Sanofi (SNY - Analyst Report) recently gained US Food and Drug Administration approval for Auvi-Q (epinephrine injection) for the emergency treatment of life-threatening allergic reactions in patients at risk or with a history of anaphylaxis.
Auvi-Q is a unique epinephrine auto-injector, which guides the patients and physicians through each step of the injection process with the help of audio and visual instructions. While Sanofi will market the drug in the US, Intelliject, Inc. possesses the rights to the drug in rest of the world.
Currently, epinephrine is the only first-line treatment for anaphylaxis. Mylan (MYL - Analyst Report) markets an epinephrine auto-injector, which is used to treat severe allergic reactions like anaphylaxis. Mylan and Pfizer (PFE - Analyst Report) currently have an agreement for EpiPen, under which Pfizer manufactures and Mylan markets the product. The EpiPen Auto-injector is the best prescribed treatment for severe allergic reactions with a US market share of over 95%.
This is the second regulatory approval for Sanofi in the last few days. Earlier this month, the FDA cleared Sanofi and Regeneron Pharmaceuticals’ (REGN - Analyst Report) oncology candidate, Zaltrap. The FDA approved Zaltrap as a combination therapy for treating patients suffering from metastatic colorectal cancer, who are either resistant to or whose disease has progressed following treatment with an oxaliplatin-containing regimen.
We expect Sanofi to contain operating costs in order to increase earnings in the face of weakening sales of some of its key drugs. We also expect the company to pursue bolt on acquisitions. We are pleased with the company’s efforts to develop its pipeline.
We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #3 Rank (Hold rating) in the short run.