Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the European Commission (EC) has approved a label expansion of Trisenox. Now, Trisenox in combination with retinoic acid can be used for the first-line treatment of low-to-intermediate risk Acute Promyelocytic Leukemia (APL).
Trisenox is presently approved to treat patients with relapsed or APL characterized by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha (PML/(RARα) gene.
The approval in the first-line setting was expected as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had granted a positive recommendation for the indication in October.
The decision was based on published academic data which demonstrated the benefit of Trisenox as the first chemotherapy-free treatment for APL.
According to the company, Trisenox, in combination with retinoic acid, can increase survival rates, dramatically reduce the risk of relapse, and help avoid chemotherapy-related side effects in low-to-intermediate risk APL patients. It has been seen in clinical studies that Trisenox, in combination with retinoic acid, can lead to a 99% overall survival rate with almost no relapses after more than four years (50 months) of median follow-up.
Notably, APL is an aggressive sub-type of acute myeloid leukemia (AML). In Europe, approximately 1,500 to 2,000 people are diagnosed with APL annually, according to the company’s press release.
For Teva, 2016 has been a transition year as it is working on the integration of Actavis Generics – Allergan plc’s (AGN - Free Report) 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 its key multiple sclerosis drug 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 (NVS - Free Report) generic arm – Sandoz – and partner Momenta Pharmaceuticals, Inc. (MNTA - Free Report) launched Glatopa, its once-daily generic version of Copaxone 20 mg.
Teva 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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