AMGN » Topics » Product candidates

This excerpt taken from the AMGN 10-K filed Mar 1, 2010.

Product candidates

We are currently studying new product candidates, including denosumab, and currently marketed products for new indications, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies.

These excerpts taken from the AMGN 10-K filed Feb 27, 2009.

Product candidates

We are currently studying new product candidates, including denosumab, and currently marketed products for new indications, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies. For example, the bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents. Competitive intensity will increase in the bone loss setting with the expected approval of new agents. If denosumab is approved, we would need to significantly expand our sales and marketing capabilities to support its successful launch.

The following table reflects other companies and their currently marketed products that will compete with denosumab, if approved:

 

Amgen Product
Candidate

  

Therapeutic Area

  

Competitor Marketed
Product

  

Potential Competitor

Denosumab

   PMO    FOSAMAX®    Merck

Denosumab

   PMO    Actonel®    Procter & Gamble/Aventis

Denosumab

   PMO    Boniva®/Bonviva®    Roche/GlaxoSmithKline

Denosumab

   PMO    Evista®   

Eli Lilly and Company (“Eli Lilly”)

Denosumab

   PMO    Forteo®/Forsteo™    Eli Lilly

Denosumab

   PMO    Miacalcin®    Novartis

Denosumab

   PMO    Aclasta®/Reclast®    Novartis

Denosumab

   PMO    generic ALN    Teva

Denosumab

   Oncology    Zometa®    Novartis

Denosumab

   Oncology    Aredia®    Novartis

 

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Merck’s patent covering the use of FOSAMAX® to treat bone loss expired in the United States in February 2008. Following the patent expiry, generic ALN became available from Teva, as noted in the table above, and has also become available from other companies.

Product candidates

We
are currently studying new product candidates, including denosumab, and currently marketed products for new indications, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face
substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies. For example, the bone loss setting, in which denosumab would compete, is currently comprised of three
therapeutic classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents. Competitive intensity will increase in the bone loss setting with the expected approval of new agents. If denosumab is approved, we would need to
significantly expand our sales and marketing capabilities to support its successful launch.

The following table reflects other companies
and their currently marketed products that will compete with denosumab, if approved:

 




































































































Amgen Product
Candidate

  

Therapeutic Area

  

Competitor Marketed
Product

  

Potential Competitor

Denosumab

  PMO  FOSAMAX®  Merck

Denosumab

  PMO  Actonel®  Procter & Gamble/Aventis

Denosumab

  PMO  Boniva®/Bonviva®  Roche/GlaxoSmithKline

Denosumab

  PMO  Evista®  

Eli Lilly and Company (“Eli Lilly”)

Denosumab

  PMO  Forteo®/Forsteo™  Eli Lilly

Denosumab

  PMO  Miacalcin®  Novartis

Denosumab

  PMO  Aclasta®/Reclast®  Novartis

Denosumab

  PMO  generic ALN  Teva

Denosumab

  Oncology  Zometa®  Novartis

Denosumab

  Oncology  Aredia®  Novartis

 


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Merck’s patent covering the use of
FOSAMAX® to treat bone loss expired in the United States in February 2008. Following the patent expiry, generic ALN became available from Teva, as noted in the table above, and has also
become available from other companies.

These excerpts taken from the AMGN 10-K filed Feb 28, 2008.

Product candidates

We are currently studying new product candidates, including denosumab and Nplate™, and currently marketed products for new indications, including Vectibix™, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies. For example, the bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents. Competitive intensity will increase in the bone loss setting with the expected approval of new agents.

The following table reflects other companies and their currently marketed products that will primarily compete with denosumab, if approved:

 

Amgen Product Candidate

  

Competitor Marketed Product

 

Potential Competitor

Denosumab    FOSAMAX®   Merck & Co., Inc. (“Merck”)
Denosumab    Actonel®   Procter & Gamble /Aventis
Denosumab    Boniva®/Bonviva®   Roche / GlaxoSmithKline
Denosumab    Evista®   Eli Lilly and Company (“Eli Lilly”)
Denosumab    Forteo®/Forsteo   Eli Lilly
Denosumab    Miacalcin®   Novartis
Denosumab    Zometa®   Novartis
Denosumab    Aredia®   Novartis
Denosumab    Aclasta®/Reclast®   Novartis

Merck’s patent covering the use of FOSAMAX® to treat bone loss expired in the United States in February 2008. Following the patent expiry, generic aledronate became available from Teva Pharmaceutical Industries Ltd. and is expected to be available from other companies. GlaxoSmithKline is in the development of PROMACTA®, which is in phase 3, and may compete with Nplate™.

