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Data on Teva's Azilect

Zacks Equity Research

Teva Pharmaceutical (TEVA) and H. Lundbeck A/S recently presented positive data on Azilect from a double-blind, placebo controlled, randomized, multicenter study.

Teva and H. Lundbeck said that Azilect met its primary endpoint in the ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease) study, which was conducted to evaluate the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo.

Results showed that Azilect, when added to dopamine agonists, achieved a statistically significant improvement in total Unified Parkinson’s Disease Rating Scale. Teva said that Azilect was well-tolerated with no significant difference in adverse events compared to placebo.

Azilect is currently approved for the treatment of the signs and symptoms of Parkinson's disease both as initial monotherapy and as an add-on treatment to levodopa later in the disease. This is the first time that Azilect’s efficacy in combination with dopamine agonist monotherapy has been studied. The ANDANTE study results provide the company with proof-of-concept for adding Azilect to dopamine agonists.

We note that Azilect is currently in a phase IV study, MODERATO (Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Rasagiline on Cognition in Patients with Parkinson’s disease), which is being conducted to evaluate the effect of Azilect on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).

Azilect, which is a part of Teva’s central nervous system (CNS) portfolio, posted sales of $420 million in 2012, up 7%. Other players in the Parkinson's disease market include UCB's (UCBJF) Neupro.

Teva currently carries a Zacks Rank #3 (Hold). Teva is going through a transition period. Headwinds include EU pricing pressure, potential new competition for branded products (especially Copaxone) and fewer generic product launches compared to 2012. We expect investor focus to remain on the execution of the company’s new strategy.

Currently, companies like Mylan, Inc. (MYL) and Akorn, Inc. (AKRX) look better-positioned. Both are Zacks Rank #2 (Buy) stocks. UCB is a Zacks Rank #1 (Strong Buy) stock.

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