ATLANTA, Feb. 2 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. , a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced an extension of its research and development collaboration with Astellas Pharma Inc. for AGI-1096, an AtheroGenics oral drug candidate being evaluated for the prevention of chronic organ transplant rejection.
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Under the extension, AtheroGenics and Astellas will continue with additional studies to further explore the therapeutic utility of AGI-1096 in this indication. Astellas will fund all of the development costs during the extended term of the agreement and will retain the exclusive option to negotiate for late stage development and commercial rights to the compound.
"The results from our early studies have encouraged us to take the next steps to evaluate the potential of AGI-1096 to prevent chronic transplant rejection," commented William Fitzsimmons, Pharm.D., Senior Vice President Business Development, at Astellas US LLC., a U.S. subsidiary of Astellas Pharma Inc. "We are pleased to be moving forward with this extended collaboration on AGI-1096."
Earlier studies conducted under the collaboration included both clinical and preclinical studies. In a Phase I clinical trial investigating the safety and tolerability of oral AGI-1096 in combination with Astellas' tacrolimus (Prograf(R)) conducted in healthy volunteers, results indicated that regimens of AGI-1096 administered alone, and concomitant with tacrolimus, were generally well-tolerated and there were no serious adverse events associated with either regimen during the course of the study. AGI-1096 has also demonstrated pharmacological activity in certain preclinical studies that were conducted as part of the ongoing collaboration.
"The Phase I study with tacrolimus is the first controlled study to evaluate the safety and tolerability of AGI-1096 in healthy volunteers in combination with another oral therapy for the prevention of organ transplant rejection," stated Rob Scott, M.D., Senior Vice President of Clinical Development and Regulatory Affairs and Chief Medical Officer of AtheroGenics. "We are very pleased with the results and look forward to continuing our relationship with Astellas, a recognized leader in the transplant rejection field."
About AGI-1096
AGI-1096 is a novel antioxidant and selective anti-inflammatory investigational agent discovered by AtheroGenics. This compound is being developed in collaboration with Astellas to address the accelerated inflammation of grafted blood vessels, known as transplant arteritis, common in chronic organ transplant rejection. AtheroGenics has previously completed a Phase I clinical trial that assessed the safety and tolerability of AGI-1096 in healthy volunteers. The results of the AGI-1096 Phase I study indicated the drug was well tolerated over the escalating single oral doses studied, and adverse events were generally mild, and not considered clinically significant.
About AtheroGenics
AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including heart disease (atherosclerosis), rheumatoid arthritis and asthma. The Company has two drug development programs currently in the clinic. AtheroGenics' lead compound, AGI-1067, is being evaluated in the pivotal Phase III ARISE clinical trial as an oral therapy for the treatment of atherosclerosis, in collaboration with AstraZeneca. AGI-1096 is a novel, oral agent in Phase I that is being developed for the prevention of organ transplant rejection in collaboration with Astellas. AtheroGenics also has preclinical programs in rheumatoid arthritis and asthma utilizing its proprietary vascular protectant(R) technology. For more information about AtheroGenics, please visit www.atherogenics.com.
About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas US LLC, a U.S. subsidiary of Astellas Pharma Inc., is located in Deerfield, Illinois.
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that relate to events or developments that we expect or anticipate will occur in the future are deemed to be forward-looking statements, and can be identified by words such as "believes," "intends," "expects" and similar expressions. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. These risks include statements which address operating performance, events or developments that we expect or anticipate will occur in the future, such as projections about clinical trial results, our future results of operations or our financial condition, research, development and commercialization of our product candidates, anticipated trends in our business, and other risks that could cause actual results to differ materially. These and other risks are discussed in AtheroGenics' Securities and Exchange Commission filings, including, but not limited to, the risks discussed in AtheroGenics' Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2004, and our Quarterly Report on Form 10-Q for the third quarter of 2005. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Photo: http://www.newscom.com/cgi-bin/prnh/20040730/ATATHEROGENICSLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comAtheroGenics, Inc.CONTACT: Mark P. Colonnese, Chief Financial Officer of AtheroGenics, Inc.,+1-678-336-2500, or investor@atherogenics.com; or Investors, Lilian Sternof Stern Investor Relations, Inc., +1-212-362-1200, or lilian@sternir.com;or Media, Katie Brazel of Fleishman Hillard, +1-404-739-0150,brazelk@fleishman.com
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