Sanofi and Regeneron Announce Promising Phase 3 Results for Their Cholesterol Drug

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

This morning, Sanofi (NYSE: SNY  ) and Regeneron (NASDAQ: REGN  ) released some good news from a phase 3 study of its experimental cholesterol drug alirocumab, a new treatment designed to lower the production of LDL ("bad") cholesterol.

A new approach at lowering LDL cholesterol levels
Alirocumab attempts to lower LDL cholesterol by stopping the PCSK9 enzyme from binding to LDL receptors, which are essential in removing LDL cholesterol from the blood. PCSK9 degrades these LDL receptors, limiting the liver's ability to lower LDL cholesterol levels.

The previous generation of cholesterol-lowering treatments -- such as Pfizer's (NYSE: PFE  ) Lipitor, AstraZeneca's (NYSE: AZN  ) Crestor, and Merck's (NYSE: MRK  ) Zocor -- are all statins. Statins inhibit the production of LDL cholesterol by targeting an enzyme known as HMG-CoA in the liver. However, statin treatments have been shown to actually stimulate the production of PCSK9, which is counterproductive, possibly damaging to the liver, and ultimately limits the treatment's ability to lower LDL cholesterol levels.

Positive phase 3 results
In Sanofi and Regeneron's phase 3 trial, alirocumab was shown to reduce LDL cholesterol three times more than ezetimibe (marketed as Zetia or Ezetrol), a non-statin treatment that decreases the absorption of cholesterol in the small intestine. The results -- in which patients on alirocumab exhibited a 47.2% reduction in LDL compared to 15.6% for ezetimibe -- exceeded the phase 3 trial's primary endpoints.

During the 24-week study, patients initially self-injected the drug at a low dose of 75 mg every two weeks, but it was increased to a double dosage if LDL levels did not drop by the eighth week. However, the majority of patients were able to remain on the lowest dose since their LDL levels fell by the eighth week.

Although these results indicate that alirocumab could be on the right path to approval, the drug, like ezetimibe, caused some unpleasant side effects such as the common cold, influenza, and respiratory infections.

More detailed results from the study will be presented in 2014.

The road ahead
Besides alirocumab, which is a monoclonal antibody, Sanofi and Regeneron are also developing "fully human" monoclonal antibodies developed by Regeneron's VelocImmune technologies. These "fully human" monoclonal antibodies could eventually replace the current use of "humanized" monoclonal antibodies, which are altered from animal anitbodies.

However, those treatments, along with alirocumab, are still a long ways off.

For now, Sanofi's key growth driver is its diabetes franchise, which reported 12.9% year-over-year growth last quarter, although it faces generic competition for many of its other key products, such as Eloxatin, Plavix, Avapro, and Lovenox.

Most of Regeneron's revenue is currently generated by Eylea, a treatment for wet age-related macular degeneration that's co-marketed with Bayer. Sales of Eylea rose 50.7% year-over-year last quarter, although it faces competition from Novartis' Lucentis and Roche's Avastin.

Should investors be excited?
During pre-market trading at the time of this writing, investors appeared fairly indifferent to Sanofi and Regeneron's phase 3 announcement. At 9 a.m EST, shares of Sanofi were basically flat at $49.39, while shares of Regeneron were up 4.4% at $303.20.

Investors interested in other "next generation" LDL treatments might also want to check out Alnylam Pharmaceuticals, which is using gene silencing technology to lower cholesterol levels without the side effects of statin treatments.

Two biotech companies transforming cancer treatment
The best way to play the biotech space is to find companies that shun the status quo and instead discover revolutionary, groundbreaking technologies. In the Motley Fool's brand-new FREE report "2 Game-Changing Biotechs Revolutionizing the Way We Treat Cancer," find out about a new technology that big pharma is endorsing through partnerships, and the two companies that are set to profit from this emerging drug class. Click here to get your copy today.

Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2685164, ~/Articles/ArticleHandler.aspx, 9/26/2016 8:30:26 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 2 days ago Sponsored by:
DOW 18,261.45 -131.01 -0.71%
S&P 500 2,164.69 -12.49 -0.57%
NASD 5,305.75 -33.78 -0.63%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

9/23/2016 4:00 PM
REGN $410.39 Up +2.38 +0.58%
Regeneron Pharmace… CAPS Rating: ****
SNY $38.35 Down -0.22 -0.57%
Sanofi CAPS Rating: *****
AZN $33.97 Down -0.31 -0.90%
AstraZeneca CAPS Rating: ****
MRK $62.96 Down -0.06 -0.10%
Merck and Co. CAPS Rating: ****
PFE $34.26 Up +0.11 +0.32%
Pfizer CAPS Rating: ****