Teva jumps on FDA approval for generic EpiPen

August 19, 2018 10:51
1 minute read.
Teva jumps on FDA approval for generic EpiPen

THE TEVA building in Jerusalem.. (photo credit: REUTERS)


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Thursday was a good day for Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) with the share price rising 7.30% to $24.11, giving a market cap of $24.55 billion. The Israeli pharmaceutical company has now recovered its sharp losses following the announcement of its second quarter results two weeks ago.

Yesterday's gains came after two positive pieces of news. Firstly, Teva announced a successful Phase III trial for Fasinumab for the treatment of chronic pain caused by osteoarthritis of the knee or hip. Secondly, the US Food and Drug Administration (FDA) granted marketing approval for a first generic version of EpiPen, Mylan's branded treatment for severe, life-threatening allergies.

EpiPen is Mylan's flagship branded drug, which it acquired from Merck KGaA in 2007. Teva has had a protracted wait for FDA approval for generic EpiPen after its 2016 application was rejected on the grounds that a generic version could only be launched in 2017. In the end approval has been awarded only now.

EpiPen has had a controversial history with serious complaints two years ago about price hikes and a $465 million settlement in a compromise agreement with the government Medicaid insurance program over incorrect classification.

Teva said, We have received us approval for our generic version of the EpiPen injectable (epinephrine injection OSP) in 0.3 and 0.15 mg dosages, representing an important step in providing more prescription treatments for our patients that meet the FDA's rigorous standards."

Teva added, "We will allocate maximum resources in the coming months and expect to bring this product to market. With its launch, Teva's generic product will be EpiPen's only generic version."

Mylan is a bitter rival of Teva. Three years ago Mylan was the target of an unsuccessful hostile takeover by Teva. Mylan for its part, ten months ago, brought to market the first generic version of Teva's 40 mg dosage of flagship blockbuster drug Copaxone for the treatment of multiple sclerosis.

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