PharmAthene looks to remove clinical hold from anthrax vaccine
The U.S. Food and Drug Administration shut down SparVax in August. The company is also waiting for the Delaware Supreme Court to make a ruling on PharmAthene's 2006 lawsuit against the New York-based SIGA Technologies. If the court upholds a lower court ruling, PharmAthene would receive a portion of SIGA's smallpox vaccine profits, CapitalGazette.com reports.
"An anthrax vaccine is nice, but it's nowhere near as potentially dangerous as smallpox is," Raghuram Selvaraju, the head of health care equity research for the New York-based Aegis Capital Corp., said, according to CapitalGazette.com. "In the next few months, we expect the clinical hold to be removed. We believe investors will be able to start ascribing value to SparVax again."
The FDA said it put the hold on SparVax because the agency required added manufacturing data about the product, which was first made in the United Kingdom. The company moved SparVax back to the U.S. and continues to provide the FDA with stability data. Officials with PharmAthene said they expect to get a response about lifting the hold within the next two months.
In 2011, a Delaware court awarded PharmAthene 50 percent of SIGA's profits of the smallpox drug Arestvyr after the drug passes the $40 million mark in sales. The ruling was upheld in 2012 and is currently with the Delaware Supreme Court. PharmAthene anticipates a decision on the ruling by the end of the second quarter, CapitalGazette.com reports.
PharmAthene posted $25.2 million in revenue in 2012, with $23 million coming from SparVax. The company had $31.2 million in expenses, more than 60 percent of which was spent on research and development.