Raptor Pharmaceutical Announces Issuance of Key European Patent Protecting the Cysteamine Portfolio

Raptor Pharmaceutical Corp. 

30.07.2012 12:30
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NOVATO, Calif., 2012-07-30 12:30 CEST (GLOBE NEWSWIRE) -- Raptor Pharmaceutical
Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP), today announced that the
European Patent Office has issued a key patent covering enteric-coated oral
formulations of cysteamine bitartrate, including the Company's proprietary
microbead formulation, RP103. Decision to Grant the patent was announced in
July 2012. European Patent 1919458 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 twice daily dosing in the treatment of nephropathic cystinosis. The
European patent term will expire January 26, 2027. 

Raptor holds exclusive, worldwide licenses to this and other, related 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'). 

'As we continue to move towards possible marketing approval of RP103 for
nephropathic cystinosis in Europe and examine the potential utility of delayed
release cysteamine in the treatment of a variety of diseases, this patent adds
key additional IP protection for a potentially valuable portfolio,' commented
Christopher M. Starr, Ph.D., CEO of Raptor. 'This patent is part of our
commitment toward protecting the market potential of our current and
anticipated product programs and thereby protecting shareholder value.' 

The Company believes that its proprietary formulation of cysteamine may provide
therapeutic options for the potential treatment of nephropathic cystinosis. In
July 2011, Raptor announced that its Phase 3 clinical trial of RP103
(Cysteamine Bitartrate Delayed-release Capsules) met the sole primary endpoint
and there were no unexpected serious safety concerns attributable to RP103
experienced by patients in the trial. The trial was conducted at three clinical
sites in the U.S. and five clinical sites in Europe. In March 2012 the Company
filed a Marketing Authorization Application ('MAA') with the European Medicines
Agency ('EMA'), as well as a New Drug Application ('NDA') with the US Food and
Drug Administration ('FDA'), for RP103 for the potential treatment of
nephropathic cystinosis. 

About Nephropathic Cystinosis

Nephropathic cystinosis, an orphan disease, is estimated to effect a population
of 2,000 patients worldwide, including 500 patients in the U.S. and 800
patients in Europe. Cystinosis patients have inherited a defective cystine
transporter gene which results in body-wide cellular toxicity resulting from
the abnormal buildup of the amino acid cystine in the lysosomes. Cystinosis is
usually diagnosed in the first year of life and requires lifelong therapy.
Cystine crystals accumulate in various tissues and organs, including the
kidneys, brain, liver, thyroid, pancreas, muscles and eyes. Left untreated, the
disease is fatal by the first decade of life. RP103 reduces cellular toxicity
by continuously removing cystine from the lysosome. 

About Cysteamine and RP103

RP103 is Raptor's proprietary delayed and extended release oral medication
designed to treat the underlying metabolic cause of cystinosis. RP103 is an
enteric coated, microbead formulation of cysteamine bitartrate that has been
formulated to be sprinkled onto food for administration to patients too young
to take oral capsules. Raptor has been granted orphan product designation for
RP103 by the EMA and FDA. 

In December 2007, Raptor obtained an exclusive, worldwide license from the
University of California, San Diego for the development of RP103 for
nephropathic cystinosis and for cysteamine for other potential indications
including Huntington's Disease, currently in a Phase 2/3 clinical trial in
France, and non-alcoholic steatohepatitis ('NASH') currently in a Phase 2b
clinical trial in the U.S. 

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 

                           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
Raptor will obtain marketing approval for RP 103 for nephropathic cystinosis in
Europe or the U.S.; that this patent will add key additional IP protection for
Raptor's IP portfolio; that Raptor may receive market exclusivity in the US and
the EU based up Raptor's orphan designations; that Raptor's proprietary
formulation of cysteamine may provide therapeutic options for the potential
treatment of nephropathic cystinosis; and that Raptor will be able to
successfully develop RP 103 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 Form 10-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 July 10, 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. 


         CONTACT: Trout Group (investors)
         Lauren Glaser
         (646) 378-2972
         lglaser@troutgroup.com
         
         EVC Group (media)
         Janine McCargo
         (646) 688-0425
         jmccargo@evcgroup.com
News Source: NASDAQ OMX



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Language:     English
Company:      Raptor Pharmaceutical Corp.
              
               
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ISIN:         US75382F1066
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