VIVUS Expands its Commercial Product Portfolio with the Acquisition of PANCREAZE®
May 02 2018 - 9:06AM
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, today announced that it has entered into a definitive
agreement to acquire all product rights for PANCREAZE®
(pancrelipase) Delayed-Release Capsules in the United States and
Canada held by Janssen Pharmaceuticals, Inc., subject to certain
closing conditions, including Hart-Scott-Rodino review. This
is the first of what the Company expects will be a series of
product acquisitions designed to generate revenue and strengthen
its financial position.
“We are very pleased to announce the acquisition
of the PANCREAZE product rights for the U.S. and Canadian
territories. The acquisition, coupled with today’s announcement to
restructure a portion of our convertible debt with Athyrium Capital
Management, are demonstrations of our plan to create a stronger and
more financially capable VIVUS,” said John Amos, new Chief
Executive Officer at VIVUS. “We hope that the combination of a new
product for us to promote along with the strengthening of our
balance sheet will serve as initial stepping stones in our value
creating strategic vision. The VIVUS senior management team plans
to leverage the Company’s existing operating infrastructure in the
promotion of PANCREAZE. We intend to drive revenue in the future
through innovative sales and marketing of our current product
portfolio, disciplined product acquisition, strong product life
cycle management and focused expense management.”
Kenneth Suh, President and Chief Executive
Officer of Willow Biopharma Inc., a wholly-owned subsidiary of
VIVUS, stated: “PANCREAZE serves as our initial product
acquisition, one that will allow us to participate and be a
meaningful product company in the global gastrointestinal
marketplace predicted to hit $48 billion in 2022, according to GBI
Research. Through our disciplined product evaluation process, we
are hopeful to acquire additional products and through product life
cycle management, leverage the PANCREAZE platform for further
growth.”
Exocrine pancreatic insufficiency (EPI) is a
condition that results from a deficiency in the production and/or
secretion of pancreatic enzymes. It is associated with cystic
fibrosis and chronic pancreatitis, and affects approximately 85
percent of cystic fibrosis patients. There is no cure for EPI
and pancreatic enzyme replacement therapy is the main treatment for
the condition.
Approved in 2010, PANCREAZE is a pancreatic
enzyme preparation consisting of pancrelipase, an extract derived
from porcine pancreatic glands, as well as other enzyme classes,
including porcine-derived lipases, proteases and amylases. The
pancreatic enzymes in PANCREAZE act like digestive enzymes
physiologically secreted by the pancreas. PANCREAZE is specifically
indicated for the treatment of exocrine pancreatic insufficiency
due to cystic fibrosis or other conditions. Upon closing, VIVUS
will acquire PANCREAZE from Janssen for $135 million.
About PANCREAZE
PANCREAZE is a prescription medicine used to treat people who
cannot digest food normally because their pancreas does not make
enough enzymes due to cystic fibrosis or other conditions.
PANCREAZE may help your body use fats, proteins, and sugars
from food. PANCREAZE contains a mixture of digestive enzymes
including lipases, proteases, and amylases from pig pancreas.
PANCREAZE is safe and effective in children when taken as
prescribed by your doctor.
IMPORTANT SAFETY INFORMATIONWhat is the
most important information I should know about
PANCREAZE?
- PANCREAZE may increase your chance of having a serious, rare
bowel disorder called fibrosing colonopathy that may require
surgery.
- The risk of having this condition may be reduced by following
the dosing instructions that your healthcare provider gave
you.
Call your doctor right away if you have any unusual
or severe stomach area (abdominal) pain, bloating,
trouble passing stool (having bowel movements), nausea, vomiting,
or diarrhea.
Take PANCREAZE exactly as prescribed by your doctor. Do
not take more or less PANCREAZE than directed by your doctor.
What are the possible side effects of
PANCREAZE?PANCREAZE may cause serious side
effects, including:
- A rare bowel disorder called fibrosing
colonopathy.
- Irritation of the inside of your mouth.
This can happen if PANCREAZE is not swallowed
completely.
- Increase in blood uric acid levels. This
may cause worsening of swollen, painful joints (gout) caused by an
increase in your blood uric acid levels.
- Allergic reactions including trouble with
breathing, skin rashes, or swollen lips.
Call your doctor right away if you have any of these
symptoms.The most common side effects include pain in your
stomach (abdominal pain) and gas. Other possible side effects:
PANCREAZE and other pancreatic enzyme products are made from the
pancreas of pigs, the same pigs people eat as pork. These pigs may
carry viruses. Although it has never been reported, it may be
possible for a person to get a viral infection from taking
pancreatic enzyme products that come from pigs.
These are not all the side effects of PANCREAZE. Talk to
your doctor about any side effect that bothers you or does not go
away.
You may report side effects to FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
What should I tell my doctor before taking
PANCREAZE?Tell your doctor if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or
thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or high blood uric acid
(hyperuricemia).
- have trouble swallowing capsules.
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed.
Tell your doctor about all the medicines you
take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
The Product Information and Medication Guide for PANCREAZE is
available at www.pancreaze.net.
About VIVUSVIVUS is a biopharmaceutical company
committed to the development and commercialization of innovative
therapies that focus on advancing treatments for patients with
serious unmet medical needs. For more information about the
Company, please visit www.vivus.com.
Forward-Looking
StatementsCertain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to potential change in our business strategy to enhance
long-term stockholder value, including the acquisition of revenue
generating products and the strengthening of our balance sheet;
risks and uncertainties related to our agreement with Janssen
Pharmaceuticals, Inc. for the acquisition of all product rights for
PANCREAZE in the U.S. and Canada, including that the closing of the
agreement is subject to governmental reviews and other closing
conditions; risks and uncertainties related to our
commercialization of PANCREAZE as a new product and our recently
changed management team initiating the commercialization of
PANCREAZE; risks and uncertainties related to our ability to
address or potentially reduce our outstanding balance of the
convertible notes due in 2020; risks and uncertainties related to
our expected future revenues, operations and expenditures; risks
and uncertainties related to our ability to identify and acquire
development and cash flow generating assets; and risks and
uncertainties related to the impact, if any, of changes to our
Board of Directors and senior management team. These risks
and uncertainties could cause actual results to differ materially
from those referred to in these forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. Investors should read the risk factors set forth in
VIVUS’ Form 10-K for the year ended December 31, 2017 as filed on
March 14, 2018, and as amended by the Form 10-K/A filed on April
26, 2018, and periodic reports filed with the Securities and
Exchange Commission. VIVUS does not undertake an obligation
to update or revise any forward-looking statements.
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VIVUS,
Inc. |
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Investor
Relations: Lazar Partners |
Mark Oki |
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David Carey |
Chief Financial
Officer |
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Managing
Director |
oki@vivus.com |
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dcarey@lazarpartners.com |
650-934-5200 |
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212-867-1768 |
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