August 6, 2008
Ore Pharmaceuticals Acquires Rights to Develop a Second Drug Candidate From Roche
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.