The troubles keep mounting for San Diego-based Sequenom, which fired its CEO and head of research after a five-month internal investigation found a lack of controls surrounding its Down syndrome test.
The company has been keeping the details of what occurred under wraps as it deals not only with the Securities and Exchange Commission, but also the U.S. attorney’s office and the FBI.
In a regulatory filing last week, Sequenom revealed it had met with officials from both agencies and said it intends to “cooperate fully” with Nasdaq officials and those with the U.S. attorney’s office. (San Diego FBI Special Agent Darrell Foxworth said he could not confirm nor deny an investigation involving Sequenom.)
The company also faces several class action lawsuits filed on behalf of its shareholders.
Sequenom first alerted investors to its troubles in April, warning them not to rely on results of its SEQureDx prenatal test for Down syndrome because of “employee mishandling.”
The business had originally intended to launch the product in June, before publishing scientific data in a peer-reviewed journal.
Investigators are likely to look into the fact that when Sequenom first unveiled the test it said it could detect Down syndrome in unborn babies with 99.9 percent accuracy. But it later revised its data, saying in February that the test was 96.6 percent accurate in identifying the chromosomal abnormality.
The company said Sept. 28 that it fired President and CEO Harry Stylli and Senior Vice President of Research and Development Elizabeth Dragon effective immediately.
Sequenom’s technology was anticipated to become a dominant force in the $2 billion-a-year prenatal testing market. It held hope that pregnant women might one day forgo invasive tests such as amniocentesis, which poses risk of miscarriage.
A day after its Oct. 5 filing, shares of Sequenom, traded under the symbol SQNM, traded as low as $2.83. At that price, its shares were the lowest they had been in the last 52 weeks. The stock’s 52-week high was $25.99 as of Oct. 6.
• • •
Battling Swine Flu: A small study revealed early clues for San Diego-based DNA vaccine company Inovio Biomedical last week. The biotech, which is vying to come up with the first “universal” flu vaccine to combat H1N1 swine flu and other sub-types, demonstrated that its vaccine worked in ferrets, an animal commonly used in vaccine research for its humanlike immune system.
After a single shot, seven out of nine ferrets produced a significant immune response, measured as generating an antibody titer of 1-to-20 or greater. After two booster shots, all of the immunized ferrets produced an immune response.
The data, presented at a Singapore vaccine conference, follows other successful results using SynCon H1N1 vaccine candidates in mice and pigs. Inovio aims to test its vaccine in human trials late next year.
“The beauty of our approach is that we can design universal DNA vaccines with broad protective capabilities against known and unknown strains,” said Dr. J. Joseph Kim, CEO of Inovio.
To support its goals, Inovio closed a $30 million stock offering July 31. As of June 30, Inovio reported it had cash and equivalents of $8.3 million, enough to last through the second half of 2011.
• • •
Speeding Up The Process: Pharmatek Laboratories said it has invested $550,000 into an automated machine that could produce greater efficiencies for pharmaceutical companies looking to conduct their first human trials.
The San Diego-based contract research and manufacturing organization said last week that its Xcelodose purchase makes it the first CRO on the West Coast to own such equipment.
Made by Pfizer’s Capsugel division, the machine delivers precise powder micro doses through a system that encapsulates the active pharmaceutical ingredient or formulation.
“Pharmatek is always looking for ways to move our customers’ drug candidates into the clinic more efficiently without compromising quality,” said Jeffrey Bibbs, chief scientific officer of Pharmatek. “For powder-in-capsule applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials.”
Pharmatek, which has 100 local employees, said it will begin offering the micro-dosing service for manufacturing productions in November.
Send biotechnology news to Heather Chambers at firstname.lastname@example.org.