Back to top

Analyst Blog

GlaxoSmithKline plc (GSK - Analyst Report) and XenoPort, Inc. (XNPT - Snapshot Report) recently announced that their drug, Horizant, has been approved by the US Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN) in adults.

PHN is a nerve pain that follows herpes zoster (shingles). According to Glaxo and XenoPort, approximately 100,000 patients develop PHN in the US annually.

Glaxo had submitted a supplemental New Drug Application (sNDA) to the FDA in August 2011. The approval was based on data from a 12-week principal efficacy trial and two supportive studies. A total of 574 PHN patients above 18 years were enrolled in these three studies. All three studies met their primary endpoints.

Horizant is already approved in the US for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults. However, the product is not recommended for use in patients who are required to sleep during the day and remain awake at night.

Glaxo and XenoPort have co-development and co-promotion rights in the US for Horizant. Astellas Pharma Inc. has exclusive rights to the drug in Japan and five other countries in Asia. Astellas markets the drug in Japan under the trade name Regnite for the treatment of RLS. Xenoport has rights to Horizant in the rest of the world. The first commercial sale of the product, following the PHN approval, will result in a $10 million milestone payment from Glaxo to XenoPort.

Our Recommendation

We currently have a Neutral recommendation on both Glaxo and XenoPort. Both stocks carry a Zacks #3 Rank (‘Hold’ rating) in the short run.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
CTPARTNERS… CTP 13.33 +3.49%
SAIA INC SAIA 45.65 +1.00%
VASCO DATA… VDSI 13.57 +0.67%
AMEDISYS IN… AMED 20.18 +0.10%
FIRSTSERVIC… FSRV 55.66 -0.13%