VIVUS and Nordmark Amend Contract Manufacturing Agreement to Supply Current and Future Demand for PANCREAZE®
June 26 2019 - 3:05PM
VIVUS, Inc. (Nasdaq: VVUS) (“VIVUS”), a biopharmaceutical company,
today announced an amendment to its manufacturing and supply
agreement with Nordmark Arzneimittel GmbH & Co. KG (“Nordmark”)
for PANCREAZE® (pancrelipase) Delayed Release Capsules. The amended
agreement covers a ten-year initial term and may be renewed for
additional five-year periods, the first at VIVUS’ option and by
mutual agreement thereafter. Financial terms of the agreement
were not disclosed.
“As VIVUS continues its 10-quarter turnaround,
ensuring PANCREAZE supply to meet the current and future demand for
PANCREAZE at a stable and predictable price was a key step in our
strategy, and we are pleased to have achieved this important
milestone,” said John Amos, Chief Executive Officer at VIVUS. “We
believe that there is a significant opportunity to grow the
PANCREAZE market with our current product formulations and expect
to create additional clinical and commercial value with the future
introduction of advanced formulations of the product. We view
our manufacturing partner, Nordmark, as a world class partner and
we are fortunate to work with them.”
Under the terms of the agreement, VIVUS and
Nordmark will jointly develop an advanced formulation of PANCREAZE
with the objective of extending the shelf life of the product.
VIVUS expects that the advanced formulation will be available in
2021.
“Nordmark has established expertise in
manufacturing PANCREAZE Delayed Release Capsules, and we are
pleased to extend our agreement with VIVUS for at least another ten
years,” said Jörn Tonne, Chief Executive Officer at Nordmark. “We
have a track record of success in developing new products and are
committed to meeting the needs of our customers and the patients
they serve. We look forward to working with VIVUS to develop new
formulations of PANCREAZE that make treatment more convenient for
patients with exocrine pancreatic insufficiency.”
About Nordmark Arzneimittel GmbH & Co.
KG
Nordmark Arzneimittel GmbH & Co. KG is a
privately owned biopharmaceutical company specialized in the
development and manufacture of biological drug substances and drug
products. For more information about the company, please visit
www.nordmark-pharma.de.
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 Information for
PANCREAZE
What 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.com.
About VIVUS
VIVUS 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 VIVUS, please visit
www.vivus.com.
Forward-Looking Statements
Certain 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 our ability to execute on our business strategy to
enhance long-term stockholder value; risks and uncertainties
related to our expected future revenues, operations and
expenditures; risks and uncertainties related to our ability to
maintain the relationship with the sole manufacturer for PANCREAZE;
risks and uncertainties related to our ability to accurately
forecast PANCREAZE demand; risks and uncertainties related to our
ability to maintain a satisfactory level of PANCREAZE inventory;
risks and uncertainties related to the timing, strategy, tactics
and success of the marketing and sales of PANCREAZE; risks and
uncertainties related to our ability to successfully maintain and
increase market share against current competing products and
potential competitors that may develop alternative formulations of
the drug; and risks and uncertainties related to the ability of our
partners to maintain regulatory approvals to manufacture and
adequately supply our products to meet demand. 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, 2018 as filed
on February 26, 2019, and periodic reports filed with the
Securities and Exchange Commission. VIVUS does not undertake
an obligation to update or revise any forward-looking
statements.
VIVUS, Inc.Mark OkiChief Financial
Officeroki@vivus.com650-934-5200
Investor Relations: Lazar PartnersDavid
CareyManaging
Director dcarey@lazarpartners.com 212-867-1768
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