January 25, 2002
`
`Press Release
`
`
`
`To whom it may concern:
`
`
`
`Regarding extended indication for selective histamine H1 receptor antagonist/anti-allergic
`agent Talion® Tablets 5 and Talion® Tablets 10 in treating pruritus/itching accompanying
`urticaria and other skin diseases
`
`Tanabe Seiyaku Co., Ltd. (President: Toshio Tanaka) received approval as of January 22,
`2002 for Talion® Tablets 5 and Talion® Tablets 10, regarding extended indication in treating
`“pruritus/itching accompanying urticaria and other skin diseases (eczema/dermatitis, pru-
`rigo, and pruritus cutaneous).” Talion® is currently available for the treatment of allergic
`rhinitis.
`
`Talion® Tablets 5 and Talion® Tablets 10, second-generation antihistamines jointly deve l-
`oped by Tanabe Seiyaku and Ube Industries, Ltd. (President: Kazumasa Tsunemi), were
`approved for the treatment of allergic rhinitis in July 2000 and launched in October in the
`same year. They quickly relieve three most common symptoms of allergic rhinitis, i.e.,
`sneezing, nasal discharge, and nasal obstruction, and can now be prescribed to improve skin
`symptoms, as approval for this use has been granted. Pruritus/itching and wheals,
`symptoms of urticaria, are caused by histamine binding to histamine H1 receptors in
`sensory nerves and blood vessels. Talion® suppresses these symptoms by blocking
`histamine access to these H1 receptor sites. Since the drug does not readily enter the CNS,
`it less often causes drowsiness, an adverse side effect of antihistamines.
`
`For the clinical trial of Talion® aimed at obtaining approval for the extended indication, we
`recruited patients with chronic urticaria from the public through advertisements for the first
`time. The study went smoothly. Urticaria symptoms are transient and recur repeatedly.
`Since the symptoms pruritus/itching and wheals can be assessed by patients themselves, for
`the first time in Japan in assessing these two symptoms we used patients’ subjective as-
`sessment severity scores (recorded in patients’ diaries) to augment physicians’ objective
`evaluations. Ta lion® treatment effect was clinically assessed using this highly accurate
`system, and rapid improvement in target symptoms was demonstrated.
`
`to continue helping patients with allergic rhinitis and with
`We are determined
`pruritus/itching accompanying urticaria or other skin diseases, by providing Talion® Tablets
`5 and Talion® Tablets 10 and by continuing to gather useful information that we will share
`with those in need.
`
`
`
`MYLAN Ex. 1015, Page 1