Ore Pharmaceuticals Inc. Acquires Repositioned Clinical-Stage Drug Candidate from Roche
GAITHERSBURG, Md.--(BUSINESS WIRE)--Ore Pharmaceuticals Inc. (NASDAQ:ORXE - News) announced today that it has acquired from Roche the clinical-stage compound tiapamil. Ore Pharmaceuticals had previously identified potentially novel therapeutic uses for tiapamil in central nervous system (CNS) disease and recently filed for patent protection regarding the use of the compound. The Company plans to further develop tiapamil, and will select the most appropriate of several potential indications, prepare for Phase II clinical trials, and initiate out-licensing activities.
Ore Pharmaceuticals analyzed and subsequently acquired the compound as part of the previously announced drug repositioning partnership agreement with Roche. Tiapamil had reached Phase II or Phase III clinical testing for its original indications in hypertension, arrhythmia, and angina. Repositioning efforts at Ore Pharmaceuticals discovered that tiapamil activates a major regulatory protein in the brain, an activity for which the compound or its class was previously not developed.
Thomas Barnes, Ph.D., Senior Vice President of Discovery at Ore Pharmaceuticals, said, "Tiapamil is one of several success stories Ore Pharmaceuticals has had. We were able to show that tiapamil has some unique properties in the CNS, which we are hoping to exploit. We have already shown that the compound was able to improve memory in two different animal models."
Stephen Donahue, M.D., Senior Vice President of Clinical Development at Ore Pharmaceuticals, said, "Tiapamil is a great addition to our emerging development pipeline. It has been well characterized by Roche in prior studies. Since tiapamil has been studied in more than 1,000 patients for periods up to 12 months, development risk is reduced relative to similar compounds that are just entering patient trials."
Tiapamil joins GL1001, a clinical-stage candidate for Inflammatory Bowel Disease, in the Ore Pharmaceuticals development pipeline. The Company submitted an investigational new drug application (IND) with the FDA for GL1001 on June 30, 2008 and plans to resume clinical trials on GL1001 in September 2008. Ore Pharmaceuticals is currently seeking a development partner for the late-stage development of GL1001.
Ore Pharmaceuticals Chief Executive Officer, Charles L. Dimmler, III, commented, "Our acquisition of tiapamil is an important step in our plan to transform our Company to drug development. This development opportunity is the result of outstanding work on the part of our Discovery scientists who applied our proprietary indications discovery capabilities successfully to identify this new therapeutic application. We have recently taken significant steps to focus our resources and decrease other expenses, enabling us to proceed with development and out-licensing efforts for GL1001 and tiapamil. Further, we anticipate the acquisition of additional repositioned drug candidates in the near term."
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 inflammation, including inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease) and other conditions. GL1001 has shown indications of efficacy at relevant doses in in vivo testing for IBD. 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 stage testing by our partners but that are in later 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.