VIVUS Receives U.S. Food and Drug Administration Approval for Improved Formulation of PANCREAZE® with a 36-Month Shelf Life
February 05 2020 - 7:30AM
VIVUS, Inc. (Nasdaq: VVUS) (“VIVUS”), a biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
has approved the supplemental New Drug Application (sNDA) for an
improved formulation of PANCREAZE® (pancrelipase) Delayed Release
Capsules that extends the shelf life to 36 months across all
PANCREAZE dosages. VIVUS worked closely with Nordmark Arzneimittel
GmbH & Co. KG, its manufacturing partner for PANCREAZE, on the
FDA approval pursuant to the terms of the amended contract
manufacturing agreement announced in June 2019. PANCREAZE is
indicated for the treatment of exocrine pancreatic insufficiency
(EPI) due to cystic fibrosis or other conditions.
“The approval of this sNDA is an important
milestone for VIVUS and for the patients with EPI we seek to
treat,” said John Amos, Chief Executive Officer at VIVUS. “It
highlights our ability to derive additional value from our marketed
products and allows patients to store PANCREAZE for longer periods
of time, which may help to reduce their out-of-pocket expenses. We
also expect that the 36-month shelf life will limit the amount of
returned product and, over time, will lower our overall supply
chain costs. We look forward to working with Nordmark and our
supply chain and commercial partners on the transition to the
improved formulation.”
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.
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 transition to the improved
formulation 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. |
Investor Relations: Lazar FINN Partners |
Mark
Oki |
David
Carey |
Chief
Financial Officer |
Senior
Partner |
oki@vivus.com |
david.carey@finnpartners.com |
650-934-5200 |
212-867-1768 |
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