 |
|||
 |
 |
 |
|
Shareholders Letter
Dear Shareholders:Early in 2008, we achieved our most significant accomplishment – the approval of our first pharmaceutical product!
During 2007, we submitted our first New Drug Application to the U.S. Food and Drug Administration (FDA) for our lead product candidate, RELISTOR. In collaboration with Wyeth, regulatory marketing applications for RELISTOR were also submitted in the European Union, Australia and Canada.
In late March 2008 and after priority review, RELISTOR received marketing approval from Health Canada, the Canadian regulatory agency. This event marked the first approval of this first-in-class medication anywhere in the world and the first drug approval for Progenics. In Canada, RELISTOR (methylnaltrexone bromide injection) for subcutaneous use is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care.
We await FDA’s decision, scheduled for April 30, 2008, regarding marketing approval for RELISTOR in the U.S. We also await decisions from Europe’s European Medicines Agency (EMEA) by mid-year and thereafter a decision rendered by Australia’s Therapeutic Goods Administration (TGA).
We took the strategic decision to make RELISTOR available to patients with the greatest unmet medical need first, where the benefit was clear. Since January 2006, the development of RELISTOR has greatly benefited from our collaboration with Wyeth. Together, we are developing RELISTOR in three formulations designed to expand the clinical utility of this drug beyond the palliative care setting to all patients who can benefit from its use. Therefore, results from additional clinical studies in 2008 will be important for the market expansion of this product.
In the second half of 2008, we and Wyeth plan to announce results from a phase 3 study of subcutaneous RELISTOR to treat OIC in patients receiving opioids for chronic, non-cancer pain. We also expect to have completed phase 2 studies evaluating oral forms of RELISTOR in this patient setting by mid-2008.
In the post-operative ileus (POI) setting, preliminary results from a Wyeth-led phase 3 clinical trial of the intravenous formulation of RELISTOR in patients recovering from segmental colectomy surgical procedures showed that RELISTOR treatment did not achieve the primary end point of the study: a reduction in time to recovery of gastrointestinal function. Currently, we and Wyeth are conducting further analyses of that clinical study. By mid-2008, we plan to complete analysis of a second phase 3 clinical study conducted by us of intravenous RELISTOR for the management of POI.
In addition to our first product approval, we have focused on furthering our programs in the areas of human immunodeficiency virus (HIV) infection and prostate cancer. We are particularly pleased with the progress of PRO 140, our humanized monoclonal antibody therapy that targets the co-receptor CCR5, a novel therapeutic approach designed to prevent entry of HIV into immune system cells.
In July 2007, we presented positive data from a phase 1b clinical trial of PRO 140 at the International AIDS Society meeting in Sydney, Australia. In this study, treatment with PRO 140 resulted in significant and prolonged viral load reductions following a single dose in HIV-infected individuals. We are enthusiastic about the prospects for PRO 140, because we believe that it has the potential to complement existing therapies at different stages of HIV treatment. By early 2009, we expect results from two, multiple-dose-level phase 2 clinical trials of PRO 140 in HIV-infected individuals. These studies are designed to assess the most feasible dosing regimen for this therapy to advance into pivotal studies.
In 2007, we also prepared our antibody-drug conjugate, PSMA ADC, for testing in patients with metastatic prostate cancer. Our fully human monoclonal antibody-drug conjugate selectively targets prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. We plan to file an Investigational New Drug Application with FDA for PSMA ADC shortly and begin clinical testing of this innovative therapy in the coming months.
We thank our investors – many of whom have been with us for our entire 10-year life as a public company. We are also very grateful to the patients, caregivers and clinical investigators who have supported our efforts, as well as our collaborators at Wyeth.
As we look forward, we see 2008 as a transforming year for Progenics with the sales of our first approved product, RELISTOR (methylnaltrexone bromide injection) for subcutaneous use, decisions regarding marketing of this product in the U.S., European Union and Australia, the completion of two phase 2 studies of our novel HIV therapy, PRO 140, and the commencement of clinical trials for our antibody-drug conjugate therapy to treat metastatic prostate cancer.
The development of innovative, breakthrough drugs that are first-in-class are crucial in the current commercial environment. Progenics will continue to strive to set an example of leadership and innovation in the biotechnology industry. Given the dedication of our employees, our strong collaboration with a global pharmaceutical company, and the novel focus of our development programs, we are confident about our path ahead.
Sincerely,
Founder, Chief Executive Officer and Chief Science Officer
April 2008