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The present disclosure provides methods for treating hepatic encephalopathy (HE) and for optimizing and adjusting nitrogen scavenging drug dosage for subjects with HE.

The present disclosure provides methods, systems, and instruments for the determination by a physician or medical professional whether a subject is experiencing or has recently experienced an overt HE episode and for grading overt HE episodes as well as methods, systems, instruments and tools for screening for overt HE episodes by a non-medical professional such as a caregiver. Also provided are methods of treating HE episodes and methods of monitoring HE episode treatment that incorporate these methods, systems, instruments, and tools.

Hyperion Therapeutics | Date: 2013-02-22

The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.

News Article | April 24, 2014
Site: www.iati.co.il

U.S. biopharmaceutical company Hyperion Therapeutics said on Thursday it agreed to buy Israel's Andromeda Biotech, a developer of a new diabetes drug, in a deal that could be worth close to $600 million. Andromeda is a subsidiary of Clal Biotechnology Industries. Hyperion would make milestone payments of $120 million, the first of which would not be made until acceptance of the first marketing application filing for review in either the United States or Europe. Andromeda is developing DiaPep277, a treatment for Type I diabetes. DiaPep277 is currently undergoing a second advanced Phase III clinical study, with results expected in the first quarter of 2015. Once the drug hits annual global sales of $450 million, Hyperion would pay up to $430 million in commercial milestones. It would also pay as much as 17 percent in contingent sales for annual worldwide sales above $1.2 billion, Hyperion said. "The acquisition of Andromeda Biotech is a transformative event for Hyperion," said Donald Santel, chief executive of Hyperion. "We believe DiaPep277 has the potential to become a highly differentiated, first-in-class medicine for an orphan indication with a significant unmet need." For the full Reuters news item click here.

News Article | February 17, 2015
Site: www.fiercebiotech.com

Hyperion Therapeutics ($HPTX), which argues it was tricked into signing a $570 million deal for an Israeli biotech, has reached a ceasefire with the seller over a diabetes drug with a checkered past. The saga began last spring when Hyperion agreed to pay Clal Biotechnology $20 million up front and up to $550 million in milestones in exchange for Andromeda Biotech, developer of a Phase III diabetes treatment called DiaPep277. Everything came unraveled by September, however, as Hyperion discovered that the drug's existing late-stage data had some major holes, accusing Andromeda staffers of tampering with trial results and taking up legal arms to get some of its cash back. Now the two have reached an agreement under which Clal will hand over $2.5 million and Hyperion will promise to complete an ongoing Phase III trial of the drug for an estimated $10.5 million. Once the study is complete, an independent committee with members from Hyperion, Clal and the Weizmann Institute of Science's Yeda will pore over its results. At that point, Clal will have the option to buy Andromeda back for $3.5 million, agreeing to fork over up to $36.5 million more in milestone payments. If the Israeli company chooses not to reacquire its former seedling, the rights to DiaPep277 will revert to Yeda. Hyperion will have sunk about $40 million into Andromeda by the time the trial concludes, and so the best case for the American biotech is a simple refund. If Clal walks away from the deal, Hyperion will have nothing to show for the months and millions expended on DiaPep277. The drug, an immune intervention treatment for the orphan indication of new-onset Type 1 diabetes, was once partnered with Teva ($TEVA) before Clal paid $72 million to reacquire exclusive rights in February. The Israeli company at the time talked up negotiations with an unnamed U.S. company that turned out to be Hyperion, whose CEO, Donald Stansel, called the Andromeda acquisition a "transformative event" upon signing the deal in April. Related Articles: Hyperion and Clal come to temporary terms over a $570M biotech boondoggle Hyperion claims it was duped by fraudulent data into $570M Andromeda buyout Hyperion bets up to $570M on diabetes biotech Andromeda

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