Friday, June 30, 2017
Trovagene, Inc., a precision medicine biotechnology company, today announced it has executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., in Milan, Italy, to manufacture drug product for PCM-075. The agreement covers the clinical and commercial supply of PCM-075 for Trovagene, and includes both Active Pharmaceutical Ingredients (API) and GMP (Good Manufacturing Process) production of capsules.
NerPharMa has previously supplied drug product for PCM-075 in a completed phase 1 study conducted by Nerviano Medical Sciences. NerPharMa has an established manufacturing process scaled for producing PCM-075 for future clinical studies and commercial use. Under the terms of the agreement, Trovagene directs NerPharMa to produce GMP-grade PCM-075 drug substance for use in Trovagene's Phase 1b/2 clinical program and for other related clinical and commercial activities. Trovagene is developing PCM-075, a polo-like kinase 1 (PLK1) inhibitor, and plans to initiate a Phase 1b/2 clinical trial in patients with acute myeloid leukemia (AML).
"This contract represents a significant step forward for the development of PCM-075," said Bill Welch, Chief Executive Officer of Trovagene. "We are excited to have a manufacturer of NerPharMa's caliber and experience producing GMP supply of PCM-075 bulk product and finished capsules. The availability of validated API and the ability to immediately initiate capsule production enables a cost-effective and accelerated start-up of our Phase 1b/2 clinical program."
NerPharMa's GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA) for the production of PCM-075.
"We are pleased to be working with Trovagene to manufacture and provide finished product for their investigational and commercial needs," said Angelo Colombo, CEO of NerPharMa.
