VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical
company, and HarborPath Direct, Inc., today announced a partnership
to facilitate access to PANCREAZE® (pancrelipase) Delayed Release
Capsules for uninsured or underinsured patients with exocrine
pancreatic insufficiency (EPI) that meet applicable eligibility
criteria. The Company intends to make PANCREAZE available to
eligible patients through the VIVUS Health Platform and the
PANCREAZE Advantage Program integrated with HarborPath Direct’s
SuccorRx™ Patient Assistance Program (PAP) platform. Financial
terms of the partnership were not disclosed.
“Following the launch of PANCREAZE under the VIVUS
brand in the first quarter of 2019, we are now working to ensure
access to this important therapy for as many eligible EPI patients
as possible, regardless of their health insurance status,” said
John Amos, Chief Executive Officer at VIVUS. “HarborPath
Direct’s focus on leveraging technology and innovative approaches
to maximize program benefits is very well aligned with our plans
for the VIVUS Health Platform and the PANCREAZE Advantage
Program. We believe that HarborPath Direct is a critical
partner in helping VIVUS to meet its goal of making the PANCREAZE
Advantage Program the most user-friendly and efficient patient
support program in the United States.”
VIVUS is continuing the development of the
VIVUS Health Platform with the goal of enabling the Company to
partner with medical doctors, dieticians, nutritionists,
self-insured employers, private and public insurers and, most
importantly, patients, to achieve healthy patient weight
goals. The developing VIVUS Health Platform is expected to
continue expanding VIVUS’ integration of medical, pharmaceutical,
nutritional and information technology into its sales, marketing
and patient access programs. The PANCREAZE Advantage Program
is a component of the developing VIVUS Health Platform and, as
planned, comprises a physician sampling program, Patient Assistance
Program (PAP), co-pay card and integration with the VIVUS Health
store front powered by Amazon for vitamins and nutritional
supplements.
SuccorRx is an easy-to-use, single-page PAP web
application developed to meet the growing need of ensuring that
eligible uninsured and underinsured patients have access to
life-changing therapies. The platform features benefits for
patients, healthcare providers and participating pharmaceutical
companies, including streamlining the process of enrollment and
approval, ordering, and tracking shipments of pharmaceutical
products for delivery to a patient’s home or healthcare
facility.
“Our partnership with VIVUS on their PANCREAZE PAP
provides further validation of the value that HarborPath Direct’s
programs, services and technologies provide to patients and leading
pharmaceutical companies,” said Trond Waerness, VP of Strategy and
BD at HarborPath Direct. “We are committed to innovating PAPs
that truly address the critical and growing needs of uninsured and
underinsured patients. We welcome the opportunity to work
with VIVUS, a company that shares our commitment to taking
innovative approaches to improving patient access to important
therapies.”
About HarborPath Direct
HarborPath Direct is a subsidiary of HarborPath Inc., which was
established to manage the front and back end of Patient Assistance
Programs (PAPs) for small to medium-sized pharmaceutical companies
in all disease areas. HarborPath Direct offers clients a
suite of cost-effective and efficient services ranging from
managing the eligibility process, providing call center services,
to expediting shipment of prescription products through its
innovative trademarked SuccorRx™ platform.
For more information,
visit www.harborpathdirect.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 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 the Company, 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 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, 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.
HarborPath Media ContactKen Trogdon
Jr.PresidentHarborPath980-859-3483Ken.trogdon@harborpath.org
VIVUS Contacts
VIVUS, Inc.
Mark Oki
Chief
Financial Officer
oki@vivus.com
650-934-5200
Investor Relations: Lazar PartnersDavid
CareyManaging Directordcarey@lazarpartners.com212-867-1768
VIVUS (NASDAQ:VVUS)
Historical Stock Chart
From Aug 2024 to Sep 2024
VIVUS (NASDAQ:VVUS)
Historical Stock Chart
From Sep 2023 to Sep 2024