AstraZeneca’s Faslodex met primary endpoint in first-line treatment of advanced breast c...
`
`Page 1 of 4
`
`AstraZeneca§
`
`AZ Network
`Global site
`
`What science can do
`Our science
`Our focus areas
`
`Our company
`Careers
`Investors
`
`Partnering
`
`% S
`
`ustainability
`
`AstraZeneca’s Faslodex met primary endpoint in
`first-line treatment of advanced breast cancer
`
`PUBLISHED
`
`27 May 2016
`
`AstraZeneca today announced positive results from the Phase III FALCON trial comparing Faslodex 500mg
`(fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-
`menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer.
`
`Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of
`extended progression-free survival. The trial showed an adverse event profile generally consistent with current
`knowledge of the safety profile of the medicines.
`
`Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said:
`“The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with
`HR+ |oca|ly—advanced or metastatic breast cancer; the potential to delay disease progression is important for these
`patients as there is currently no cure. Faslodex has over 10 years of clinical evidence and we are committed to
`exploring its potential along with the rest of our outstanding oncology portfolio.”
`
`A full evaluation of the data is ongoing and the results are expected to be presented at a medical meeting in 2016.
`
`Aromatase inhibitors (such as Arimidex) are the current standard of care in first-line treatment for postmenopausal
`women with advanced HR+ breast cancer‘.
`
`Faslodex 500mg is approved for the treatment of postmenopausal women with oestrogen-receptor (ER)-positive
`locally-advanced or metastatic breast cancer whose cancer has progressed following anti-oestrogen therapy? Most
`recently, on 2 March 2016, the US Food and Drug Administration approved Faslodex 500mg, in combination with
`palbociclib, for the treatment of women with hormone-receptor-positive, human-epidermal-growth-factor-receptor
`
`https://www.astrazeneca.com/media-centre/press-releases/2016/astrazenecas-fas1odex-met-. .
`.
`AstraZeneca Ex. 2079 p. 1
`Mylan Pharms. Inc. V. AstraZeneca AB IPR2016-01324
`
`5/27/2016
`
`

`

`AstraZeneca’s F aslodex met pnmary endpoint in first-line treatment of advanced breast c...
`
`Page 2 of 4
`
`2—negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine
`therapy3.
`
`NOTES TO EDITORS
`
`About FALCON
`
`The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Nai've advanced breast cancer) trial is a
`Phase III, randomised, double-blind, multicentre trial. The trial compared the anti-tumour effects and tolerability profile
`of a 500mg dose of Faslodex plus placebo with a 1mg dose of Arimidex plus placebo, in postmenopausal women with
`hormone-receptor-positive, locally-advanced or metastatic breast cancer who have not been treated previously with
`any hormonal therapy.
`
`About Advanced breast cancer (ABC)
`
`ABC is the most advanced stage of breast cancer (stage IV), and occurs when cancer cells have spread beyond the
`initial tumour site to other parts of the body outside of the breast. Since there is no cure for ABC, the goal of current
`treatment is to delay disease progression‘‘.
`
`About Faslodex 500mg (fulvestrant)
`
`Faslodex 500mg is indicated for the treatment of postmenopausal women with ER+, locally-advanced or metastatic
`breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with
`an anti-oestrogen?
`
`In the US, Faslodex 500mg is also approved, in combination with palbociclib, for the treatment of US women with HR+,
`human epidermal growth factor receptor 2—negative (HER2-) advanced or metastatic breast cancer (M BC), whose
`cancer has progressed after endocrine therapy. Faslodex 500mg represents a hormonal therapy approach that helps to
`slow tumour growth by blocking and degrading the oestrogen receptor - a key driver of disease progression5.
`
`About AstraZeneca in Oncology
`Astrazeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has
`the potential to transform patients’ lives and the Company‘s future. With at least 6 new medicines to be launched
`between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to
`advance New Oncology as one of AstraZeneca‘s six Growth Platforms focused on lung, ovarian, breast and blood
`cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that
`accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.
`
`By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance,
`DNA damage response and antibody drug conjugates -- and by championing the development of personalised
`combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of
`death.
`
`About Astrazeneca
`
`Astrazeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and
`commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas -
`respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVM D) and oncology —
`as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are
`used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
`
`Refe ren ces
`
`https1//www.astrazeneca.com/media—centre/press—re1eases/2016/astrazenecas—fas1odex—met—...
`AstraZeneca Ex. 2079 p. 2
`
`5/27/2016
`
`

`

`AstraZeneca’s F aslodex met pfimary endpoint in first-line treatment of advanced breast c... Page 3 of 4
`
`1. Journal of Clinical Oncology. Endocrine Therapy for Hormone Receptor—Positive Metastatic Breast Cancer:
`American Society of Clinical Oncology Guideline. Available at:
`httg://"co.ascogubs.org/content/early/2016/05/19/JCO.2016.67.1487.fu||.pdf+htm|. Last accessed 25.05.2016
`
`2. FASLODEX Summary of Product Characteristics. Available at:
`httg://www.ema.euroga.eu/docs/en GB/document
`library/EPAR Product Information/human/000540/WC500021174.gdf.
`Last accessed 25/02/2016
`
`3. FASLODEX full Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE
`
`4. National Cancer Institute. What Is Cancer?: Metastatic Cancer. Available online at: htt|:_)://www.cancer.gov/about-
`cancer/what-is-cancer/metastatic-fact-sheet. Last accessed 25/04/2016.
`
`5. Howell A. Is fulvestrant (“Fas/odex“) just another selective estrogen receptor modulator? Int J Gynecol Cancer.
`2006;16 (suppl 2):521—523.
`
`CONTACTS
`
`Media Enquiries
`
`Neil Burrows
`UK/Global
`+44 7842 350541
`Vanessa Rhodes
`UK/Global
`+44 7880 400690
`
`Karen Birmingham
`UK/Global
`+44 7818 524012
`Jacob Lund
`Sweden
`+46 8 553 260 20
`Michele Meixell
`US
`+1 302 885 2677
`
`Investor Enquiries
`
`UK
`
`Thomas Kudsk Larsen
`
`+44 7818 524185
`Nick Stone
`
`https://www.astrazeneca.com/media—centre/press—re1eases/2016/astrazenecas—fas1odex—met—... 5/27/2016
`AstraZeneca Ex. 2079 p. 3
`
`

`

`AstraZeneca’s F aslodex met pfimary endpoint in first-line treatment of advanced breast c. .. Page 4 of 4
`
`Media Enquiries
`
`CVMD, RIA
`+44 7717 618834
`
`Henry Wheeler
`Oncology
`+44 7788 354619
`
`Craig Marks
`Finance
`+44 7881 615764
`Christer Gruvris
`
`ING, Consensus Forecasts
`+44 7827 836825
`
`US
`
`Lindsey Trickett
`CVMD, Oncology
`+1 240 543 7970
`Mitch Chan
`
`Oncology
`+1 240 477 3771
`Dial / To||—Free
`
`+1 866 381 7277
`
`Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,
`
`ING - Infection, Neuroscience and Gastrointestinal
`
`https://www.astrazeneca.com/media—centre/press—re1eases/2016/astrazenecas—fas1odex—met—... 5/27/2016
`AstraZeneca Ex. 2079 p. 4
`
`