PharmaGap Completes Manufacturer Site Audits Required for Clinical Trial Submission

PharmaGap Completes Manufacturer Site Audits Required for Clinical Trial Submission

OTTAWA, ONTARIO--(Marketwire - Oct. 19, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF)("PharmaGap" or "the Company") is pleased to report that quality audits for cGMP (current Good Manufacturing Practices) grade peptide have now been completed by PharmaGap under the direction of Dr. Ken Sokoll, Vice President of Clinical Development and Chief Operating Officer. The audits were performed at the manufacturers' sites and represent a required step toward the submission of an Investigational New Drug ("IND") Application in the United States.

The manufacturers have produced research grade GAP-107B8 and variants for PharmaGap's in vitro and in vivo testing and development program over the past 12 months. The choice of manufacturer is targeted to be made in November by Dr. Sokoll following assessment of the manufacturers' capability for cost-effectively delivering quality-controlled, stable product in quantities and on an expedited timeline, which is required for use in all future testing. This future testing includes scale-up of liposomal formulations and formal GLP safety-pharmacology and toxicology testing for GAP-107B8 during 2012, and all subsequent testing in PharmaGap's clinical trials in humans thereafter.
Regulatory requirements for IND Applications provide that pharmaceutical companies bringing new drugs into clinical trials are ultimately responsible to ensure that processes are in place to assure the control of outsourced activities and quality of purchased materials. Audits of manufacturers are required in order to meet PharmaGap's responsibility to assess, prior to selection of manufacturer, the suitability of the manufacturer to produce in a timely manner the drug product using defined procedures and quality control systems.
Dr. Sokoll commented that "The completion of this audit process and establishment of a manufacturer of clinical grade source for GAP-107B8 peptide in November is a key component in our ability to meet all testing and data generation requirements for the IND submission next year."
About PharmaGap Inc.
PharmaGap Inc. (TSX VENTURE:GAP), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is a novel peptide drug that has been shown to be highly cytotoxic to numerous cancer types, including chemo-resistant cancers, in vitro. For more information on PharmaGap please visit the Company's website at www.pharmagap.com.
Forward Looking Statements
This news release contains certain statements that constitute forward-looking statements as they relate to the Company and its management. Forward-looking statements are not historical facts but represent management's current expectations of future events, and can be identified by words such as "believe", "expects", "will", "intends", "plans", "projects", "anticipates", "estimates", "continues", and similar expressions. Although management believes that expectations represented in such forward-looking statements are reasonable, there can be no assurance that they will prove to be correct.
By their nature, forward-looking statements include assumptions and are subject to inherent risks and uncertainties that could cause actual future results, conditions, actions or events to differ materially from those in the forward-looking statements. If and when forward-looking statements are set out in this news release, PharmaGap will also set out the material risk factors or assumptions used to develop the forward-looking statements. Except as expressly required by applicable securities laws, the Company assumes no obligation to update or revise any forward-looking statements. The future outcomes that relate to forward-looking statements may be influenced by many factors, including, but not limited to: results of ongoing product testing and development; regulatory approvals required to complete development of products; ability to manufacture product at quality and scale for human use on an economically sound basis; patient reimbursement by private and public health insurance programs; unintended side effects of products; competitive products; product liability; intellectual property; reliance on key personnel; risks of future legal proceedings; income tax matters; availability and terms of financing; distribution of securities; effect of market interest rates on price of securities, and potential dilution.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.