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Injectafer

Generic name: ferric carboxymaltose
Treatment for: Iron Deficiency Anemia

Update: Injectafer (ferric carboxymaltose injection) Now FDA Approved - July 25, 2013

Luitpold Pharmaceuticals, Inc., Comment on FDA Advisory Committee Meeting to Evaluate Injectafer (Ferric Carboxymaltose Injection)

SHIRLEY, NY, Feb. 4, 2008 - Luitpold Pharmaceuticals, Inc. announced today that the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that the available safety and efficacy data support a favorable risk / benefit profile of Injectafer (ferric carboxymaltose injection) (Internal name VIT-45) for the treatment of iron deficiency anemia patients with heavy uterine (HUB) or postpartum bleeding who have an unsatisfactory response to oral iron or are intolerant to oral iron.

"Although we are disappointed that the Advisory Committee didn’t support our proposed indication, we are pleased with their recommendation for approval with a restricted indication," said Mary Jane Helenek, President & CEO. “The recommendation establishes a path forward with the FDA. We are committed to working closely with the FDA to see the product through approval."

The FDA is expected to make a decision on the NDA, requesting approval for the use of Injectafer in these patient populations by mid-March, 2008. The agency is not bound by the Committee’s recommendation but takes its advice into consideration when reviewing products for approval. The development program for Injectafer represents the largest prospectively enrolled program of any intravenous iron product ever submitted to the Agency for approval. Data were derived from 12 multi-center trials involving more than 3,000 subjects.

Iron deficiency anemia represents a significant health issue in women. More than half of the 4 million women who give birth each year develop iron deficiency and approximately 1 million of these women progress to iron deficiency anemia. In addition, as many as one in five women will suffer from heavy uterine bleeding, defined as excessive or prolonged blood loss.

Injectafer was approved in 18 countries in Europe in September 2007 and in Switzerland in November 2007.

About Luitpold Pharmaceuticals, Inc. Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 65 pharmaceutical products including Venofer (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 Co., Ltd. is a major Japanese pharmaceutical company. Injectafer will be marketed under license from Vifor (International) Inc., a company of the Galenica Group. See http://www.luitpold.com, Source: Luitpold Pharmaceuticals, Inc.

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Contact: Walter Tozzi – Director, Professional Services

631-924-4000

wtozzi@americanregent.com

Posted: February 2008

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