HOUSE_OVERSIGHT_026365.jpg
3.28 MB
Extraction Summary
1
People
6
Organizations
3
Locations
4
Events
1
Relationships
1
Quotes
Document Information
Type:
Press release / corporate announcement
File Size:
3.28 MB
Summary
This document is a press release from pharmaceutical companies Sanofi and Regeneron regarding their cholesterol drug, Praluent (alirocumab). It announces the drug's approval based on clinical trial data, its U.S. price of $40 per day, and the launch of patient support programs. The release also advertises an investor relations conference call scheduled for July 24, 2015, and notes a pending marketing authorization decision in the European Union.
People (1)
| Name | Role | Context |
|---|---|---|
| Unnamed Officer, Regeneron | Officer |
Quoted at the beginning of the document regarding the development of Praluent.
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Organizations (6)
| Name | Type | Context |
|---|---|---|
| Regeneron |
Co-developer and co-marketer of the drug Praluent.
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| Sanofi |
Co-developer and co-marketer of the drug Praluent.
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| European Medicine Agency (EMA) |
Regulatory agency whose committee (CHMP) recommended Praluent for approval.
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| Committee for Medicinal Products for Human Use (CHMP) |
A committee of the EMA that adopted a positive opinion for the marketing authorization of Praluent.
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| European Commission (EC) |
Expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union.
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| HOUSE_OVERSIGHT |
Appears as a document identifier in the footer, likely indicating it is an exhibit for a House Oversight committee.
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Timeline (4 events)
Approval of Praluent based on data from the Phase 3 ODYSSEY program.
U.S.
The European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Praluent.
CHMP
EMA
September 2015 (expected)
The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent.
European Union
European Commission
Locations (3)
| Location | Context |
|---|---|
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The location where the Wholesale Acquisition Cost (WAC) of Praluent is set and where patient support programs will be...
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The region where a final marketing authorization decision for Praluent is expected in September 2015.
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A specific telephone number is provided for accessing the investor conference call from France.
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Key Quotes (1)
"Praluent represents the culmination of more than a decade of tireless work to translate the genetic-based discovery of PCSK9 into an innovative medicine that brings meaningful value to patients."Source
HOUSE_OVERSIGHT_026365.jpg
Quote #1
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