To Our Shareholders:
2011 was an important year for Progenics and its Relistor® and PSMA ADC programs.
Company Strategy. We focused as a company during 2011 on defining our strategic direction. This work was accomplished through an in-depth review involving our management team, our Board of Directors and key advisors to Progenics. The task was not an easy one and difficult decisions had to be made.
Our experience with Relistor, as a supportive care product for patients with cancer, and our work with PSMA ADC in patients with prostate cancer, were among the important elements in our decision to concentrate Progenics' work in the field of oncology. As a result, Progenics in 2012 is a more focused company with a clear sense of direction and purpose. Our objective is to pursue a compelling product pipeline in cancer therapeutics that benefits patients and supports the company's further growth.
Relistor. In 2011 we partnered our lead product Relistor with Salix Pharmaceuticals, a specialty pharmaceutical company. As a result of the marketing efforts of Salix, which began April 1, global sales of Relistor increased 67% in 2011 compared to the prior year.
Development work on Relistor continued during 2011 and an application to the FDA was filed in June seeking to expand the Relistor label to include the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. The PDUFA goal date for the FDA to take action on this submission is now July 27, 2012.
We completed the Phase 3 trial of the oral formulation of Relistor in August and announced positive top-line results from this trial at the end of the year. A detailed presentation of the results of this trial will be made at this year's DDW conference in San Diego.
PSMA ADC. Our lead oncology product, PSMA ADC, advanced through dosing levels in a Phase 1 trial in men with advanced prostate cancer. We plan a presentation of data from this trial at this year's ASCO conference in Chicago. We expect that the Phase 1 trial of this antibody-drug conjugate targeting prostate specific membrane antigen will be completed and a Phase 2 trial commenced this year.
I'd like to close this letter with thanks to two individuals. First, to Dr. Paul Maddon who is retiring this June, 26 years after he founded Progenics. I'm pleased that we will have the benefit of Paul's wisdom and experience as he continues on the Board of Directors. Second, to Mr. Mark Dalton, who is retiring from the Board of Directors at this year's annual meeting after having served an extraordinary 22 years as an outside director of the company. Mark's insights and leadership have been an invaluable asset to the Progenics Board. These two talented men have been an important part of Progenics' successes.
Thanks are also due to our research collaborators, to the doctors, nurses and other medical personnel who guided our clinical trials, to the patients who participated in those trials and, of course, to you, our shareholders, for your continuing support of Progenics and our mission to create innovative medicines.
With best regards,