Intec Pharma Ltd. 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. Furthermore, LTS´ Andernach facility has successfully passed audits from all major global regulatory agencies including the European EMA, J-PMDA, KFDA, CFDA, and ANVISA.
In addition to securing commercial scale manufacturing for AP-CD/LD, Intec has made other inroads advancing its pre-commercial strategy. In recent months, Intec has enhanced its leadership with a number of key hires and initiated an in-depth market access analysis of the potential for AP-CD/LD in the Parkinson’s Disease market. Initial results of the market analysis indicate there is a substantial market for AP-CD/LD to potentially serve hundreds of thousands of patients suffering with Parkinson’s Disease.
(Source: Intec Pharma Ltd.)
March 14, 2018