Highly Accomplished Executives Join BioVie’s Board of Directors
June 16 2020 - 8:30AM
BioVie, Inc. (OTCQB: BIVI) (“BioVie” or “Company”), a
clinical-stage company developing innovative drug therapies for
liver disease, is pleased to announce the appointments of Dr.
Robert Hariri, Mr. Steve Gorlin, and Mr. Sig Rogich to its Board of
Directors. Terren Peizer, BioVie’s Chairman and Chief Executive
Officer commented, “We are humbled to have these industry titans
join our company. Robert has leveraged his deep expertise in
biology to pioneer and found leading-edge life science companies.
Steve has been founder and initial investor in many successful
biopharma companies. Sig has served multiple US presidents over the
years and has been dedicated to improving Alzheimer’s disease
patient care. The new directors join current member and industry
leader Cuong Do, who was formerly Chief Strategy Officer at Merck
& Co. and currently President of Samsung Global Strategy Group.
The combination of unique talents and capabilities of these
distinguished gentlemen will greatly benefit BioVie as we advance
the Company.
Mr. Steve Gorlin has founded many biotechnology and
pharmaceutical companies over the past forty-five years, including
Hycor Biomedical, Inc. (acquired by Agilent), Theragenics
Corporation, Medicis Pharmaceutical Corporation (sold to Valeant
for approximately $2.6 billion), EntreMed, Inc., MRI Interventions
(MRIC), DARA BioSciences, Inc., MiMedx, Medivation, Inc., sold to
Pfizer for $14 billion and Conkwest which became NantKwest. Mr.
Gorlin served for many years on the Business Advisory Council to
the Johns Hopkins School of Medicine and on The Johns Hopkins
BioMedical Engineering Advisory Board. He also served on the Board
of the Andrews Institute. He is currently a member of the Research
Institute Advisory Committee (RIAC) of Massachusetts General
Hospital. He started The Touch Foundation, a nonprofit organization
for the blind and was a principal financial contributor to the
founding of Camp Kudzu for diabetic children.
Robert J. Hariri, MD, PhD, is the chairman, founder, and chief
executive officer of Celularity, Inc., a leading human cellular
therapeutics company. Dr. Hariri was the founder and CEO of
Anthrogenesis Corporation, and after its acquisition by Celgene
Corporation, served as CEO of Celgene Cellular Therapeutics. Dr.
Hariri also co-founded the genomic-based health intelligence
company, Human Longevity, Inc. He has served on numerous public
boards including Cryoport. Dr. Hariri pioneered the use of stem
cells to treat a range of life-threatening human diseases and
continues to make transformative contributions in the fields of
immuno-oncology and cell therapeutics. He is widely acknowledged
for his discovery of pluripotent stem cells derived from the human
placenta, and assisting with the discovery of the physiological
activities of tumor necrosis factor (TNF). He holds over 170 issued
and pending patents and has authored over 150 published chapters,
articles, and abstracts. Over the years he has garnered numerous
awards for contributions to the fields of biomedicine and
aviation.
Mr. Sigmund “Sig” Rogich is President of The Rogich
Communications Group and serves on the Board of Keep Memory Alive,
a philanthropic organization which raises awareness about brain
disorders and Alzheimer's disease. Keep Memory Alive funds clinical
trials through Cleveland Clinic’s Lou Ruvo Center for Brain Health
to advance new treatments for patients with Alzheimer’s,
Huntington’s and Parkinson’s disease, as well as frontotemporal
dementia and multiple sclerosis. Mr. Rogic was formerly the US
Ambassador to Iceland. He has served as a senior consultant to
candidates for the highest office, including Presidents Ronald
Reagan and George H.W. Bush. Mr. Rogich serves on the Board of
Directors for many charitable causes.
