DGAP-News: Raptor Pharmaceutical Corp. Announces Presentation of PROCYSBI(TM) (RP103) Extension Study Data at the ASN Annual Meeting
(firmenpresse) - Raptor Pharmaceutical Corp.
17.10.2012 12:30
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NOVATO, Calif., 2012-10-17 12:30 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP),
announced that Craig B. Langman, M.D., Head of Kidney Diseases, and the Isaac
A. Abt, M.D., Professor of Kidney Diseases and Tenured Professor of Pediatrics,
Northwestern University Feinberg School of Medicine, will present a Late
Breaking Poster session titled 'Extended Treatment with RP103 (PROCYSBI(tm)) in
Patients with Nephropathic Cystinosis' at Kidney Week 2012, the world's premier
nephrology meeting, which is being held October 30-November 4th at the San
Diego Convention Center in San Diego, California. Dr. Langman's presentation is
on Saturday, November 3rd in a session beginning at 10:00 A.M. PT.
About Nephropathic Cystinosis
Nephropathic Cystinosis is a rare, life-threatening metabolic disorder that
causes systemic toxic cystine accumulation. Toxic cystine accumulation causes
progressive and irreversible tissue damage and organ failure including renal
failure, blindness, CNS toxicities, respiratory deficiencies and muscle
wasting. 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.
About Cysteamine and PROCYSBI(tm) (RP103)
PROCYSBI(tm) is Raptor's delayed-release oral medication currently in clinical
development for several indications. PROCYSBI(tm) is an enteric-coated, delayed
and extended-release formulation of cysteamine bitartrate. PROCYSBI(tm) was
engineered specifically to allow release of micro-spheronized enteric-coated
cysteamine bitartrate in the duodenum for optimal absorption while
simultaneously enabling administration every 12-hours.
In December 2007, Raptor obtained an exclusive, worldwide license from the
University of California, San Diego to intellectual property related to the
development of PROCYSBI(tm) and other forms of cysteamine for the potential
treatment of non-alcoholic steatohepatitis ('NASH'), currently in a Phase 2b
clinical trial in the U.S., Huntington's Disease, currently in the Phase 2/3
clinical trial in France, and for the development of PROCYSBI(tm) for 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 PROCYSBI(tm) 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 PROCYSBI(tm) 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 been granted
orphan product designation for PROCYSBI(tm) for the potential treatment for
nephropathic cystinosis by the European Medicines Agency and FDA and for the
potential treatment of Huntington's Disease by the FDA. Raptor's intellectual
property portfolio also includes patents covering the use of transglutaminase
inhibitors, a class of molecules chemically similar to cysteamine, in the
potential treatment of Huntington's Disease and other neurological disorders
from the Weizmann Instituteof Science in Israel and Niigata University in
Japan; the use of cysteamine and related compounds in the potential treatment
of parasitic diseases, including malaria, from McGill University in Montreal,
Canada; the use of cysteamine and related compounds in the potential treatment
of Parkinson's Disease from Universite Laval, Quebec, Canada; and the use of
cysteamine and related compounds in the potential treatment of tissue fibrosis
from the Seattle Children's Research Institute.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) ('Raptor') seeks to research,
develop, and provide access to 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'), and
aldehyde dehydrogenase deficiency ('ALDH2').
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 the
NIDDK will be able to complete enrollment and complete the Phase 2b clinical
trial; that Raptor will be able to supply clinical material and funding for the
Phase 2b clinical trial; if the Phase 2b clinical trial is completed, that the
resulting clinical trial results will meet its primary objectives and secondary
clinical endpoints; that the Phase 2b clinical trial will emulate the results
of the Phase 2a open label study; that RP103 will prevent significant GSH
depletion and potentially reverse NASH-related liver damage; 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.
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
17.10.2012 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
Phone:
Fax:
E-mail:
Internet:
ISIN: US75382F1066
WKN:
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