LANSING (AP) In 1998, the buyers of the only U.S. laboratory making the anthrax vaccine thought they had a can”t-miss deal.
The aging state-owned lab in Michigan needed millions in renovations on top of the $24 million purchase price. But the Pentagon already had announced it would require all 2.4 million American military personnel to take a series of six shots of the vaccine, and turning the lab into a profitable enterprise seemed childishly easy.
Four years later, Lansing-based BioPort Corp. has yet to ship a single dose of the vaccine to the Pentagon.
Unable to pass inspections by the Food and Drug Administration, BioPort has intermittently produced the vaccine but has not been able to release it.
Now, the company appears to be on the verge of finally winning FDA approval to begin shipments, possibly as early as this month.
“It”s clearly a very positive story for the company,” said BioPort spokeswoman Kim Brennen Root.
A laboratory in Washington state that puts the vaccine into vials still needs FDA approval, and the vaccine still must be tested for purity, potency and sterility before any 200,000-dose lots will be released by the FDA.
The vaccine was held up by contamination, inadequate record-keeping and unapproved procedures at the laboratory.
“I”m glad it took four years. That stuff needed to be done right,” said Rep. Mike Rogers (R-Brighton) whose district includes BioPort.
Pressure to get the lab approved has grown since U.S. troops began heading overseas in the war on terrorism and since last fall”s anthrax outbreak killed five people on the East Coast. Because of the standstill at BioPort, the Pentagon stockpile of the vaccine is dwindling.
Although privatizing the lab didn”t turn out to be nearly as easy as the new owners expected, it was largely the federal government that sweated and paid while the approval process went on.
Over the past four years, BioPort has received at least $16.8 million from the Pentagon to renovate and expand the lab. It also asked for more money for the vaccine, complaining that the state had never charged enough.
The Pentagon agreed in 1999 to more than double the per-dose payment, from $4.36 to $10.36. Instead of having to supply 8.7 million anthrax vaccine doses for $29.4 million, BioPort had to supply only 4.6 million doses for $53.5 million, in part because the company couldn”t make as many doses as it originally promised.
Yet even with the extra money, BioPort”s problems continued. Considering who owns BioPort, it was something of a surprise that the project did not turn out to be as easy as the new owners expected.
BioPort”s chief executive officer and major investor is Fuad El-Hibri, a German-born businessman of Lebanese descent who now is a U.S. citizen. El-Hibri is a former director of the British maker of a different anthrax vaccine. His father, Ibrahim El-Hibri, also invested in BioPort.
A major shareholder in BioPort is retired Adm. William J. Crowe, former chairman of the Joint Chiefs of Staff, who brought his experience dealing with the Pentagon to the fledgling company. The former director of the state-owned lab, Robert Myers, is BioPort”s chief operating officer.