DiaMedica Inc.

DiaMedica Inc.

November 29, 2011 09:00 ET

DiaMedica Announces Formation of Development Advisory Group for Its DM-199 and DM-204 Diabetes Products

WINNIPEG, MANITOBA--(Marketwire - Nov. 29, 2011) - DiaMedica Inc. (TSX VENTURE:DMA) a biopharmaceutical company focused on the development of novel treatments for Type 1 and Type 2 diabetes announces the formation of a development advisory group for its DM-199 and DM-204 products for the treatment of Type 1 and Type 2 diabetes. The advisory group consists of Dr. Joy Cavagnaro, Dr. Patrick Gearing, and Mr. Larry Johnson; industry experts in the areas of pharmacology and toxicology, manufacturing and regulatory affairs.

"We are pleased to welcome Dr. Cavagnaro, Dr. Gearing, and Mr. Johnson to our product development advisory group. They bring together significant industry experience in protein-based diabetes therapeutics from development, through regulatory approval and commercialization. They have all worked at or closely with the US Food and Drug Administration (FDA) with numerous biotechnology and pharmaceutical companies on successful drug approvals and are now guiding DiaMedica towards hitting its product development milestones," said Rick Pauls, Chief Executive Officer of DiaMedica.


Joy Cavagnaro, PhD, DABT, ATS. Pharmacology and Toxicology

Dr. Cavagnaro assists DiaMedica in the design and implementation of pre-clinical toxicology studies to access safety, tolerability and pharmacokinetics of protein-based therapies. Dr. Cavagnaro is President and Founder of Access BIO consultancy specializing in pre-clinical pharmacology and toxicology programs and science-based regulatory strategies to support Phase I clinical trials. She has over 25 years of experience in biotech. Previously, Dr. Cavagnaro served as Vice President of Regulatory Affairs at Human Genome Sciences, Inc. and spent close to a decade at the FDA Center for Biologics Evaluation and Research (CBER), including serving as Senior Pharmacologist & Director of Quality Assurance Office of the Center Director. While at the FDA, Dr. Cavagnaro was instrumental in establishing key policy, and guidance documents for biologic-based products and served as rapporteur for the "ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals". Additional responsibilities included review of 100s of INDs and 6 licensing applications. Prior to the FDA, Dr. Cavagnaro was a Senior Staff Scientist, Department of Toxicology at Covance, overseeing pre-clinical pharmacology and toxicology client studies of biotechnology products. Dr. Cavagnaro is a Diplomate American Board of Toxicology and a Fellow Academy of Toxicological Sciences. www.accessbio.com

Patrick Gearing, PhD. cGMP Manufacturing and CMC Product Development

Dr. Gearing provides critical technical and regulatory advice on the manufacturing of cGMP quality biologic-based therapeutics to DiaMedica. Dr. Gearing has a well-established track record of working with clients to achieve successful process development and manufacture of cGMP protein therapeutics appropriate for clinical trials. Dr. Gearing routinely works with world-leading contract manufacturing organizations (CMOs), using his 19 years of industry experience to help clients overcome development and manufacturing challenges unique to each protein. Dr. Gearing has product development experience in several regulatory jurisdictions including the US, Europe, Japan, Canada and Australia, thereby being able to provide sound product development advice. Prior to founding Ridge Biotechnology, Dr. Gearing was Director of Pharmaceutical Development and Quality Systems at Seattle Genetics, Inc., helping to guide the development of their monoclonal cancer antibody pipeline. Additional industry experience also includes positions at Coulter Pharmaceutical, Inc., PDL BioPharma, Inc., and Immunex Corp. (Amgen). www.ridgebiotechnology.com

Larry Johnson, MSc. Regulatory Affairs

Mr. Johnson provides expertise in the interaction with regulatory agencies, including the FDA, EMA, and Health Canada, to achieve clinical and marketing approvals. Mr. Johnson has over 35 years of experience in working with over 50 international and US-based pharmaceutical companies at all stages of product development (pre-clinical, clinical and market approval stages) to expedite development. This has included assisting with the filing of over 30 INDs, NDAs for drug products, and PLAs for biologic-based products. He has also participated in several hundred meetings with the FDA and other regulatory agencies on behalf of clients. Additionally, Mr. Johnson assists companies in the development of compliance procedures, standards and documentation (GLP, GCP, GMP) appropriate to the stage of product development. Previously, Mr. Johnson was Responsible Head and Director of Regulatory Affairs at Amgen, Inc., helping to obtain its first product approval; he continued working closely with the company for over 16 years as a regulatory consultant. Mr. Johnson has also been employed by Abbott Laboratories and the US Centers for Disease Control. www.biofinity.org

About DiaMedica

DiaMedica is a biopharmaceutical company that has developed novel therapeutic compounds aimed to improve the lives of patients with diabetes and other major, medically-unmet diseases. DiaMedica's lead compound, DM-199, represents a novel approach to treating Type 1 and Type 2 diabetes by demonstrating significant results against three major aspects of these diseases: 1) halting the autoimmune attack on beta cells; 2) proliferating insulin producing beta cells and 3) improving glucose control.

DiaMedica is also developing a monoclonal antibody, DM-204. In pre-clinical studies, DM-204 significantly improved glucose control and decreased blood pressure.

The company is listed on the TSX Venture Exchange under the trading symbol 'DMA'.

Caution Regarding Forward-Looking Information

The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address DiaMedica's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Company's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. The Company undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.

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