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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 Crohns

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.
Philip L. Rohrer, Jr. (investors)
Chief

Financial Officer
301-361-4400
[email protected]
or
Christopher

Culotta (investors and media)
Senior Director, Strategic

Communications
240-361-4433
[email protected]

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Blake Masterson

Freelance Writer, Journalist and Father of 5

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