Eisai Inc., a US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., announced the signing of a US co-promotion agreement with Salix Pharmaceuticals, Ltd. in which Eisai receives exclusive rights to co promote Colazal (balsalazide disodium) capsules 750 mg, and balsalazide tablets, if and when approved by the US Food and Drug Administration (FDA).

Colazal is indicated for the treatment of mildly to moderately active ulcerative colitis in patients five years of age and older. Salix submitted a New Drug Application to the FDA on July 17, 2007 seeking approval to market an 1100 mg tablet formulation of balsalazide disodium (balsalazide tablet) for the treatment of mildly to moderately active ulcerative colitis.

"We are pleased to be working with Salix to copromote Colazal, an important treatment for patients with ulcerative colitis," said Lonnel Coats, president and chief operating officer, Eisai Inc. "Aricept, our treatment for mild, moderate and severe Alzheimer's disease, and Aciphex, for gastroesophageal reflux disease, have helped Eisai to build a strong presence in gastroenterology and primary care. We are well positioned to increase the benefits to patients with ulcerative colitis by bringing information about Colazal to more health care professionals."

Gastrointestinal disorders is one of Eisai's long-standing therapeutic areas of focus, supporting the company's human health care (hhc) mission to satisfy unmet medical needs and increase benefits to patients and their families.

"This agreement provides the opportunity for Eisai and Salix to combine their experience in gastroenterology and expand our reach in the primary care area," stated Carolyn Logan, president and chief executive officer, Salix. "Colazal has already benefited many patients, and we believe that together we can increase awareness of this important treatment."

Safety and effectiveness of Colazal (balsalazide disodium) capsules 750 mg beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults has not been established. Colazal was well tolerated in clinical studies. In clinical trials, patients reported the following adverse reactions most frequently: headache (8%), abdominal pain (6%), diarrhoea (5%), nausea (5%), vomiting (4%), respiratory infection (4%) and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable to placebo.

Aricept is well tolerated but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhoea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies, these were usually mild and temporary.

In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with Aricept in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.