The formulation, known as Accordion Pill Carbidopa/Levodopa (AP-CD/LD), is for people with advanced Parkinson’s disease.
LTS will manufacture the capsules using Intec’s proprietary Accordion Pill production technology at a facility in Andernach, Germany.
AP-CD/LD is a new version of the commonly used Parkinson’s therapy Carbidopa/Levodopa. Current formulations of levodopa offer limited effectiveness because levodopa’s absorption is restricted to the upper part of the gastrointestinal tract. The AP-CD/LD formulation allows the drug to be released in both an immediate and a controlled manner by retaining it in the GI tract.
A Phase 2 clinical trial showed that the time when AP-CD/LD wasn’t working — that is, when symptoms return — was significantly reduced in patients who received AP-CD/LD. The trial also showed that the formulation was safe.
Intec has a manufacturing facility in Jerusalem that has been producing AP-CD/LD capsules for a Phase 3 clinical trial (NCT02605434). It plans to work with LTS on commercial production of AP-CD/LD once the formulation is approved.
“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,” Jeffrey A. Meckler, the CEO of Intec Pharma, said in a press release.
LTS’s manufacturing facility meets U.S. Food and Drug Administration Good Manufacturing Practices requirements. These standards are aimed at ensuring the proper design, monitoring and control of manufacturing processes and facilities.
LTS’s German facility has also passed muster with other major global regulatory agencies, including Europe’s and Japan’s.
“Built on nearly 10 years of research and development, our state-of-the art and proprietary manufacturing process for the Accordion Pill is in good hands with LTS and its team of experts at it cGMP facilities,” said Nadav Navon, the chief operating officer of LTS.