Global leader in formulation and film technology manufacture to establish commercial scale production capabilities for Intec’s lead product candidate in FDA compliant facility

Mar 12, 2018, JERUSALEM, March 12, 2018 /PRNewswire/ —

Intec Pharma Ltd. (NASDAQ, TASE: NTEC) (“Intec” or the “Company”) today announces that it has partnered with LTS Lohmann Therapie-Systeme AG (“LTS”) 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.

“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.”

Nadav Navon, Chief Operating Officer, added “Built on nearly ten 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.”

“LTS is highly committed to contribute to the innovative opportunities of the Accordion Pill technology for Carbidopa/Levodopa. LTS´ well proven capabilities in the scale-up and large volume manufacture meet Intec´s requirements for a reliable supply that conforms with the most stringent quality requirements,” commented Michael Hoffmann, Chief Technology and Operating Officer of LTS.

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.