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1/22/2013 2:00:01 PM
Sanofi ( SNY ) recently announced that its epinephrine injection, Allerject, is available in Canada for the emergency treatment of anaphylactic reactions in patients at risk or with a history of anaphylaxis. Allerject is a unique epinephrine auto-injector, which guides the patients and physicians through each step of the injection process with the help of audio instructions.
We note that Allerject is approved in the US under the brand name Auvi-Q. Currently, epinephrine is the only first-line treatment for anaphylaxis. Mylan ( MYL ) and Pfizer ( PFE ) currently have an agreement for EpiPen auto-injector. While Pfizer manufactures the product, Mylan is responsible for its marketing. The EpiPen Auto-injector is the best prescribed treatment for severe allergic reactions with a US market share of over 95%.
We remind investors that several of Sanofi's candidates will be up for approval in the coming quarters. The French pharma giant expects regulatory decisions in the EU on Zaltrap (aflibercept) for second-line metastatic colorectal cancer and Lyxumia (lixisenatide) for type II diabetes by Mar 31, 2013. Moreover, a decision from the US Food and Drug Administration (FDA) regarding Lyxumia's new drug application (NDA) is expected shortly.
Sanofi expects the FDA to give a final decision on its candidate, Kynamro (mipomersen) for treating patients suffering from homozygous familial hypercholesterolemia, by Jan 29, 2013.
We are pleased with Sanofi's efforts to develop its pipeline, which should make significant revenue contributions upon approval. However, we note that Sanofi's biggest challenge is the generic threat that is faced by several of its products.
Sanofi carries a Zacks Rank #2 (Buy) in the short run. Valeant Pharmaceuticals ( VRX ), carrying a Zacks Rank #1 (Strong Buy), currently looks more attractive in the pharma space.
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