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01-Jul-2019

Intec Pharma Announces Publication of Article Reviewing Accordion Pill's Unique Gastric Retention Platform in Therapeutic Delivery

JERUSALEM, July 1, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announced that a review highlighting the benefits of the Accordion Pill® (AP) oral drug delivery platform was published in the peer-reviewed journal, Therapeutic Delivery.  The article titled, "The Accordion Pill®: unique oral delivery to enhance pharmacokinetics and therapeutic benefit of challenging drugs," highlights the technical and clinical achievements of the AP platform in a variety of applications. The article is now available online as an e-publication ahead of print and can be accessed here.

The AP is an oral drug delivery system that uses biodegradable polymeric films, which combine and load drugs and inactive ingredients onto the films, folds the films into an undulated shape and then places them inside a capsule. This innovative drug delivery system has a number of unique advantages based on its gastric retention properties. With the AP, drug is released slowly in the stomach over hours, allowing the body to absorb it more steadily. The unique gastric retention performance of the platform is due to the size, shape and mechanical properties of the physical multilayer structure which unfolds to a planar structure once it reaches the stomach.

A variety of Phase 2 clinical studies of AP have demonstrated gastric retention and improved pharmacokinetic (PK) properties for several drugs including those with a narrow absorption window, narrow therapeutic window and/or poor solubility.

"The AP facilitates the development of molecules with poor solubility and permeability and the enhancement of drugs that suffer from a narrow absorption window and short half-life, leading to the possibility of better dosage forms, new indications and potentially better safety profiles," stated Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma and author of the journal article.  "Based on the performance characteristics of the AP, we have advanced AP-Carbidopa/Levodopa (AP-CD/LD) to a late-stage Phase 3 clinical study in Parkinson's disease (PD).  We also have engaged in a feasibility agreement for the development of a custom-designed AP for a proprietary compound with Novartis Pharmaceuticals and a similar type of research collaboration with Merck & Co."

In Phase 2 studies in PD patients, AP-CD/LD produced stable LD plasma concentrations and provided daily coverage of LD therapeutic plasma levels that resulted in significantly less total daily OFF time in comparison with those receiving an active control or their current treatment. In addition, AP formulation of a poorly soluble drug demonstrated an extended absorption phase and greater exposure compared with the commercial formulation of the drug.

"We are pleased to have this review of the AP platform's capabilities published in a peer-reviewed journal article as it enhances awareness of the flexibility and versatility of AP to address a number of challenges in the delivery of poorly soluble drugs and/or drugs with a narrow absorption window," commented Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.  "We are well-positioned to build upon our AP drug delivery technology platform with partner-sponsored R&D programs, such as the Novartis and Merck collaborations, as well as with internally-led drug reformulation programs. Our AP platform offers multiple opportunities to enhance the characteristics of a wide variety of proprietary compounds and develop innovative approaches for the treatment of diseases with its unique gastric retention platform."

About Intec Pharma Ltd.

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 utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage Phase 3 development for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with Novartis Pharmaceuticals and a research collaboration with Merck & Co. 

For more information, visit www.intecpharma.com. Intec Pharma routinely posts information that may be important to investors in the Investor Relations section of its website.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our ability to continue as a going concern, our ability to obtain additional financing, our ability to successfully operate our business or execute our business plan, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, manufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influence of extensive and costly government regulation. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in our most recent Annual Report on Form 10-K filed with the SEC on February 27, 2019, and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

Intec Pharma Investor Contact:
Anne Marie Fields  
VP-Corporate Communications & Investor Relations   
+1-646-200-8808 
amf@intec-us.com

 

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SOURCE Intec Pharma Ltd.

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Last Updated: 01-Jul-2019