It is axiomatic within the intensely competitive pharmaceutical business that one needs to be either first to market or best-in-class to thrive. All of FIT Biotech’s R&D targeted products will represent medical breakthroughs. Our products based on cutting edge gene delivery technology should replace current expensive biological drugs at an order of magnitude lower price.
Our therapeutic HIV-vaccine will be tested in a phase II clinical study by the European HIV Vaccine Alliance. Should the outcome be positive it would represent a “best-in-class” therapeutic breakthrough.
The chosen development strategy is straightforward and faster than developing entirely new biological drugs that typically takes over ten years and has significant drug development risk.
We plan to license the product candidates that have demonstrated preclinical proof-of-concept or alternatively when we have documented clinical safety and efficacy, respectively, in early Phase clinical trials.
The pharmaceutical industry typically invests up to 2,6 billion dollars to develop one new drug to the market. Pharmaceutical companies continuously scout for promising drug candidates that smaller companies develop and test in preclinical and early clinical studies. Development companies have ongoing contacts and negotiations with big pharmaceutical companies to timely execute long term collaboration and licensing agreements with optimal partners.
The pharma market has recently evidenced a multitude of licensing agreements at early development stage between biotech companies developing gene based therapies and the so called “large pharma”. A high demand on a rapidly growing market has resulted in rapidly escalating the total values of the licensing agreements. Advance payments can amount to hundreds of millions of dollars with running royalties exceeding ten percent of net sales. This licensing market is targeted by us.
FIT Biotech offers investors an unprecedented opportunity to participate in the international commercialization of drug candidates based on Finnish biotechnology aiming at a dramatic improvement of human health and affordability. We also offer a huge market potential – our target markets are in the billions of euros (antibodies against cancer approximately 100 billion euros and HIV about 20 billion euros). While drug development is an inherently long term process, there should be multiple milestones met along the way and early stage licensing agreements are current norm.