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Teva's Two Pivotal Studies on Ajovy in Japan Meet Goal

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Teva Pharmaceutical Industries Limited TEVA announced positive results from two phase II/III studies on its new migraine drug Ajovy in patients with chronic and episodic migraines in Japan.

The company has an exclusive license agreement with Otsuka for the development and sales of Ajovy in Japan. The medicine is being developed by Otsuka in the country.

Preliminary data from the studies showed that the primary endpoints were achieved with both clinical and statistical significance compared to placebo. The studies also met all the secondary endpoints by demonstrating statistically significant improvements compared to placebo.

Detailed results from the study will be presented at the upcoming medical conference.

Otsuka/Teva will file regulatory applications seeking approval of Ajovy in Japan based on data from these studies.

Shares of Teva were up 7.2% following the above favorable news on Monday. However, the stock has declined 44.1% in the past year compared with the industry’s decrease of 6.2%.

Ajovy for the prevention of chronic/episodic migraine was approved by the FDA in September 2018 and in the EU in April 2019. The drug is the first and the only anti-CGRP medicine offering both quarterly and monthly dosing options. In the first nine months of 2019, Ajovy recorded sales of $68 million.

Last week, the FDA approved an autoinjector device for Ajovy injection, which is expected to be available to patients in the coming months. During the third-quarter conference call held last November, management informed that Ajovy saw a decline in new prescription shares, which was due to patients’ preference for auto injectors while Ajovy is available as a subcutaneous injection. The approval for the autoinjector device for Ajovy could reignite growth for the drug in 2020.

However, Ajovy faces intense competition from Amgen (AMGN - Free Report) / Novartis NVS and Lilly’s LLY respective CGRPs of Aimovig and Emgality. Both were approved by the FDA in mid-2018. Both are also approved in the EU.

Zacks Rank

Teva currently 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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