Continuing Momentum in 2008
May 2008
 Harvey J. Berger, M.D, |
The past year was among the most successful in the history of our company, with important achievements in all our business areas, highlighted by our landmark partnership agreement with Merck & Co., Inc. for the global development and commercialization of our lead product candidate, deforolimus. ARIAD is well positioned for continued growth in 2008 and beyond as we advance the discovery and development of new molecularly targeted therapies to improve the lives of patients with cancer.
This year, we remain focused on several key corporate goals:
- Maximize the deforolimus opportunity through timely and effective execution of the global development plan with our partner Merck,
- Advance additional product candidates from our innovative oncology pipeline, including initiation of clinical trials with our new multi-targeted kinase inhibitor, AP24534,
- Build a world-class commercial organization to realize the significant value of our cancer product candidates, and
- Maintain a strong financial position while moving the company towards launch of our first product.
We have adopted a comprehensive and ambitious three-year global development plan for our investigational mTOR inhibitor – deforolimus – that includes parallel clinical initiatives and potential paths to product registration in addition to our initial efforts in patients with metastatic sarcomas.
The two primary drivers of the deforolimus opportunity are expeditious completion of the SUCCEED Phase 3 trial of oral deforolimus in patients with metastatic sarcomas and expansion of the global development of deforolimus to include multiple solid tumors. To meet these objectives, ARIAD and Merck are devoting substantial resources to achieving accelerated enrollment in the SUCCEED trial at cancer centers throughout the world. We also anticipate that patients with at least four different types of cancers will be studied in addition to sarcomas: endometrial, prostate, breast, and non-small cell lung cancer.
We will continue to evaluate deforolimus, both as a single agent and in combination with various targeted agents, driven by elucidated mechanisms of action and biology. During 2008, the global development plan calls for conducting multiple clinical trials, including Phase 2 trials in endometrial, breast, and prostate cancers; the successful initiation of these trials will result in substantial milestone payments from Merck. Importantly, our partnership agreement with Merck is structured to make the development of deforolimus largely cost-neutral to ARIAD over the next three years. We take great pride in the collaborative relationship that we have developed with Merck’s organization worldwide.
In late 2007, we also filed the investigational new drug (IND) application for AP24534 and are now proceeding with the clinical development program for this targeted kinase inhibitor, initially in patients with hematological cancers, with a trial in patients with solid tumors to follow. AP24534 has undergone extensive preclinical studies, which demonstrate the activity of AP24534 against the known clinically relevant forms of Bcr-Abl, including the T315I mutant, highlighting its potential to overcome resistance to currently approved therapies in chronic myeloid leukemia.
We expect this year to continue the flow of novel targeted cancer therapies from discovery into development with the goal of advancing our next development candidate into pre-IND studies.
We are well positioned financially to support our key business objectives, and we will continue to invest in the development of our lead oncology product candidates, expansion of our product pipeline with additional innovative, targeted-cancer therapies, and establishment of the commercial capabilities we will need to market and sell our oncology products once approved.
I am very gratified to be able to report these accomplishments to our shareholders, which represent the results of an exceptionally dedicated and talented team at ARIAD. I look forward to communicating again later this year, when I expect that we will have moved even closer to our goals of becoming a fully integrated oncology company focused on delivering innovative and clinically differentiated cancer therapies to patients all over the world, providing a fulfilling experience for our valued employees, and importantly delivering long-term value to our shareholders.
Harvey J. Berger, M.D.
Chairman and Chief Executive Officer
