Acasti Pharma Inc. - CaPre
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`CaPre ®
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`Acasti has an exclusive licence from Neptune to develop pharmaceutical products customized to manage cardiovascular
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`disease. CaPre® is currently Acasti's only prescription drug candidate, and is being developed to address the prevention
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`and treatment of cardiometabolic disorders including hypertriglyceridemia, a condition which is characterized by
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`abnormally high levels of triglycerides.
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`CaPre® is a highly purified omega-3 phospholipid concentrate derived from krill oil. The active ingredient of CaPre ® is a
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`mixture of concentrated omega-3 fatty acids purified from krill oil and developed as an oral formulation. CaPre ® contains
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`EPA and DHA bound to phospholipids as well as free EPA and DHA for a total concentration of approximately two-thirds
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`phospholipids and approximately 30% EPA and DHA.
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`Acasti's near-term strategy is to develop and commercialize CaPre ® in the United States as a prescription drug with a
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`claim for the treatment of severe hypertriglyceridemia and, as a next step, the treatment of mild to moderate
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`hypertriglyceridemia.
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`Going forward Acasti hopes, CaPre ® can be used as a therapy in conjunction with positive lifestyle changes and
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`administered either alone or with other treatments such as statins (statins are a class of drug used to reduce cholesterol
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`1 (cid:9) AKBM 1101
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`Acasti Pharma Inc. - CaPre (cid:9)
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`levels) and potentially for use by statin-intolerant or statin-resistant patients. In addition to targeting the reduction of high
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`to very high triglycerides, Acasti's longer-term objective is to demonstrate that CaPre ® can also reduce LDL (bad
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`cholesterol) and raise HDL (good cholesterol). Based on nonclinical and clinical studies to date, Acasti believes CaPre®
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`may provide significant benefits in all three areas. However, further clinical research is required in order to confirm an
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`analogous efficacy in humans. CaPre ®'s precursor, NKO ® , has demonstrated significant clinical benefits in all three
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`areas.
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`Acasti initiated two Phase ll clinical trials designed to evaluate the safety and efficacy of CaPre ® for the management
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`of hypertriglyceridemia. These trials are a central part of its US and international regulatory compliance program and are
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`an essential step in securing regulatory approval to distribute and market CaPre ® as a prescription drug in the
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`pharmaceutical marketplace. To date, Acasti has successfully completed one Phase II trial, announcing positive
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`results in August 2013. Obtaining regulatory approval for CaPre ® requires that safety is confirmed and the product is
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`effective for sufficiently reducing triglycerides.
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`There are competing products in the marketplace to treat hypertriglyceridemia, including products that have been
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`manufactured from omega-3 fish oil, and products that, if approved, would compete with CaPre ®. However, to Acasti's
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`knowledge, CaPre ® is the only omega-3 phospholipid product being developed with a potential to demonstrate a clear
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`clinical superiority in treating triglycerides, LDL and HDL. To date, no competing product currently on the market has
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`demonstrated efficacy in treating all three indications.
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`Based on preclinical evaluations and the demonstrated benefits of NKO ®, Acasti has reason to expect that the
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`competitive advantages of CaPre ® may also include a range of clinical benefits that are superior to products currently
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`being prescribed for the treatment of hypertriglyceridemia, as well as efficacy at lower dosage levels than products now
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`on the market, which is essential for good patient compliance, and no gastrointestinal side-effects.
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`Market participants have estimated that the total prescription omega-3 market generated over $2 billion in sales
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`worldwide in 2012. Acasti believes that there will be increased growth in the prescription omega-3 market based on the
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`expected introduction, and resulting increased promotion and awareness, of new prescription omega-3 products, as well
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`as the emergence of new clinical data regarding the efficacy of omega-3 in the treatment and prevention of
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`cardiometabolic disorders.
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