Formulation and film technology manufacturer LTS has announced it will be partnering with Intec Pharma to establish commercial-scale production capabilities for Accordion Pill™ capsules in a US Food and Drug Administration (FDA) compliant facility.
Accordion Pill™ (carbidopa/levodopa) (AP-CD/LD) is indicated as a treatment for the severe symptoms in advanced Parkinson’s Disease patients. Under the agreement, LTS will manufacture the 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 a Phase III 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 FDA’s current good manufacturing practice (cGMP) requirements, which 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 Medicines Agency (EMA), the Japan Pharmaceuticals and Medical Devices Agency (J-PMDA), the Korea Food and Drug Administration (KFDA), China Food and Drug Administration (CFDA) and the Brazilian Health Regulatory Agency (ANVISA).
CEO of Intec Pharma Jeffrey A. Meckler 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 III ACCORDANCE clinical trial in advanced Parkinson’s Disease patients and advance our pre-commercial strategies for AP-CD/LD.”
Chief Operating Officer Nadav Navon added: “Built on nearly ten years of research and development (R&D), 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.”
Chief technology and operating officer of LTS Michael Hoffmann said: “LTS is highly committed to contributing to the innovative opportunities of the Accordion Pill technology for AP-CD/LD. LTS’ well proven capabilities in the scale-up and large volume manufacture meet INTEC’s requirements for a reliable supply conforming with most stringent quality requirements.”
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.
About Intec Pharma
Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The company’s Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilising an efficient gastric retention and specific release mechanism.