About BioVie and
BIV201
BioVie Inc. is developing BIV201 (continuous infusion terlipressin)
an Orphan Drug candidate for the treatment of ascites due to
advanced liver cirrhosis. First-to-market Orphan therapies
typically receive 7 years of market exclusivity in the US for the
designated use(s). It is being investigated as a potential new
therapy for patients suffering from ascites, and future development
opportunities include hepatorenal syndrome (HRS) and other
life-threatening complications of advanced liver cirrhosis. The
initial disease target for BIV201 therapy is ascites, which is a
serious complication of advanced liver cirrhosis. The Company has
completed a Phase 2 clinical trial protocol that is summarized on
www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has
never approved any drug specifically for treating ascites, and the
Company is not aware of any competing drugs in late-stage
development for ascites. The active agent in BIV201, terlipressin,
is approved for use in about 40 countries for the treatment of
related complications of advanced liver cirrhosis but is not
available in the US or Japan. BIV201 has also received Orphan Drug
designation for the treatment of hepatorenal syndrome (HRS) and has
FDA Fast Track status.
BioVie recently invented a patent-pending BIV201 prefilled
syringe for use in the upcoming Phase 2 trial subject to conducting
certain additional standard analytical testing expected to take
approximately two weeks. Room temperature stability of the
prefilled syringe has been confirmed at 6 months, with the
potential for 12 months or up to two years of stability (yet to be
confirmed). Room temperature storage presents a key product
differentiation versus terlipressin products in countries where the
drug is approved. To the best of the Company’s knowledge, all other
terlipressin products sold globally must be stored under
refrigeration and there is no prefilled syringe format of
terlipressin available for treating patients in these countries.
Terlipressin, which is not available in the US or Japan, is often
sold as a lyophilized powder for reconstitution in hospital
pharmacies in Europe and Asia. The traditional powder format is
satisfactory for hospital use, but creates a logistical challenge
when administering terlipressin via ambulatory infusion pump in
patients located outside the hospital setting. To solve this
challenge, the Company developed a patent-pending liquid
formulation for delivery via prefilled syringe. This novel
drug delivery system is expected to simplify at-home patient
treatment and improve patient compliance by enabling easy injection
of the liquid concentrate into the IV bag connected to the infusion
pump. It avoids the manual mixing of minute (2 – 4 mg) quantities
of terlipressin powder in saline solution, thereby reducing the
possibility of dosing errors during reconstitution, and is expected
to improve drug solution sterility. The Company has begun applying
for global patent protection for our novel BIV201 prefilled
syringe, which could eventually provide up to 20 years of patent
coverage in each country for which the Company seeks patent
protection, including the US, according to the patent laws of that
country. For more information about BioVie, please visit our
website: www.biovieinc.com.
About Liver Cirrhosis, Ascites, and Hepatorenal
Syndrome Chronic liver cirrhosis and its complications are
the eighth-leading cause of death in the US (Runyon 2013).
Cirrhosis results primarily from hepatitis, alcoholism, and
nonalcoholic steatohepatitis (NASH) linked to fatty liver disease
and obesity. Ascites is the most common serious complication of
advanced liver cirrhosis. Patients with cirrhosis and ascites
account for an estimated 116,000 US hospital discharges annually
with frequent early readmissions. Those requiring paracentesis
(physical removal of ascites fluid with a large-bore needle)
experience an average hospital stay lasting 8 days and generate
approximately $5 billion annually in medical costs in the US (HCUP
Nationwide Readmissions Database 2016). Certain drugs
approved for other uses may provide initial relief, but patients
develop so-called refractory ascites, failing to respond to them as
the ascites worsens. For refractory ascites the mean one-year
survival rate is only 50% (Bureau et al. 2017). Patients with
refractory ascites often progress to hepatorenal syndrome (HRS)
which is the onset of kidney failure and requires emergency
hospitalization. About one-half of these patients typically succumb
within only 2 to 4 weeks and no drug therapies have been FDA
approved specifically to treat HRS.
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 successfully completing pre-clinical testing or
clinical studies, or may not be granted regulatory approval to be
sold and marketed in the United States or elsewhere. BioVie cannot
guarantee the effectiveness of its Orphan Drug designations or any
patents that BioVie may be issued. A more complete description of
these risk factors is included in BioVie's filings with the
Securities and Exchange Commission. 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.
INVESTOR RELATIONS:Dave Gentry, CEORedChip Companies
Inc.407-491-4498dave@redchip.com
BioVie (NASDAQ:BIVI)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioVie (NASDAQ:BIVI)
Historical Stock Chart
From Apr 2023 to Apr 2024