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HCV Drug Development Slowed for Two Drugs
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"Hepatitis C Market: Plenty Of Potential, But Little Progress"
BY PETER BENESH
INVESTOR'S BUSINESS DAILY
Posted 3/31/2006
The month of March was not kind to a pair of companies racing to find a cure or vaccine for hepatitis C, the often fatal liver disease that's been called a global epidemic by the World Health Organization.
On March 21, Valeant Pharmaceuticals (VRX) said its drug Viramidine, in combination with current treatments for chronic hepatitis C, had no beneficial effect. Valeant's stock fell 14% on the news. (Note from jules: this is not exactly true, my understanding is that a new study is examining weight-based dosing of Viramidine).
Two days later, Idenix, (IDIX) partnering with Novartis, (NVS) said it will delay the phase two clinical trial of its drug NM283 (note from Jules: delay is to examine lower NM283 doses to address the GI-nausea side effects found associated with NM283)..
Idenix will cut doses from 800 mg to either 400 mg or 200 mg because of gastrointestinal side effects.
Idenix was subsequently downgraded and watched its shares plummet 28%.
Valeant and Idenix are among several companies trying to find treatments that are better than the current two-drug standard.
One of those drugs is Ribavirin. It's an oral antiviral sold generically and as Copegus by Roche and Rebetol by Schering-Plough. (SGP)
The second drug is Pegylated Interferon, a natural human protein that fights infection.
Pegylated Interferon is sold as Pegasys by Roche and PEG-Intron by Schering-Plough. It reduces the amount of hepatitis C virus in the blood, but doesn't eliminate it.
With 4 million Americans infected by hepatitis C, there's an urgent medical need.
Drug makers also have another incentive to produce a treatment, says analyst Andrew McDonald of ThinkEquity Partners.
Assuming new drugs come on the market by 2009 or 2010, he predicts the number of patients needing new hepatitis C drugs will peak in 2011, then trail off through 2016.
"After the debut of new treatment options, more patients will seek treatment, but at a declining rate (as they get cured)," McDonald said.
"The best treatment - the one that offers the greatest efficacy with the least amount of patient inconvenience - will be the dominant player. It will likely be able to command a premium price, with the other therapies left to compete on price alone."
Taking The Lead
McDonald says the race's current leader is Vertex, (VRTX) with its drug VX-950. The firm has completed a small phase two trial that was so successful, it's become "legendary," McDonald said.
Like many drugs targeting hepatitis C, VX-950 is a protease inhibitor. In simple terms, a protease inhibitor interferes with virus replication.
The trial was 100% successful, says Dr. John Alam, Vertex's chief medical officer and executive vice president. In the trial, 12 patients took VX-950, an oral drug, along with Ribavirin and interferon.
"All 12 patients went to undetectable levels of hepatitis C with only four weeks of treatment," Alam said. "That's a level of response that has not been approached by any other therapy."
He estimates that $2.5 billion is spent every year in the U.S. and Europe to battle hepatitis C.
Vertex's only direct competitor is Schering-Plough. Schering's developmental drug, SCH7, seems to take the same approach as VX-950, analyst McDonald says. Its success will depend on performance, dosage and side effects.
"Should Schering be unable to achieve similar results, they will likely be at a significant disadvantage to Vertex," McDonald said.
Vertex could use a win. The company has never turned a profit. Analysts don't see it moving into the black until 2010 - assuming VX-950 reaches the market. The firm is about to start a 200-patient phase two trial.
The Food and Drug Administration gave VX-950 a fast-track designation in December.
Nabi Biopharmaceuticals, (NABI) maker of Civacir, also has the FDA fast-track designation.
Civacir is aimed at hepatitis C patients who've had liver transplants. These patients risk reinfection because the virus remains in their blood or elsewhere, says Nabi Chief Executive Thomas McLain.
Transplant patients are in a bind, he says. "(After transplant), they can't take interferon and antivirals because of the immuno-suppressive drugs they're on."
Nabi's strategy is to give liver transplant patients antibodies to fight the remaining hepatitis C virus. The tricky part is getting the antibodies.
The idea is to get those antibodies from the blood of people who are infected with hepatitis C but are successfully fighting the disease.
"We could collect and purify their antibodies and give them to patients having transplants," McLain said.
The problem is limited supply. While it might be possible to synthesize antibodies, hepatitis C mutates. That means it's difficult to come up with a vaccine.
"We're looking for common targets across the strains, but it seems elusive," McLain said.
He puts the global market for Civacir at $300 million to $400 million a year and figures it'll hit the market no earlier than 2010.
No one company will find the cure for hepatitis C, McLain says. "It will take a combination of products to have a comprehensive solution."
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