VIVUS Supports the Cystic Fibrosis Community Through Sponsorship of and Participation in the Cystic Fibrosis Foundation’s C...
September 21 2018 - 7:30AM
-Fundraising event at AT&T Stadium on
September 22 supports the Dallas-Fort Worth chapter of the Cystic
Fibrosis Foundation-
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, announced today that it is supporting the Dallas-Fort
Worth chapter of the Cystic Fibrosis Foundation (CFF) in its CF
Climb fundraising event. This support includes financial
sponsorship of the event as well as employee participation in the
climb. This sponsorship demonstrates VIVUS’ support of the cystic
fibrosis (CF) patient community as the Company launches PANCREAZE®
(pancrelipase) Delayed-Release Capsules for the treatment of
exocrine pancreatic insufficiency (EPI), a common complication of
CF. The CF Climb is being held at AT&T Stadium in Arlington,
Texas, home of the Dallas Cowboys, on September 22nd.
“We acquired the U.S. and Canadian rights to PANCREAZE because
we believe it offers great clinical benefit to CF patients living
with EPI, and that deploying our clinical, sales and marketing
expertise in support of this product would make it more broadly
available to patients who may benefit from it,” said John
Amos, Chief Executive Officer at VIVUS. “We are committed to
improving the lives of CF patients, and intend to pursue activities
beyond the marketing of PANCREAZE, such as the CF Climb, that allow
us to support the CF community. We are proud of the VIVUS employees
who will travel to Arlington to participate in the climb.”
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 CF and chronic
pancreatitis, and affects approximately 85 percent of CF
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 EPI due to cystic
fibrosis or other conditions. VIVUS acquired the U.S. and
Canadian rights to PANCREAZE from Janssen in June 2018 for $135
million.
The CF Climb is a CFF fundraising event held in multiple cities
throughout the United States each year. This weekend’s event at
AT&T Stadium comprises climbing over four stadium levels using
both stairs and ramps for a total of two miles and 1,555 steps. The
route is not timed and climbers of all ages and fitness levels can
participate. Climbers will have the opportunity to take an official
AT&T Stadium tour and will have field access to take pictures
of the famous Dallas Cowboys’ Star. Additional information about
the CF Climb is available at
http://fightcf.cff.org/site/TR/Climb/91_Northeast_Texas_Ft_Worth?pg=entry&fr_id=7033.
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 the Company, please visit
www.vivus.com.
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
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.
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 the timing, strategy,
tactics and success of the marketing and sales of PANCREAZE; and
risks and uncertainties related to our commercialization of
PANCREAZE as a new product and our recently changed management team
initiating the commercialization of PANCREAZE. 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.
|
|
VIVUS,
Inc. |
Investor
Relations: Lazar Partners |
Mark Oki |
David Carey |
Chief Financial
Officer |
Managing Director |
oki@vivus.com |
dcarey@lazarpartners.com |
650-934-5200 |
212-867-1768 |
VIVUS (NASDAQ:VVUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
VIVUS (NASDAQ:VVUS)
Historical Stock Chart
From Apr 2023 to Apr 2024