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Several catalysts should play out for Teva this year. With the impending loss of the Copaxone patent in September 2015, the company is strengthening its MS franchise. Teva has submitted an application for a three-time-per-week 40mg/ml dose of Copaxone, with an expected launch in 2014. The new formulation of Copaxone is protected until 2030. In addition to Copaxone, the company has also submitted Laquinimod—an oral MS drug—for approval in the EU. The decision is expected by the end of the year. For U.S. approval, the company has initiated a third phase III trial CONCERTO for Relapsing Remitting Multiple Sclerosis (RRMS). The data readout should be in 2016, with the potential to reach the U.S. market in 2018.
Through its partnerships, the company is extending its reach into cardiovascular disease (CV). This is a huge unmet need. The American Heart Association (AHA) estimates that 80 million adults in the United States (approximately one in three) have one or more forms of CV. CV is associated with 1 million deaths, 1 million heart attacks, 400,000 strokes, and 350,000 sudden deaths per year in the U.S. alone. The company has a partnership with Mesoblast for its proprietary product, mesenchymal progenitor cells (MPCs). Mesenchymal—or human stromal—stem cells are non-hematopoietic progenitor cells that have the ability to transform into a variety of structural tissues in the laboratory. Although the precise signals necessary to direct cell differentiation to specialized cells are not known, placement of a precursor cell into the appropriate environment is believed to trigger the secretion of a number of cytokines (growth factors) that then exert an endogenous response, allowing the body to initiate the repair mechanisms. These cells are believed to be more potent than mesenchymal stem cells (MSCs) further downstream in the cell lineage. They are selected via unique expression of STRO-3, a surface marker only found in the earliest precursors of the mesenchymal lineage. These cells have multipotential capability. The resulting cell type is able to secrete potent cytokines that allow an endogenous repair and regenerative response. Teva and Mesoblast are testing these in clinical trials in multiple CV indications.
Teva Pharmaceutical Industries Ltd. (TEVA)
Maxim Group LLC 6
The most advanced program in CV is a clinical trial in congestive heart failure (CHF). The MPC in phase II data reached its primary endpoint of safety and feasibility, with no adverse events associated with the treatment. Even though the trial was not powered to show statistical significance, a single administration of 150M MPC induced sustained improvement in heart-failure-related hospitalizations and no cardiac deaths in the 30-month time frame. The CHF phase III trial is expected to initiate in 2013........ Be patient I have lots to report .V