University of California, San Diego for the development DR Cysteamine for nephropathic cystinosis and cysteamine for other potential indications including Huntington's Disease and NASH.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp.(Nasdaq:RPTP) ("Raptor") is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest potential impact. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, non-alcoholic steatohepatitis ("NASH"), Huntington's Disease ("HD"), aldehyde dehydrogenase ("ALDH2") deficiency, 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 ("RAP") and related proteins that are designed to target cancer, neurodegenerative disorders and infectious diseases.
For additional information, please visit www.raptorpharma.com.
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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 both patent applications will issue before the end of 2011; that Raptor may receive market exclusivity in the US and the European Union based up Raptor's orphan designations; that the claims in these patent applications will create significant market protection for Raptor's expanding portfolio of orphan and non-orphan cysteamine clinical indications; that Raptor will gain approval of an improved therapy for nephropathic cystinosis; that work performed at UCSD will support Raptor's additional indications; that Raptor's proprietary DR Cysteamine formulation may provide significant therapeutic and compliance advantages compared to the presently marketed, immediate-release cysteamine bitartrate for the treatment of nephropathic cystinosis; that Raptor will report top-line data from its Phase 3 clinical trial in nephropathic cystinosis by the end of July 2011; that Raptor will initiate a Phase 2b clinical trial in NASH in 2012; and that Raptor will be able to successfully develop DR Cysteamine 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 filed with the SEC on November 22, 2010; and Raptor's quarterly report on Form 10-Q filed with the SEC on April 14, 2011; 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.
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