Intec Pharma has partnered with LTS Lohmann Therapie-Systeme AG for the manufacture of the company's lead product candidate, Accordion Pill Carbidopa/Levodopa (AP-CD/LD) as a treatment for the severe symptoms in advanced Parkinson's Disease patients. Under the agreement, LTS will manufacture the AP-CD/LD capsules using Intec's proprietary Accordion Pill production technology in LTS' manufacturing facility in Andernach, Germany upon the completion of assembly of the production line. Currently, Intec is producing the AP-CD/LD capsules for its Phase 3 clinical trial at its existing manufacturing facility in Jerusalem and will work together with LTS to establish commercial scale production capabilities for AP-CD/LD capsules.
LTS' Andernach facility is compliant with the U.S. Food and Drug Administration's current Good Manufacturing Practices (cGMP) requirements that assure the proper design, monitoring and control of manufacturing processes and facilities. LTS´ Andernach facility has successfully passed audits from all major global regulatory agencies including the European EMA, J-PMDA, KFDA, CFDA and ANVISA.
"We are particularly pleased to be partnering with LTS, a global leader in the commercial manufacture of formulation and film technologies for the pharmaceutical industry. This is a key achievement for Intec as we near completion of our pivotal Phase 3 ACCORDANCE clinical trial in advanced Parkinson's Disease patients and advance our pre-commercial strategies for AP-CD/LD," said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma."