PharmAthene repudiated by FDA over SparVax

PharmAthene, which recently came under fire for its close ties to Tara O'Toole, the Under Secretary for Science and Technology Directorate at the Department of Homeland Security, has been repudiated by the FDA over "false and misleading statements" made about its anthrax vaccine.

In a letter sent to David Wright, PharmAthene's president and CEO, the FDA questioned statements about Sparvax, the Weekly Standard reports.

"The product fact sheet contains false or misleading statements that represent your product as safe and effective for the purposes for which it is being investigated," the FDA's letter said. "This is problematic from a public health perspective because it suggests that SparVax is safe and effective when the product has not yet been approved by FDA and the promotional claims have yet to be demonstrated by substantial evidence or substantial clinical experience.  As a result, these materials misbrand your investigational product in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a)&(n), and 321(n), and FDA’s implementing regulations.  (See 21 CFR 312.7(a))."

PharmAthene then wrote to the SEC in an attempt to keep the matter confidential, the Weekly Standard reports.

"PharmAthene, Inc., submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the Exhibits to a Form 10-Q filed on May 13, 2010," PharmAthene wrote in a filing with the SEC. "Based on representations by PharmAthene, Inc., that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it."

This is just the latest in PharmAthene's troubles. The company was informed in July that it was not in compliance with the listing standards of the New York Stock Exchange because it had stockholder equity of less than $2 million, $4 million and $6 million, as well as losses from continuing operations and/or net losses in two of its three most recent fiscal years, three of its four most recent fiscal years and its five most recent fiscal years, respectively, the company said in a release.

PharmAthene has also faced questions over its close ties to O'Toole, who was head of the Center for Biosecurity, which maintains close ties to the University of Pittsburgh Medical Center, before becoming under secretary.

People close to O'Toole have worked to position the University of Pittsburgh Medical Center for a major biosecurity vaccine production contract, which would pump billions of dollars into the late Congressman John Murtha's district. UPMC's vaccine production facility is expected to be run by PharmAthene.

PharmAthene's founder, Joel McLeary, is also a founding partner at the Washington, DC-based Four Seasons Ventures private equity firm and is an advisor to UPMC.

At Four Seasons, McCleary is partnered with former Murtha aide James Ervin, who lobbies for PharmAthene, in which Four Seasons is heavily invested.

O'Toole herself once advised for the Alliance for Biosecurity, which is believed to be run by PharmAthene.

At the time of O'Toole's nomination, the Washington Times noted that "President Obama’s nominee at the Department of Homeland Security overseeing bioterrorism defense has served as a key adviser for a lobbying group funded by the pharmaceutical industry that has asked the government to spend more money for anthrax vaccines and biodefense research."