This marks Zydus' first branded product launch in the U.S. and Medicure's second cardiovascular drug on the U.S. market
Zydus Cadila, a leading innovation-driven, global healthcare provider, announced that it has entered into a definitive agreement with Medicure International Inc., a subsidiary of Medicure Inc. (Medicure) to commercialize its 505(b)(2) New Drug Application (NDA) product, pitavastatin magnesium (ZYPITAMAGTM) in the United States. The launch of ZYPITAMAG, which is used to manage cholesterol levels, marks the first branded product launch for Zydus in the U.S.
Medicure is a U.S. pharmaceutical company and has a proven track-record of successful commercialization of products in the therapeutic segments of cardiovascular and metabolic diseases. As a part of this agreement, Zydus will hold the NDA and Medicure will be responsible for the sales and marketing of ZYPITAMAG.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Cadila said, "The launch of this proprietary drug is in continuation of our commitment to exploring new pathways in pharmaceutical technology with a thrust on enhancing patient care and well-being. In this endeavour, we are happy to partner with Medicure in reaching out to the patient community and helping them access this NDA for desired health outcomes".
"Medicure is pleased to partner with Zydus Cadila and add ZYPITAMAG to its cardiovascular commercial operation. This partnership fits well with Medicure's mission of being a significant cardiovascular pharmaceutical company focused on the U.S. market," commented Medicure's President and CEO, Dr. Albert D. Friesen.
Approved in strengths of 1 mg, 2 mg and 4 mg, ZYPITAMAG is an HMG-CoA reductase inhibitor indicated for Patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).