Amgen: Launching Repatha

Abstract

In March 2015, Amgen is preparing for the launch of Repatha, a new molecule that has demonstrated a remarkable ability to treat high cholesterol. Through a series of clinical trials, Amgen has proven that the molecule is both safe and effective for patients with high cholesterol. It also is effective for patients with familial hypercholesterolemia, a difficult-to-treat population that has exceptionally high levels of cholesterol. Amgen expects the FDA to approve the molecule before the end of the year. Now, the Repatha team has to develop a revenue forecast.

This case was prepared for inclusion in Sage Business Cases primarily as a basis for classroom discussion or self-study, and is not meant to illustrate either effective or ineffective management styles. Nothing herein shall be deemed to be an endorsement of any kind. This case is for scholarly, educational, or personal use only within your university, and cannot be forwarded outside the university or used for other commercial purposes.

2024 Sage Publications, Inc. All Rights Reserved

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Exhibit 1: Amgen Financial Highlights ($ in billions)

2012

2013

2014

Sales

17.3

18.7

20.1

COGS

2.1

2.1

2.1

SG&A

8.1

9.0

8.9

     R&D

3.4

4.1

4.3

Operating income

6.1

6.3

6.9

Net income

4.3

5.1

5.2

Source: Amgen Annual Reports.

Exhibit 2: Amgen’s Largest Products ($ in billions)

2012

2013

2014

Neulasta/Neupogen

5.4

5.8

5.8

Enbrel

4.2

4.6

4.7

Aranesp

2.0

1.9

1.9

Epogen

1.9

2.0

2.0

Xgeva

0.7

1.0

1.2

Prolia

0.5

0.7

1.0

Sensipar/Mimpara

1.0

1.1

1.2

Source: Amgen Annual Reports.

Exhibit 3: Selected Trial Results for PCSK9 Inhibitors

Company/Drug

Clinical Stage

Summary of Results

Amgen: Repatha

Phase II

Lowered LDL by 51% in patients intolerant of statins after 12 weeks

Phase III

Reduced LDL by 57% over placebo on patients with LDL levels higher than 75 mg/DL

Phase III

For hypercholesterolemic patients, lowered LDL 55–57% over placebo, and 38–40% over Zetia

Phase III

Reduced LDL levels by 75% over placebo when combined with a statin

Phase III

For patients with HoFH, reduced LDL levels by 31% compared with placebo; 40% greater reduction in LDL than Zetia

Phase III

Reduced LDL levels by 53–56% for patients who failed on four or more statins; 75% of patients achieved LDL levels lower than 100 mg/dL

Phase III

Reduced rate of major cardiac events from 2.1% if taking just a statin to 0.95% if taking a statin and Repatha

Sanofi/Regeneron: Praluent

Phase III

After 24 weeks, reduced LDL by 54% in patients at high risk of cardiovascular disease over placebo

Phase III

Reduced LDL levels by 45% in patients intolerant of statins; ten times more patients reached cholesterol goals than those on Zetia in trial

Phase III

For patients with HeFH, reduced LDL by 46% as opposed to 7% for placebo

Phase III

Reduced LDL levels by 60% over placebo for patients with high cardiovascular risk

Phase III

Half the risk of major cardiovascular event for high-risk patients (3% versus 1.4% for placebo)

Pfizer: bococizumab

Phase II

Reduced LDL by 52% on patients also taking statins

Phase II

Reduced LDL levels by up to 53 mg/dL over placebo at all dosing levels

Exhibit 4: Sanofi/Regeneron’s “Cholesterol Counts” Campaign

Figure

This case was prepared for inclusion in Sage Business Cases primarily as a basis for classroom discussion or self-study, and is not meant to illustrate either effective or ineffective management styles. Nothing herein shall be deemed to be an endorsement of any kind. This case is for scholarly, educational, or personal use only within your university, and cannot be forwarded outside the university or used for other commercial purposes.

2024 Sage Publications, Inc. All Rights Reserved

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