SCHAUMBURG, Ill., Sept. 26 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (APP) today said the upgrade of equipment and re-validation of production conditions at its Melrose Park, IL manufacturing facility is now expected to be completed in November 2005. Previously, the company had said it expected the program to be completed and full production resumed by late September 2005. APP said the re-validation processes which are required following the completion of renovations are taking longer than expected. Limited production activities will continue to package work-in-process.
As previously reported on August 25, 2005, APP expects to incur incremental, unabsorbed third quarter expenses of approximately $10 million and estimates the third quarter sales impact on generic products to be approximately $15 million. The impact of the delay on fourth quarter sales as well as unabsorbed expenses cannot be accurately quantified at this time. APP intends to provide further information on the status of the Melrose Park facility and the expected impact on 2005 sales and operating results during its third quarter conference call in late October.
The company reiterated that sales of the proprietary product ABRAXANE(TM), which also is produced at the Melrose Park facility, are not anticipated to be impacted by the delay. APP currently has sufficient finished goods inventory of ABRAXANE available to meet both the currently projected demand in the marketplace and American BioScience's clinical trial requirements through the end of the 2006 first quarter.
About American Pharmaceutical Partners
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.
Because these forward-looking statements, whether expressed or implied, 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, without limitation, the uncertainties regarding the costs and time involved in bringing our Illinois manufacturing facility to a fully operational status, the adverse impact of production delays on the sales and marketing our products, the costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in our Form 10-K for the year ended December 31, 2004 and other documents filed by us with the Securities and Exchange Commission.
Contacts: American Pharmaceutical Partners, Inc. Nicole Williams Executive Vice President & CFO (847) 969-2700 Rob Whetstone/Robert Jaffe PondelWilkinson Inc. (310) 279-5963
American Pharmaceutical Partners, Inc.CONTACT: Nicole Williams, Executive Vice President & CFO of AmericanPharmaceutical Partners, Inc., +1-847-969-2700; or Rob Whetstone, or RobertJaffe, both of PondelWilkinson Inc., +1-310-279-5963, for AmericanPharmaceutical Partners, Inc.