Updates on the regulatory front are eagerly awaited by investors in the pharma/ biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Last week, Sanofi SNY announced that it has filed a new drug application (NDA) with the FDA for the fixed-ratio combination of its diabetes drugs, Lantus (insulin glargine, 100 units/mL) and Lyxumia (lixisenatide). Sanofi is looking to get the fixed-ratio combination approved as a single daily injection for the treatment of adults suffering from type II diabetes.
Sanofi redeemed a priority review voucher with the filing, which if accepted would shorten the review period from the standard 10 months to just 6 months. The company also intends to submit a regulatory application for the combination in the EU in the first quarter of 2016.
According to the company, the fixed-ratio combination could provide an additional treatment option as more than half the people suffering from type II diabetes are unable to maintain their blood sugar levels despite treatment with oral medications or insulin.
We note that Sanofi’s diabetes business is under significant pressure with its best-selling diabetes drug, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets (including Germany, the UK, the Netherlands and Denmark) and Japan. The company’s Diabetes segment recorded global sales of €5.7 billion in the first nine months of 2015, reflecting a year-over-year decline of 4.6% at constant exchange rate (CER). Moreover, considering recent sales trends for the diabetes business and ongoing market dynamics, Sanofi expects global diabetes sales to decline 6–7% at CER in 2015.
As Sanofi is looking to make up for the loss of revenues in the Diabetes segment with the launch of new products like Toujeo and Afrezza, the approval would be a huge boost for the company.
Sanofi is a Zacks Rank #5 (Strong Sell) stock. Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Mylan N.V. MYL and Anika Therapeutics Inc. ANIK. All three carry a Zacks Rank #1 (Strong Buy).
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