The document provides an overview of biotechnology company Amgen, including its introduction, current management, awards won in 2016, top-selling drugs like Epogen and Neupogen, and controversial issues. It discusses Amgen's collaborations with NASA on bone loss research and its strengths such as its large sales profits and patent portfolio. It also lists some risks facing Amgen like competition and potential challenges to its intellectual property.

1. Geeta Iyer
Date -4/18/2016

2. overview
 Introduction
 Current management
 Awards won in 2016
 About the three drugs
 Controversial issues
 Biosimilar
 Environment sustainability
 Strengths
 Risk factors

3. Introduction
 Applied Molecular Genetics (1983) - formed by venture capitalist
William K, CEO George B. Rathmann and 3 employees
 Biotechnology based company
 Drugs for cancer, kidney disease, rheumatoid arthritis, bone
disease and other serious illnesses
 No of employees-18,000 worldwide

4.  Revenue generated in 2015-21.7 billion dollars
 R&D expense in 2015 -3.9 billion dollars
 Price of each stock -145.51 dollars as of 3/18/2016
 Present in more than 75 countries
 Corporate Headquarters- One Amgen Center Drive
Thousand Oaks, CA
 Website- www.amgen.com

5. Current management

6. AWARDSwonin2016

7. AmgenANDnasa
 In 2011, Amgen collaborated with National Aeronautics
and Space Administration (NASA) to conduct
preclinical trials of Sclerostin antibody.
 Bone loss is a critical issue when it comes to human
space mission.
 The experiment will be carried out on 30 mice in the
space flight.
 Half the mice will be treated and the rest will be used as
placebo

8. CKD– chronickidneydisease
Anemia is multifactorial
 About 14% of the population in US has CKD and 15.4% of that
population have anemia irrespective of any stage of CKD

9. Epogen(Epoetinalpha)
 Recombinant protein -erythropoietin helps body create more red blood
cells.
 In 1989 Amgen got the patent for Epogen and started marketing it as an
orphan drug
 In 1992 EPOGEN generates 1 billion dollar from product sales.

10. cancer
 Cancer is the second most common cause of death in USA
 Chemotherapy slows down or ceases cancer cell growth which
divide and grow rapidly.
 It may be the only treatment or may be combined with any
other treatment.
 Chemotherapy not only kills the cancerous cells but also
decreases the growth of normal cells such as immune cells or
cells of the organs.
Cancer cells attacked
by immune cells

11. Neupogen-Filgrastim
 On 21st Feb 1991, Neupogen was approved by the FDA.

12. HowNeupogenworks

13. Heartdiseases
 Heart diseases is one of the leading causes of death in US.
 Every year about 610,000 people die of heart diseases.
 LDL (low-density lipoprotein) is known as a bad cholesterol as it
accumulates in the arteries and forms a plaque which may lead to
many heart diseases

14. Repatha-Evolocumab
 Repatha is a fully human monoclonal antibody used in adjunct to statin
therapy.
 It is used by people suffering from heterozygous familial
hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular
disease (ASCVD) who are more tolerated towards statin therapy. It is used
as an adjunct for more lowering of LDL-C in homozygous familial
hypercholesterolemia (HoFH).
 On 27th Aug 2015, Repatha was approved by the FDA.

15. Modeof actionof Repatha
 Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a
regulatory serine protease.

16. Controversialissues
 On 16th of March 2016 Amgen won the patent infringement
case against Sanofi and Regron for its drug Repatha.
 The case was fought in the federal court in Delaware.
 Seven patent claims were infringed of which the company
acknowledged the infringement of two patent claims in U.S.
Patent Numbers 8,829,165, and 8,859,741.
 The case was dismissed on the basis of obviousness as the other
companies didn’t have enough proof of written description.

