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Raptor Pharmaceutical Receives Notices of Allowance for Key European Patent Applications Protecting Its Cysteamine Portfolio (deutsch)

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

[phone]

[e-mail]

EVC Group (media)

Janine McCargo

[phone]

[e-mail]

News Source: NASDAQ OMX

12.04.2012 Dissemination of a Corporate News, transmitted by DGAP -

a company of EquityStory AG.

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Language: English

Company: Raptor Pharmaceutical Corp.

United States

Phone:

Fax:

E-mail:

Internet:

ISIN: US75382F1066

WKN:

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