-
CMLPath to Care(TM)
collaboration replaces Glivec International Patient Access Program
(GIPAP) with a new, independent, patient-centered access
model
-
GIPAP was introduced 15 years
ago and has provided approximately 75,000 patients access to free,
cancer treatment
-
The Max Foundation to lead
program for patients and oversee supply chain management; Novartis
to contribute funding and product donation
Basel, September 22, 2017
- Novartis announced a new collaboration with
The Max Foundation to support continued access to treatment at no
cost for nearly 34,000 current patients with chronic myeloid
leukemia (CML), gastrointestinal tumors (GIST) and other rare
cancers. The two organizations have been long-time collaborators in
providing access to care for patients in lower-income countries
through the Glivec International Patient Assistance Program
(GIPAP), one of the most innovative patient assistance programs
ever implemented on a global scale.
The new collaboration, called CMLPath to Care(TM),
is an evolution from GIPAP, a partnership that provided
Glivec® (imatinib)*
at no cost to diagnosed patients in lower-income countries where
there may not be access to reimbursement or funding mechanisms, and
to those unable to pay for the medication. Under the new
initiative, The Max Foundation, a global, patient-focused,
non-governmental organization (NGO), will assume from Novartis the
responsibility for delivering the treatment to these patients,
including supply chain management. Novartis will provide funding
and drug donation support. The collaborative agreement runs through
Q1 2021 with an option to extend. During this timeframe, Novartis
expects to donate more than $29 million to the collaboration, along
with approximately 315,000,000 doses of medicine.
Novartis introduced GIPAP in 2002 after
recognizing the impact of its breakthrough cancer therapy, Glivec.
The program has served the CML treatment needs of approximately
75,000 people since its inception.
"Fifteen years ago, Novartis recognized the
critical importance of ensuring patients in lower-income countries
had access to breakthrough cancer therapy, and we partnered with
The Max Foundation to develop a revolutionary global program to
address this need," said Bruno Strigini, CEO of Novartis Oncology.
"CMLPath to Care renews and extends our unique collaboration with
The Max Foundation and builds on the strengths of both
organizations to better serve these patients."
CMLPath to Care: A Patient-Centered Model of Access and
Support
The goal of CMLPath to Care is to help people living with CML by
connecting them and their carers with effective treatments,
professional medical capabilities, trained physicians and hands-on
support. Under the previous GIPAP model, Novartis managed the
entire supply chain for the medicine and interacted directly with
local stakeholders (e.g., physicians, treatment centers, NGOs,
private companies and governments) in more than 75 countries where
it operated. The Max Foundation provided CML patients with
psychosocial support and education, services that did not
previously exist in certain countries. Over time, changes in local
infrastructures and capabilities, new and innovative treatments,
and the growth and impact of patient groups prompted Novartis and
The Max Foundation to recognize that a new, more flexible approach
to access was needed.
With CMLPath to Care, Novartis will provide access
to Glivec in nearly 70 countries, and in a subset of countries
second-line Tasigna® (nilotinib)
therapy will be available for approved indications. The Max
Foundation will manage the entire medicine supply chain and
interactions with local stakeholders under the umbrella of Max
Access Solutions, while continuing to provide hands-on, local
patient support.
"Since our founding 20 years ago, The Max
Foundation has grown extensively in its efforts and ability to help
people face cancer with dignity and hope," said Pat
Garcia-Gonzalez, CEO of The Max Foundation. "We are proud of the
thousands of patients' lives touched by our long-standing
collaboration with Novartis and are pleased with our shared
continued innovation, commitment and support for underserved
patients with CML and other rare cancers in low resource
countries."
Novartis and The Max Foundation
Innovate with a Global Direct-to Patient Humanitarian Program:
Reimagining What's Possible for CML Care
CMLPath to Care is one of the broadest cancer treatment access
initiatives led by a patient-centered NGO. During the last 15
years, the Novartis-Max Foundation partnership created and
maintained a standard of care in many lower-income countries that
may not have otherwise been possible for people with CML. In this
new model - as in GIPAP - the medicine is provided at no cost for
individual patients. This contrasts with more traditional
humanitarian programs that provide bulk donations of a medicine.
The Max Foundation is unique among NGOs in its ability to manage
the complex administration of individual patient care. The
transition to CMLPath to Care includes The Max Foundation's
assumption of program administration, supply chain management and
oversight of the nearly 34,000 patients, 1,400 physicians, and 450
treatment centers in nearly 70 countries on four
continents.
