Life-saving research rewarded
Transforming cancer treatment
Juerg Zimmermann, Ph.D., Novartis Institutes for Biomedical Research, together with Brian Druker, M.D., Oregon Health & Science University Cancer Institute, received the 2009 European Inventor Award in the "industry" category for the development of Glivec (imatinib), a therapy that has revolutionized the treatment of certain life-threatening cancers:
- Kit-positive malignant gastrointestinal stromal tumors (GIST)
- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Prior to Glivec, about half of patients with Ph+ CML progressed from the initial phase to more advanced stages after only three to five years. Once patients reached the final blast crisis phase, survival was generally three to six months. Glivec revolutionized the treatment of this life-threatening disease, resulting in the longest overall survival ever observed for people with the Ph+ CML.
"When we started the journey to develop Glivec, we could only hope to produce a drug that might someday become the standard of care for life-threatening cancers," said Dr. Zimmermann. "Knowing that our efforts have directly helped the lives of so many patients is extremely rewarding."
Fighting malaria with Coartem
Ancient remedy. Modern cure
In search of a treatment for malaria, Professor Zhou became interested in an old herbal remedy, Artemisia annua, or Sweet Wormwood. It was used in China beginning around 168 BC. He mixed the active ingredient, artemisinin, with a proven anti-malarial agent, benflumetol, and developed a highly effective antimalarial treatment, Coartem.
Professor Yiqing Zhou and his team of researchers at the Microbiology and Epidemiology Institute in Beijing, were awarded the 2009 European Inventor Award in the "non-European" category for developing Coartem (artemether 20 mg/lumefantrine 120 mg), a leading treatment for malaria.
Malaria is a devastating disease that infects nearly 250 million people and causes approximately 880,000 deaths annually. In sub-Saharan Africa, it is estimated that a child dies of malaria every 30 seconds.
Data shows that Coartem is generally well tolerated, controls malaria-related fever in as little as 24 to 36 hours, and delivers cure rates of over 96% after only three to four days of treatment. Coartem also carries a low risk of resistance, when used in combination with other antimalarials.
To get this medicine to patients, Novartis and its Chinese partners completed one of the largest and fastest scale-ups in the industry.
Ensuring patient access to Coartem is a priority for Novartis. That is why, through a collaboration with the World Health Organization, since 2001, Novartis has provided more than 235 million malaria treatments without profit for public sector use in Africa. These treatments have helped to save approximately 600,000 lives.
"My hope was very simple. We had a great drug for treating malaria in China, and my hope was to make it available to all the people who were suffering from malaria," said Professor Yiqing Zhou of the Academy of Military Medical Sciences in China. "We wanted to ease their suffering and give them new opportunity."
Silvio Gabriel, Executive Vice-President Novartis and Leader of Malaria Initiatives at Novartis, speaks about Coartem at the European Inventors Award event.
Learn how Novartis is fighting Malaria:
Getting products to patients
To ensure that this innovative cancer treatment is available to the patients who need it, Novartis developed the Glivec International Patient Assistance Program (GIPAP). The GIPAP provides Glivec at no cost to qualified patients in one of the most generous and far-reaching patient assistance programs ever developed on a global scale.
Glivec safety information
The majority of patients treated with Glivec in clinical trials experienced adverse events at some time. Most events were of mild-to-moderate grade and treatment discontinuation was not necessary in the majority of cases.
The safety profile of Glivec was similar in all indications. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well tolerated in all of the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception of a transient liver toxicity in the form of transaminase elevation and hyperbilirubinemia observed when Glivec was combined with high-dose chemotherapy.
Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/ necrosis and hip osteonecrosis/avascular necrosis.
Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated. Cardiac screening should be considered in patients with HES/CEL, and patients with MDS/MPD with high level of eosinophils (echocardiogram, serum troponin level).
Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.