Kyowa Hakko’s antiasthmatic agent, KW-4490,
has entered early phase II clinical studies in Europe.

 Kyowa Hakko Kogyo Co., Ltd. (Chiyoda-ku, Tokyo, Japan; President, Dr. Tadashi Hirata) started early phase II clinical studies of KW-4490 (code number) for the treatment of asthma in April 2002.

 Originally developed by Kyowa Hakko, KW-4490 has selective inhibitory effects on phosphodiesterase-4 (PDE4).
 Asthma is considered chronic respiratory tract inflammation, which is presumably triggered by the activation of leukocytes, such as eosinophils and neutrophils, lymphocytes, and others. PDE4 plays a role in their activation. KW-4490 is expected to improve asthmatic symptoms by inhibiting PDE4 and thereby suppressing the migration, infiltration and activation of leukocytes and lymphocytes.

 The current mainstay of treatment for asthma is beta-stimulants having bronchodilating effects and/or steroid inhalants with antiinflammatory activity. PDE4 inhibitors are expected to provide high therapeutic benefit by acting through a mechanism that is distinct from conventional antiasthmatic agents; on the other hand, they are known to be associated with a high incidence of vomiting. The results from the Phase I studies performed in France last year suggest that KW-4490 can potentially achieve adequate separation between therapeutic doses and its tendency to induce vomiting.

 "We are satisfied with the results of Phase I clinical studies, which support the projected vomiting dose and pharmacokinetic profile,"said Hiroyuki Kuniyasu, executive officer of phamaceuticals research & development at the Phermaceuticals business of Kyowa Hakko. In future clinical trials, the utmost efforts will be made to obtain evidence of its therapeutic efficacy and broad safety margin.
Mr.Kuniyasu continued, " we expect KW-4490 to offer a unique treatment approach having various advantages over traditional asthma therapies."

 In recent years, an increasing number of people suffer from asthma. This disease is estimated to affect more than 40 million people in the USA and Europe combined, and more than two million in Japan alone, including untreated patients.

 Kyowa Hakko proceeds with the development program for KW-4490 outside Japan first, and aims to file a New Drug Application (NDA) overseas in 2008. KW-4490 is believed to be a promising compound with high commercial potential.

About Kyowa Hakko
 Kyowa Hakko (www.kyowa.co.jp), a leading Japanese research-based pharmaceutical and biotechnology company, is devoted to discovering, developing, manufacturing, and marketing quality pharmaceutical products and bio-products such as amino acids. Pharmaceutical central research is focused on two therapeutic fields and drug discovery using antibody-based technologies. Those therapeutic fields are cancer and allergies, where Kyowa Hakko has a strong background worldwide with products such as Mitomycin and Olopatadine. Kyowa Hakko is currently developing four compounds for cancer and allergies overseas. In addition, the Company is also moving forward with the development of KW-6002, an agent for the treatment of Parkinson's disease, and KW-7158, an agent for treating urinary incontinence.