The enduring partnership with The Max Foundation
has been a key component of Novartis' long-term focus on bringing
CML care to those who need the most support. The company is
dedicated to transforming the lives of people with CML and holds an
unwavering commitment to reimagining what is possible for CML
treatment through scientific innovation and creative solutions that
provide access to care regardless of geography or financial
situation.
To ensure a seamless transition for patients, the
program will move from Novartis to The Max Foundation through the
first half of 2018 on a country-by-country basis. Both
organizations are represented on an operational committee that will
meet four times each year to ensure the collaboration is meeting
its goals and operating efficiently.
About CMLPath to
Care
CMLPath to Care is a unique global initiative for people with CML.
Developed and managed by The Max Foundation and supported by
Novartis Oncology through drug donations and funding, CMLPath to
Care connects people living with CML and their carers with
effective treatments, professional medical capabilities, trained
physicians and hands-on support. With origins in a novel
collaboration between the two organizations beginning in 2002, the
program has delivered individual care to approximately 75,000
patients in more than 75 countries.
About Glivec
(imatinib)
Glivec (imatinib) is approved in more than 110 countries, for the
treatment of adult patients in all phases of Philadelphia
chromosome-positive (Ph+) CML, for the treatment of patients with
KIT (CD117)-positive GIST, which cannot be surgically removed
and/or have metastasized and for the treatment of adult patients
following complete surgical removal of KIT+ GIST.
Not all indications are available in every
country.
Glivec Important Safety
Information
Glivec is contraindicated in patients who are hypersensitive to
imatinib or any of the excipients.
Glivec can cause fetal harm when administered to a
pregnant woman. Women should not become pregnant, and should be
advised of the potential risk to the unborn child.
Glivec has been associated with severe edema
(swelling) and serious fluid retention. Cytopenias (anemia,
neutropenia, thrombocytopenia) are common, generally reversible and
usually managed by withholding Glivec or dose reduction. Monitor
blood counts regularly. Severe congestive heart failure and left
ventricle dysfunction, severe liver problems including cases of
fatal liver failure and severe liver injury requiring liver
transplants have been reported. Caution in patients with cardiac
dysfunction and hepatic dysfunction. Monitor carefully.
Reactivation of hepatitis B can occur in patients who are chronic
carriers of this virus after receiving TKI treatment.
Bleeding may occur. Severe gastrointestinal (GI)
bleeding has been reported in patients with KIT+ GIST. Skin
reactions, hypothyroidism in patients taking levothyroxine
replacement, GI perforation, in some cases fatal, tumor lysis
syndrome which can be life threatening have also been reported with
Glivec. Correct dehydration and high uric acid levels prior to
treatment. Long-term use may result in potential liver, kidney,
and/or heart toxicities; immune system suppression may also result
from long-term use. In patients with hypereosinophilic syndrome and
heart involvement, cases of heart disease have been associated with
the initiation of Glivec therapy. Growth retardation has been
reported in children taking Glivec. The long-term effects of
extended treatment with Glivec on growth in children are
unknown.
The most common side effects include fluid
retention, muscle cramps or pain and bone pain, abdominal pain,
loss of appetite, vomiting, diarrhea, decreased hemoglobin,
abnormal bleeding, nausea, fatigue and rash. Glivec should be taken
with food and a large glass of water.
Please see full Prescribing Information available
at www.glivec.com.
About Tasigna (nilotinib)
Tasigna® (nilotinib)
is approved in more than 122 countries for the treatment of chronic
phase and accelerated phase Philadelphia chromosome-positive
chronic myelogenous leukemia (Ph+ CML) in adult patients resistant
or intolerant to at least one prior therapy, including
Glivec® (imatinib),
and in more than 110 countries for the treatment of adult patients
with newly diagnosed Ph+ CML in chronic phase.
IMPORTANT SAFETY INFORMATION for
TASIGNA® (nilotinib)
Capsules
Use with caution in patients with uncontrolled or significant
cardiac disease and in patients who have or may develop
prolongation of QTc. Low levels of potassium or magnesium must be
corrected prior to Tasigna administration. Monitor closely for an
effect on the QTc interval. Baseline ECG is recommended prior to
initiating therapy and as clinically indicated. Cases of sudden
death have been reported in clinical studies in patients with
significant risk factors. Avoid use of concomitant drugs known to
prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2
hours before and 1 hour after taking dose. Reactivation of
hepatitis B can occur in patients who are chronic carriers of this
virus after receiving TKI treatment.
