UNLOCKING THE POTENTIAL OF BIOLOGY FOR PATIENTS

1. PRESENTED BY:
Dhruvi Panchal
Roll No.: 506
F. Y. M. Pharm (Pharmaceutics)
Subject: Modern Pharmaceutics
Sinhgad College of Pharmacy, Vadgaon Bk., Pune.
UNLOCKING THE POTENTIAL OF BIOLOGY FOR PATIENTS

2. › Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American
multinational biopharmaceutical company
› Headquartered in Thousand Oaks, California.
› Founded by William K. (Bill) Bowes and George B. Rathmann in 1980.
ABOUT AMGEN
MISSION
› To serve patients
› “Doing the right thing is central to our
mission to serve patients.”

3. AMGEN RnD STRATEGIES

4. KEY MILESTONES
› 1980: Amgen is established in Thousand Oaks, California
› 1983: Amgen employee Fu-Kuen Lin clones erythropoietin gene
› 1985: Research team at Amgen clones granulocyte colony-stimulating factor
(G-CSF)
› 1989: EPOGEN® (epoetin alfa) is approved
› 1991: NEUPOGEN® (filgrastim) is approved
› 2001: Aranesp® (darbepoetin alfa) is approved
› 2002: Immunex, developer of Enbrel® (etanercept), is acquired Neulasta®
(pegfilgrastim) is approved
› 2004: Sensipar® /Mimpara® (cinacalcet) is approved
› 2006: Vectibix® (panitumumab) is approved

5. › 2008: Nplate® (romiplostim) is approved
› 2010: Prolia® (denosumab) and XGEVA® (denosumab) are approved
› 2012: deCODE Genetics, a global leader in human genetics, is acquired
Micromet, Inc., is acquired
› 2013: Amgen-Betta Pharmaceuticals joint venture established in China
Amgen Astellas BioPharma K.K. announces Japan alliance Onyx
Pharmaceuticals is acquired
› 2014: Amgen Singapore Manufacturing Pte. Ltd. construction is
completed Asia Research and Development Center opened in Shanghai,
China BLINCYTO® (blinatumomab) is approved
› 2015: Corlanor® (ivabradine) is approved Repatha® (evolocumab) is
approved IMLYGIC® (talimogene laherparepvec) is approved
› 2016: Purchased the rights to Boehringer Ingelheim’s Phase I bispecific T-
cell engager compound (BI 836909, now AMG 420) for use in the
treatment of multiple myeloma

6. PRODUCTS
ONCOLOGY PRODUCTS:
› BLINCYTO® (blinatumomab)
› IMLYGIC® (talimogene laherparepvec)
› Nplate® (romiplostim)
› Vectibix® (panitumumab)
› XGEVA® (denosumab)
› Neulasta® (pegfilgrastim)
› NEUPOGEN® (filgrastim)
› Sensipar® / Mimpara® (cinacalcet)
› KYPROLIS® (carfilzomib)
CARDIOLOGY/ VASCULAR PRODUCTS:
› Corlanor® (ivabradine)
› Repatha® (evolocumab)
ENDOCRINOLOGY PRODUCTS:
› Prolia® (denosumab)
› Parsabiv® (etelcalcetide)
NEUROLOGY PRODUCTS:
› Aimovig® (erenumab-aooe)
IMMUNOLOGY PRODUCTS:
› INFERGEN® (interferon alfacon-1)
RHEUMATOID ARTHRITIS PRODUCTS:
› Kineret® (anakinra)
› Enbrel® (etanercept)
HEMATOLOGY PRODUCTS:
› Aranesp® (darbepoetin alfa)
› EPOGEN® (epoetin alfa)

7. PRODUCTS DEVELOPED AND THEN SOLD OFF
› Kepivance (palifermin) for oral mucositis: sold to Biovitrium,
now Swedish Orphan Biovitrum, in December 2008
› StemGen (ancestim) for use in combination with filgrastim for mobilizing
peripheral hematopoietic stem cells: sold to Biovitrium, now Swedish
Orphan Biovitrum, in December 2008
› Kineret (anakinra) for rheumatoid arthritis: exclusively licensed to
Biovitrium, now Swedish Orphan Biovitrum, in December 2008

8. PRODUCTS IN CLINICAL TRIALS
PHASE 2
• AMG 301- Neuroscience (monoclonal Antibody)
• AMG 557- Inflammation (Monoclonal Antibody)
• AMG 714- Inflammation (Monoclonal Antibody)
• Blinatumomab- Hemato/Oncology (BiTE Antibody Construct)
• Tezepelumab- Inflammation (Monoclonal Antibody)
PHASE 3
• AMG520- Neuroscience (Small Molecules)
• Blinatumomab- Hemato/Oncology (BiTE Antibody Construct)
• Etanercept- Inflammation (Fusion Protein)
• Romosozumab- Bone Health (Monoclonal Antibody)
• Talimogene laherparepvec- Hemato/Oncology (Oncolytic Immunotherapy)
• Carfilzomib- Hemato/Oncology (Small Molecule)
• Omecarmtiv mecarbil- Cardiovascular (Small Molecule)
• Tezepelumab- Inflammation (Monoclonal Antibody)

9. APPROVED AMGEN BIOSIMILARS
› AMJEVITA™ (Adalimumab- atto injection)
› MVASI™ (Bevacizumab- awwb injection/ vial)- Currently not available
commercially.
IN- PIPELINE AMGEN BIOSIMILARS
› ABP 798 (biosimilar rituximab)- Oncology, Inflammation
› ABP 710 (biosimilar infliximab)- Inflammation
› ABP 494 (biosimilar cetuximab)- Oncology
› ABP 959 (biosimilar eculizumab)- Hematology
› ABP 980 (biosimilar trastuzumab)- Oncology
In Phase 3
clinical trials.

11. CONCLUSION
› In a perfect world..
– Every patient that can benefit from Amgen’s therapies is
identified, prescribed and remains adherent to achieve the
full therapeutic benefit of the product.
– The healthcare system fully covers the cost of this care since
the benefit and outcome is known and confirmed with real
world data.

12. REFERENCE
› Amgen.com. (2018). Amgen . [online] Available at:
https://www.amgen.com/ [Accessed 9 Dec. 2018].