BioVie Advances the BIV201 Clinical Program and Prefilled Syringe
June 11 2020 - 8:30AM
BioVie Inc. (OTCQB: BIVI) (“BioVie” or “Company”), a clinical-stage
company developing innovative drug therapies for liver disease,
announced today that following the company’s successful Phase 2a
study, it has received guidance from the US Food and Drug
Administration (“FDA”) regarding the next clinical trial design for
BIV201 (continuous infusion terlipressin) in patients with
refractory ascites due to liver cirrhosis. The Company plans to
commence a randomized 24-patient Phase 2 study this year, to be
followed by a larger pivotal Phase 3 clinical trial targeted to
begin the first half 2021. The FDA has communicated that pending
positive Phase 2 study results, a sufficiently large and
well-controlled Phase 3 trial, with supportive data from the Phase
2 (statistical significance not required), could potentially yield
the clinical data needed to apply for BIV201 marketing approval.
The Company estimates that the pivotal Phase 3 study will involve
approximately 120 ascites patients.
Terren Peizer, BioVie Chief Executive Officer, stated, “We
appreciate the FDA’s detailed guidance for planning the next BIV201
clinical trial in ascites patients who are seriously ill and often
hospitalized with life-threatening complications of their disease.
The primary goal of the upcoming Phase 2 study will be to reduce
the occurrence of dangerous complications linked to refractory
ascites, which is the accumulation of large volumes of fluid in the
abdomen no longer responding to off-label diuretic therapy. We
anticipate that the pivotal Phase 3 trial design will mirror the
Phase 2 study design. Based on our US Phase 2a trial results and
global studies, we believe that our Orphan Drug candidate BIV201
has the potential to greatly relieve the suffering of ascites
patients and improve their health outcomes.”
Importantly, BioVie may use the new patent-pending BIV201
prefilled syringe in the upcoming Phase 2 trial subject to
conducting certain additional standard analytical testing that is
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 development of a novel liquid version of terlipressin
offering the potential for long-term stability at room temperature
is an important breakthrough in the quest for an at-home therapy
for ascites patients,” commented Denise Smith, BioVie Vice
President of Manufacturing and Quality Control. “In addition to
simplifying product storage, it creates the opportunity for our
next generation terlipressin delivery system that will be further
optimized for home care.”
BIV201 (continuous infusion terlipressin) has received an Orphan
Drug designation from the FDA for the treatment of ascites.
First-to-market Orphan therapies typically receive 7 years of
market exclusivity in the United States for the designated use(s).
In addition, the Company has begun applying for global patent
protection of our proprietary liquid formulation of terlipressin.
This 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.
About BIV201BIV201 (continuous infusion
terlipressin) 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 received Orphan Drug
designations for the treatment of ascites and for HRS and has FDA
Fast Track status. 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 been FDA approved
specifically for treating 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
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