Acasti Pharma Inc. reports fiscal 2009 results and scientific updateLaval, Québec, CANADA – June 30th, 2009 – Acasti Pharma Inc. (“Acasti”) today announced its financial results for the nine-month period ended February 28, 2009 (fiscal year end) and provides a scientific update. “During the fiscal year, the Company has made significant progress in the scientific research and development programs and has achieved several value-creating milestones within the over-the-counter (“OTC”), medical food and prescription drug programs,” said Dr. Tina Sampalis, Acasti Pharma’s President. “Acasti’s objective is to research, develop and license active pharmaceutical ingredients designed to prevent and treat cardiovascular disease,” she added. Update on recent Highlights - Under the OTC program, product development has now been completed. According to the strategic business development plan, negotiations with prospective development partners are ongoing to evaluate a monotherapy and two formulations.
- With regards to the medical food program, product development has been completed and the Company has successfully obtained a positive review from the Food and Drug Administration (“FDA”) for medical food product opportunities. The Company is discussing with potential partners in order to evaluate customized formulations.
- Under the prescription drug development program, the product development under Good Laboratory Practice (“GLP”) has now been completed for the prescription drug candidates. The Company has received FDA guidance for an Investigational New Drug in the United States and a Clinical Trial Application in Canada. The FDA approved the general outline of the development plan and detailed protocols are in preparation for submission. The Company has during its fiscal year, initiated preclinical toxicity, dose response and efficacy studies in animals required for regulatory submissions. Studies are progressing according to timelines and budgets.
Financial Results 1 In the nine-month period ended February 28, 2009, Acasti Pharma created a loss of $782,000. At February 28, 2009, the Company had cash, cash equivalents and short-term investments totaling $1,595,000 net of accounts payable to the parent company. Acasti Pharma is researching and developing novel active pharmaceutical ingredients for cardiovascular applications and the expenses can be mainly attributed to R&D; expenses and administrative expenses, initially and previously supported by the parent company Neptune Technologies & Bioressources Inc.
Milestones Anticipated for 2009 and 2010 - Submission of a investigational new drug (“IND”) application in the United States with completed animal pharmacology and toxicology studies, pharmacokinetics, mechanism of action, GMP chemistry, manufacturing, control and proposed clinical protocols information.
- Submission of a clinical trial application (“CTA”) in Canada required for the initiation of clinical trials of experimental drug development.
- Partnership with a pharmaceutical company to evaluate over-the-counter and/ or medical food formulations.
1 Please find complete financial information on www.sedar.com . About Acasti Pharma Inc.
Acasti Pharma’s product portfolio of proprietary novel long-chain omega-3 phospholipids are sourced from sustainable abundant marine biomass including Antarctic krill (Euphausia superba). Phospholipids are the major component of cell membranes and are essential for all vital cell processes. They are one of the principal constituents of High Density Lipoprotein (good cholesterol) and play, as such, an important role in modulating cholesterol efflux. Acasti Pharma’s proprietary novel phospholipids carry and functionalize the polyunsaturated omega-3 fatty acids EPA and DHA, which have been shown to have substantial health benefits and which are stabilized by potent antioxidants. Acasti Pharma is focusing initially on treatments for chronic cardiovascular conditions. Acasti Pharma is a subsidiary of Neptune Technologies & Bioressources Inc. (NASDAQ:NEPT; TSX.V:NTB). NASDAQ does not accept responsibility for the adequacy or accuracy of this press release. Neither 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. Acasti Pharma Contact:
Acasti Pharma Inc.
Toni Rinow, Ph.D., MBA
Corporate Development & Investor Relations
(450) 687-2262
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