BioVie Manufactures Novel Terlipressin Prefilled Syringe
December 09 2019 - 8:00AM
BioVie Inc. (OTCQB: BIVID) (“BioVie” or “Company”), a
clinical-stage company developing innovative drug therapies for
liver disease, announced today that its first batch of BIV201
prefilled syringes containing a patent-pending formulation of
terlipressin liquid concentrate has been manufactured and released
following quality control testing. BIV201 (continuous infusion
terlipressin) has not yet been approved for human use. The Company
is planning to submit an amendment to its CMC package to the FDA
for review and will test the new prefilled syringe in an upcoming
US Phase 2b/3 clinical trial if cleared to proceed.
“Our new prefilled terlipressin syringe represents a potential
breakthrough in dosing convenience and safety. Over time it should
enable us to build the market for outpatient terlipressin therapy
around the world,” commented Terren Peizer, BioVie Chief Executive
Officer. “BioVie recently submitted a detailed protocol to the FDA
to evaluate BIV201 in a large-scale US Phase 2b/3 clinical trial in
refractory ascites patients. We are excited about testing this new
simplified method for delivering BIV201 therapy in the home care
setting.”
BIV201 (continuous infusion terlipressin) has an Orphan drug
designation 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 a pending patent application covering the proprietary liquid
formulation of terlipressin to be used in its planned Phase 2b/3
trial, subject to FDA clearance. 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.
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. BioVie experienced this
drug-delivery challenge when supplying BIV201 to the refractory
ascites patients who participated in our recently completed US
Phase 2a clinical trial. To solve it, the Company developed a novel
liquid formulation for delivery via prefilled syringe. This is
expected to greatly improve convenience by enabling easy injection
of the liquid concentrate into the IV bag connected to the infusion
pump for at-home terlipressin administration. It will avoid 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.
BioVie’s new patent-pending formulation of terlipressin has
demonstrated the potential for room-temperature storage. If
extended room-temperature product stability can be shown, this
feature could provide another key product advantage. To the best of
the Company’s knowledge, all other terlipressin products sold
globally must be stored under refrigeration and there are no
prefilled syringe formats available for treating patients.
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
submitted a Phase 2b/3 clinical trial protocol to the FDA 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). 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 in medical
costs (HCUP Nationwide Readmissions Database 2016). 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. Certain drugs approved for other uses may provide
initial relief, but patients often fail to respond to them as the
ascites worsens. At this stage, known as refractory ascites,
patients often progress to hepatorenal syndrome (HRS) which is the
onset of kidney failure and requires emergency hospitalization.
Refractory ascites survival is reported to be only approximately
50% at six months (Moreau 2004) and 33% at one year (Planas
2006). Nor have any drug therapies been approved specifically
for treating HRS, and about one-half of these patients typically
succumb within only 2 – 4 weeks.
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.
CONTACT INFORMATIONBioVie Inc.info@biovieinc.com
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