The US Food and Drug Administration has given the green light to two drugs - Amarin Corp’s heart pill Vascepa and Horizon Pharma's anti-inflammatory Rayos.
First up, the agency has approved Vascepa (icosapent ethyl), formerly known as AMR101, as an adjunct to diet to reduce triglyceride (levels in adult patients with severe hypertriglyceridemia. The approval is principally based on data from the MARINE trial which showed that the drug, a prescription-grade omega-3 fatty acid demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, or 'bad cholesterol. Some analysts have said that this could give Amarin's treatment an advantage over GlaxoSmithKline/Pronova Biopharma's Lovaza (omega-3-acid ethyl esters).
Amarin considers sale
Amarin chief executive Joseph Zakrzewski, said the Irish-American company, which is listed on the Nasdaq, will consider "three potential paths for the marketing and sale of the product". These consist of "an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support".
He added that the firm is finalising the introduction of Vascepa, likely in the first quarter of 2013, "to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities".
Meantime the FDA has also approved Horizon's New Drug Application for Rayos (delayed-release prednisone) for the treatment of a broad range of diseases including rheumatoid arthritis. The drug, developed using SkyePharma’s Geoclock technology, is sold in Europe by Mundipharma as Lodotra.
Horizon chief executive Timothy Walbert said the initial focus will be on the launch of Rayos in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of this 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," he added.
The approval is a nice boost for SkyePharma which is entitled to a "low-mid single digit" percentage royalty (put by analysts at Singer at 3%) on US sales of Rayos, plus manufacturing fees. The drug is made at the UK firm’s Lyon facility which is leased to Aenova, a German-based pharmaceutical contract manufacturing organisation.