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      Polycythemia Vera by the Numbers

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      RESPONSE Clinical Trial Fact Sheet

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    1. Polycythemia Vera by the Numbers

    2. RESPONSE Clinical Trial Fact Sheet

    3. Polycythemia Vera Fact Sheet

  • Jun 03, 2014 04:45 PM WES

    Pivotal Phase III data show polycythemia vera patients on Novartis drug Jakavi® achieved significant improvement in disease control

    • 77% of patients on Jakavi® (ruxolitinib) vs 20% on best available therapy achieved hematocrit control or spleen reduction, key treatment goals in PV1

    • Nearly half of ruxolitinib-treated patients had a 50% or more reduction in debilitating PV symptoms compared to 5% on best available therapy1

    • Global regulatory filings are underway based on these data; if approved, ruxolitinib will be the first JAK 1/2 inhibitor available for PV patients

    Basel, June 3, 2014 –
    Novartis today announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera (PV). Jakavi® (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells2) and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea1. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois.

    PV is a chronic, incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack
    2. Currently, there are limited treatments for polycythemia vera and a high unmet need exists for new therapies that provide effective disease control3.

    “Patients with polycythemia vera may not have their disease controlled with existing therapies, increasing their risk for cardiovascular complications,” said Srdan Verstovsek, MD, PhD, of MD Anderson Cancer Center, Houston, Texas and lead study author. “In the RESPONSE trial, patients treated with ruxolitinib showed better disease control, including controlled hematocrit levels without the need for phlebotomy, reduced spleen size and improved symptom management compared to current therapies.”

    “New treatments for polycythemia vera are greatly needed, as this is a disease that causes debilitating daily symptoms, which are as severe as symptoms associated with myelofibrosis, and also puts patients at risk for serious cardiovascular complications, such as stroke and heart attack,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. “These findings reinforce ruxolitinib’s significant clinical benefit and potential to become an important new treatment option for polycythemia vera patients who are no longer responding to or are intolerant of prior therapy.”

    In the study, a 50% or more improvement in PV-related symptoms was seen in 49% of ruxolitinib-treated patients compared to 5% of patients treated with best available therapy
    1. Patients treated with ruxolitinib also experienced a reduction in night sweats and itchiness (approximately 99% and 95%, respectively)4. In addition, a greater proportion of patients on the ruxolitinib treatment arm achieved complete hematologic response as defined by the modified 2009 European LeukemiaNet (ELN) criteria, a key secondary endpoint, when compared to the best available therapy arm (24% compared to 9%, respectively; p=.003)1.

    Ruxolitinib was well tolerated and adverse events (AEs) were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis
    1,5,6. Within the first 32 weeks of treatment, Grade 3 or 4 hematologic AEs in the ruxolitinib treatment arm were anemia (1.8%) and thrombocytopenia (5.5%), and fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received best available therapy (1 patient compared to 6 patients, respectively)1. The most common non-hematologic AEs were headache, diarrhea and fatigue, which were mainly Grade 1 or 21. Additionally, 3.6% of patients randomized to the ruxolitinib treatment arm discontinued treatment due to AEs compared to 1.8% on the best available therapy arm4.

    Data from the RESPONSE trial will support worldwide regulatory submissions planned this year. The data will also be presented at the upcoming 19th Congress of the European Hematology Association in Milan, Italy.

    Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis, a debilitating and life-threatening blood cancer.

  • Full Press Release

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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, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

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