SCHAUMBURG, Ill., Feb. 13 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Octreotide Acetate Injection, single-dose and multiple dose vials, the generic equivalent of Novartis Pharmaceuticals’s Sandostatin(R) Injection. Sales of this product exceeded $145 million in 2005, according to IMS. APP expects to commence marketing Octreotide Acetate shortly.
“Octreotide Acetate is used in the critical care as well as the oncology setting,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer. “These two approvals mark the first two product approvals APP has received in 2006.”
The full line of Octreotide products will be available from APP in single- dose vials and multiple-dose vials. The product is AP rated and each vial will include a bar code and latex-free vial stopper.
Octreotide Acetate Injection is indicated for the treatment of agromegaly (excessive secretion of growth hormone). Octreotide is also used to reduce flushing and watery diarrhea caused by metastatic cancerous tumors or tumors called vasoactive intestinal peptide tumors.
About American Pharmaceutical Partners, Inc.
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(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). For more information, visit APP’s website at http://www.appdrugs.com and http://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, successfully commercializing octreotide acetate, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, 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.
Sandostatin is a registered trademark of Novartis Pharmaceuticals Corp. Contacts: American Pharmaceutical Partners, Inc. Nicole Williams Executive Vice President & CFO (847) 969-2700 PondelWilkinson Inc. Robert Jaffe/Rob Whetstone (310) 279-5963
American Pharmaceutical Partners, Inc.
CONTACT: Nicole Williams, Executive Vice President & CFO of AmericanPharmaceutical Partners, Inc., +1-847-969-2700; Robert Jaffe or RobWhetstone, both of PondelWilkinson Inc., +1-310-279-5963
