December 01, 2004

Bristol Myers Squibb Provides Plan on Abilify

In Late November, Bristol-Myers Squibb provided an R&D Review of their plans going forward with Abilify (to investor groups). Following is an excerpt of this presentation by David Boyko, the Bristol-Myers Senior Vice President of Global Medical Affairs and Lifecycle Management.

[Note: Bristol Myers is an advertiser here at at this time - but we try to cover all new developments in schizophrenia equally, no matter what the source. This information below is just a short except from a very long presentation by Bristol-Myers. As with any information provided by a company on its own products... take any commentary that is "positive" with a heavy dose of skepticism]:

  In the next few minutes or so, I'll discuss each compounds profile, a revision on its future, and a development program that will help us attain that vision. I will start with Abilify.

   As you know, Abilify is a new generation antipsychotic, with a novel mechanism of action and excellent tolerability, including a low instance of sedation and low likelihood of weight gain or lipid changes. Abilify is a partial agonist at the dopamine and serotonin receptors. It stabilizes both dopamine and serotonin transmission instead of simply blocking transmission. Put another way, it is a net antagonist when serotonin and dopamine levels are high, and a net agonist when levels of these transmitters are low.

   Now, based on its novel mechanism of action, we are focusing on new areas that differentiate Abilify from other antipsychotics. These fall into two categories. First, we'll be focusing on disorders where there is a reduction in dopamine and serotonin transmission, such as the depressive disorders. And second, we'll address conditions associated with dysfunction of dopamine modulation, such as certain pediatric disorders, in substance dependence, and in cognitive deficits associated with psychiatric disorders.

   Our vision for Abilify therefore is to do three things. First, to firmly establish Abilify in the traditional antipsychotic arenas, such as schizophrenia and bipolar disorder. We're well on track in this regard. Second, to continue to differentiate Abilify from other antipsychotics. Based on data to date, indicating that the use of Abilify is associated with a lower likelihood of either weight gain or potentially harmful lipid changes, and with improvement in cognition. At the same time, we'll be developing multiple formulations for ease-of-use in the acute settings. This will further establish Abilify's overall effectiveness as a convenient well-tolerated and efficacious medicine. Third, we will further differentiate Abilify through a series of comprehensive registrational programs, designed to capitalize on its novel mechanism of action. These include adjunctive treatments in depression, bipolar depression, pediatric disorders and substance abuse.

   So here is our plan, our schedule, to realize this vision, not only in the U.S. but in other markets around the world. Building on our approvals in schizophrenia and acute bipolar mania, and to date by the way Abilify gained approval for a second indications faster than any other atypical antipsychotic, you can see how we'll be delivering a new formulation, new indications, and more robust data to support current areas of differentiation.

   So in the near term, here is when we expect several of these deliverables. In the first half of 05, we expect FDA approval for two new formulations, liquid and the disintegrating tablet, and a new indication for bipolar maintenance. By the end of this year, we'll be filing with the FDA for an acute agitation indication in both schizophrenia and bipolar mania with our new antimosity formulation. Lastly, we've now started programs in the other new areas. Overall, we are investing heavily in Abilify to build on its novel mechanisms to provide patients and physicians with new treatments for psychiatric diseases with significant unmet medical need.


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