Teva Pharmaceutical Industries Ltd. (TEVA) and Alcobra Ltd. announced top-line results on their attention deficit hyperactivity disorder (ADHD) candidate, MG01CI. Results were presented from a six week, randomized, placebo-controlled, phase II multi-center study that was conducted to evaluate the safety and efficacy of the candidate in adults suffering from ADHD.
Results showed that MG01CI met its primary efficacy endpoint by achieving a significant improvement on the Conners’ Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CAARS-INV) compared to placebo.
Results showed that 56% of patients in the MG01CI arm achieved an improvement of at least 25% in their CAARS-INV score compared to 36% of patients in the placebo arm. Moreover, 44% of patients in the MG01CI arm showed an improvement of more than 40% in their CAARS-INV score compared to only 25% in the placebo arm.
MG01CI also showed improvement in secondary endpoints like Adult ADHD Quality of Life Scale (AAQoL) and the Test of Variables of Attention (T.O.V.A.) scores. MG01CI was found to be well tolerated. Teva and Alcobra intend to move the candidate into phase III studies in adults in 2012. The companies also intend to study the candidate in children.
The ADHD market represents huge potential. According to Business Insights, about 23.3 million adults and 21.6 million children and adolescents suffered from ADHD in 2009 in the world’s seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK and Japan), representing a market size of about $5 billion.
Currently available treatments include Shire’s (SHPGY) Adderall, Vyvanse and Intuniv, Johnson & Johnson’s (JNJ) Concerta and Eli Lilly’s (LLY) Strattera.
We currently have a Neutral recommendation on Teva, which carries a Zacks #3 Rank (short-term Hold rating).
