Protein Sciences Corporation
Address: 100 Research Parkway, Meriden
Leadership: Manon cox, president and CEO
Tucked away in the town of Meriden is a high-tech business that's on the verge of radically changing the way vaccines are being made and the speed at which they can be manufactured.
Protein Sciences Corporation, founded in 1983 with an initial mission to develop an HIV vaccine, could be just months away from getting FDA approval for FluBlok®, a seasonal flu vaccine that appears to be more effective than current ones for elderly and immune-compromised individuals.
As an added advantage, FluBlok is made using the company's patented Baculovirus Expression Vector System (BEVS), which can produce large amounts of proteins faster and at a lower cost than other platforms.
The FDA approval process for FluBlok has been grinding on for four years, but Protein Sciences President and CEO Manon Cox hopes the end is in sight.
"You have to be extra careful with drugs that are being given to healthy people to be sure you don't cause harm," she said. "The burden of safety becomes super, super high, so we've been asked to do any and every experiment. My patience has been challenged," she said, noting that getting approval for a drug to treat patients stricken with cancer or HIV would be an easier path.
Cox is hopeful that the FDA has submitted its final set of questions and that FluBlok will receive the green light in four to six months. If that happens, she believes the vaccine can definitely save lives.
"Influenza is a killer. It's more dangerous than HIV in the United States at this time," she said.
In addition to FluBlok, Protein Sciences is working on a number of other vaccines that are not as far along in the pipeline. PanBlok®, a vaccine designed to combat pandemic flu strains, is currently in the clinical trial stage. Using the company's proprietary BEVS technology, PanBlok would enable a quick response to emerging strains such as the H1N1 swine virus, but the FDA will not consider approving the vaccine until the seasonal FluBlok vaccine has received final approval.
Also in the works is FluNhance™, an additive designed to shorten the duration and severity of flu if someone becomes ill despite taking a seasonal vaccine. It has proven effective in clinical trials, but is now on hold to avoid strain on the company's resources as development of FluBlok and PanBlok continues.
Protein Sciences also includes an arm called GeneXpress®, which develops and manufactures antigens, proteins and other research materials for pharmaceutical and biotechnology companies.
"We make money on those programs, but then we spend it on the flu vaccines," Cox said.
The company recently expanded its Meriden facility, which now includes four buildings and new laboratory space with leading edge equipment, along with open office space to facilitate collaboration. Protein Sciences has 90 employees, all based in Connecticut, and plans to add more, primarily people with technical or engineering backgrounds.
"We're always looking for good people," Cox said.
The company is in the fourth year of a five-year, $147 million contract from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority. The money goes toward flu vaccine development and has driven Protein Sciences, which posted revenues of more than $20 million in 2010, into profitability, Cox said.
If FluBlok is approved, Cox and her colleagues will face a new dilemma — how to get it to market. Ideally, she would like to partner with a company with an existing infrastructure and expertise in manufacturing, marketing and sales, but finding an interested partner has been challenging.
"This will radically change how vaccines are being made and there are those who don't want this on the market. They don't want to make products than can cure or prevent disease. They want to make products that can treat it."
And if no partner steps up?
"We're looking to rent or buy a facility," Cox said. "We've always said we're a development company, but if we don't have a partner, we'll do it ourselves."