FDA lifts hold on Allergy Therapeutics' grass pollen allergy vax

Allergy Therapeutics will court a partner to market its Pollinex Quattro Grass vaccine now that the FDA lifted a clinical hold on the grass pollen allergy shot.

The company can move forward with a Phase III efficacy study, which will take place in an environmental exposure chamber, according to a release. The vaccine--commercialized in some European countries--comes as a four-shot series, requiring the injections over the course of a year.

The FDA froze the vaccine in 2007, after a volunteer experienced numbness and weakness during a trial. Allergy Therapeutics' stock tumbled 22% at the time, according to FierceBiotech. But the U.K.-based company's shares jumped almost 30% after the FDA lifted the hold.

"This product has the potential to greatly benefit allergy sufferers in the U.S. in the absence of registered products by being the first subcutaneous immunotherapy vaccine to reach the U.S. market," said CEO Manuel Llobet. "Additionally, lifting the hold will allow for discussions with potential partners with whom we will finalize the clinical development and start the commercialization of Pollinex Quattro in a market estimated to be around $2 billion."

- read the release
- get more from Proactive Investors

Special Report: Blockbuster Vaccines of the Future

Suggested Articles

The FDA is evaluating the possibility of prosecuting those involved in rogue herpes vaccine research led by a Southern Illinois University professor.

New legal complaints focus on eight Sanofi executives, most of them with local management titles, and 15 managers at distributor Zuellig Pharma.

Experts say technology is advancing to develop vaccines faster at a time of increasing emerging disease outbreaks.