Novartis and The Max Foundation transform pioneering cancer access program for people in lower-income countries

Basel: 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.

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 the 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.