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Impax (IPXL) Applies for Generic Aubagio; Sanofi Files Lawsuit

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Impax Laboratories, Inc. announced that it has filed an Abbreviated New Drug application (ANDA) with the FDA for a generic version of Sanofi’s Aubagio (teriflunomide) tablets, 14 mg. Aubagio has been approved for the treatment of relapsing forms of multiple sclerosis (MS).

Impax’s share price has plunged 61.8% in the past one year compared with Zacks classified Medical-Generic Drugs industry’s fall of 32.4%.

Coming to the latest news, Aubagio became part of Sanofi’s (SNY - Free Report) portfolio through the Genzyme acquisition. Sanofi has filed a patent infringement lawsuit against Impax in the U.S. District Court for the District of Delaware.
According to Sanofi, Aubagio had posted sales of €334 million in third-quarter 2016, ending Sep 2016.

The Impax’s Generics segment has been under pressure, lately, due to continued competition among high-volume generic products, like Solaraze and Skelaxin, as well as lower sales of Adderall XR. In addition, for generic products acquired from Teva Pharmaceutical Industries Limited (TEVA - Free Report) , Impax undertook price concessions as high as 35% in order to retain its key customers. Impax acquired 18 generic products (including 15 marketed products) from Teva and Allergan plc in Aug 2016 and full commercial rights to the generic version of Concerta as well. These reductions produced significantly lower-than-expected operating cash flows.

The company expects reduced contributions primarily from Teva-acquired products and other legacy products in the portfolio. Due to market dynamics, the company estimated launching fewer generic products in 2016. Impax lowered its 2016 outlook to reflect management's current expectations with respect to prescription trends, pricing and inventory levels, and the anticipated timing of the future product launches and events.

Zacks Rank

Impax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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