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TECHNOLOGY

BIV201 – A NEW THERAPEUTIC APPROACH

BioVie’s BIV201 could potentially yield a breakthrough approach to treating ascites due to liver cirrhosis, with the goal of directly targeting its “mechanistic source. ” The active agent in our technology is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world. The goal is to interrupt the ascites disease pathway, thereby halting the “vicious cycle” of accelerating fluid generation.

Reducing ascites formation promises to improve patients’ quality of life and potentially avoid certain life-threatening complications. However unless the patient is able to regain liver function (for example, if an alcoholic quits drinking), he or she may eventually require a liver transplant.

BIV201 DEVELOPMENT STATUS

The Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA regarding BIV201 in early 2016 and received guidance for an upcoming IND submission. The Company’s new drug candidate could potentially commence US clinical trials as early as 2017.

The active ingredient in BIV201 is a compound which many US physicians who specialize in liver disease are familiar with, even though it is not yet available in the US. It has been studied extensively overseas in related conditions and its efficacy and safety profile has been elucidated by hundreds of scientific publications. It is approved in about 50 countries to treat esophageal variceal bleeds, a frequent complication of liver cirrhosis, and in some countries for treating type 1 (hospitalized) hepatorenal syndrome. These conditions share a similar root cause – portal hypertension – and are often accompanied by ascites.

INTELLECTUAL PROPERTY

BioVie relies on a combination of trade secrecy and patent strategy to protect our confidential information and seek market exclusivity for our products. The Company has submitted patent filings for BIV201 technology in the US and Japan as well as submitted a PCT in Europe. Additionally, BioVie has applied for US Orphan Drug Designation for its new drug candidate since the number of ascites patients (about 100,000 Americans) meets the required patient population size.

FUTURE POSSIBILITIES

Based on investigative studies around the world, BIV201 has the potential for future applications in other life-threatening conditions due to liver cirrhosis, such as those listed below. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries’ regulatory requirements, none of which have commenced at this time.

  • Esophageal variceal bleed (EVB): The bursting of blood vessels lining the esophagus due to high blood pressure (“portal hypertension”) in the vein which supplies blood to the liver resulting as a result of advanced liver cirrhosis. This situation requires emergency treatment to avoid blood loss and death.
  • Hepatorenal syndrome (HRS): As their disease progresses liver cirrhosis patients’ kidneys may begin to fail, and this deadly condition may set in. It often occurs once a patient no longer responds to (off-label) drugs used to control ascites. The second stage is called “type 1 HRS” and requires hospitalization as multiple organ failure and death may occur.
  • Hyponatremia: This term refers to “low salt in the bloodstream,” another dangerous condition which can occur as a result of advanced liver cirrhosis.

POSSIBLE ACCESS TO EARLY-STAGE COMPOUNDS

The Company has an Agreement with PharmaIN Corporation (Bothell, WA) providing certain limited rights and information on their program to develop novel modified terlipressin compounds. Although at an early stage, these compounds hold the promise of simpler and potentially safer dosing for patients outside the hospital. If this program makes significant advances, BioVie may contact PharmaIN to explore a licensing opportunity. For more about PharmaIN’s innovative drug development program, visit: www.pharmaIN.com.

EFFLUX PUMP ANTIBIOTICS PROGRAM

The Company (formerly NanoAntibiotics, Inc.) was founded in 2013 to focus on the discovery and development of new classes of broad spectrum antibiotics for gram-negative and gram-positive bacterial infections,including some of the most difficult to treat multi-drug resistant bacteria, also called “Superbugs.”

Our antibiotic drug discovery platform is built upon a multi-pronged understanding of the interactions between drug candidates and their bacterial targets, and enables the engineering of antibiotics with enhanced characteristics to attack a drug resistant bacteria. Our novel compounds originated with Kard Scientific, Inc. (“Kard”), a preclinical contract research organization. Researchers at Kard synthesized these compounds and have conducted in vitro studies. In 2013 Kard assigned all of their rights, formulations, studies and data related to efflux pump antibiotics to the Company. These new drug candidates have been studied in cell-based assays (in-vitro), but have not yet been studied in small animals (in vivo) or in animals with drug resistant bacteria to assess their efficacy, efficiency, and toxicity. We own all development and marketing rights to this program. Since the Company is now exclusively focused on developing BIV201 for liver disease, we are seeking to contract research and development of the antibiotic program to a third party.

FORWARD LOOKING STATEMENTS

This website 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. The fact is that BioVie’s compounds may not successfully complete pre-clinical or clinical testing, or 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. 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.