Etobicoke, Ont.-based pharmaceutical company HLS Therapeutics Inc. and Amarin Corp. of New Jersey are seeking Health Canada approval to distribute and sell Vascepa (icosapent ethyl) capsules in Canada.
The two companies had earlier signed an exclusive agreement to register, commercialize and distribute in the country, the medication which they hope would become part of physicians’ selection of drugs for treating patients with cardiovascular disease.
Vascepa is the only product of Amarin. It is an Omega-3 fatty acid drug that is commonly known as EPA in ethyl-ester form. It is used to treat hypertriglyceridemia. The medication received U.S. Food and Drug Administration approval in 2012. The capsule is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Vascepa competes against Lovaza, which was developed by GlaxoSmithKline.
“We are excited to enter into a collaboration with HLS to seek regulatory approval and commercialize Vascepa in Canada,” stated John F. Thero, president and chief executive officer of Amarin. “The proven track record of HLS’s leadership in commercializing pharmaceutical products in Canada, along with our shared vision and commitment, bestow confidence that we will provide Vascepa as a treatment option for millions of Canadians.”
“…we expect Vascepa to be the first highly pure, omega-3 fatty acid product available by prescription in Canada,” stated Greg Gubitz, chief executive officer of HLS Therapeutics.
Heart disease is a leading cause of death in Canada. An estimated 2.4 million Canadians live with heart disease.
Twenty-five per cent of Canadians has high triglycerides, a key comorbidity associated with cardiovascular disease.
Earlier this year, a judge’s ruling allowed Amarin to engage in so-called Off-label promotion of Vascepa. The ruling gives the company permission to “legally share truthful, scientific data” which demonstrates that Vascepa can lower triglyceride levels in patients with less severe hypertriglyceridemia.
The FDA approval Amarin received in only indicated Vascepa as a treatment for patients with severely high triglyceride levels. This condition affected an estimated four million people in the United States. Amarin sought a broader indication that would provide it access to a larger population of potential users and differentiate its product from rival medications.
When FDA rejected Amarin’s request, the drug maker sued the regulator. The company alleged the FDA violated its First Amendment rights. According to Amarin, the information it wanted to give doctors were mostly derived from a FDA-approved study and FDA materials.
Industry watchers believe this year’s court ruling in favour of Amarin may likely influence the way pharma companies are allowed to promote their products.