DGAP-News: Raptor Pharmaceutical Obtains Tissue Fibrotic Disease Intellectual Property Related to Cysteamine
(firmenpresse) - Raptor Pharmaceutical Corp.
10.10.2012 12:30
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NOVATO, Calif., 2012-10-10 12:30 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP), today
announced that the Company has acquired exclusive world-wide rights to
intellectual property related to cysteamine and related compounds in the
potential treatment of tissue fibrosis from the Seattle Children's Research
Institute ('SCRI').
Raptor's agreement with SCRI provides exclusive rights to technology related to
compositions and methods for treating patients having or being at risk of
developing pathological fibrosis including chronic kidney disease ('CKD').
Raptor holds a portfolio of intellectual property related to composition of
matter and methods of use of cysteamine and related compounds, covering
therapeutic applications, including genetic diseases, metabolic disorders and
neurological diseases. Raptor's RP103, its proprietary, delayed-release oral
formulation of cysteamine bitartrate, is in clinical development for the
potential treatment of nephropathic cystinosis, a rare metabolic lysosomal
storage disease, Huntington's Disease, a genetic neurological disease, and
non-alcoholic steatohepatitis ('NASH'), a severe form of non-alcoholic fatty
liver disease.
In addition to other fibrotic conditions, the license covers the use of
cysteamine or cystamine in the potential amelioration of progressive
interstitial renal fibrosis by modulating oxidative stress. Researchers at SCRI
have shown in preclinical studies in mice that daily treatment with cysteamine
attenuated renal fibrosis, with up to 25% reduction of extracellular fibrotic
material observed over a 21-day study period.
'Fibrosis can occur in many organ systems in the body resulting in serious
health and in some cases life-threatening consequences,' said Patrice P. Rioux,
M.D., Ph.D., Raptor's Chief Medical Officer. 'This licensing agreement with
Seattle Children's Research Institute further expands the applications of our
cysteamine formulations in the potential treatment of fibrotic disease,
including chronic kidney, liver and severe gastrointestinal diseases, as well
as metabolic diseases, and we look forward to continuing to collaborate with
the SCRI researchers as we expand our clinical development into these areas.'
Daryl Okamura, M.D., Principal Investigator at SCRI and Assistant Professor of
Pediatrics at the University of Washington School of Medicine, said, 'Kidney
dysfunction is a recognized risk factor for poor outcome in a variety of
disease states, yet there are few therapies to stop the relentless progression
of CKD and alleviate the ongoing oxidative stress within the kidney. We believe
that our preclinical results support further development with cysteamine for
this indication. We hope to see the study of this potential cysteamine
treatment move into a clinical trial.'
About Chronic Kidney Disease
CKD affects approximately 26 million Americans and is characterized by the
progressive loss of renal function over a protracted period of time. If the
progression of CKD is not halted, CKD can develop into end stage renal disease,
or chronic renal failure where the kidney no longer functions and the patient
requires dialysis or a kidney transplant. There is no cure for CKD. The goalsof treatment are to slow disease progression, treat the underlying causes,
treat complications of the disease and when necessary, replace lost kidney
function. The most common causes of CKD are diabetes mellitus, hypertension and
glomerulonephritis. CKD is also caused by genetic disorders, including
nephropathic cystinosis.
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 use of cysteamine and related compounds for the potential
treatment of Parkinson's Disease from Laval University, for the use of
cysteamine and related compounds for the potential treatment of malaria and
other parasitic diseases from McGill University and for the potential treatment
of tissue fibrosis from the Seattle Children's Research Institute. Raptor has
been granted orphan product designation for RP103 for the potential treatment
of nephropathic cystinosis by the EMA and the 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.
The Raptor Pharmaceutical Corp. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7180
For additional information, please visit www.raptorpharma.com.
About Seattle Children's Research Institute
Located in downtown Seattle's biotech corridor, Seattle Children's Research
Institute is pushing the boundaries of medical research to find cures for
pediatric diseases and improve outcomes for children all over the world.
Internationally recognized investigators and staff at the research institute
are advancing new discoveries in cancer, genetics, immunology, pathology,
infectious disease, injury prevention and bioethics, among others. As part of
Seattle Children's Hospital, the research institute brings together leading
minds in pediatric research to provide patients with the best care possible.
Seattle Children's serves as the primary teaching, clinical and research site
for the Department of Pediatrics at the University of Washington School of
Medicine, which consistently ranks as one of the best pediatric departments in
the country. For more information, visit
http://www.seattleChildrens.org/research.
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 continue to collaborate with the SCRI researchers; that Raptor will
expand its clinical development into the areas of fibrotic disease; that
preclinical results involving daily treatment with cysteamine in CKD can be
duplicated in a clinical trial; 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
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(at)troutgroup.com
EVC Group (media)
Janine McCargo
(646) 688-0425
jmccargo(at)evcgroup.com
News Source: NASDAQ OMX
10.10.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Raptor Pharmaceutical Corp.
United States
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