17. Decreasein thesalesof EpogenandNeupogen

18. Biosimilars
 A biosimilar is a biological product that is highly similar to a U.S.
licensed reference biological product notwithstanding minor
differences in clinically inactive components, and for which there
are no clinically meaningful differences between the biological
product and the reference product in terms of safety, purity and
potency of the product. -U.S. FDA

19. Strengths

20. 1) Over all salesprofit

21. 2)Strongpatent portfolio

22. 3) Morethan30 productsin pipeline

23. 4)PartnershipswithKirin,Pfizer,
Onyxpharmaceuticals,UCB

24. 5) Ranks1st forits sales

25. Environment sustainability

26. SharingClinicalTrialSummaryResultsWithPatientsandtheMedicalCommunity
 Patients and investigators can view all Amgen-sponsored clinical
trials by visiting www.amgentrials.com .
 The clinical trials disclosed on www.clinicaltrials.gov (CT.gov) are
reflected in the www.amgentrials.com website.
 The website also has an investigator survey where medical
professionals and investigators can provide a request to be considered
on future Amgen clinical trials.

27. Current competition
• J&J
• Teva pharmaceuticals
Smaller subset of
market
• Biogen Idec
• Celgene
• Gilead Sciences
Larger companies

28. The possible risk factors are :
 Competition for the product
 Regulatory approval
 Not all products in R&D is commercialized
 Clinical trials may take a lot of time
 Intellectual property rights might be challenged
 Adapting new tax laws may affect profits
 Global economic conditions may have a negative impact

29. http://www.amgenbiotech.com/tour/amgen-
manufacturing.html
 Virtual tour

30. References:
1. Science lessons-what the business of biotech taught me about management- Gordon Binder (former CEO of AMGEN)
2. www.amgen.com
3. Mechanisms of Anemia in CKD-Jodie L. Babittcorresponding author and Herbert Y. Lin, J Am Soc Nephrol. 2012 Sep 28; 23(10): 1631–1634
4. www.epogen.com
5. Chapter 3: Use of ESAs and other agents* to treat, anemia in CKD, Kidney International Supplements (2012) 2, 299–310; doi:10.1038/kisup.2012.35)
6. Prevalence of Anemia in Chronic Kidney Disease in the, United States
7. Melissa E. Stauffer1*, Tao Fan21 SCRIBCO, Effort, Pennsylvania, United States of America, 2 Merck & Co., Inc., Whitehouse Station, New Jersey, United States of America
8. Downloaded from http://pmj.bmj.com/ on March 31, 2016 - Published by group.bmj.com,Recombinant erythropoietin in clinical practice,T Ng, G Marx, T Littlewood, I Macdougall
9. https://pubs.acs.org/cen/coverstory/83/8325/8325erythropoietin.html
10. Cancer Statistics, 2015,Rebecca L. Siegel, MPH1*; Kimberly D. Miller, MPH2; Ahmedin Jemal, DVM, PhD3,CA CANCER J CLIN 2015;65:5–29
11. http://www.cancer.gov/
12. http://www.neupogenhcp.com/
13. http://www.cdc.gov/heartdisease/facts.htm
14. https://www.amgen.ca/english/media/repatha_press_release.html
15. Drug Des Devel Ther. 2015; 9: 3073–3082.Published online 2015 Jun 15. doi: 10.2147/DDDT.S67498PMCID: PMC4474387,Profile of evolocumab and its potential in the treatment of
hyperlipidemia,Arrigo FG Cicero, Alessandro Colletti, and Claudio Borghi
16. (http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-reportsannual)
17. http://www.investopedia.com/ask/answers/082714/who-are-amgen-incs-amgn-main-competitors.asp
18. http://environment.amgen.com/sustainability
19. http://bidnessetcnews.tumblr.com/post/128202019381/can-amgen-withstand-biosimilars
20. ((J Bone Joint Surg Am. 2014 Oct 1; 96(19): 1659–1668. Published online 2014 Oct 1. doi: 10.2106/JBJS.M.01096 PMCID: PMC4179450 A Review of Osteocyte Function and the Emerging
Importance of Sclerostin Jocelyn T. Compton, MS1 and Francis Y. Lee, MD, PhD1 Author information Copyright and License information
21. http://www.amgenbiosimilars.com/the-basics/the-promise-of-biosimilars/
22. https://finance.yahoo.com/q/co?s=AMGN

32. l