Nabi Biopharmaceuticals develops vaccines addressing the unmet medical need of nicotine addiction. Its current sole remaining product in development is NicVAX® [Nicotine Conjugate Vaccine], an innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse based on patented technology. With over 1.3 billion smokers worldwide today and nearly five million tobacco-related deaths each year, tobacco addiction has been a hot topic for many countries around the world, prompting a need for medication provided by companies such as Nabi. As a result, the FDA has approved a Fast Track Designation for its drugs developed to fight nicotine addiction.
Nabi has a working relationship with GlaxoSmithKline (GSK) whereby revenues recognized under its drugs, PentaStaph and NicVAX, pertain to agreements where fees are recognized as revenue ratably over the period of participation in joint steering committees.
The U.S. Centers for Disease Control and Prevention (CDC) estimates that, among the 43.4 million adult smokers in the United States, roughly 70% want to quit. Unfortunately, despite this need, only 5% of those who attempt to quit remain smoke-free after 12 months, showing that current nicotine treatment methods are inadequate to match the millions of Americans desiring to quit. Most current therapies use nicotine replacement products such as patches, lozenges or chewing gum, but all have shown limited efficacy. Should NicVAX be approved, the upside potentials for mass distribution of this drug could mean unprecedented change in an industry that has not yet found a sustainable solution to quitting tobacco related products.
Tobacco use is considered the number one preventable cause of death in the United States, and it is estimated that smoking results in an annual health-related economic cost in the U.S. of approximately $193 billion. As a result, the Food and Drug Administration (FDA) is more inclined to grant a Fast Track Designation for products like NicVAX, which will speed up the approval process. Further, but being able to speed up the approval process, Nabi will have more time to enjoy the patent benefits should the drug be approved.
Nabi competes with other bio-pharmaceutical companies that try to achieve working relationships with pharma giants such as GlaxoSmithKline (GSK) and Merck (MRK), as well as subsidiaries of pharma giants that currently market addition-related treatment drugs such as: