Gallus Enters Agreement with Progenics Pharmaceuticals, Inc. for Manufacture of Anti-PSMA Monoclonal Antibody
(St.Louis, Missouri, August 21, 2014)– Gallus BioPharmaceuticals, LLC, a premier, full service biopharmaceutical contract development and manufacturing organization (CMO) announced today that it has been selected by Progenics Pharmaceuticals, Inc., an oncology company focused on the development of innovative approaches to targeting and treating cancer, to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate. Under the agreement the antibody will be produced in Gallus’ commercial manufacturing facility in St. Louis, Missouri for use in ongoing clinical trials.
“Our extensive commercial manufacturing experience and proven quality systems make Gallus an ideal partner to support Progenics in the manufacture of their anti-PSMA antibody,” said Mark R. Bamforth, President & CEO of Gallus. “We look forward to working with Progenics as they advance this treatment for patients with prostate cancer.”
PSMA ADC is a fully human monoclonal antibody-drug conjugate designed to deliver chemotherapeutic drug selectively to prostate cancer cells. It does so by targeting the three-dimensional structure of PSMA, a protein that is a clinically validated biomarker of prostate cancer which is expressed on the surface of prostate cancer cells. The PSMA antibody produced at Gallus is designed to internalize into the cancer cell, release active anti-cancer drug, and destroy the malignant cell.
“Gallus has impressed us with their ability to meet our high standards, combined with the experience and expertise necessary to manufacture our anti-PSMA antibody,”said Nitya Ray, PhD, Sr. Vice President, Manufacturing of Progenics. “We look forward to a productive partnership with Gallus as we develop this product for patients in need of this therapy.”
About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional development and manufacturing services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records. For additional information, please visit www.gallusbiopharma.com.
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics’ first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic in a two-cohort phase 2 clinical trial and a small molecule targeted imaging agent that has completed patient dosing in a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics’ first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. For additional information, please visit www.progenics.com.
This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. Information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Information on or accessed through its website is not included in its SEC filings.