Use with caution in patients with liver
impairment, with a history of pancreatitis and with total
gastrectomy. Patients with rare hereditary problems of galactose
intolerance, severe lactase deficiency or glucose-galactose
malabsorption should not use Tasigna. Tasigna may cause fetal harm
in pregnant women. If pregnancy is planned during the
treatment-free remission phase, the patient must be informed of a
potential need to re-initiate treatment with Tasigna during
pregnancy. Women taking Tasigna should not breastfeed.
Cases of cardiovascular events included ischemic
heart disease-related events, peripheral arterial occlusive
disease, and ischemic cerebrovascular events have been reported.
Serious cases of hemorrhage from various sites including
gastrointestinal were reported in patients receiving Tasigna. Grade
3 or 4 fluid retention including pleural effusion, pericardial
effusion, ascites and pulmonary edema have been reported. Cases of
tumor lysis syndrome have been reported in Tasigna-treated patients
who were resistant or intolerant to prior CML therapy.
Eligible patients who are confirmed to express the
typical BCR-ABL transcripts, e13a2/b2a2 or e14a2/b3a2, can be
considered for treatment discontinuation. Frequent monitoring of
BCR-ABL transcript levels in patients eligible for treatment
discontinuation must be performed with a quantitative diagnostic
test validated to measure molecular response levels with a
sensitivity of at least MR4.5 (BCR-ABL/ABL <=0.0032% IS).
BCR-ABL transcript levels must be assessed prior to and during
treatment discontinuation. Loss of major molecular response
(MMR=BCR-ABL/ABL <=0.1%IS) or confirmed loss of MR4 (two
consecutive measures separated by at least 4 weeks showing loss of
MR4 (MR4=BCR-ABL/ABL <=0.01%IS)) will trigger treatment
re-initiation within 4 weeks of when loss of remission is known to
have occurred. It is crucial to perform frequent monitoring of
BCR-ABL transcript levels and complete blood count with
differential in order to detect possible loss of remission. For
patients who fail to achieve MMR after three months of treatment re
initiation, BCR-ABL kinase domain mutation testing should be
performed.
The most frequent Grade 3 or 4 adverse events are
hematological (neutropenia, thrombocytopenia, anemia) which are
generally reversible and usually managed by withholding Tasigna
temporarily or dose reduction. Chemistry panels, including
electrolytes, lipid profile, liver enzymes, and glucose should be
checked prior to therapy and periodically. Tasigna can cause
increases in serum lipase. The most frequent non-hematologic
adverse events were rash, pruritus, nausea, fatigue, headache,
alopecia, myalgia, constipation and diarrhea.
Musculoskeletal pain, myalgia, pain in extremity,
arthralgia, bone pain and spinal pain may occur upon discontinuing
treatment with Tasigna within the framework of attempting
treatment-free remission.
Please see full Prescribing Information including
Boxed WARNING at www.tasigna.com.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "potential," "can," "will," "plan," "expect,"
"anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by
express or implied discussions regarding potential marketing
approvals, new indications or labeling for the investigational or
approved products described in this press release, or regarding
potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that the
investigational or approved products described in this press
release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that such products
will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among
other things, the uncertainties inherent in research and
development, including clinical trial results and additional
analysis of existing clinical data; regulatory actions or delays or
government regulation generally; our ability to obtain or maintain
proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; global trends
toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures; general
economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many
countries; safety, quality or manufacturing issues, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About The Max Foundation
(www.themaxfoundation.org)
The Max Foundation is a non-profit global health organization that
believes all people living with cancer deserve access to the best
treatment, care and support.
The Foundation decreases premature mortality from
cancer by channeling humanitarian donations of life-saving oncology
products to underserved populations in countries where those
products are not locally available. Our organization solicits
in-kind donations of targeted oncology drugs from major
pharmaceutical manufacturers and distributes them to verified
patients in need using an innovative model that provides end-to-end
supply chain controls.
By partnering with the major cancer institutions
and patient associations in low- and middle-income countries, we
enable effective solutions for access to treatment.
About Novartis
Novartis provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 119,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
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*Known as Gleevec® (imatinib
mesylate) tablets in the US, Canada and Israel.
# # #
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