FDA allows ViroPharma and Halozyme to continue clinical trials, stock up on the news

Food and Drug Administration (FDA) allowed both ViroPharma and Halozyme Therapeutics to resume their combined clinical trial treatment Friday after close inspection that spanned more than a month.

Both ViroPharma and Halozymes were working on a hereditary angioedema disorder with a combination of former’s Cinryze and latter’s Enhanze platform. Cinryze ViroPharma’s patented drug that is used to treat the disorder and Enhanze is Halozymes platform for delivering it subcutaneously.

FDA halted the clinical trials after discovering a discrepancy in the data of antibodies in one of enzymes used in the drug. However, that data was from another company’ medicine. After close inspection of over a month, FDA finalized that antibody in rHuPH20, the enzyme, was limited to that companies medicine and not any other. However, the regulator suggested both companies to keep a close eye and notify if there are any levels of antibodies found in rHuPH20.

“The FDA believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical development program of another company’s product are limited to that specific program,” the regulator said in a statement. “FDA has advised ViroPharma to amend the study protocol, allowing for increased laboratory sampling to monitor rHuPH20 antibody levels, and keep the Agency informed of elevated antibody levels during the treatment phase of the study.”

Both companies were up on the graph in the stock market shortly after the announcement by FDA. Halozymes were up a whopping 25 percent up on the graph to $8.07. The company fell down making a steep slope on the news a month ago.

VIroPharma were 7 percent up to jump $30 at the day’s start but were down to $29.52 at the day’s end with a 5 percent increase to previous day.

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Posted by Usman Khalid on Sep 22 2012. Filed under Sci-Tech. You can follow any responses to this entry through the RSS 2.0. You can skip to the end and leave a response. Pinging is currently not allowed.