 

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Product candidates

STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%">We are currently studying new product candidates, including denosumab and Nplate™, and currently marketed products for new indications, including
Vectibix™, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face substantial competition from products currently marketed as well as those under development by other
biotechnology and pharmaceutical companies. For example, the bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents.
Competitive intensity will increase in the bone loss setting with the expected approval of new agents.

The following table reflects other
companies and their currently marketed products that will primarily compete with denosumab, if approved:

 






































































Amgen Product Candidate

  

Competitor Marketed Product

 

Potential Competitor

Denosumab  FOSAMAX® Merck & Co., Inc. (“Merck”)
Denosumab  Actonel® Procter & Gamble /Aventis
Denosumab  Boniva®/Bonviva® Roche / GlaxoSmithKline
Denosumab  Evista® Eli Lilly and Company (“Eli Lilly”)
Denosumab  Forteo®/Forsteo Eli Lilly
Denosumab  Miacalcin® Novartis
Denosumab  Zometa® Novartis
Denosumab  Aredia® Novartis
Denosumab  Aclasta®/Reclast® Novartis

Merck’s patent covering the use of
FOSAMAX® to treat bone loss expired in the United States in February 2008. Following the patent expiry, generic aledronate became available from Teva Pharmaceutical Industries Ltd. and is
expected to be available from other companies. GlaxoSmithKline is in the development of PROMACTA®, which is in phase 3, and may compete with Nplate™.

STYLE="margin-top:0px;margin-bottom:0px"> 


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This excerpt taken from the AMGN 10-K filed Feb 28, 2007.

Product candidates

We are currently studying new product candidates, including denosumab, and currently marketed products for new indications, including Vectibix™, which, if approved, we expect will enter into highly competitive markets. If successful, these product candidates will face substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies. For example, the bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents. Competitive intensity will increase in the bone loss setting with the expected approval of new agents.

 

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Table of Contents

The following table reflects other companies and their currently marketed products that will primarily compete with denosumab, if approved:

 

Amgen Product Candidate

    

Competitor

Marketed Product

 

Potential Competitor

Denosumab      Fosamax®   Merck & Co., Inc.
Denosumab      Actonel®   Procter & Gamble/Aventis
Denosumab      Boniva®   Roche/GlaxoSmithKline
Denosumab      Evista®   Eli Lilly and Company (“Eli Lilly”)
Denosumab      Forteo®   Eli Lilly
Denosumab      Miacalcin®   Novartis
Denosumab      Zometa®   Novartis
Denosumab      Aredia®   Novartis
This excerpt taken from the AMGN 10-K filed Mar 10, 2006.

Product candidates

We are currently developing product candidates, including denosumab, panitumumab, and others, which, if approved, we expect will enter into highly competitive markets. These product candidates will face substantial competition from products currently marketed as well as those under development by other biotechnology and pharmaceutical companies. The bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic classes: bisphosphonates, selective estrogen receptor modulators, and anabolic agents. The oncology setting, in which panitumumab would compete, is currently comprised of several therapeutic classes, including, but not limited to, cytotoxic agents, and VEGF and EGFr inhibitors. Competitive intensity will increase in the bone loss and oncology settings with the expected approval of new agents.

The following table reflects other companies and their currently marketed products that will primarily compete with denosumab and panitumumab, if approved:

 

Amgen Product Candidate

 

 

 

Competitor
Marketed Product

 

 

 

Potential Competitor

 

Denosumab

 

Fosamax®

 

Merck & Co., Inc.

Denosumab

 

Boniva®

 

Roche /GlaxoSmithKline

Panitumumab

 

Erbitux®

 

Imclone Systems Incorporated/Bristol Myers Squibb /Merck KGaA

 

17




"Product candidates" elsewhere:

Dendreon (DNDN)
ONYX Pharmaceuticals (ONXX)
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