PARIS Thu Dec 19, 2013 3:47am EST
An employee walks into an office of French drugmaker Sanofi in Shanghai August 2, 2013.
Credit: Reuters/Aly Song
<span id="articleText"/>PARIS (Reuters) - French drug maker Sanofi and its U.S. partner Regeneron are collaborating with the American College of Cardiology (ACC) to identify patients for clinical trials on alirocumab, their new cholesterol treatment and potential blockbuster.
<span id="midArticle_0"/>Under this agreement, the ACC will use its expertise in clinical research and its extensive patient registries to identify appropriate candidates for a cardiovascular outcomes clinical trial, Sanofi said in a statement on Thursday.
<span id="midArticle_1"/>This is the first time that the ACC's "Pinnacle" registry will be used for clinical trial recruitment, and Sanofi hopes accessing its millions of patient records will help it fully enroll the trial, which seeks some 18,000 patients who recently suffered an acute coronary syndrome.
<span id="midArticle_2"/>Alirocumab is an injectable drug from a promising new class of medicines called PCSK9 inhibitors that is also being developed by Amgen Inc and other drugmakers. It has been touted by industry analysts as a potential blockbuster that could reap annual sales of over $3 billion.
<span id="midArticle_3"/>PCSK9 drugs are mainly aimed at the millions of people who either cannot tolerate statins such as Pfizer Inc's Lipitor or AstraZeneca Plc's Crestor or who cannot get their cholesterol levels under control with statins alone.
<span id="midArticle_4"/>In the first of a dozen late-stage trials, alirocumab cut levels of "bad" LDL cholesterol almost in half. The drug's ultimate success will depend on longer-term studies, some of which will only give results around 2018. But Sanofi and Regeneron are hoping positive earlier data could get the drug approved for some patients before then.
<span id="midArticle_5"/>(Reporting by Natalie Huet. Editing by Jane Merriman)
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An employee walks into an office of French drugmaker Sanofi in Shanghai August 2, 2013.Credit: Reuters/Aly Song
<span id="articleText"/>PARIS (Reuters) - French drug maker Sanofi and its U.S. partner Regeneron are collaborating with the American College of Cardiology (ACC) to identify patients for clinical trials on alirocumab, their new cholesterol treatment and potential blockbuster.
<span id="midArticle_0"/>Under this agreement, the ACC will use its expertise in clinical research and its extensive patient registries to identify appropriate candidates for a cardiovascular outcomes clinical trial, Sanofi said in a statement on Thursday.
<span id="midArticle_1"/>This is the first time that the ACC's "Pinnacle" registry will be used for clinical trial recruitment, and Sanofi hopes accessing its millions of patient records will help it fully enroll the trial, which seeks some 18,000 patients who recently suffered an acute coronary syndrome.
<span id="midArticle_2"/>Alirocumab is an injectable drug from a promising new class of medicines called PCSK9 inhibitors that is also being developed by Amgen Inc and other drugmakers. It has been touted by industry analysts as a potential blockbuster that could reap annual sales of over $3 billion.
<span id="midArticle_3"/>PCSK9 drugs are mainly aimed at the millions of people who either cannot tolerate statins such as Pfizer Inc's Lipitor or AstraZeneca Plc's Crestor or who cannot get their cholesterol levels under control with statins alone.
<span id="midArticle_4"/>In the first of a dozen late-stage trials, alirocumab cut levels of "bad" LDL cholesterol almost in half. The drug's ultimate success will depend on longer-term studies, some of which will only give results around 2018. But Sanofi and Regeneron are hoping positive earlier data could get the drug approved for some patients before then.
<span id="midArticle_5"/>(Reporting by Natalie Huet. Editing by Jane Merriman)
<span id="midArticle_6"/>
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We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
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