News | August 21, 2014

Gallus Enters Agreement With Progenics Pharmaceuticals, Inc. For Manufacture Of Anti-PSMA Monoclonal Antibody

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.

“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.

About Progenics
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.

SOURCE: Gallus BioPharmaceuticals, LLC

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