Teva's Trisenox Gets FDA Approval As First-Line Treatment
Zacks Investment Research | Jan 15, 2018 10:02PM ET
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that the FDA has approved the label expansion of Trisenox injection to include first-line treatment of acute promyelocytic leukemia (“APL”) patients in combination with tretinoin.
The eligible APL patients should have t(15;17) translocation or PML/RAR-alpha gene expression.
Trisenox is currently approved for a similar indication in patients who are refractory/relapsed to retinoid and anthracycline chemotherapy.
The drug is already approved in the EU as both first-line and second-line treatment for this indication.
Teva’s shares have declined 35% in the past year, underperforming the industry ’s decline of 19% in that period.
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 relapse after more than four years (50 months) of median follow-up.
Teva’s oncology portfolio includes five drugs, which performed well in the third quarter of 2017. It registered year-over-year growth of 12% to reach $302 million. The label expansion of Trisenox is expected to further boost the portfolio’s performance in the coming quarters.
However, Teva is facing headwinds due to pricing pressure in the generics industry. Also, the approval of Mylan’s (NASDAQ:MYL) generic version of its key drug, Copaxone, in October last year had a negative impact on its fourth quarter revenue guidance.
Moreover, the Israeli firm is also facing a huge debt load, which swelled with the acquisition of Allergan’s (NYSE:AGN) generic division in 2016.
In a bid to get rid of its problems, the company brought in a new chief executive officer (“CEO”), Kare Schultz, who had played an instrumental role in the turnaround of Denmark’s H. Lundbeck A/S, which was struggling with a string of losses. He also worked as the chief operating officer of another Denmark based drug giant, Novo Nordisk (CO:NOVOb) A/S (NYSE:NVO) .
The new CEO announced restructuring plans in December 2017 in order to reduce cost and improve business performance, profitability, cash flow generation and productivity. Teva has announced to cut about 14,000 job cuts (more than 25% of the company’s global workforce) over the next two years with the majority expected in 2018. The company will also shut down many of its offices and R&D facilities around the globe and divest the assets. The moves are expected to reduce its $16.1 billion cost base (estimated for 2017) by $3 billion at the end of 2019.
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