Intec Pharma asserted that it has partnered with LTS Lohmann Therapie-Systeme AG for manufacturing Company’s lead candidate, Accordion Pill Carbidopa/Levodopa (AP-CD/LD) as a treatment for the severe symptoms in advanced Parkinson’s Disease patients.
As far as the agreement is concerned LTS will manufacture the AP-CD/LD capsules utilising Intec’s proprietary Accordian Pill production technology in LTS’ manufacturing facility in Andernach, Germanyupon the completion of assembly of the production line. Currently, Intec is producing the AP-CD/LD capsules for its Phase 3 clinical trial.
The Andernach facility of LTS’s adheres to U.S Food and Drug Administration’s current Good Manufacturing Practices requirements that assure the proper design, monitoring and control of manufacturing processes and facilities.
Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma said “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.”
It is to be noted that 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