Eisai Initiates Procedures to Acquire AkaRx, Inc. in the United States
Eisai Obtains Worldwide Rights to Develop, Market and Manufacture AKR-501, Therapeutic Agent for Thrombocytopenia
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, "Eisai") today announced that the Company will initiate procedures to acquire AkaRx, Inc. (Headquarters: New Jersey, U.S., CEO: Robert E. Desjardins, "AkaRx"). As a result of the acquisition, AkaRx will become a subsidiary of Eisai Inc., Eisai's U.S. subsidiary. The buyout price has been set at US$255 million (approximately ¥22.7 billion, converted yen at 89 to the US$).
Eisai obtained an option right to acquire AkaRx through the Company's acquisition of MGI PHARMA, INC. ("MGI") in January 2008, as well as a development and license agreement relating to AKR-501 (current research code: E5501). Eisai has expressed its intention to exercise this option, and will acquire all of AkaRx's capital stock to make it a wholly-owned subsidiary of Eisai Inc. as well as the exclusive worldwide rights to develop, market and manufacture AKR-501. The Company plans to consummate this acquisition on or before January 8, 2010.
AKR-501 is a pharmacological agonist of the receptors of thrombopoietin (TPO), which stimulates platelet production, and is expected to demonstrate its effects in various diseases associated with thrombocytopenia. Eisai is currently conducting Phase II clinical studies of the compound in the U.S. for idiopathic thrombocytopenic purpura (ITP) and thrombocytopenia associated with liver diseases, and has confirmed POC (Proof of Concept) in the clinical studies for ITP. In addition, Eisai will explore its potential as a treatment for cancer chemotherapy-induced thrombocytopenia.
ITP is a disorder that causes a variety of bleeding symptoms due to a decrease in platelet count caused by the destruction of blood platelets as a result of the production of autoantibodies against platelets. The number of patients with the disorder is estimated to be approximately 800,000 (Japan, U.S., major European countries, China, and India). It is known that, in patients with liver diseases, decrease in platelet count as a complication resulting from deficient TPO production causes bleeding tendency, and in many patients with hepatitis C, interferon-induced thrombocytopenia could lead to the cessation of their interferon therapy. If successfully developed, Eisai expects that AKR-501 will provide a new treatment option for patients with thrombocytopenia, as well as increase its contributions to patients in China, India and other countries with a high incidence of hepatitis.
Through this acquisition, Eisai will further enhance its portfolio of pipeline products, and will make contributions towards increasing benefits of patients and their families by addressing the unmet medical needs.
In accordance with the acquisition, Eisai has revised its full-year consolidated business forecast for the fiscal year ending March 31, 2010, (April 1, 2009 to March 31, 2010) as outlined below.
1. Revised full-year consolidated business forecast for the fiscal year ending March 31, 2010 (April 1, 2009 to March 31, 2010)
(unit: million yen)
Net Sales Operating Income Ordinary Income Net Income
Previous Forecast (A) 820,000 103,000 97,000 63,000
Revised Forecast (B) 820,000 80,300 74,300 40,300
Changes in Amount (B-A) 0 22,700 22,700 22,700
Percentage of Change - 22.0 23.4 36.0
(Reference)
Business Results for the fiscal year ended March 31, 2009 781,743 91,808 82,583 47,678
The above revised forecasted figures are based only on the estimation of the impact of the acquisition. No revision has been made to the company's non-consolidated full year business forecast.
Further information with regards to the full-year consolidated business forecast for the fiscal year ending March 31, 2010 (April 1, 2009 to March 31, 2010) will be announced in the financial report for the third quarter of this fiscal year.
2. Reasons for revision
The Company anticipates that it will incur an in-process research & development expense*1 of US$255 million (approximately ¥22.7 billion*2) in accordance with the acquisition of AkaRx.
*1 The amounts assigned to product candidate compounds under development that have no alternative future use shall be booked as one-time R&D expense.
*2 The amount in yen is based on the most recent currency exchange rate. (converted yen at 89 to the US$)
3. Year-end dividend forecast
In cash-flow, the expense that will occur in association with the acquisition of AkaRx, will be accounted as cash-flow used in investment activities and will not affect cash income,* which expresses the company's ability to generate cash. Therefore, the full-year consolidated cash income forecast of ¥120 billion (an increase of 0.8% year-on-year) shall remain unchanged.
Accordingly, the year-end dividend forecast of ¥80 per share remains the same as the previous forecast and the annual dividend is expected to be ¥150 per share (an increase of ¥10 from the previous fiscal year).
* Cash income = Net income for this period + Depreciation of property, plant and equipment and amortization of intangible assets + In-process R&D expenses + Amortization of goodwill + loss on impairment of long-lived assets (including loss on devaluation of investment securities).
[Please refer to the following notes for an outline of AkaRx, Inc. and AKR-501 as well as information on ITP and thrombocytopenia associated with liver diseases]
Contact:
Public Relations Department
Eisai Co., Ltd.
TEL: +81-(0)3-3817-5120
< Notes to Editors >
Outline of AkaRx, Inc.
Location: Bridgewater, New Jersey, United States
CEO: Dr. Robert E. Desjardins
Establishment: December 1, 2004
Pipeline Product: AKR-501
About AKR-501
AKR-501(current research code: E5501) is a pharmacological agonist of the receptors of thrombopoietin (TPO), which stimulates platelet production acting on megakaryocytes and their precursors. When administered orally, this novel compound is expected to demonstrate its effects in various diseases associated with thrombocytopenia by promoting an increase in platelet count. Eisai is currently conducting Phase II clinical studies of the compound in the United States for idiopathic thrombocytopenic purpura (ITP) and thrombocytopenia associated with liver diseases, and has confirmed POC (Proof of Concept) in the clinical studies for ITP.
About Idiopathic Thrombocytopenic Purpura (ITP)
Idiopathic thrombocytopenic purpura (ITP) is a disorder that causes a variety of bleeding symptoms due to a decrease in platelet count caused by the destruction of blood platelets. The number of patients with this disorder is estimated to be approximately 800,000 (Japan, U.S., major European countries, China, and India). ITP can be classified into two types: acute ITP which is common in children and chronic ITP common in adults. It is thought that approximately 5 to 20% of the latter are refractory or intractable to treatment.
About thrombocytopenia associated with liver diseases
It is known that, in patients with liver diseases, decrease in platelet count as a complication resulting from deficient TPO and increased destruction of platelet in spleen associated with portal hypertension causes bleeding tendency. While such patients may undergo a platelet transfusion as a surgical procedure, the development of more useful treatment is anticipated due to difficulty in securing transfusable platelets and risk of infection. In many patients with hepatitis C, interferon-induced thrombocytopenia could lead to the cessation of their interferon therapy.