APP Pharmaceuticals Receives Final Approval For Irinotecan Hydrochloride Injection

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 03 Mar 2008 - 1:00 PDT

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APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Irinotecan Hydrochloride Injection, 40 mg/2mL and 100mg/5mL, the generic equivalent of Camptosar® Injection manufactured by Pfizer Inc. APP has immediately commenced marketing and shipping the product. APP's irinotecan is AP-rated, bar-coded and latex-free. According to IMS data, sales of Camptosar® in the United States were approximately $556 million in 2007.

Pfizer's Camptosar® Injection is a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colorectal cancer. The drug is also indicated for patients with metastatic colorectal cancer whose disease has recurred or progressed following initial fluorouracil-based therapy.

"Irinotecan is a large market opportunity," said Tom Silberg, President of APP. "Since receiving tentative approval for this product in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the U.S. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008."

About APP Pharmaceuticals

APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is one of the largest producers of injectables, with more than 100 products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit http://www.APPpharma.com.

Forward-Looking Statement

The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of irinotecan. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in APP Pharmaceuticals Form 10-K for the year ended December 31, 2006 filed under the company name Abraxis BioScience, Inc. and other documents it has filed with the Securities and Exchange Commission.

The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.

Camptosar® Injection is a registered trademark of Pfizer Inc.

APP Pharmaceuticals

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