Back to top

Analyst Blog

ViroPharma Incorporated recently announced that the US Food and Drug Administration (FDA) has advised the company and its partner, Halozyme Therapeutics (HALO - Snapshot Report), to put the phase II study evaluating the combination subcutaneous Cinryze (C1 esterase inhibitor [human]) and recombinant human hyaluronidase enzyme (rHuPH20) on temporary clinical hold.

The Center for Biologics Evaluation and Research (CBER) division of the FDA informed the companies that the US regulatory body is assessing the potential risk of the long-term effect of anti-rHuPH20 non-neutralizing antibodies associated with the use of Halozyme's rHuPH20. The FDA detected some risks pertaining to rHuPH20 in a separate study without Cinryze.

Halozyme informed ViroPharma that it must first provide results from additional pre-clinical studies to the CBER before they can resume the on-hold combination study. The US regulatory body also mentioned that the problem does not specify Cinryze and ViroPharma can continue evaluating subcutaneous administration of Cinryze without rHuPH20.

ViroPharma has decided to inform the European regulatory authorities of the FDA’s action. The company has also decided to postpone its enrollment process in Europe for the phase II combination study of Cinryze and rHuPH20, until the FDA confirms the safety of the latter.

Following the FDA’s decision, ViroPharma is set to commence a phase II study, evaluating the safety and efficacy of two different doses of the subcutaneous administration of Cinryze as a stand-alone therapy. The US regulatory body cleared ViroPharma’s Investigational New Drug (IND) application for the stand-alone therapy of Cinryze in 2011.

ViroPharma recently announced positive results from an open label prophylaxis study of Cinryze in patients suffering from hereditary angioedema (HAE).

We note that Cinryze is approved both in the US and Europe. In the US the drug is approved as intravenous (IV) administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In Europe it is approved for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks in adolescent and adult patients with HAE.

Our Take

We currently have a Neutral recommendation on ViroPharma. The stock carries 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
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%