LOS ANGELES--(BUSINESS WIRE)--April 26, 2006--Abraxis BioScience, Inc. (NASDAQ:ABBI - News): Abraxis BioScience, Inc. (NASDAQ:ABBI - News), an integrated, global biopharmaceutical company, today announced they have entered into an agreement with AstraZeneca (NYSE:AZN - News) for the co-promotion of Abraxis’ proprietary drug ABRAXANE®, in the United States for a term of five and a half years. Abraxis also announced an agreement that will significantly bolster its injectable business by acquiring AstraZeneca’s U.S. branded anesthetic and analgesic injectable portfolios. These products encompass over 100 dosage forms and include the leading branded anesthetic agent, Diprivan® (propofol), and a proprietary Naropin® (ropivacaine), as well as a comprehensive suite of local anesthetics including EMLA® (Eutectic Mixture of Lidocaine and Prilocaine), Xylocaine® (lidocaine), Polocaine® (mepivacaine), Nesacaine® (chloroprocaine HCl Injection, USP), Sensorcaine® (bupivacaine), and Astramorph® (morphine sulfate injection, USP).
These agreements significantly enhance Abraxis’ proprietary oncology and injectables businesses. Through this transaction, Abraxis is able to double the sales force and promotional investment in ABRAXANE as well as share the cost of certain clinical trials that are part of the overall clinical development program, without incurring additional costs. Abraxis will also expand its injectables business by acquiring a profitable portfolio of branded products, which generated 2005 sales for AstraZeneca of $217 million. The addition of over 100 dosage forms is highly complementary to the Abraxis injectable business and broadens the large scale of its critical care portfolio to hospitals and clinics. These combined transactions are immediately accretive to earnings.
“We are pleased to have entered into these agreements with AstraZeneca, a global pharmaceutical company and oncology leader with significant experience in the field of breast cancer,” said Patrick Soon-Shiong, M.D., chief executive officer and chairman of the board of Abraxis BioScience. “These agreements represent an important step in executing our strategic plan to build Abraxis BioScience into a global, fully integrated biopharmaceutical company and increases the opportunity for ABRAXANE to reach its full potential.”
“This deal gives AstraZeneca access to the key U.S. chemotherapy market. ABRAXANE brings significant benefits to cancer patients over existing therapies and complements and extends our oncology product portfolio in the U.S.,” said Tony Zook, president and chief executive officer, AstraZeneca U.S. “At the same time Abraxis BioScience is acquiring a strong anesthetic and analgesic portfolio which enhances their market leading injectable drug portfolio in the U.S.”
ABRAXANE, the first commercially approved product based on the nab(TM) technology platform, received approval by the U.S. Food and Drug Administration (FDA) in January 2005 for the treatment of breast cancer. ABRAXANE sales totaled $134 million in 2005 in its first eleven months on the market. ABRAXANE is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast and non-small cell lung, adjuvant breast, neo-adjuvant breast, malignant melanoma, ovarian, prostate, pancreatic, gastric, and head and neck. In November 2005, a Journal of Clinical Oncology article was published on the Phase III pivotal trial which included an accompanying editorial that discussed ABRAXANE compared to Taxotere®. The J-code for ABRAXANE was received in January 2006.
Terms of the Co-Promotion Agreement
Under the terms of the agreement, AstraZeneca will pay Abraxis an up-front fee of $200 million and equally share in the costs associated with advertising, promotions in the United States and certain clinical trials that are part of the overall clinical development program. Further milestone payments will be made to Abraxis upon the achievement of new indication approvals within pre-specified timelines. The co-promotion agreement, beginning July 1, 2006, will run for five and a half years. AstraZeneca will receive a 22 percent commission on net sales of ABRAXANE during the term of the agreement, with a trailing commission of ten percent for the first year and five percent for the second year following the five year term. Abraxis will retain all responsibility for clinical and regulatory development, manufacture and distribution of the product.
In addition to the sales force already established at Abraxis, AstraZeneca will add an experienced sales force who will now solely co-promote ABRAXANE in the U.S. market. This commercial collaboration will provide significantly greater reach and is expected to accelerate the market penetration of ABRAXANE in the U.S. Abraxis BioScience will grant AstraZeneca a right of first offer to license or co-promote ABRAXANE outside the U.S., other than selected countries, should a partner be sought.
Terms of the Branded Anesthetic and Analgesic Product Lines Purchase Agreement
Abraxis will pay to AstraZeneca $275 million at closing and $75 million on the first anniversary of closing consideration of the sale of AstraZeneca’s U.S. branded anesthetics and analgesic business. AstraZeneca and Abraxis have entered into an exclusive supply agreement providing for AstraZeneca to supply these products to Abraxis for an initial term of five years.
AstraZeneca will grant Abraxis BioScience the right of first offer to purchase or license its branded anesthetics and analgesics portfolio outside of the U.S. should AstraZeneca decide to divest these assets. In addition, AstraZeneca has agreed that Abraxis will be its preferred partner for consideration of certain proprietary injectable products when patents on these products expire. The sale of AstraZeneca’s U.S. branded anesthetics and analgesic business is subject to Hart-Scott-Rodino clearance and other customary conditions to closing.
Abraxis, through its Abraxis Pharmaceutical Products division, manufactures the largest anti-infective injectable product portfolio and one of the broadest portfolios of oncology and critical care products. This product acquisition of over 100 dosage forms, combined with the over 300 dosage forms currently manufactured and marketed, together with the eight FDA approvals received this year and the 23 ANDA’s currently under review by the FDA, positions Abraxis to be one of the largest manufacturers of injectable pharmaceutical products for the critically ill patient.
About ABRAXANE®
The U.S. Food and Drug Administration approved ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE® please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE®, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
FORWARD-LOOKING STATEMENT
The statements contained in this press 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 press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the expected cost benefits and the acceleration of the market penetration for ABRAXANE as a result of the co-promotion agreement, global expansion, and the accretive effect of these transactions to earnings. 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, without limitation, the continued market adoption and demand of ABRAXANE in North America and its potential market penetration outside of the U.S., the costs associated with the ongoing launch of ABRAXANE, the continued market acceptance of the new products acquired from AstraZeneca, AstraZeneca’s ability to satisfy its obligations under the supply agreement, the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing any other products, including those in the pipeline, 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 Abraxis BioScience’s Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission.
ABRAXANE® is a registered trademark of Abraxis BioScience, Inc.
Diprivan®, Naropin®, EMLA®, Xylocaine®, Polocaine®, Nesacaine®, Sensoracaine®, and Astramorph®are registered trademarks of AstraZeneca plc.
Taxotere® is a registered trademark of Aventis Pharmaceuticals, Inc.
Contact: Abraxis BioScience, Inc. Christine Cassiano, 310-826-5102
Source: Abraxis BioScience, Inc.
