Download Launch of "Asacol® Tablets 400mg", Agent for Ulcerative Colitis

December 11th, 2009
PRESS RELEASE
Zeria Pharmaceutical Co., Ltd.
(Code 4559 Tokyo stock exchange)
Kyowa Hakko Kirin Co., Ltd.
(Code 4151 Tokyo stock exchange)
Launch of “Asacol® Tablets 400 mg”,
Agent for Ulcerative Colitis
We would like to announce that Zeria Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Tokyo;
President and Chief Executive Officer: Sachiaki Ibe; “Zeria”) and Kyowa Hakko Kirin Co., Ltd.
(Headquarters: Chiyoda-ku, Tokyo; President and Chief Executive Officer: Yuzuru Matsuda;
“Kyowa Hakko Kirin”) launch “Asacol® Tablets 400 mg” (“Asacol®”; pH dependent controlled
release mesalazine) on December 16th, 2009.
Zeria obtained the marketing approval for Asacol® on October 16th, 2009, and its National Health
Insurance price was listed today. Under the Agreement with Kyowa Hakko Kogyo Co., Ltd.
(currently Kyowa Hakko Kirin) for co-development and co-marketing concluded in January 2007,
Asacol® is manufactured by Zeria, and marketed by both companies with a single brand through
two channels. Clinical development for ulcerative colitis*1 was conducted by Zeria alone, but for
Crohn’s disease*2, co-development is carried out.
Asacol® was developed for the treatment of inflammatory bowel disease (IBD) by Tillotts Pharma
AG (Headquarters: Switzerland; Chief Executive Officer: Thomas A. Tóth von Kiskér) which
became a subsidiary of Zeria as of September 1st, 2009. Asacol® has become available in over 60
countries worldwide including various countries where the rights to Asacol® have been divested
(such as, but not limited to the United States, Canada and the United Kingdom). This mainstay
product has secured an approximately 50% market share in the United States, the world’s largest
market for IBD treatment agents, and also commands the top global pharma market share in this
field.
–1–
Asacol® is an enteric-coated tablet with pH-dependent release that enables the delivery of
mesalazine to the lower gastrointestinal tract (from the distal end of ileum to colon), and it is
expected to improve the inflammation of the lower gastrointestinal tract in patients with IBD.
*1
Ulcerative colitis is an intractable disease where inflammation occurs on the mucosa of the colon, and
lesions and erosions continually occur from the anus and spreading upwards through the digestive
tract. It is common for this disease to alternate between an “active phase” characterized by severe
abdominal pain and diarrhea, and a “remission phase” during which symptoms are mostly absent. A
number of factors have been suggested to cause the disease such as genetic factors, abnormalities of
the immune system and environmental factors including diet, however the real cause of disease is still
not fully understood. The number of patients with ulcerative colitis in Japan is gradually increasing.
*2
Crohn’s disease develops mainly in younger people, and inflammations or lesions (loss of mucosa)
occur everywhere from the oral cavity to the anus. Such pathological changes are frequently observed
in the distal end of the small intestine, and are characterized by discontinuous inflammations
(existence of normal areas next to inflamed areas). Those pathological changes produce abdominal
pain, diarrhea, bloody stool and loss of body weight.
Zeria and Kyowa Hakko Kirin aim a fast market penetration with Asacol®, and to provide more
alternatives of drug therapies for ulcerative colitis as well as improvement of patients’ quality of
life.
Contacts for inquiries
Zeria Pharmaceutical Co., Ltd.
Kyowa Hakko Kirin Co., Ltd.
Public Relations
Corporate Communications
Tel.: 03-3661-1039
Tel.: 03-3282-1903
–2–
Outline of Asacol® Tablets 400 mg
[Brand name]
Asacol® Tablets 400mg
[Generic name of active ingredient]
Mesalazine
[Dosage form]
Film-coated tablet
[Indication]
Ulcerative colitis (excluding severe case)
[Administration and dosage]
Generally, to adults, mesalazine 2,400 mg/day is orally administered by
dividing into 3 times after meal, but in active phase, 3,600 mg/day is orally
administered by dividing into 3 times after meal. Dependent on patient’s
condition, the dosage may be decreased.
[Main features]
• An oral mesalazine (5-ASA) product approved and used in over 60 countries
worldwide (as of January 2009)
• A pH-dependent enteric-coated tablet that enables to release and deliver
mesalazine at pH 7 or higher, and mainly from the distal end of ileum to colon
• In the induction of remission therapy in patients with ulcerative colitis, the
efficacy was demonstrated in the types of pancolitis, left-sided colitis and
proctitis.
• In the maintenance of remission therapy (48 weeks), percentage of patients
without bloody stool was 76.9 % (50/65 cases), and percentage of non-relapse
was 80.0 % (52/65 cases)
• Percentage of adverse drug reactions observed in clinical trials in Japan was
48.5 % (116/239 cases)
[Packaging]
PTP 100 tablets (10 tablets × 10), 500 tablets (10 tablets × 10 × 5)
[NHI price]
400 mg 1 tablet: 89.1 Japanese yen
[Approval date]
October 16th, 2009
[Date of NHI price listing]
[Launch date]
December 11th, 2009
December 16th, 2009
[Marketing authorization holder]
[Distributor]
Zeria Pharmaceutical Co., Ltd.
Kyowa Hakko Kirin Co., Ltd.
–3–