Teva Copaxone EU Label To Omit Pregnancy Contraindication
Zacks Investment Research | Dec 06, 2016 09:05PM ET
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that it has received a positive outcome to remove the pregnancy contraindication from the label of its key drug Copaxone in the EU. The latest label update will improve the safety and tolerability profile of the multiple sclerosis drug.
The positive outcome was received through a variation report issued by the UK Medicines and Healthcare Products Regulatory Agency. However, the new label does recommend avoiding the drug during pregnancy unless its treatment benefits outweigh its risks.
On Monday, Teva announced the appointment of Dipankar Bhattacharjee to succeed Sigurdur (Siggi) Olafsson as President and Chief Executive Officer (CEO) of the global generic medicine group. Siggi is stepping down from the post of the CEO and he is due to retire at the end of the first quarter of 2017. Bhattacharjee, on the other hand, has been the CEO of Teva Generics Europe since 2013. Shares of Teva dropped more than 5% on Tuesday as Siggi’s departure took the investment community by surprise.
In fact, Teva’s share price has declined 46.6% so far this year, comparing unfavorably with the Zacks classified Generic Drugs industry’s 38.3% decline.
For Teva, 2016 has been a transitional year as it is working on the integration of Actavis Generics – Allergan plc’s (NYSE:AGN) generics business acquired in August – and is progressing with its branded pipeline. The Actavis Generics acquisition will help the company strengthen its position in the key generic markets. Teva is also looking to strengthen its biosimilar pipeline.
Meanwhile, Teva intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals, and reduce the cost base. However, headwinds remain in the form of generic competition for Copaxone, as well as new competition for branded products. We note that Teva is facing patent challenges for the 40 mg formulation of Copaxone. Last June, Novartis AG’s (NYSE:NVS) generic arm, Sandoz, and partner Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) launched Glatopa, the once-daily generic version of Copaxone 20 mg.
Teva carries a Zacks Rank #3 (Hold). You can see .
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