27th Apr 2006 07:09
AstraZeneca PLC27 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) toco-promote ABRAXANE(R) for Injectable Suspension (paclitaxel protein-boundparticles for injectable suspension) (albumin-bound) in the U.S. In addition tothe co-promotion agreement for ABRAXANE(R), AstraZeneca also announced thedivestment of its US anaesthetics and analgesic products to Abraxis BioScience. ABRAXANE is a novel, albumin-bound formulation of paclitaxel approved by the FDAin January 2005. In a randomized Phase III study in women with metastatic breastcancer who had failed prior combination chemotherapy, ABRAXANE demonstrated asignificantly higher response rate than standard paclitaxel. In additionABRAXANE does not require pre-medication to avoid hypersensitivity reactions andis given over a shorter infusion time than standard paclitaxel. AbraxisBioScience's clinical development programme for ABRAXANE spans a variety oftumour 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 AbraxisBioScience for the right to co-promote ABRAXANE within the U.S. The co-promotionis for an initial five and a half year term, beginning on July 1st, 2006.During the co-promotion term, AstraZeneca will dedicate sales representatives tosupport ABRAXANE and will fund half of the spend for the promotional andadvertising programme. Further milestone payments will be made to Abraxis uponthe achievement of new indication approvals within pre-specified timelines.AstraZeneca will be paid a commission of 22 per cent of ABRAXANE net saleswithin the U.S. during this term, with a trailing commission of 10 per cent and5 per cent for the two years following the end of this period. AbraxisBioScience will also grant AstraZeneca right of first refusal to license orco-promote ABRAXANE outside the U.S., other than selected countries, should apartner be sought. In 2005, Abraxis BioScience recorded $134m of ABRAXANE saleswithin the U.S. in its first year of launch. AstraZeneca has further agreed to sell its range of U.S. branded anaestheticsand analgesic products to Abraxis BioScience. Under the terms of this part ofthe agreement, Abraxis BioScience will pay AstraZeneca $350m for the productsand will enter into a five-year supply agreement. The products covered by theagreement (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 topurchase or license these products outside of the U.S. should the company seekto divest these assets. In addition, AstraZeneca has agreed that AbraxisBioscience will be its preferred partner for consideration of certain injectableproducts when patents on these products expire. The impact of the agreements with Abraxis BioScience for the co-promotion ofABRAXANE in the U.S. and the divestment of the Company's U.S. anaesthesiaproducts is anticipated to be broadly neutral to earnings in the first twelvemonths 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 therapiesand complements and extends our U.S. oncology product portfolio," said TonyZook, President and CEO, AstraZeneca U.S. "At the same time Abraxis BioScienceis acquiring a strong anaesthetic and analgesic portfolio which enhances theirmarket leading injectable drug portfolio in the U.S." We are pleased to have entered into these agreements with AstraZeneca, a globalpharmaceutical company and oncology leader with significant experience in thefield of breast cancer," said Patrick Soon-Shiong, M.D., chief executive officerand chairman of the board of Abraxis BioScience. "These agreements represent animportant step in executing our strategic plan to build Abraxis Bioscience intoa global, fully integrated biopharmaceutical company and increases theopportunity for ABRAXANE to reach its full potential." The collaboration announced today is subject to clearance under theHart-Scott-Rodino Antitrust Improvements Act. About AstraZeneca AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $23.95 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. About Abraxis BioScience Abraxis BioScience, Inc. is an integrated global biopharmaceutical companydedicated to meeting the needs of critically ill patients. The companydevelops, manufactures and markets one of the broadest portfolios of injectableproducts and leverages revolutionary technology such as its nabTM platform todiscover and deliver breakthrough therapeutics that transform the treatment ofcancer and other life-threatening diseases. The first FDA approved product touse this nab platform, ABRAXANE(R) , was launched in 2005 for the treatment ofmetastatic breast cancer. Abraxis trades on the Nasdaq National Market underthe 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 thetreatment of cancer. However, the solvents that have historically been requiredto deliver these treatments are linked to clinically important adverse eventsthat limit the therapeutic potential of taxane therapy. To address potentiallyserious hypersensitivity reactions that occur frequently with solvent-basedtaxanes, cancer patients need to receive steroid premedication before receivingchemotherapy. 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 forinjectable suspension) (albumin-bound), utilizes albumin and avoids solventsaltogether, and thus, may maximize the dosage, while minimizing certaintoxicities. By delivering optimum doses of chemotherapy while minimizing certainsolvent-related toxicities, it is hoped that an improvement can be made to boththe treatment and the outcome for cancer patients. Albumin is a protein that acts as the body's transporter of nutrients and otherwater-insoluble molecules. It has been shown that albumin selectivelyaccumulates in tumor tissues. ABRAXANE is indicated for the treatment of breast cancer after failure ofcombination chemotherapy for metastatic disease or relapse within 6 months ofadjuvant chemotherapy. Prior therapy should have included an anthracyclineunless clinically contraindicated. In the randomized metastatic breast cancer study, the most important adverseevents included lower white and red blood cell counts, infections, tingling andnumbness, 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, allergicreactions, cardiovascular reactions, and injection site reactions were uncommon. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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