One week after reporting success in a clinical trial of Fremanezumab, a drug for treatment of chronic migraine headaches, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) yesterday also reported success in a Phase III trial of the same drug as a treatment for acute migraines - a much larger market for the company. The trial showed that patients treated with monthly and quarterly dosages experienced substantial and statistically significant improvement, thereby meeting all the preset targets.
Teva expects to submit its request for US marketing approval in the second half of this year, and to launch the drug in the second half of 2018.
"We are now complementing last week's announcement of success in the trial for chronic migraines with success in the trial for acute migraines. These two things together are very good news for patients," acting Teva CEO Yitzhak Peterburg said. "Migraines are a disease that severely disrupts the course of ordinary life, and there are 75 million patients in the world, 10% of whom suffer from chronic migraines."
Teva obtained the drug as part of its acquisition of Labrys three years ago. The drug is believed likely to prove a blockbuster when it reaches the market, compensating Teva for its loss of sales and profits from Copaxone, Teva's flagship drug for treatment of multiple sclerosis.
Peterburg continued, "There is a dispute about the volume of the market, and how much people will be willing to pay for the drug. I have no intention of discussing Teva's marketing strategy, so I will not talk about the market volume in dollars. Nevertheless, we are confident that this is a very significant drug for patients and a very significant one for Teva, which is distinguishable from the competition. Without citing figures, Teva undoubtedly has a multibillion dollar drug."
"Globes": Is this the hoped for replacement for Copaxone?
Peterburg: "Life is not based on substitutes for anything. Copaxone is an amazing drug that we have had for 20 years, and which is still surprising everyone. A drug does not disappear overnight, or even in a year. Teva is building itself correctly in the innovative drug business."
The fact that Teva's drug can be administered once every three months is likely to distinguish it from its competitors. Peterburg states that it gives patients more control and more comfort. "Most patients today do not have suitable drugs. There are drugs that attempt to predict migraine attacks, and this does not always work. Our drug meets the 25 indices we measured in the two trials, and the result is good news for patients – there is a treatment."
Credit Suisse writes that the drug's effectiveness is apparently lower than expected, but that the flexibility in administering it once a month or once a quarter will give Teva with an advantage and differentiation in a market crowded with competitors. Teva's current market cap is $29.2 billion.
Published by Globes [online], Israel Business News - www.globes-online.com - on June 8, 2017
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