Raptor Pharmaceutical Corp.
06.07.2011 12:30
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Patents Claim Covers Composition and Methods of Use
NOVATO, Calif., 2011-07-06 12:30 CEST (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
Derivatives Thereof.'
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
Products.'
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(r),
and Russell 2000(r) 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.
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 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.
CONTACT: Trout Group (investors)
Lauren Glaser
(646) 378-2972
lglaser@troutgroup.com
The Ruth Group (media)
Victoria Aguiar
(646) 536-7013
vaguiar@theruthgroup.com
News Source: NASDAQ OMX
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Language: English
Company: Raptor Pharmaceutical Corp.
United States
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ISIN: US75382F1066
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DGAP-News: Raptor Pharmaceutical Receives Notices of Allowance for Two Key Patent Applications Protecting Its Cysteamine Portfolio
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