Geeta IyerDate -4/18/2016

overview Introduction

Current management

Awards won in 2016

About the three drugs

Controversial issues

Biosimilar

Environment sustainability

Strengths

Risk factors

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

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

Current management

AWARDS won in 2016

Amgen AND nasa

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

CKD – chronic kidney disease

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

Epogen (Epoetin alpha)

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.

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

Neupogen -Filgrastim

On 21st Feb 1991, Neupogen was approved by the FDA.

How Neupogen works

Heart diseases 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

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.

Mode of action of Repatha Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a

regulatory serine protease.

Controversial issues

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.

Decrease in the sales of Epogen and Neupogen

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

Strengths

1) Over all sales profit

2) Strong patent portfolio

3) More than 30 products in pipeline

4) Partnerships with Kirin, Pfizer, Onyx pharmaceuticals,

UCB

5) Ranks 1st for its sales

Environment sustainability

Sharing Clinical Trial Summary Results With Patients and the Medical Community

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.

Current competition

• J&J• Teva pharmaceuticals

Smaller subset of market

• Biogen Idec• Celgene• Gilead Sciences Larger companies

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

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

Virtual tour

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

l