Acquires Rights from UCSD to Develop Cysteamine for the Treatment of NASH
Enters Convivia(TM) Formulation and Manufacturing Agreement with Patheon
NOVATO, Calif., March 19 /CNW/ -- Raptor Pharmaceuticals Corp. ("Raptor"
or the "Company") (OTC Bulletin Board: RPTP), today announced that its
clinical development subsidiary, Bennu Pharmaceuticals Inc. ("Bennu"), has
acquired an exclusive worldwide license to intellectual property from the
University of California, San Diego ("UCSD") around the use of Cysteamine, and
Delayed Release Cysteamine ("DR Cysteamine") for the treatment of
Non-alcoholic Steatohepatitis ("NASH"). In collaboration with doctors from
UCSD School of Medicine, Bennu plans to initiate a Phase 2a clinical study of
DR Cysteamine in NASH patients in 2008.
(Logo: http://www.newscom.com/cgi-bin/prnh/20071022/NYM074LOGO )
NASH is a form of progressive liver disease resulting from triglyceride
fat accumulation in vacuoles of the liver cells, which causes decreased liver
function and potentially leads to cirrhosis and liver failure. Cysteamine is
currently approved by the FDA for the management of nephropathic cystinosis
("cystinosis"), a genetic lysosomal storage disease characterized by the poor
transport of cystine out of lysosomes.
Ted Daley, President of Bennu stated, "We are delighted to extend our
relationship with UCSD. Additional rights to Cysteamine in NASH complement our
license to DR Cysteamine for cystinosis and neurodegenerative diseases. In
addition to our ongoing clinical trial in cystinosis, we look forward to
initiating a clinical trial of DR Cysteamine in NASH patients in 2008."
In a separate announcement, Raptor said that Bennu has entered into a
formulation and manufacturing agreement for its Convivia(TM) product candidate
with Patheon Pharmaceuticals Inc. ("Patheon"), of Cincinnati, Ohio. Under
terms of the agreement, Patheon will provide Bennu's proprietary oral
formulation of 4-methylpyrazole ("4-MP") for usage in clinical studies, which
Bennu plans to initiate in the second half of 2008.
Convivia(TM) is a proprietary, oral formulation of 4-MP currently in
development for the treatment of ALDH2 Deficiency, which is a metabolic
disorder characterized by the inability to tolerate alcoholic beverages.
Especially prevalent in East Asian populations, ALDH2 deficiency is associated
with increased risk of digestive tract cancers and other serious health
disorders in affected persons who drink alcoholic beverages.
NASH is a form of progressive liver disease characterized by the
accumulation of fat in the liver. It is often diagnosed in people who are
overweight, have diabetes or show abnormal serum lipid profiles. The disorder
is believed to affect 2 to 5% of the U.S. population. NASH results from fat
accumulation in vacuoles of the liver cells resulting in inflammation, which,
if allowed to progress may ultimately lead to cirrhosis and liver failure.
NASH has most commonly been diagnosed in obese adults, who are insulin
resistant, but can also occur in children, the elderly, normal-weight, and
NASH accounts for about 10% of newly diagnosed cases of chronic liver
disease. The disorder ranks as one of the leading causes of cirrhosis in the
United States, following hepatitis C and alcoholic liver disease.
Characteristics of the disease include abnormal levels of liver enzymes in the
serum, liver cell injury, and inflammation, fibrosis, and excess fat storage
in the liver. Though most people with NASH feel healthy and show no outward
signs of liver disease, the progressive nature of NASH can lead to cirrhosis
and end-stage liver disease, which may require liver transplantation.
About Raptor Pharmaceuticals Corp.
