US Oncology Co-Promotion
AstraZeneca PLC
27 April 2006
AstraZeneca and Abraxis BioScience to co-promote cancer therapy ABRAXANE;
Abraxis BioScience to acquire AstraZeneca's U.S Anaesthetic and Analgesic
Product Portfolio
AstraZeneca today announced an agreement with Abraxis BioScience Inc. (ABBI) to
co-promote ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound
particles for injectable suspension) (albumin-bound) in the U.S. In addition to
the co-promotion agreement for ABRAXANE(R), AstraZeneca also announced the
divestment of its US anaesthetics and analgesic products to Abraxis BioScience.
ABRAXANE is a novel, albumin-bound formulation of paclitaxel approved by the FDA
in January 2005. In a randomized Phase III study in women with metastatic breast
cancer who had failed prior combination chemotherapy, ABRAXANE demonstrated a
significantly higher response rate than standard paclitaxel. In addition
ABRAXANE does not require pre-medication to avoid hypersensitivity reactions and
is given over a shorter infusion time than standard paclitaxel. Abraxis
BioScience's clinical development programme for ABRAXANE spans a variety of
tumour types including Non Small Cell Lung, Ovarian, Prostate, Adjuvant Breast,
Melanoma, Head and Neck and Upper GI Cancers.
Under the terms of the agreement, AstraZeneca will pay $200m to Abraxis
BioScience for the right to co-promote ABRAXANE within the U.S. The co-promotion
is for an initial five and a half year term, beginning on July 1st, 2006.
During the co-promotion term, AstraZeneca will dedicate sales representatives to
support ABRAXANE and will fund half of the spend for the promotional and
advertising programme. Further milestone payments will be made to Abraxis upon
the achievement of new indication approvals within pre-specified timelines.
AstraZeneca will be paid a commission of 22 per cent of ABRAXANE net sales
within the U.S. during this term, with a trailing commission of 10 per cent and
5 per cent for the two years following the end of this period. Abraxis
BioScience will also grant AstraZeneca right of first refusal to license or
co-promote ABRAXANE outside the U.S., other than selected countries, should a
partner be sought. In 2005, Abraxis BioScience recorded $134m of ABRAXANE sales
within the U.S. in its first year of launch.
AstraZeneca has further agreed to sell its range of U.S. branded anaesthetics
and analgesic products to Abraxis BioScience. Under the terms of this part of
the agreement, Abraxis BioScience will pay AstraZeneca $350m for the products
and will enter into a five-year supply agreement. The products covered by the
agreement (Xylocaine, Polocaine, Naropin, Nesacaine, Sensorcaine, Astramorph,
Emla Cream, and Diprivan) had U.S. sales of approximately $217m in 2005.
AstraZeneca will also grant Abraxis BioScience right of first refusal to
purchase or license these products outside of the U.S. should the company seek
to divest these assets. In addition, AstraZeneca has agreed that Abraxis
Bioscience will be its preferred partner for consideration of certain injectable
products when patents on these products expire.
The impact of the agreements with Abraxis BioScience for the co-promotion of
ABRAXANE in the U.S. and the divestment of the Company's U.S. anaesthesia
products is anticipated to be broadly neutral to earnings in the first twelve
months and accretive to earnings thereafter.
'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 U.S. oncology product portfolio,' said Tony
Zook, President and CEO, AstraZeneca U.S. 'At the same time Abraxis BioScience
is acquiring a strong anaesthetic and analgesic portfolio which enhances their
market leading injectable drug portfolio in the U.S.'
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.'
The collaboration announced today is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act.
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 $23.95 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4Good Index.
About Abraxis BioScience
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 nabTM 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(R) , 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.
26 April, 2006
Contacts
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Jorgen Winroth, Tel +1 (212) 579 0506
Notes To News Editors
Taxanes are among the most active cytotoxic agents currently used for the
treatment of cancer. However, the solvents that have historically been required
to deliver these treatments are linked to clinically important adverse events
that limit the therapeutic potential of taxane therapy. To address potentially
serious hypersensitivity reactions that occur frequently with solvent-based
taxanes, cancer patients need to receive steroid premedication before receiving
chemotherapy. In some patients this leads to conditions such as hyperglycemia
(high blood sugar), immunosuppression (suppression of patient's immune system),
and insomnia (inability to sleep).
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound), utilizes albumin and avoids solvents
altogether, and thus, may maximize the dosage, while minimizing certain
toxicities. By delivering optimum doses of chemotherapy while minimizing certain
solvent-related toxicities, it is hoped that an improvement can be made to both
the treatment and the outcome for cancer patients.
Albumin is a protein that acts as the body's transporter of nutrients and other
water-insoluble molecules. It has been shown that albumin selectively
accumulates in tumor tissues.
ABRAXANE is indicated for the treatment of breast cancer after failure of
combination chemotherapy for metastatic disease or relapse within 6 months of
adjuvant chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated.
In the randomized metastatic breast cancer study, the most important adverse
events included lower white and red blood cell counts, infections, tingling and
numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores.
Other adverse reactions included weakness, visual disturbances, fluid retention,
hair loss, and liver and kidney dysfunction. Low platelet counts, allergic
reactions, cardiovascular reactions, and injection site reactions were uncommon.
This information is provided by RNS
The company news service from the London Stock Exchange
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