Shorter Title for Testing
Eisai Inc., a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., today announced the signing of a U.S. copromotion agreement with Salix Pharmaceuticals, Ltd. in which Eisai receives exclusive rights to copromote COLAZAL® (balsalazide disodium) Capsules 750 mg, and balsalazide tablets, if and when approved by the U.S. 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 & 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%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%) and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable to placebo.
About ARICEPT® (donepezil HCl tablets)
While there is no cure for Alzheimer's disease, ARICEPT can help slow the progression of symptoms, including memory loss. Once-a-day prescription ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate and severe Alzheimer's disease. ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and Alzheimer's disease.
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, diarrhea, 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.
ARICEPT is the number one prescribed Alzheimer's disease therapy worldwide, with more than 3 billion patient days of ARICEPT therapy. Nearly 2.3 million people in the United States alone have taken ARICEPT.
ARICEPT is copromoted in the United States by Eisai Inc. and Pfizer Inc, which are dedicated to advances in Alzheimer's therapy.
For more information about managing Alzheimer's disease and about ARICEPT, call (888) 999-9616 or visit http://www.aricept.com/.
About ACIPHEX® (rabeprazole sodium)
ACIPHEX is a prescription medication. One ACIPHEX 20 mg tablet daily is used for the treatment of persistent, frequent (2 or more days a week) heartburn and other symptoms associated with acid reflux disease.
ACIPHEX is also used for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease) and to maintain healing of damage (erosions) and relief of heartburn symptoms that happen with acid reflux disease. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin®) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the important product information at http://www.aciphex.com/.
About COLAZAL® (balsalazide disodium)
COLAZAL (balsalazide disodium) Capsules 750 mg is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL 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%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%) and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable to placebo. For full prescribing information on Salix products, please visit http://www.salix.com/.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $2.6 billion in fiscal year 2006 (year ended March 31, 2007).
Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com/.
About Salix Pharmaceuticals, Ltd.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company's 150-member gastroenterology specialty sales and marketing team.
SOURCE: Eisai Inc.
CONTACT: Judee Shuler, Director, Corporate Planning and Communications
of Eisai Inc., +1-201-746-2241; or Mike Freeman, Executive Director, Investor
Relations and Corporate Communications of Salix Pharmaceuticals, Ltd.,
Type Press Release
Date Released September 05, 2007