They are known as silent killers: highly infectious viruses whose symptoms appear often only when it is too late. While HIV, the AIDS virus, garners more headlines, Hepatitis B and C pose an equally serious global health threat. More infectious even than HIV, both the B and C strains of Hepatitis attack the liver and if left untreated can lead to cirrhosis, liver cancer, and ultimately death. Some half a billion people worldwide are chronically infected with Hepatitis B or C -- and more than two million die annually from them.
Now there's a new ray of hope. Franco-Italian-American biotech Idenix (IDIX) has developed novel drug treatments for both Hepatitis B and C that could stop the viruses in their tracks. Taken orally just once a day, instead of by injection like some other hepatitis treatments, both drugs prevent the viruses from replicating, by targeting specific enzymes.
Very few patients are ever cured of Hepatitis B, though current treatments can slow the disease. The main aim of new therapies is to stop it from progressing. With Hep C, by contrast, there are no drugs now on the market to prevent the virus from replicating. Idenix's new treatment -- if it's approved -- should help boost the cure rate for Hep C, which is now less than 50%.
The potential market is significant. Chronic Hepatitis B affects about 350 million people around the globe, of whom 1.25 million are in the U.S. Up to 1.2 million people die each year from Hepatitis B-related liver disease, making it the 10th leading cause of death worldwide. According to the Center for Disease Control and Prevention (CDCP), the U.S. alone spends $720 million each year on treating Hep B.
At the end of 2005, Idenix submitted its first drug, a treatment for Hepatitis B called Telbivudine, to the U.S. Food and Drug Administration for approval. Although there are five different drugs on the market already that tackle the virus, they don't always work or they may cause serious side effects for many patients. What sets Telbivudine apart, says Idenix founder and CEO Jean-Pierre Sommadossi, is that it causes the Hep B viral load to drop faster than any other drug so far in use.
Hepatitis C has, until now, been an even knottier problem. The most common blood-borne infection in the U.S., Hep C is also the leading reason for liver transplants. Worldwide, an estimated 170 million people suffer from the virus, with up to 4 million new cases reported each year. And unlike Hepatitis B, there are no vaccines to prevent infection with Hep C. The market for drugs to treat it is expected to reach up to $10 billion in worldwide sales by 2013.
Idenix is now leading a race among a number of other companies such as Vertex Pharmaceuticals (VRTX), Schering-Plough (SGP), and Anadys Pharmaceuticals (ANDS) to launch new treatments for Hepatitis C. Idenix could have the inside track because its drug, Valopicitabine, is the furthest along in development. Equally important, Idenix has a big partner in Swiss pharmaceutical giant Novartis (NVS), which owns 56% of the company. On Mar. 29, Novartis announced plans to license Valopicitabine, following a deal in 2003 to license Idenix's Hep B treatment, Telbivudine.
Idenix's Sommadossi helped to discover both drugs. Prior to founding Idenix, he spent 20 years in academia researching treatments to combat viruses. Involved in most of the major pharmaceutical trials of HIV drugs, the French native was one of the first researchers to recognize the importance of using a cocktail of medicines to treat HIV, an approach which has since revolutionized treatment of the disease.
Convinced that a small biotech focused solely on anti-viral drugs would be able to bring new products to market faster than bureaucratic global giants, Sommadossi founded Idenix in 1998. The company went public in 2004 and is currently worth $640 million. Its headquarters are in Cambridge, Mass., and it has research operations in Montpellier, France and Cagliari, Italy. The company's sharp focus on infectious disease has allowed it to develop a promising pipeline. BusinessWeek London correspondent Kerry Capell spoke with Sommadossi about the outlook for Idenix.
How big is the market for Hepatitis B drugs and when do you think Telbivudine could hit the market?
The market is currently worth $1 billion in sales globally. We foresee that increasing to between $1.7 billion and $2 billion by 2009. You have to understand that of the 30% of Hepatitis B patients who need treatment, only 5% are actually getting it. But sales of Hepatitis B treatments in the U.S. are growing at more than 30% a year over the last three years. And as more potent therapies come to market, doctors are encouraging diagnosed patients to step up for treatment. We think Telbivudine could be on the market by end of 2006 in the U.S. and early 2007 in Europe and Asia.
How important is the collaboration with Novartis to Idenix's development?
The collaboration has been transformational and one of the major milestones in our development. It allows us to keep our entrepreneurial culture and benefit from all Novartis' expertise, especially in marketing, manufacturing, and regulatory affairs. Because Novartis does not have to license a product until it reaches initiation of Phase III clinical trials, we take on the early discovery and clinical development risk.
Once a product is licensed, Novartis fully funds the development and we share the marketing costs. Right now, we are in very strong financial position that enables us to fund the development of several programs simultaneously. In eight years, we have moved this company from a research outfit with six employees to a multinational biotech with a sustainable future.
There are already five drugs on the market for Hepatitis B. Why is a sixth needed, and how will yours differ?
While currently approved treatments are able to control the disease in some patients, many patients fail to respond adequately, cannot tolerate treatment, or develop resistance to the therapy. Current therapies aren't potent enough to adequately suppress the extremely high levels of virus often present in patients infected with chronic hepatitis B. What we know is that the quicker you can reduce the level of virus in the blood which is known as the viral load, the better the outcome for the patient.
We conducted the largest clinical trials for Hepatitis B ever at more than 130 medical centers in 20 countries, including sites in China, where one in 10 people is infected with chronic hepatitis B. These trials demonstrated that after six months of treatment, Telbivudine has the most profound and rapid decline in viral load of any drug available. That's why we believe Telbivudine will be the best in class treatment.
You were one of the discoverers of Idenix's drug for Hep C. What is significant about your approach?
I helped discover it in 2000. There are two different schools of thought on the development of new treatments for Hepatitis C. One approach is what we are doing: developing drugs which stop the virus from replicating. The other attempts to alter the body's immune response to the virus. But the hepatitis viruses are complex and will not be treated by one single drug. Finding the best cocktail of drugs will be a slow evolution rather than an overnight transformation.