San Diego, CA, United States

Amira Pharmaceuticals

www.amirapharm.com
San Diego, CA, United States
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BEVERLY, MA--(Marketwired - May 10, 2017) - BioVie Inc. ( : BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today welcomed Dr. Hari Kumar, a highly accomplished biopharmaceutical industry executive, to its Board of Directors as an independent director. In addition, Dr. Kumar purchased common shares of BioVie stock through a private placement. After earning a PhD in immunology in 1984, Dr. Kumar embarked upon a successful career in the biopharmaceutical industry. He held positions of increasing responsibility at Roche Pharma culminating in serving as Global Business Development Director, and in 2007 assumed the role of Chief Business Officer for Amira Pharmaceuticals. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million. He then served as Chief Executive Officer (CEO) for Panmira Pharmaceuticals LLC, which is developing anti-inflammatory compounds, and in 2013 became CEO for Adheron Therapeutics, which Roche Pharma acquired in 2015 for $580 million. Beyond his impressive track record, Dr. Kumar brings deep experience in fibrotic and liver diseases to the Company. "We are very pleased that Hari is joining our team," said BioVie CEO Jonathan Adams. "He has expertise in our therapeutic area and will contribute to planning the clinical development of our Orphan Drug candidate BIV201, which is about to enter a Phase 2 clinical trial. On a strategic level he will assist with seeking to build substantial company value. His enthusiasm for BioVie was apparent from our first discussion about four months ago." Dr. Kumar commented: "Speaking with the Company's core team members, including their preeminent medical advisor Guadalupe Garcia-Tsao MD, reinforced my opinion that BIV201 has the potential to become an important medical breakthrough for patients at risk of life-threatening complications due to advanced liver cirrhosis. I look forward to working with the team at BioVie to pursue success for this potential new therapy and for the overall company." BIV201 is a continuous infusion of the peptide terlipressin, initially being developed by BioVie for the treatment of refractory ascites. It will soon commence a Phase 2a trial in 6 patients with liver cirrhosis and ascites refractory to, or intolerant of, diuretic therapy requiring large-volume paracentesis. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no FDA-approved drugs specifically for treating ascites. More information about the trial may be found at clinicaltrials.gov, identifier: NCT03107091. About BioVie Inc. BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com. About Liver Cirrhosis and Ascites More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually. Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the completion or success of its planned Phase 2a clinical trial.


Patent
Amira Pharmaceuticals and Bristol Myers Squibb | Date: 2016-12-16

Described herein is the LPA1 antagonist 1-{4-[3-methyl-4-((R)-1-phenyl-ethoxycarbonylamino)-isoxazol-5-yl]-biphenyl-4-yl}-cyclopropanecarboxylic acid (Compound 1), or pharmaceutically acceptable salts thereof. Also described are methods of preparing the LPA1 antagonist, or pharmaceutically acceptable salts thereof, as well as pharmaceutical compositions suitable for administration to a mammal that include the LPA1 antagonist, or pharmaceutically acceptable salt thereof, and methods of using such pharmaceutical compositions for treating LPA-dependent or LPA-mediated diseases or conditions.


Patent
Amira Pharmaceuticals | Date: 2015-02-23

Described herein are compounds that are inhibitors of autotaxin. Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such inhibitors, alone and in combination with other compounds, for treating autotaxin-dependent or autotaxin-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2012-04-04

Described herein are compounds that are antagonists of lysophosphatidic receptor(s). Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such antagonists, alone and in combination with other compounds, for treating LPA-dependent or LPA-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2011-04-22

Described herein are compounds that are antagonists of lysophosphatidic receptor(s). Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such antagonists, alone and in combination with other compounds, for treating LPA-dependent or LPA-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2015-06-30

Described herein are compounds that are antagonists of lysophosphatidic receptor(s). Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such antagonists, alone and in combination with other compounds, for treating LPA-dependent or LPA-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2011-08-19

Described herein are compounds that are inhibitors of autotaxin. Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such inhibitors, alone and in combination with other compounds, for treating autotaxin-dependent or autotaxin-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2012-01-11

Described herein are compounds and pharmaceutical compositions containing such compounds, which modulate the activity of 5-lipoxygenase-activating protein (FLAP). Also described herein are methods of using such FLAP modulators, alone and in combination with other compounds, for treating respiratory, cardiovascular, and other leukotriene-dependent or leukotriene mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2012-05-21

Described herein are compounds that are inhibitors of autotaxin. Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such inhibitors, alone and in combination with other compounds, for treating autotaxin-dependent or autotaxin-mediated conditions or diseases.


Patent
Amira Pharmaceuticals | Date: 2014-05-21

Described herein are compounds that are antagonists of lysophosphatidic receptor(s). Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such antagonists, alone and in combination with other compounds, for treating LPA-dependent or LPA-mediated conditions or diseases.

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