It could be that Bioject owns the only practical drug delivery system for administering DNA-based vaccines.
Seroconversion is said to occur when the body acquires immunity. Tests have shown that the rate of seroconversion from DNA-based vaccines is considerably higher when those vaccines are administered with an intramuscular jet injection. This is because the dispersal pattern of the vaccine, as it enters the muscle tissue, causes it to come into contact with many more cells than the concentrated bubble pattern that results from an intramuscular needle injection. For some DNA-based vaccines, the high level of bio-availability with jet injection allows less vaccine to be used. For others, it is the only delivery method being considered. At least one company, undergoing clinical trials for FDA approval on a newly developed DNA-based vaccine, is using the Biojector as the exclusive delivery method for those trials. If and when FDA approval is gained, it will only be approved for delivery with jet injection.
The great majority of work being done by pharmaceutical companies in developing new vaccines is on DNA-base vaccines. There are 2 reasons for this. One, the developers have access to high tech genetic engineering techniques. Two, DNA-base vaccines can be patented. Many companies are involved in the race to develop a DNA-based vaccine for HIV.
There are several companies with jet injection systems, and some of them claim they are able to deliver intramuscular injections. But Bioject has the only product able to deliver accurate and reliable intramuscular injections across the entire range of human body types. The other companies' injectors are all powered by springs and are appropriate for subcutaneous injections, but they can't deliver enough power to deliver a controlled IM injection. Bioject's injector is powered by a CO2 cartridge, which delivers enough power throughout the duration of the injection to reliably inject up to 1.5 cc through whatever fat layer presents itself.
Yesterday's announcement of the alliance with Merck was very good news for Bioject and its shareholders. The company is receiving $1.5 million up front from Merck, and all Merck gets for that money is an agreement in principle and the right to negotiate further details for specific vaccines. The agreement is non-exclusive, so Bioject is free to enter alliances with other vaccine producers. There is the potential for Bioject, as the owner of the enabling delivery technology, to receive royalties.
Bioject is currently talking with other vaccine developers. I expect that we will be hearing more announcements like yesterday's.
At first, I was very disappointed that Bioject changed their strategy from focusing on direct sales of the Biojector system to focusing on developing corporate alliances. Now, I can see what's happening, and it makes sense. We now have a market which needs us.
Marc Kahn |