 |
|||
 |
 |
 |
|
Shareholders Letter
A Message from the CEODear Shareholders, Employees and Friends,
In 2008, Progenics Pharmaceuticals achieved
its first U.S. product approval: RELISTOR .
This first-in-class drug is now approved in over 30 countries.
Progenics has entered a new era since our first commercial product approval.
Following FDA approval last April, our collaborator, Wyeth Pharmaceuticals, began
full commercialization of subcutaneous RELISTOR in August for the treatment of
advanced-illness patients with opioid-induced constipation (OIC) - an area of critical
unmet medical need in an important population. Since the launch, we have been
working to extend the benefits of this novel drug to broader populations and other
markets. Part of this effort has been demonstrated by the successful completion of a
pivotal phase 3 trial in chronic pain patients. In October, we signed a license
agreement with Ono Pharmaceutical Co., Ltd. for the development and
commercialization of subcutaneous RELISTOR in Japan.
ONCOLOGY: PSMA ADC for the treatment of prostate cancer
We also made significant progress in our clinical programs, initiating clinical trials of
our investigational drug, PSMA ADC, for the treatment of metastatic prostate cancer.
PSMA ADC is a monoclonal antibody-drug conjugate that targets prostate-specific
membrane antigen, a protein abundantly expressed on prostate cancer cells, making
it a promising therapeutic target. PSMA ADC is comprised of our fully human
monoclonal antibody to PSMA that is linked (conjugated) to a potent
chemotherapeutic drug. PSMA ADC is designed to release the chemotherapeutic
payload after entering the targeted cancer cell, substantially reducing exposure of
surrounding non-cancerous cells to the toxic effects of systemic chemotherapy. We
expect to report initial results from these clinical studies in the second half of 2009.
We also initiated a clinical trial of a novel PSMA-targeted therapeutic vaccine
designed to prevent the relapse and recurrence of prostate cancer.
VIROLOGY: PRO 140 for the treatment of HIV/AIDS
Our HIV program also had meaningful advances in 2008. PRO 140,
our FDA-designated Fast Track investigational humanized monoclonal antibody for
the treatment of HIV/AIDS, successfully completed two, phase 2 clinical trials in
which both subcutaneous and intravenous formulations exhibited robust, potent and
prolonged activity in HIV-infected individuals. We are developing PRO 140 as an
injection to be self-administered, once weekly. We plan to meet with FDA this year
to determine the next steps in the development of this novel viral-entry inhibitor.
While advancing our clinical programs, we are also guided by a conservative
financial strategy, especially during these challenging economic times.
Our significant progress during 2008 was made possible by the financial support of our collaborators, Wyeth and Ono, in the form of upfront and milestone payments, reimbursement by Wyeth of development expenses, and royalties on worldwide sales of RELISTOR. In addition, Progenics has been awarded approximately $70 million in U.S. government grants to date.
We are proud of our strong financial position. Going forward, we will continue to seek multiple non-dilutive revenue sources to conduct leading-edge research and development on our own and through existing and new industry relationships. We will also continue to set an example of leadership and innovation in the biotechnology industry while generating value for our shareholders. I thank you for your continued support.
Sincerely,
Founder, Chief Executive Officer and Chief Science Officer
April 27, 2009