Raptor Pharmaceutical Receives Notices of Allowance for Key European Patent Applications Protecting Its Cysteamine Portfolio
Raptor Pharmaceutical Corp.
12.04.2012 12:30
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Patent Claims Cover Use of Delayed-Release Cysteamine in Cystinosis
NOVATO, Calif., 2012-04-12 12:30 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP), today
announced that the European Patent Office has issued a Notice of Allowance for
a key patent covering the use of enteric-coated, delayed-release ('DR') oral
formulations of cysteamine bitartrate, including Raptor's proprietary microbead
formulation, RP103, as well as other formulations of cystamine and cysteamine,
as outlined below:
Application 07 762 690.1 / 1919458
No. / Patent
No.:
Issued Notice March, 14, 2012
of Allowance:
Patent Title: 'Enterically Coated Cystamine, Cysteamine and Derivatives
Thereof.'
Expected to Use of DR Cysteamine for administration to patients for the
Cover: potential treatment of cystinosis, including nephropathic
cystinosis
Expected 20 years from the filing date; expiring January 26, 2027
Initial Term:
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'). In 2011, counterpart patents were granted in the US directed to DR
cysteamine compositions, including RP103, and methods of use for any
indication, including nephropathic cystinosis.
'Having submitted a Marketing Authorization Application for RP103 for the
potential treatment of nephropathic cystinosis to the European Medicines
Agency, this notice of allowance gives the Company key additional IP protection
in Europe,' commented Ted Daley, President of Raptor.
Patent application 07 762 690.1 covers the use of a 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 potential treatment of cystinosis, including
nephropathic cystinosis. Raptor believes that its proprietary formulation of
cysteamine may provide significant therapeutic and compliance advantages
compared to the presently marketed, immediate-release cysteamine bitartrate 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 Raptor 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 potentially 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 US.
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 this
notice of allowance adds key additional IP protection in Europe; that Raptor's
proprietary formulation of cysteamine may provide significant therapeutic and
compliance advantages compared to the presently marketed, immediate-release
cysteamine bitartrate for the treatment of nephropathic cystinosis; 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@troutgroup.com
EVC Group (media)
Janine McCargo
(646) 688-0425
jmccargo@evcgroup.com
News Source: NASDAQ OMX
12.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Raptor Pharmaceutical Corp.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US75382F1066
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Raptor Pharmaceutical Corp.
12.04.2012 12:30
---------------------------------------------------------------------------
Patent Claims Cover Use of Delayed-Release Cysteamine in Cystinosis
NOVATO, Calif., 2012-04-12 12:30 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP), today
announced that the European Patent Office has issued a Notice of Allowance for
a key patent covering the use of enteric-coated, delayed-release ('DR') oral
formulations of cysteamine bitartrate, including Raptor's proprietary microbead
formulation, RP103, as well as other formulations of cystamine and cysteamine,
as outlined below:
Application 07 762 690.1 / 1919458
No. / Patent
No.:
Issued Notice March, 14, 2012
of Allowance:
Patent Title: 'Enterically Coated Cystamine, Cysteamine and Derivatives
Thereof.'
Expected to Use of DR Cysteamine for administration to patients for the
Cover: potential treatment of cystinosis, including nephropathic
cystinosis
Expected 20 years from the filing date; expiring January 26, 2027
Initial Term:
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'). In 2011, counterpart patents were granted in the US directed to DR
cysteamine compositions, including RP103, and methods of use for any
indication, including nephropathic cystinosis.
'Having submitted a Marketing Authorization Application for RP103 for the
potential treatment of nephropathic cystinosis to the European Medicines
Agency, this notice of allowance gives the Company key additional IP protection
in Europe,' commented Ted Daley, President of Raptor.
Patent application 07 762 690.1 covers the use of a 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 potential treatment of cystinosis, including
nephropathic cystinosis. Raptor believes that its proprietary formulation of
cysteamine may provide significant therapeutic and compliance advantages
compared to the presently marketed, immediate-release cysteamine bitartrate 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 Raptor 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 potentially 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 US.
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 this
notice of allowance adds key additional IP protection in Europe; that Raptor's
proprietary formulation of cysteamine may provide significant therapeutic and
compliance advantages compared to the presently marketed, immediate-release
cysteamine bitartrate for the treatment of nephropathic cystinosis; 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@troutgroup.com
EVC Group (media)
Janine McCargo
(646) 688-0425
jmccargo@evcgroup.com
News Source: NASDAQ OMX
12.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Raptor Pharmaceutical Corp.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US75382F1066
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------