Here at Stinson Brand Innovation, we're always on the look-out for novel ideas that accelerate the development of new medical treatments. So we are intrigued by what Swedish biotech company, Karo Bio, is doing with its potential cholesterol game-changer. Their problem: raising $500 million for testing to gain FDA approval.
Their solution: Karo has developed is enlisting the help of noted cardiologist and FDA advisor, Steven Nissen. With Nissen's help, Karo is working to recruit a big drugmaker to finance clinical trials, and to convince the FDA of a clinical trial that could cut the usual approval time in half.
This new drug, eprotirome, works in the liver to clear cholesterol from the body, in contrast to Lipitor, the largest selling cholesterol drug, which blocks the liver enzyme needed to produce cholesterol. Upon approval, eprotirome could reach sales over $1.3 billion a year.
The proposed expedited approval plan includes testing on more patients for less time and money. The goal is to push through the approval process in less than 3 years, saving nearly $200 million. With assets of only $35 million, however, Karo still needs a big pharma partnership. The biggest obstacles to achieving this goal come in the form of Lipitor's looming 2011 patent expiration, and the doubts many healthcare professionals have about fast-track drug approvals. The real task is determining if the drug's benefits of outweigh the risks of a fast-tracked approval.
