Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Sanofi SA (ADR) (SNY)’s GLP-1 Accepted for Review by FDA

Page 1 of 2

Sanofi SA (ADR) (NYSE:SNY) announced this week that the Food and Drug Administration began to review the company’s once-daily type 2 diabetes injectable lixisenatide. The GLP-1 agonist would join a crowded market led by Novo Nordisk A/S (ADR) (NYSE:NVO) and the teaming of Bristol Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (ADR)(NYSE:AZN).

The FDA approval follows the recent EU approval, which put the drug on track for an overseas launch in the late first quarter under the name Lyxumia. But is the drug effective enough to find a market among the other contenders?

Sanofi SA (ADR) (NYSE:SNY)Entering the crowd
GLP-1 agonists have remained popular because they pair well with insulin products to offer flexible treatment customization for patients — a key selling point in diabetes.

Novo Nordisk’s Victoza leads the drug class with a 2012 annual sales growth of nearly 60% to 9.5 billion Danish kroner (about $1.7 billion at current currency rates). But Victoza missed sales estimates in the fourth quarter, perhaps because of Bydureon coming onto the market last year.

Bydureon is a once-weekly injection developed by Amylin that joined the existing once-daily Byetta. The two drugs proved so enticing that Bristol-Myers and AstraZeneca teamed up last summer to acquire Amylin. Bristol recorded sales of $149 million and $78 million for Bydureon; AstraZeneca reported  $75 million and $37 million, respectively.

There’s room in the market for a new drug if it offers an efficacy improvement. But that’s not lixisenatide’s strong point. And there are other pipeline contenders waiting in the wings.

Efficacy battle
Victoza leads more than the sales race. Last year, the FDA approved a product label update that allowed Victoza to mention the drug’s superiority to Merck’s DPP-4 inhibitor Januvia at controlling blood sugar and lowering weight. Novo’s drug has also bested Byetta in trials.

A second place finish would require better efficacy than at least Byetta. Eli Lilly’s dulaglutide was the only pipeline contender to meet that mark. GlaxoSmithKline’s albiglutide didn’t go up against Byetta but underperformed Victoza. Sanofi drew about even, showing that lixisenatide wasn’t any worse than Byetta.

But lixisenatide did show some signs of strength. It did a better job than Byetta at reducing the risk of hypoglycemia, a common side effect of diabetes treatments. And in a different late-stage trial, the drug showed significant blood sugar decreases when used in combination with Sanofi’s $6 billion insulin Lantus.

Combo advantage
I’ve repeatedly said that lixisenatide’s strength lies in its potential bolstering of Lantus sales once the insulin’s patent expires around 2014. A lixisenatide and Lantus combination drug is undergoing several trials using different types of dosage devices; phase 2b should report data this year, but an expected phase 3 trial was pushed back indefinitely.

Page 1 of 2

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!