Horizon’s Rayos and Amarin’s Vascepa Approved by FDA

The US Food and Drug Administration (FDA) have announced that they have approved Amarin Corp’s heart pill, Vascepa, and Horizon Pharma’s anti-inflammatory, Rayos.

The FDA approved Vascepa (icosapent ethyl), formerly known as AMR101, as an addition to diet to reduce triglyceride (levels in adult patients with severe hypertriglyceridemia).  Triglycerides is a blood fat that contributes to heart disease in conjunction with cholesterol.

The green light was based primarily on data from the MARINE trial which displayed that the drug, a prescription-grade omega-3 fatty acid, demonstrated a statistically noteworthy placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, or ‘bad’ cholesterol.  Some analysts have commented that this could give Amarin’s treatment an advantage over GSK/Pronova Biopharma’s Lovaza.

Amarin considers sale

Joseph Zakrzewski, Amarin’s chief executive,  confirmed that the Irish-American company will consider “three potential paths for the marketing and sale of the product.”  These comprise of “an acquisition of Amarin, a strategic collaboration, or self-commercialisation, the latter of which could include third-party support.”

In addition, he noted that the organisation is finalising the introduction of Vascepa, likely in the initial quarter of 2013, “to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities.”

Last week, the company accidentally posted online that the drug had already been approved, increasing their share value.  The company’s shares, which have remained flat since the erroneous publication, closed up 5% at $15.31 on Thursday on the Nasdaq.

Horizon Pharma’s Rayos Approved

Meantime the regulatory agency have also approved Horizon’s New Drug Application (NDA) for Rayos (delayed-release prednisone) for the treatment of a broad range of inflammatory diseases, including rheumatoid arthritis.  The medication, developed using SkyePharma’s Geoclock technology, is currently sold in Europe by Mundipharma as Lodotra.

Timothy Walbert, Horizon’s chief executive, noted that the initial focus will be on the launch of Rayos in rheumatologic diseases such as rheumatoid arthritis and polymyalgia rheumatica in the fourth quarter of the year.

However, “based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity…in key interleukin-6 (IL-6) mediated diseases, including asthma and chronic obstructive pulmonary disease,” Walbert added.

The approval is a nice lift for SkyePharma which is entitled to a “low-mid single digit” percentage royalty on US sales of Rayos, in addition to manufacturing fees.  Rayos is made at the UK firm’s Lyon facility which is leased to Aenova, a German-based pharmaceutical contract manufacturing organisation.


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