Sanofi SNY announced that the FDA has approved its once-daily injection, Soliqua 100/33 – a combination of its diabetes drugs, Lantus and lixisenatide (EU trade name: Lyxumia) for the treatment of type 2 diabetes in adults who have inadequately controlled their disease with basal insulin or lixisenatide.
The combination drug was submitted for review in a total of 10 markets, including the EU. However, it has not yet been approved by any regulatory body outside the U.S.
Soliqua 100/33 was studied in a phase III program of more than 1,900 patients. The study showed that patients treated with Soliqua 100/33 experienced similar rates of documented hypoglycemia compared to Lantus-treated patients. Also, Soliqua 100/33 showed better average blood sugar lowering than Lantus.
Soliqua 100/33 will be available in U.S. retail pharmacies starting Jan 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.
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, UK, Netherlands and Denmark) and Japan. Moreover, a biosimilar version of Lantus could hit the U.S. markets by the end of 2016.
Sanofi carries a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked stocks in the healthcare sector include Incyte Corporation INCY, Anika Therapeutics ANIK and Exelixis, Inc. EXEL. All the three stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Incyte’s earnings estimates increased from 20 cents to 68 cents for 2016 and from $1.42 to $1.68 for 2017 over the last 60 days. The company posted a positive average beat of 431.43% over the last four quarters.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 20.6% year to date.
Exelixis’ loss estimates narrowed from 63 cents to 47 cents for 2016 and from 3 cents to earnings of 5 cents for 2017 over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 38.52%. Its share price has skyrocketed above 200% year to date.
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