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Racing to The Market with New HCV Drugs
Vertex May Beat Roche, Merck on Drug for Hepatitis C
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By Angela Zimm
Nov. 3 (Bloomberg) -- Vertex Pharmaceuticals Inc., a biotechnology company founded in 1989, may beat drugmakers from Roche Holding AG to Merck & Co. to produce the first medicine in a decade to treat hepatitis C, the main cause of liver cancer.
Vertex's drug, which the company plans to seek approval for in 2008, is one of several treatments in patient testing. The experimental medicines target the biological machinery the hepatitis C virus uses to thrive and draws on advances in gene science employed in the discovery of AIDS drugs. Researchers say the competing medicines may be combined someday, much as AIDS is treated by a so-called cocktail of drugs.
Hepatitis C, identified only 17 years ago, infects as many as 200 million people worldwide and about 1 percent of the U.S. population. Symptoms of the blood-borne virus can take 20 years to emerge, and existing drugs help only about half of patients, doctors say. More effective treatments from Vertex, Merck, Roche, Novartis AG, Pfizer Inc. and Schering-Plough Corp. may generate $10 billion in annual sales, analysts say.
``We're at the dawn of a new era of advances in the field of hepatitis C,'' said Ira Jacobson, chief of gastroenterology and hepatology at Weill Medical College of Cornell University in New York. ``Several drugs may be the breakthroughs we are hoping for.''
A hepatitis C health crisis is emerging worldwide as people progress to more severe stages of the disease since its discovery in 1989, doctors say. In poor countries, unscreened blood transfusions and re-use of needles that haven't been properly sterilized remain a main cause of infection. About 10,000 people die from hepatitis C each year in the U.S., approaching the 15,000 annual deaths from AIDS.
Most Potent Drug
Human Genome Sciences Inc., Vertex, Roche, Novartis and Pfizer are among companies that reported results of experimental hepatitis C drugs this week at a meeting in Boston of the American Association for the Study of Liver Diseases.
Vertex may have the most potent treatment in a compound called telaprevir, researchers and analysts say. The shares gained 18 percent on Oct. 27 when the Cambridge, Massachusetts- based company announced study results at the start of the medical conference.
Shares of Vertex gained 43 percent this year before today on positive research data on the pill. The stock rose 12 cents to $39.78 at 10:27 a.m. New York time in Nasdaq Stock Market composite trading.
Virus Levels
The study showed that the pill, taken in combination with standard therapy, helped cut the virus to undetectable levels in half the time of standard therapy alone. Twelve weeks after ending treatment, five out of six patients still had undetectable levels of the virus.
``The news is extraordinarily exciting,'' Geoffrey Porges, an analyst with Sanford C. Bernstein in New York, said in a telephone interview. ``It suggests the company has a drug that can transform the outlook for millions of patients with hepatitis C.''
Porges estimates Vertex's telaprevir can reach the market by 2009 and generate annual sales of $2 billion by 2011.
The virus is one of several forms of the liver disease hepatitis, which damages the organ slowly. The infection often isn't detected until the later stages of the disease. Unlike the fight against hepatitis A and B, no vaccine exists to protect against the virus.
Hepatitis C is spread through infected blood. Those most at risk include injecting drug users or people who received blood transfusions prior to 1992, before a reliable test was developed to screen donated blood for hepatitis C.
Standard Care
The current standard of care for hepatitis C involves a yearlong course of injections with one of two interferon drugs, Schering-Plough Corp.'s Peg-Intron or Roche's Pegasys, combined with an older pill called ribavirin. Interferon is a natural human protein that can boost the immune system while ribavirin can reduce virus in the blood.
Injections are given weekly and can cause flu-like symptoms. Other side effects include depression, anemia and fatigue. The two interferon products generated a combined $2 billion in sales last year.
The most promising experimental medicines target the hepatitis C virus similar to ways AIDS drugs attack HIV, by blocking proteins the virus uses to reproduce inside the body.
Vertex's telaprevir blocks the protease enzyme the virus needs to reproduce. Schering-Plough, based in Kenilworth, New Jersey, is working on a similar drug known as SCH 503034. Both medicines are in the second of three stages of human testing needed for U.S. Food and Drug Administration approval.
Roche Drug
A drug from Basel, Switzerland-based Roche, called R1626, is from a class that inhibits polymerase, another key protein the virus uses to multiply. An early-stage study presented at the liver conference in Boston found it reduced the virus in hard-to- treat patients.
Novartis, also based in Basel, and Idenix Pharmaceuticals Inc., a Cambridge, Massachusetts-based biotechnology company, are testing a polymerase inhibitor called valopicitabine in the second of three phases of human trials. A study at this week's meeting found the drug combined with interferon lowered virus in the blood to undetectable levels after 24 weeks.
Pfizer, based in New York, is working on a new drug called a pancaspase inhibitor that, instead of targeting the virus, is designed to protect the liver against damage from the infection.
Other companies developing new treatments for hepatitis C include Wyeth, ViroPharma Inc., InterMune Inc. and Abbott Laboratories, all based in the U.S.
``A cure for hepatitis C is what we're after, and it's a very robust environment right now,'' John M. Vierling, chief of hepatology at Baylor College of Medicine in Houston, said in an interview at the Boston meeting.
Better drugs may increase the market to $10 billion to $20 billion in sales annually, according to Ding Ding, an analyst with Maxim Group in New York.
``This is a race and there are a lot of companies involved,'' Ding said in an interview.
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