Raptor Pharmaceuticals Corp.'s business consists of two segments: its
100% ownership of development stage biotechnology company Raptor
Pharmaceutical Inc. ("Raptor Inc."); and its 100% ownership of clinical-stage
development company Bennu Pharmaceuticals Inc. Raptor Inc. bioengineers novel
drug candidates and drug-targeting platforms derived from the human receptor-
associated protein ("RAP") and related proteins, while Bennu advances
clinical-stage product candidates towards marketing approval and
Raptor Inc.'s preclinical programs target cancer, neurodegenerative
disorders and infectious diseases. HepTide(TM) is designed to utilize
engineered RAP-based peptides conjugated to drugs to target their delivery to
the liver to potentially treat primary liver cancer and hepatitis. In
neurodegenerative diseases, engineered RAP peptides called NeuroTrans(TM) are
currently undergoing evaluation at Stanford University in cell culture and
preclinical models for their ability to enhance the transport of molecules
from blood to brain. In an effort to protect its novel approach, Raptor Inc.
currently has five patent applications in review in the U.S., and countries in
Europe and Asia, as well as two provisional patent applications licensed from
Washington University. In addition, Raptor Inc. has submitted two new
provisional patent applications in the U.S., the first of which covers a new
family of RAP peptides, and the second application to further support and
expand its coverage in specific disease indications.
Bennu executes the clinical development of internal product candidates
and in-licensed candidates that are: 1) new chemical entities in mid-to-late
stage clinical development; 2) currently approved drugs with potential
efficacy in additional indications; and 3) treatments that Bennu could
repurpose or reformulate as potentially more effective or convenient
treatments for their currently approved indications. Bennu's initial clinical
programs include the treatment of aldehyde dehydrogenase ("ALDH2") deficiency
and nephropathic cystinosis.
For additional information, please visit www.raptorpharma.com.
About Patheon Pharmaceuticals Inc.
Patheon (TSX: PTI) is a leading global provider of drug development and
manufacturing services to the international pharmaceutical industry. The
Company operates a network of 12 facilities in the United States, Canada and
Europe, employing more than 4,650 people and serving a global client base of
250 pharmaceutical and biotechnology companies. For further information about
Patheon, please visit www.patheon.com or contact the company at
email@example.com or (905) 821-4001.
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: the
Company's ability to initiate a Phase 2a study of Cysteamine or Delayed
Release Cysteamine in NASH patients in 2008, develop an oral formulation of
4MP, develop clinical assays for the oral formulation of 4MP and initiate a
clinical trial for the oral formulation of 4MP in the second half of 2008.
These statements are only predictions and involve known and unknown risks,
uncertainties and other factors, which may cause our actual results to be
materially different from these forward-looking statements. Factors which may
significantly change or prevent our forward looking statements from fruition
include that we may be unsuccessful in developing any products or acquiring
products; that our technology may not be validated as we progress further and
our methods may not be accepted by the scientific community; that we are
unable to retain or attract key employees whose knowledge is essential to the
development of our products; that unforeseen scientific difficulties develop
with our process; that our patents are not sufficient to protect essential
aspects of our technology; that competitors may invent better technology; that
our products may not work as well as hoped or worse, that our products may
harm recipients; and that we may not be able to raise sufficient funds for
development or working capital when we require it. As well, our products may
never develop into useful products and even if they do, they may not be
approved for sale to the public. We caution 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 our filings from time to time with the
Securities and Exchange Commission (the "SEC"), which we strongly urge you to
read and consider, including our Registration Statement on Form SB-2, as
amended, that was declared effective on July 10, 2006 and our annual report on
Form 10-KSB filed with the SEC on November 13, 2007, and our quarterly report
on Form 10-QSB filed with the SEC on January 14, 2008, 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 us or
to persons acting on our behalf are expressly qualified in their entirety by
the cautionary statements set forth in our reports filed with the SEC. We
expressly disclaim any intent or obligation to update any forward-looking
For more information, please contact:
The Ruth Group
Sara Ephraim (investors) Janine McCargo (media)
(646) 536-7002 (646) 536-7033
For further information:
For further information: Investors, Sara Ephraim, +1-646-536-7002,
firstname.lastname@example.org, or Media, Janine McCargo, +1-646-536-7033,
email@example.com, both of The Ruth Group for Raptor Pharmaceuticals
Corp. Web Site: http://www.raptorpharma.com