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Acologix and Toray Partner on Phase III Therapeutic for Dialysis Patients

Hayward, CA – June 16, 2005 — Acologix, Inc., a privately held biopharmaceutical company, and Toray Industries, Inc. of Tokyo, Japan, announced that the companies have entered into a collaboration and license agreement for Toray’s TRK-820 in North America and Europe. Under this agreement, Acologix is granted an exclusive license to develop and commercialize TRK-820 in North America. In Europe, Acologix and Toray will co-develop the compound and Acologix retains a commercialization option. The financial terms were not disclosed. TRK-820 is a highly selective kappa opioid receptor agonist that has completed multiple Phase II studies for the treatment of uremic pruritus, a severe itching condition in dialysis patients. A pivotal Phase III study is planned to begin in Europe later this year.

Uremic pruritus is a systemic itching condition in dialysis patients for which there are no approved drugs and conventional anti-itch therapies, such as antihistamines, are ineffective. Serious consequences of “uremic itch” include loss of sleep, depression, skin lesions, infections, hospitalization, and an overall reduction in health and quality of life. As many as 50% of dialysis patients may suffer from uremic pruritus with approximately 20% developing severe and long-lasting effects.

“Our agreement with Acologix on TRK-820 supports Toray’s development effort in Europe as well as facilitates clinical studies in North America. The problem of uremic pruritus exists on a worldwide basis and the Toray-Acologix partnership expands the TRK-820 development program to meet this need,” stated Kozo Nagai, Director of Pharmaceutical and Medical Products Division at Toray Industries, Inc. Mr. Nagai further stated, “We were very pleased to find Acologix familiar with the unmet needs in the renal disease area. Our confidence in their ability to develop TRK-820 in this field was a strong motivator in choosing to partner with Acologix.”

“Developing novel therapeutics for unmet medical needs of renal failure patients is an important component of Acologix’s corporate objectives. Our agreement with Toray strengthens Acologix’s pipeline while taking advantage of our expanding product development expertise,” stated Yoshi Kumagai, President and CEO of Acologix, Inc. Mr. Kumagai added, “Acologix is honored to work with Toray, a company committed to innovation with significant expertise in chemistry, pharmaceutical development and manufacturing, particularly in kidney dialysis.”

Acologix and Toray plan to submit a Marketing Authorization Application in Europe following the completion of the planned pivotal study. In North America, Acologix will begin discussions with regulatory agencies to determine the appropriate development plan for product approval. In Japan, Toray is co-developing TRK-820 with Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd. for uremic pruritus and Maruho Co., Ltd. for atopic dermatitis.

About Toray Industries, Inc.

Toray, www.toray.co.jp, founded in 1926, is a diversified chemical manufacturer with operations in 18 countries and regions. Throughout its history, Toray has kept itself focused on research and technological development, seeking to contribute to society by creating new value. Underlying Toray’s operations is technological expertise in the three core fields of organic synthetic chemistry, polymer chemistry, and biochemistry. Toray’s operation also diversifies into such business fields as Information and Telecommunications Related (IT-Related) Products, Housing and Engineering, Pharmaceuticals and Medical Products, and Advanced Composite Materials. Toray positions its Life Sciences business, including pharmaceuticals and medical products, as one of its strategic businesses destined for future expansion and likely to become a nuclear business in the 21st century. Notably, Toray was the first company to obtain approval for a human natural interferon-ß product (Feron) and an orally active prostacyclin (PGI2) derivative (Dorner). Feron is primarily used to treat chronic hepatitis C, and Dorner is used to treat chronic arterial occlusion. Toray has also established its preeminence as a global leader in medical device products such as Filtryzer and Toraysulfone artificial kidneys, and Toraymyxin an extra-corporeal blood purification column for the treatment of septicemia.

About Acologix, Inc.

Acologix strives to improve patients’ lives by developing and commercializing innovative biopharmaceuticals targeting “osteo-renal” (bone and kidney) diseases. Acologix’s substantial expertise in identifying and developing therapeutics with unique mechanisms of action (such as mineral metabolism sciences) is key to solving major kidney and bone health problems. Chronic kidney failure, renal osteodystrophy, orthopedics, periodontal disease, general dentistry and oral care represent significant underserved medical needs. Acologix is unique in its focus on these rapidly growing health care problems. Acologix has recently announced the start of enrollment in two Phase II studies in Europe and the United States for the repair of periodontal defects and in dental restorations, respectively, using AC-100 (Dentonin®). Acologix is also developing Phosphatonin to treat hyperphosphatemia and its subsequent clinical problems in chronic kidney disease.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’s business.

Company Contact

Yoshi Kumagai
President and CEO
Phone: 510.512.7200
Fax: 510.786.1116

     
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