a future filled with opportunities
We have before us a period of remarkable opportunity, based on our diverse pipeline of early- and late-stage compounds, innovative new products and the potential to expand our marketed product labels.
Our growing oncology business and our well-established pain management franchise will play a vital role in the continued growth of our business. Over the next three years, we anticipate several product approvals and launches. In 2008, we are making plans for two U.S. FDA approvals in our oncology franchise, two approvals in our pain management franchise and the launch of our exciting oncology product, TREANDA. Today, our plans for 2009 include the launch of a second oncology product. In addition, we have an ambitious goal to deliver annual basic adjusted EPS growth of 15 to 20 percent through 2010.
Our oncology business will play a vital role in the continued growth of our company. TREANDA is at the forefront of that business, with two U.S. FDA applications filed in both CLL and indolent NHL. If approved, we would launch TREANDA for both of these indications in 2008.
We continue to make progress in our clinical trial with CEP-701 (lestaurtinib) and expect the completion of the trial in 2008. If the data from this program are positive, we anticipate filing for regulatory approval in the U.S. and Europe for this compound as a treatment for certain acute myelogenous leukemia (AML) patients. If approved, we would expect to launch this exciting product in 2009.
Also on the horizon, we expect the U.S. FDA to make a decision on our request for an expanded indication for FENTORA for breakthrough pain in opioid-tolerant patients with specific chronic pain conditions. The U.S. FDA has scheduled an advisory committee to consider this application, with a decision expected by September 13, 2008.
As we prepare for the anticipated launch of a broader label for FENTORA in 2009, our pain management franchise will benefit from a full year of commercial activity for AMRIX. By sampling the product and further expanding our reach into primary care with a 120-person contract sales organization, we are well positioned to grow AMRIX sales in 2008.
Longer term, with U.S. FDA approval and patent protection through 2023, NUVIGIL provides us with an exciting opportunity to extend our wakefulness franchise beyond conditions of sleep and wakefulness. Our strategy is focused on seeking additional data in areas including bipolar depression, disorders associated with excessive sleepiness, negative symptoms in schizophrenia patients treated with antipsychotics, and cancer-related fatigue. With new data, a 2010 launch would provide an even greater opportunity to maximize the value this compound can offer to patients and physicians.
Reaching underserved patients is critical to our continued growth and our global strategy also is focused on broadening usage of our products through geographic expansion. We are expecting approval of our application for EFFENTORA in the European Union in the first quarter of 2008. In addition, if our study of CEP-701 in AML is positive, we expect to file for approval in both the U.S. and Europe.
Europe is already contributing to our growth, with 30 products and a growing oncology business that includes four products. And we are looking beyond Europe to Asia. Last year, modafinil (under the brand name MODIODAL®) was launched in Japan for the treatment of excessive daytime sleepiness associated with narcolepsy by our partners, Alfresa Pharma and Mitsubishi Tanabe Pharma.
Our current efforts seek to cultivate our business in Japan and elsewhere in Asia to help more patients and physicians and to capitalize on opportunities in these burgeoning international markets.
