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`3/29/04 Pharrna Marketletter (UK) (Pg. Unavail. Or1line)
`2004 WLNR 21943 944
`Loaded Date: 01/21/2009
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`Pharrna Marketletter
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`Copyright 2004 Marketletter Publications Ltd.
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`March 29, 2004
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`AstraZeneca's Faslodex meets unmet need in breast cancer.
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`Faslodex ( fulvestrant), the first new estrogen receptor antagonist since tamoxifen, has finally been launched by
`AstraZeneca in Europe, two years after it has been available in the USA and South America. The product, which
`boasts a unique mode of action, is now available in Germany, Sweden and Austria and will be rolled out over the next
`year across the whole of the European Union, including the EU accession countries, Iceland and Norway.
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`The drug acts by binding to estrogen receptors in breast cancer cells and degrading them. It therefore puts a stop to
`tumor estrogen receptor activity, preventing transcription occurring that promotes cell growth. Unlike aromatase
`inhibitors, which prevent the synthesis of estradiol in other body tissues by blocking the aromatase enzyme, Faslodex
`does not reduce the normal amount of circulating estradiol needed to help keep a normal lipid profile and healthy
`cardiovascular system, prevent vaginal symptoms, maintain bone mineral density and protect cognitive function.
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`Faslodex is now licensed for post-menopausal women with estrogen receptor—positive locally—advanced or metastatic
`breast cancer who have experienced disease progression on or after anti—estrogen therapy. There has been an unmet
`need for an effective endocrine therapy which works in women who have become resistant to other hormonal treat-
`ments including tamoxifen and aromatase inhibitors. The potential population for this in Europe is around 120,000
`WOIIIGII.
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`US medical oncologist John Pippen of Baylor Sammons Cancer Center, Dallas, said the availability of Faslodex for a
`similar indication in the USA has led to rapid uptake among thousands of women. Usually the next step would be
`cytoxic chemotherapy treatment but Faslodex offers another strategy to delay this move and so has proved highly
`popular. There is no cross-resistance between this drug and other hormonal treatments, he said.
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`Sales so far "beyond expectations"
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`Uptake has been "beyond expectation," says the company. Global brand director Sarah Holland says Faslodex has
`been AstraZeneca's most successful hormonal cancer treatment at launch in the USA, reaching armual sales of $75
`million by its second year.
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`© 2015 Thomson Reuters. No Claim to Orig. US Gov. Works.
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`AstraZeneca Ex. 2066 p. l
`Mylan Pharrns. Inc. v. AstraZeneca AB IPR20l6-013 l6
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`3/29/04 PHARMAIVIKT (No Page)
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`Speaking at the European launch during the 4th European Breast Cancer Conference in Hamburg, Germany, John
`Robertson, head of Nottingham University's breast cancer unit in the UK, said the new drug, administered as a
`once-monthly ir1jectior1, improves on tamoxifen because, while it also blocks estrogen uptake by breast tumors it does
`not have tamoxifen‘s partial estrogenic activity.
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`The latter is implicated in tamoxifen complications such as endometrial cancer, venous thrornbo-embolism and
`stimulation of tumor cells once estrogen receptors start to show resistance following around five years‘ therapy.
`Faslodex is a better tolerated treatment than tamoxifen and aromatase inhibitors, causing fewer troublesome side
`effects in the way of hot flushes, joint disorders and vaginal symptoms.
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`Kurt Possinger, chairman of the Department of Oncology and Hematology, Huboldt University, Berlin, Germany,
`said Faslodex is supported by two large trials comparing it against tamoxifen and aromatase inhibitors. The drug is
`able to shrink breast tumors more than 50%. Compared against the aromatase inhibitor Arimidex (anastrozole), also an
`AstraZeneca drug (see page 20), it has a significantly longer duration of response. Prof Possinger already believes it is
`a better treatment than other endocrine therapies and could be used in preference to aromatase inhibitors after ta-
`moxifen or, eventually, even before tamoxifen. "In my eyes it's the first-line therapy," he concluded.
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`INDEX REFERENCES
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`COMPANY: ASTRAZENECA; ASTRAZENECA LTD; ASTRAZENECA SA; ASTRAZENECA PHARMA-
`CEUTICALS LP; ASTRAZENECA (NETHERLANDS ANTILLES); ASTRAZENECA (LATVIA); APTIUM
`ONCOLOGY; ASTRAZENECA (NICARAGUA); ASTRAZENECA PLC
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`NEWS SUBJECT: (European Union (IEU94); EU News (lEU58); Major Corporations (IMA93); Health & Family
`(1HE30); World Organizations (1IN77))
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`INDUSTRY: (Healthcare Practice Specialties (IHE49); Internal Medicine (1IN54); Physical Science (lPHl5);
`Pharmaceuticals & Biotechnology (IPHI3); Science (ISCS9); Science & Engineering (ISC33); Oncology & He-
`matology (1ON95); Healthcare (IHEO6); Cancer Drugs (1CA21))
`
`REGION: (Central Europe (lCE50); North America (INO39); USA (IUS73); Americas (lAM92); Germany
`(IGEI6); Europe (1EU83); Western Europe (1WE4l))
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`Language: EN
`
`OTHER INDEXING: (4TH EUROPEAN BREAST CANCER; ASTRAZENECA; BAYLOR SAMMONS CANCER
`CENTER; DEPARTMENT OF ONCOLOGY; EU; EUROPEAN UNION; HEMATOLOGY; HUBOLDT UNI-
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`VERSITY; NOTTINGHAM UNIVERSITY; UK; USA) (Faslodex; John Pippen; John Robertson; Kurt Possinger;
`Possinger; Sarah Holland) (United States; United Kingdom)
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`© 2015 Thomson Reuters. No Claim to Orig. US Gov. Works.
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`AstraZeneca Ex. 2066 p. 2
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`3/29/04 PHARMAMKT (No Page)
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`KEYWORDS: (Business, international); (Product introduction); (New Products/Services); (Faslodex (Medication));
`(Faslodex (Medication) - Product introduction); (Product introduction); (Pharmaceutical industry); (Pharmaceutical
`industry — Product introduction)
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`COMPANY TERMS: ASTRAZENECA PLC
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`TICKER SYMBOL: AZN
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`Word Count: 732
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`3/29/04 PHARMAMKT (No Page)
`END OF DOCUMENT
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`© 2015 Thomson Reuters. No Claim to Orig. US Gov. Works.
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`Astrazeneca Ex. 2066 p. 3