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American Pharmaceutical Partners Receives FDA Approval for Carboplatin Injection, 600 mg |
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17 Feb 2006 |
SCHAUMBURG, IL, USA | Feb 17, 2006 | American Pharmaceutical Partners, Inc. (Nasdaq: APPX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carboplatin Injection (liquid form) in a 600 mg multi-dose vial. Carboplatin is the generic equivalent of Bristol-Myers Squibb Company's Paraplatin(R).
Combined sales of the 600 mg dosage form by all suppliers exceeded $18.5 million in 2005, according to IMS. American Pharmaceutical Partners (APP) expects to commence marketing the 600 mg vial in the near future.
"This approval is an important line extension to our portfolio of carboplatin products," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of APP. "According to IMS, sales from all suppliers of the 600 mg multi-dose vials of carboplatin are increasing. The addition of this dosage form expands our strong and growing oncology portfolio and allows us to compete in a growing market with only two other suppliers of this particular presentation."
APP's carboplatin 600 mg is preservative-free and AP rated, and the product vials include a latex-free vial stopper, bar code and Tall Man Lettering label enhancements to help differentiate APP's carboplatin from other commonly used platinum-based chemotherapies with the same name suffix. APP also offers carboplatin in 450 mg (liquid and lyophilized), 150 mg (lyophilized) and 50 mg (lyophilized) vials.
Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in combination with other established approved chemotherapeutic agents, as well as for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy.
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 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, successfully commercializing carboplatin, 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.
Paraplatin(R) is a registered trademark of Bristol-Myers Squibb Company.
Contacts: American Pharmaceutical Partners, Inc.
Nicole Williams
Executive Vice President & CFO
(847) 969-2700
Rob Whetstone/Robert Jaffe
PondelWilkinson Inc.
(310) 279-5963
SOURCE: American Pharmaceutical Partners, Inc |
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