Ore Pharmaceuticals Acquires Rights to Develop a Second Drug Candidate from Roche
2008-08-06 16:00:00
Ore Pharmaceuticals Acquires Rights to Develop a Second Drug Candidate from Roche
Ore Pharmaceuticals Files for Patents, Plans to Develop and
Out-License Candidate for Metabolic Conditions Such as Obesity or High
Cholesterol
GAITHERSBURG, Md.–(EMWNews)–Ore Pharmaceuticals Inc. (NASDAQ:ORXE) announced today that it has
acquired from Roche the exclusive development rights for the
clinical-stage compound romazarit. Ore Pharmaceuticals had previously
identified potentially novel therapeutic uses for romazarit in metabolic
diseases and subsequently observed a lowering of lipids, weight, and
glucose levels in in vivo testing. The Company filed recently for
patent protection regarding the use of the compound for treatment of
metabolic diseases. Ore Pharmaceuticals plans to further develop
romazarit, select the most appropriate of the potential indications, and
prepare for Phase II clinical trials. The Company will engage in
out-licensing efforts in parallel with development efforts.
Ore Pharmaceuticals acquired the development rights for romazarit
through its partnership with Roche, where it was initially developed as
an anti-inflammatory compound and had reached Phase II clinical testing
for rheumatoid arthritis. Repositioning efforts at Ore Pharmaceuticals
discovered that romazarit modulates a key pathway related to metabolic
function.
Thomas Barnes, Ph.D., Senior Vice President of Discovery at Ore
Pharmaceuticals, said, “Romazarit joins
tiapamil and GL1001 as success stories resulting from our indication
seeking program. Based on the data derived from our program, we
initiated in vivo tests and were pleased to observe decreases in
lipid levels, body weight, and plasma glucose in various preclinical
models. There are significant opportunities for development in each of
these areas.”
Stephen Donahue, M.D., Senior Vice President of Clinical Development at
Ore Pharmaceuticals, said, “Romazarit has
exhibited potential for treating dyslipidemia and other highly prevalent
metabolic conditions such as obesity. The compound was well tolerated in
clinical testing, and has been well characterized by Roche in prior
studies.”
Ore Pharmaceuticals Chief Executive Officer, Charles L. Dimmler, III,
commented, “Our top priority goal has been to
increase the number of compounds in our development pipeline. We are
extremely pleased with the recent acquisition of development rights to
tiapamil and romazarit, two high-quality compounds originated and
studied by Roche. We believe that the potential indications for
romazarit – obesity and lipid lowering in
particular – make the compound an attractive
partnering candidate for pharmaceutical companies. Further, we
anticipate the acquisition of additional repositioned drug candidates in
the near term.”
Ore Pharmaceuticals currently has three compounds in its development
pipeline: romazarit, tiapamil (beginning development for CNS), and
GL1001 (in development for Inflammatory Bowel Disease). The Company
cleared FDA review of the GL1001 IND and plans to resume clinical trials
on that compound later in 2008. Ore Pharmaceuticals is currently seeking
a development partner for the late-stage development of GL1001 and
tiapamil.
Ore Pharmaceuticals Overview
Ore Pharmaceuticals is a commercial drug development company. We have
applied our proprietary know how in integrative pharmacology to identify
potential new uses for drug candidates. We are now focused on developing
certain compounds for which we have found such new uses. Our goal is to
meet the demands of the pharmaceutical industry by supplying development
stage drug compounds to enrich drug development pipelines. We currently
have a lead compound, GL1001, in our own development pipeline for which
we have identified potential new therapeutic uses to treat
gastrointestinal disorders such as inflammatory bowel disease (IBD,
including ulcerative colitis and Crohn’s
disease). We intend to initiate clinical testing of GL1001 in 2008 while
actively seeking to out-license or partner the further clinical
development and commercialization of the compound. We have rights to
develop additional compounds that have been tested in clinical trials by
our partners but that are in late stages of preclinical testing for the
uses we have discovered. Visit us at orepharma.com or call
1-877-ORE-PHRM.
Safe Harbor Statement
This press release contains “forward-looking statements,” as such term
is used in the Securities Exchange Act of 1934, as amended. Such
forward-looking statements include the Company’s ability to identify
strategies for making its businesses successful and the impact of such
strategies on our business and financial performance and on shareholder
value. Forward-looking statements typically include the words “expect,”
“anticipate,” “believe,” “estimate,” “intend,” “may,” “will,” and
similar expressions as they relate to Ore Pharmaceuticals or its
management. Forward-looking statements are based on our current
expectations and assumptions, which are subject to risks and
uncertainties. They are not guarantees of our future performance or
results. Our actual performance and results could differ materially from
what we project in forward-looking statements for a variety of reasons
and circumstances, including particularly risks and uncertainties that
may affect the Company’s operations, financial condition and financial
results and that are discussed in detail in the Company’s Annual Report
on Form 10-K and our other subsequent filings with the Securities and
Exchange Commission. They include, but are not limited to: whether we
can obtain from our partners development rights to repositioned
compounds; whether we can successfully develop to a sufficient stage and
outlicense repositioned compounds on acceptable terms and whether such
outlicensed compounds are then successfully developed and commercialized
and generate sales and resulting milestone payments from development and
royalties from sales for the Company; whether we will be able to begin
to generate sufficient new revenue from licensing or other transactions
soon enough to support our operations; whether there will be valid
claims for indemnification from the buyers of our Genomics Assets;
whether there will be claims from the landlords of the leased properties
we have assigned to buyers of our Genomics Assets or our Preclinical
Division that we would be required to pay as guarantors of such leases;
whether we will be able to collect amounts due under the terms of the
promissory note from the buyer of our Genomics Assets; whether we will
be able to manage our existing cash adequately and whether we will have
access to financing on sufficiently favorable terms to maintain our
businesses and effect our strategies, including development of
repositioned compounds; whether we will be able to recruit and retain
qualified personnel for our commercial drug development business;
whether we will be able to find a sufficiently attractive strategic
option to develop our molecular diagnostics capability that does not
require significant use of our financial assets; potential negative
effects on our operations and financial results from workforce
reductions and the transformation of our business; and the possibility
of further write-down of the value of certain intangible assets of the
Company. Ore Pharmaceuticals Inc. undertakes no obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Ore Pharmaceuticals Inc. Financial Officer Culotta (investors and media) Communications |
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