For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Luitpold Pharmaceuticals/American Regent and Fresenius Medical Care sign agreements for exclusive sublicense of Venofer(R)in U.S.
Shirley, NY - Luitpold Pharmaceuticals, Inc. and its subsidiary, American Regent, Inc., announced today that they have entered into a definitive agreement with Fresenius Medical Care for an exclusive U.S. manufacturing and distribution sublicense for Venofer(R) for the End Stage Renal Disease (Stage V) patient population. The agreement additionally includes a similar sublicense for the next generation ofIV iron products for the U.S. and Canada known as Injectafer(R)(ferric carboxymaltose injection), which is expected to enhance the treatment of anemia in this same patient population through the application of innovative drug administration techniques.
Venofer(R) a preparation of elemental iron in sucrose, is the only first line treatment option approved by the FDA for the intravenous treatment of both dialysis and non-dialysis chronic kidney disease patients with iron deficiency anemia. Luitpold, through its subsidiary American Regent, will continue to sell Venofer(R) for use in treating chronic kidney disease patients not yet on dialysis. Venofer(R) is currently the market leader in injectable iron sales in the U.S.
As part of this 10 year agreement (with 2 additional 5 year renewal terms), Luitpold will continue to contract manufacture these products for Fresenius Medical Care. The transaction involves the payment of royalties by Fresenius Medical Care to Luitpold over the lifetime of the agreement, and Luitpold's payment of royalties to Vifor Pharma of St. Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold.
Galenica AG, through its Vifor Pharma subsidiary, exclusively licenses the Venofer(R)and Injectafer(R)products to Luitpold and American Regent for the United States and Canada. Currently, the annual sales of IV iron in the U.S. exceeds $500 million. Sales of Venofer account for over 55% of all IV iron sales in the U.S.
Mary Jane Helenek, President and CEO of Luitpold Pharmaceuticals, Inc. commented, "This agreement reflects our shifting long-term market strategy for IV iron. We believe Fresenius Medical Care is best positioned to market Venofer(R)in dialysis, allowing Luitpold and American Regent to focus on developing Venofer and future IV iron products in new applications, including non-dialysis CKD."
The transaction is subject to customary closing conditions including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Act. The Company anticipates closing this transaction in 2008.
For more information about Luitpold, American Regent or Venofer visit the Company's website at www.luitpold.com
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Venofer・is a registered trademark of Vifor(International) Inc. St. Gallen, Switzerland.
About Luitpold Pharmaceuticals, Inc.
Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 65 pharmaceutical products including Venofer(R)(iron sucrose injection, USP), the leading IV iron therapy in the U.S., through its human health subsidiary, American Regent, Inc. Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo group company, also markets dental bone regeneration products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions. Daiichi Sankyo Company,Ltd., established in 2005 after the merger of two leading century-old Japanese pharmaceutical companies,is a global pharmaceutical innovator, continuously generating innovative drugs that enrich the quality of life for patients around the world.
Source: Luitpold Pharmaceuticals, Inc.
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