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Re: [GIWorld-Hepatitis] HCV Drug Development

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  • avansi7465
    Well, it could be worse and the reasoning behind the acts makes the news less depressing.
    Message 1 of 2 , Apr 2, 2006
      Well, it could be worse and the reasoning behind the acts makes the news less depressing.

      -----Original Message-----
      >From: claudine intexas <claudineintexas@...>
      >Sent: Apr 1, 2006 11:35 PM
      >To: giworld-hepatitis@yahoogroups.com, Web Warriors <HepCWebWarriors@yahoogroups.com>
      >Subject: [GIWorld-Hepatitis] HCV Drug Development
      >
      >
      >Subject: NATAP: HCV Drug Development
      >
      >NATAP http://natap.org/
      >_______________________________________________
      >HCV Drug Development
      >
      > 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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