For Immediate Release

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, 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 Pharmacueticals, Inc. Submits Injectafer(R) NDA to the U.S. Food and Drug Administration

Shirley, NY (October 13, 2011) – Luitpold Pharmaceuticals, Inc. has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Injectafer^® (ferric carboxymaltose injection) for the treatment of iron deficiency anemia.  The NDA includes data and information from two new large randomized controlled clinical trials investigating the cardiovascular risk profile of high dose Injectafer^®.  Injectafer^® will be marketed in the U.S. by American Regent, Inc., the current distributor of Venofer^® (iron sucrose injection, USP), the #1 prescribed IV iron in the U.S.

 

The submission reflects the conclusion of a clinical study program designed to assess the risk profile of Injectafer^® following FDA’s issuance of a non-approvable letter in March, 2008 with respect to the original NDA submission.

 

As part of this submission, Luitpold Pharmaceuticals provided the FDA with additional safety and efficacy data from these two large scale, multi-center, randomized clinical trials.  One trial compared Injectafer^® to Venofer^® in patients with iron deficiency anemia and chronic kidney disease.  The second study compares Injectafer^® to either oral or IV iron (standard of care therapy) in patients with iron deficiency anemia of various etiologies.

 

Luitpold Pharmaceuticals looks forward to working closely with the FDA to address any further questions or issues they may have in connection with the NDA.

 

Injectafer^®, the novel IV iron replacement therapy was approved by the UK Medicines & Healthcare products Regulatory Agency (MHRA), in 2007 and acting as a Reference country, supported the subsequent approval of Ferinject^® (brand name outside of U.S.) throughout the European Union and the Swiss regulatory agency Swissmedic. Ferinject^® is currently registered for use in 35 countries worldwide.

 

 

Source: Luitpold Pharmaceuticals, Inc. (Shirley, NY)