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Sanofi Diabetes Drug Suliqua Wins EU Marketing Approval
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Sanofi (SNY - Free Report) announced that the European Commission has granted marketing authorization to its once-daily injection, Suliqua a combination of diabetes drugs Lantus and lixisenatide (EU trade name: Lyxumia) for the treatment of diabetes. The drug was approved in the EU in combination with metformin to improve glycemic control, which has not been provided by metformin alone or by a combination of metformin and another oral glucose-lowering medicinal product or basal insulin.
Shares of Sanofi have outperformed the Zacks classified Large Cap Pharma industry in the last one month. The stock gained 5.7% during this period, compared with the broader industry’s increase of 0.8%.
Suliqua will be delivered in two pre-filled pens providing different dosing options using solostar technology.
The approval did not come as a surprise given that the combination had been granted a positive opinion by the Committee for Medicinal Products for Human Use in Nov 2016.
We remind investors that Suliqua was approved by the FDA in Nov 2016 under the brand name Soliqua 100/33. It is available in the U.S. since Jan 4, 2017 as a single pre-filled pen for once-daily dosing covering 15–60 units of Lantus and 5–20 mcg of lixisenatide using solostar technology.
The EU marketing approval was based on positive data from two phase III studies – LixiLan-O and LixiLan-L. The studies, conducted in more than 1,900 patients, showed that Suliqua led to a statistically superior blood sugar (HbA1c) reduction, compared to lixisenatide and Lantus in LixiLan-O as well as to Lantus in LixiLan-L.
With the approval, Sanofi is authorized to market Suliqua in 28 member states of the EU, in addition to Iceland, Liechtenstein and Norway. Launches in individual EU countries are anticipated to begin in the second quarter of 2017.
Considering recent market trends, Sanofi expects global diabetes sales to decline in the next few years as its diabetes franchise is under significant pressure with its key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets (including Germany, th UK, Netherlands and Denmark) and Japan.
Sanofi currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 2.2% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 49 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>
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Sanofi Diabetes Drug Suliqua Wins EU Marketing Approval
Sanofi (SNY - Free Report) announced that the European Commission has granted marketing authorization to its once-daily injection, Suliqua a combination of diabetes drugs Lantus and lixisenatide (EU trade name: Lyxumia) for the treatment of diabetes. The drug was approved in the EU in combination with metformin to improve glycemic control, which has not been provided by metformin alone or by a combination of metformin and another oral glucose-lowering medicinal product or basal insulin.
Shares of Sanofi have outperformed the Zacks classified Large Cap Pharma industry in the last one month. The stock gained 5.7% during this period, compared with the broader industry’s increase of 0.8%.
Suliqua will be delivered in two pre-filled pens providing different dosing options using solostar technology.
The approval did not come as a surprise given that the combination had been granted a positive opinion by the Committee for Medicinal Products for Human Use in Nov 2016.
We remind investors that Suliqua was approved by the FDA in Nov 2016 under the brand name Soliqua 100/33. It is available in the U.S. since Jan 4, 2017 as a single pre-filled pen for once-daily dosing covering 15–60 units of Lantus and 5–20 mcg of lixisenatide using solostar technology.
The EU marketing approval was based on positive data from two phase III studies – LixiLan-O and LixiLan-L. The studies, conducted in more than 1,900 patients, showed that Suliqua led to a statistically superior blood sugar (HbA1c) reduction, compared to lixisenatide and Lantus in LixiLan-O as well as to Lantus in LixiLan-L.
With the approval, Sanofi is authorized to market Suliqua in 28 member states of the EU, in addition to Iceland, Liechtenstein and Norway. Launches in individual EU countries are anticipated to begin in the second quarter of 2017.
Considering recent market trends, Sanofi expects global diabetes sales to decline in the next few years as its diabetes franchise is under significant pressure with its key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets (including Germany, th UK, Netherlands and Denmark) and Japan.
Sanofi Price
Sanofi Price | Sanofi Quote
Zacks Rank & Key Picks
Sanofi currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 2.2% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 49 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>