We are a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. Through the application of our proprietary technologies, we have established a pipeline of therapeutic product development programs in multiple disease areas. We are committed to developing therapeutic products that we believe have best-in-class potential, meaning therapeutic candidates that have the potential to be safer, more effective products than the current standard of care or other products in development, and that may have other advantages, such as superior scalability, safety or ease of administration. Our current product development portfolio consists of MultiStem®, a patented and proprietary stem cell product that we are developing as a treatment for multiple disease indications, and that is currently being evaluated in two Phase I clinical trials (one involving administration of MultiStem to patients suffering from an acute myocardial infarction, or heart attack, and the other for cancer treatment support in leukemia and lymphoma patients at risk for certain complications such as Graft versus Host Disease). In December of 2008 we received authorization from the FDA to initiate a third Phase I clinical trial involving administration of MultiStem to patients suffering an ischemic stroke, which affects more than 700,000 individuals each year in the United States.
In addition to our MultiStem programs, we are developing pharmaceuticals for the treatment of obesity and certain neurological conditions that affect cognition, attention and wakefulness. In the obesity area, we are developing compounds that selectively stimulate the 5HT2c serotonin receptor in the brain, which is known to play an important role in regulating appetite. These compounds, known as 5HT2c agonists, are designed to reduce appetite and food intake, in order to achieve substantial weight loss over time.
We are also developing novel, orally-active pharmaceutical products for the treatment of certain central nervous system disorders, including sleep disorders such as narcolepsy, or excessive daytime sleepiness, chronic fatigue associated with Parkinson’s disease or other conditions, as well as other potential indications such as attention deficit hyperactivity disorder and other cognitive disorders such as schizophrenia. These programs are focused on the development of potent, selective histamine H3 receptor antagonist compounds that act by elevating levels of neurotransmitters in the sleep and cognitive centers of the brain and stimulating neurological tone. This elevation results in an enhanced state of wakefulness and cognition, without causing hyperactivity, excessive “rebound” sleepiness or addiction. The histamine H3 receptor antagonists being developed at Athersys represent a new class of drugs that could have an improved efficacy and safety profile relative to existing drugs used for the treatment of a range of conditions that affect attention, cognitive ability or wakefulness.
In addition to our commitment to developing best in class therapeutics, we are applying a "fast-follower" approach to product development in multiple areas. This approach allows us to strategically reduce, limit or stage development risks and costs in several ways. In implementing this approach we focus heavily on the following:
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Leveraging the prior (or ongoing) clinical and/or commercial efforts and validation of others, in order to produce better, safer and/or more convenient therapeutics than our competitors (but not developing “me-too” therapeutics)
Our approach and proprietary technologies have enabled us to identify, validate, and develop potential best-in-class therapeutic candidates across multiple disease areas targeted toward clinically meaningful, attractive commercial markets. Our technologies have proven successful multiple times at enabling drug development programs in partnerships we have established with leading pharmaceutical companies, and provide us with the capability to rapidly pursue new opportunities as they arise.
Our long term commercial strategy is to advance products in selected areas through clinical trials and onto the market. While we advance certain programs on our own, we also intend to explore partnering opportunities for some of our programs at various stages of development. In establishing partnerships with other companies, we will seek to expand our capital resources, broaden our capabilities and maximize value for our shareholders. |