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DGAP-News: Raptor Pharmaceutical Appoints Kathlene L. Powell Vice President, Quality Operations
ID: 386437
(firmenpresse) - Raptor Pharmaceutical Corp.
13.04.2011 09:30
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NOVATO, Calif., 2011-04-13 09:30 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP),
announced today that it has named Kathlene L. Powell to the newly created
position of VP, Quality Operations.
Ms. Powell will be responsible for overseeing Quality Assurance and Quality
Control (QA/QC) for Raptor, as well as leading Chemistry and Manufacturing
Controls (CMC) related issues and activities, including the preparation of
documents for regulatory submission. In addition, Ms. Powell will manage the
coordination and control of outsourced manufacturing and the release of drug
product for Raptor's clinical programs and planned commercial products. Ms.
Powell will report to Ted Daley, President of Raptor Therapeutics, Raptor's
clinical development division.
Mr. Daley stated, 'We are thrilled that Kathy has agreed to join us full time
at Raptor. Kathy has been working with us as our principal quality and
manufacturing consultant in our nephropathic cystinosis program from the start,
and has been our FDA/EMA liaison for CMC-related issues over the last three
years. She has proven herself as a highly-valued member of our development team
at Raptor, and her intimate knowledge of our nephropathic cystinosis program
will provide seamless continuity as we near completion of our DR Cysteamine
Phase 3 clinical trial and look ahead to our planned submission of registration
documents later this year to the FDA and EMA. Moreover, Kathy's deep experience
overseeing contract manufacturing organizations will be integral to our plans
to scale up our CMC operations towards the potential commercial launch of DR
Cysteamine for nephropathic cystinosis in 2012.'
Prior to joining Raptor full time, Ms. Powell worked for Pacific
BioDevelopment, LLC, a San Francisco-based biotechnology consulting group,
where she most recently held the position of Vice President, Quality. During
her nine years at Pacific BioDevelopment, Ms. Powell executed numerous quality
and control initiatives for their client companies, including the development
of CMC regulatory strategies and preparation of CMC sections of regulatory
submissions; the selection and management of CMOs for the development,
manufacture, and testing of drug substances and drug products; and the
evaluation of QC test methods, QC data, stability programs, validation
protocols and validation reports.
Previous to her tenure at Pacific BioDevelopment, Ms. Powell's over 20-year
career in biotechnology was highlighted by quality control and validation
experience at such biopharmaceutical companies as Diosynth-RTP (formerly CBSI,
Inc.) and Genentech, Inc. (a member of the Roche group, SIX: RO, ROG; OTCQX:
RHHBY). While at Diosynth-RTP, Ms. Powell was involved in establishing and
implementing the company's Pre-Approval Inspection (PAI) readiness program and
hosted the facility's first FDA PAI in May 2001. Among her duties at Genentech,
Ms. Powell managed the Biochemical Manufacturing Validation group and
supervised the Quality Control Chromatography group performing chromatography
and cleaning validation testing as well as assay development, transfer, and
validation.
Ms. Powell holds an M.S. in biochemistry from the University of Missouri and a
B.A. in Chemistry, from Doane College, Crete, Nebraska, where she graduated
Summa Cum Laude.
About Nephropathic Cystinosis
Nephropathic cystinosis is an inborn metabolic error characterized by the
abnormal transport of cystine, an amino acid, out of the lysosomes. Failure to
treat nephropathic cystinosis can cause serious health consequences, including
renal failure and resultant kidney transplant, growth failure, rickets,
photophobia and blindness. Symptom onset typically occurs within the first year
of life, when cystine crystals accumulate in various tissues and organs,
including the kidneys, brain, liver, thyroid, pancreas, muscles and eyes.
About Cysteamine and DR Cysteamine
DR Cysteamine is Raptor's proprietary enteric-coated, microbead oral
formulation of cysteamine bitartrate designed to potentially reduce dosing
frequency and gastrointestinal side effects associated with immediate-release
cysteamine bitartrate, which is approved for sale by the FDA and EMA to treat
nephropathic cystinosis, a rare, genetic lysosomal storage disease.
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, NASH and Batten Disease.
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
Raptor will complete its DR Cysteamine Phase 3 clinical trial; that Raptor will
submit registration documents later this year to the FDA and EMA; that Raptor
will be able to scale up its CMC operations to support potential commercial
launch of DR Cysteamine for nephropathic cystinosis 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 January 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.
For more information, please contact:
Trout Group (investors)
Lauren Glaser
(646) 378-2972
lglaser(at)troutgroup.com
The Ruth Group (media)
Jason Rando
(646) 536-7025
jrando(at)theruthgroup.com
News Source: NASDAQ OMX
13.04.2011 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:
End of Announcement DGAP News-Service
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Datum: 13.04.2011 - 09:30 Uhr
Sprache: Deutsch
News-ID 386437
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