A team comprising researchers from the Georgia Institute of Technology and Emory University is seeking an industrial partner to help it commercialize technology that would enable painless delivery of flu vaccine through skin patches embedded with microneedles.
Researchers from the two institutions are charged with seeking a commercial partner as awardees of a product-development grant worth approximately $8 million over five years from the National Institute of Allergy and Infectious Diseases.
Richard Compans, professor of microbiology and immunology at the Emory School of Medicine, is principal investigator on the project, entitled “Self-administered microneedle patches for influenza vaccines.”
Compans’ lab is collaborating with the lab of Mark Prausnitz, a Georgia Tech professor of chemical and biomolecular engineering. Under the terms of the NIAID product-development grant, Compans and Prausnitz are supposed to collaborate with a company over the next five years on the project, during or after which time the company is expected to file an investigational new drug application and initiate clinical trials based on the research, Prausnitz told BTW last week.
Together, the schools and the company, which has yet to be chosen, will attempt to commercialize a painless skin patch for administering influenza vaccine based on microneedle technology for delivering biological compounds through the skin.
The needles are much smaller than conventional hypodermic needles and therefore are expected to be less painful because they don’t significantly stimulate nerve endings, according to Prausnitz. They would be made of titanium, stainless steel, or polymers — including some that could dissolve into the skin and carry the vaccine with them, according to the researchers.
Prausnitz and his colleagues have been developing the microneedle technology since the mid 1990s, have been awarded several patents on the technology, and have filed several more. Prausnitz said that the microneedle delivery technology can be used to deliver a variety of biological moieties into the system, such as insulin, drug molecules, or other vaccines.
“Some of the patents have to do in a more general sense with how you fabricate the needle, which you can use for all sorts of things; or how you apply a coating to a needle that is effective and stable,” Prausnitz said. “You could incorporate a variety of drugs and vaccines within the coating. Most of our patents are more general kinds of platform technology patents as opposed to application-specific ones.”
As such, Prausnitz’s group, through the Georgia Tech Office of Technology Transfer, has already licensed about two-thirds of its patents to various companies.
The biggest licensees of the technology are a Boston-area company called Valeritas, formerly known as BioValve, which acquired a startup company founded by Prausnitz and colleague Mark Allen in the late 1990s; and another Boston-based company called Apogee, which more recently licensed the technology to focus on vaccine development. Prausnitz said Valeritas is focused more on developing general applications for the microneedle technology.
But in the context of the NIAID grants, the Georgia Tech and Emory groups are seeking a company that will take the microneedle IP and run with it specifically in the area of influenza vaccination.
“Our emphasis is to identify a company that is certainly in this space, which means a company that has some microneedle expertise already in house, and would benefit by leveraging the expertise we could bring to bear,” Prausnitz said.
“Our emphasis is to identify a company that is certainly in this space, which means a company that has some microneedle expertise already in house, and would benefit by leveraging the expertise we could bring to bear.”
In addition, they are seeking a company that is “committed to a flu vaccine and wants to identify a flu vaccine manufacturer to be a further partner in this effort; and finally, a company that is willing and interested to be open, to share,” he added. “We’re going to tell them things and hopefully help them, but in order for everyone to benefit, they need to tell us some of their secrets, and there needs to be a mutual trust.”
The researchers are currently considering several undisclosed companies, including Valeritas and Apogee. Prausnitz said that when they applied for the grant, the researchers had received a letter of interest from an undisclosed company, and negotiations with that firm are ongoing.
“There are some others in this space who have microneedle expertise and technology of their own that they’re not licensing from us, but are also potentially attractive,” Prausnitz said.
It may not be as easy for the researchers to attract a partner willing to tackle the vaccine market, which doesn’t promise a near-term or lucrative return on investment, although influenza vaccine has a built-in, yearly market. A report released in February by Kalorama Information estimated that the global vaccine market is expected to top $10 billion this year and $23.8 billion by 2012.
According to the report, the fastest growing segment in the adult vaccines area is influenza vaccines, a sector that is forecast to grow by 13.2 percent and top $4 billion by 2012.
Other alternative flu vaccine methods have taken a significant amount of time to garner market share, most notably AstraZeneca’s FluMist, which was approved by the US Food and Drug Administration in 2002 but had been in development since 1991. However, sales of FluMist in 2006 were $36 million, a 71-percent increase over $21 million in sales in 2005, showing that the market is picking up.
And while FluMist is certainly advertised as being pain-free, it still has to be administered in a doctor’s office, or at least at a pharmacy clinic. The Georgia Tech and Emory researchers think that the microneedle technology can go a step further.
“A strong potential advantage for the microneedle patch as a way to deliver flu vaccine is the hope and expectation that it could be self-administered,” Prausnitz said. “So the idea is to take the annual flu vaccine out of the doctor’s office, and instead, perhaps with a prescription, go to the pharmacy, pick up the patch, self-apply it, and you’ve now been vaccinated in a more convenient way.”