Aegerion Pharmaceuticals, Inc. AEGR announced that an open-label, multi-center phase III study evaluating the efficacy and safety of Juxtapid for the treatment of homozygous familial hypercholesterolemia (HoFH) in Japanese patients has met the primary endpoint.
We note that Juxtapid is already approved for the treatment of HoFH in several countries including the U.S., EU, Mexico and Canada. It is not yet approved in Japan.
In the above study, the primary endpoint was measured by the mean percentage change in low-density lipoprotein cholesterol (LDL-C) at the maximum-tolerated dose versus baseline following 26 weeks of treatment, in combination with other lipid-lowering therapy.
Aegerion stated that data from this study was consistent with the company’s previous global phase III study on Juxtapid. Based on this data, Aegerion is planning to submit a new drug application for Juxtapid in Japan for the treatment of HoFH patients in fourth-quarter 2015 or early first-quarter 2016.
Meanwhile, patients in the Japanese study have entered a 30-week safety phase after completing 26 weeks of treatment. In this phase, they will continue to receive the maximum-tolerated dose of Juxtapid subject to safety-related dose adjustments. Aegerion intends to submit 56-week data to the regulatory authority during the review process (provided Juxtapid is accepted for review).
We note that Juxtapid is the cornerstone of Aegerion’s business. In 2014, Juxtapid generated revenues of $158.4 million, up almost 226% from the year-ago quarter. While the company is facing reimbursement issues in Europe, it is working on expanding its business in ex-U.S. markets. We are pleased with Aegerion’s efforts to get Juxtapid approved in Japan. The company is also planning to initiate a study on Juxtapid in Japan for pediatric HoFH patients in the second half of 2015. Geographical expansion for the drug should help boost the company’s top line, going forward.
Aegerion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Actelion Ltd. ALIOF, Gilead Sciences Inc. GILD and Acorda Therapeutics, Inc. ACOR. While Actelion and Gilead hold a Zacks Rank #1 (Strong Buy), Acorda carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment