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Ocera Therapeutics, Inc. Message Board

  • shushkin_ch shushkin_ch Mar 26, 2014 5:18 AM Flag

    Market Potential OCR-002

    They say the potential for the IV version in the US is about $500 - 700M. If you look at the latest slides (page 16) you will see that hospitalizations due to acute HE will increase significantly in the coming years so I guess the potential is even bigger.

    Check the sales of Rifaximin. On the way to blockbuster status. But it's actually funny that the stadard of care in treating HE is still Lactulose. When I read what Lactulose is actually doing I immediately think: "It's time for something new. There's is much more space in the area of treating HE."

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    • Acute Hepatic Encephalopathy: Current Treatment and Unmet Medical Need

      There is currently no FDA-approved treatment for patients presenting at the hospital with acute HE. The current standard of care for these patients includes hydration, supportive care and pharmacologic treatment to suppress the production of ammonia in the intestine, most commonly through administration of the laxative lactulose or non-absorbable antibiotics. There is no definitive data on the degree of effectiveness of these agents in treating the acute HE patient.

      Lactulose can be difficult to administer in the hospital setting where patients may not be able to swallow, requiring the medication to be given by nasal-gastric tube or by enema. Abdominal cramping, diarrhea and flatulence are common side effects with lactulose, making the drug difficult for many patients to tolerate. Moreover, a published review of clinical trials involving lactulose and lactitol in the treatment of HE concluded that those agents failed to demonstrate a statistically significant benefit.

      Rifaximin, a poorly absorbed non-systemic oral antibiotic manufactured by Salix Pharmaceuticals, Ltd (“Salix”) is believed to limit the local production of ammonia in the intestine. Rifaximin 550 mg tablets were FDA approved in March 2010 for the maintenance of remission from overt HE in patients 18 years of age or older. While rifaximin has been shown to be effective in preventing recurrent episode of HE in the outpatient setting, there is no evidence that it is effective in the acute care of hospitalized cirrhotic patients with HE.

      Ravicti is an oral ammonia-lowering agent currently in development by Hyperion for the prevention of HE events in patients with cirrhosis. In a Phase 2b trial, Hyperion showed that Ravicti was effective in reducing the number of episodes of overt HE. However, there is no evidence that Ravicti is effective in the acute setting for patients who present to the hospital with overt HE.

    • there is nothing out there for HE, and that's the reason for the orphan and fast track designations for ocr-002. I read that the iv potential was 700 mil. Don't forget the oral version (to be tested in 2015). That is another 700 mil, so looking at 1.5 billion and if someone is willing to invest now and wait a few yrs, they should see ocrx at $200 to $400 at 3 times potential sales. And that's just the US. Take this to eastern europe and/or central asia where all the drunks are and you will make a killing.

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