Novartis launches global program expanding access to investigational compound nilotinib (AMN107) for patients with hard-to-treat leukemia
June 05, 2006
* New worldwide program addresses unmet medical need for patients with treatment-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML)
* Nilotinib receives FDA fast track designation in US as well as orphan drug status in both the US and EU
* US and EU regulatory submissions now planned for late 2006 compared to earlier expectations for 2007
Basel, June 4, 2006 - Novartis announced today the launch of a global program, ENACT (Expanding Nilotinib Access in Clinical Trials), to provide expanded access to nilotinib (AMN107), a compound currently in late-stage registration trials for treating certain forms of the life-threatening disease leukemia.
This program is available to eligible patients in all phases of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) who are either resistant to or intolerant of treatment with Glivec� (imatinib)*. Novartis is now planning to submit nilotinib for US and EU regulatory approval in late 2006 compared to earlier estimates for submissions in 2007.
“ENACT is another example of our ongoing commitment to making innovative therapies available to patients who need new treatment options,” said David Epstein, President of Novartis Oncology. “With Glivec, Novartis launched a wide-ranging access program that enabled more than 9,000 patients around the world to obtain Glivec at no cost before it became commercially available. This program continues our dedication to patients by providing an option to those who are no longer responding to Glivec.”
Information about ENACT can be found on the clinical trial website of the US National Institutes of Health, www.clinicaltrials.gov. Information is also available by contacting the Novartis local offices or local call center, which will refer requests to the appropriate clinical team. Physicians can access information at www.amn107.com.
* Known as Gleevec� (imatinib mesylate) Tablets in the US
Nilotinib represents the next generation targeted, oral therapy specifically designed to be the most selective inhibitor of Bcr-Abl, the definite cause of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), and its mutations. Designed in the biomedical research facilities of Novartis, nilotinib is a tyrosine kinase inhibitor with high affinity and specificity to attach itself to Bcr-Abl, the definitive cause of Ph+ CML, and 32 of 33 mutant forms most commonly associated with the disease.
The US Food and Drug Administration (FDA) has granted both fast track designation and orphan drug status to nilotinib. Nilotinib also received orphan drug status from the European Medicines Evaluation Agency (EMEA).
As an investigational compound, the safety and efficacy profile of nilotinib has not yet been established. Data from a Phase I clinical trial presented at the 2005 Annual Meeting of the American Society of Hematology (ASH) showed complete hematologic responses in 92% of patients in chronic phase, as well as hematologic responses in 76% of patients in accelerated phase and in 42% of patients in myeloid blast crisis. Cytogenetic responses were also seen in 53% of patients in chronic phase, 55% in accelerated phase and 29% in myeloid blast crisis.
Access to nilotinib is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the compound’s potential benefits and risks and data will be filed with regulatory authorities such as the FDA and the EMEA for regulatory approval.
Glivec is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Ph+ CML.
The effectiveness of Glivec is based on overall hematologic and cytogenetic response rates and progression-free survival in CML. There are no controlled trials demonstrating increased survival.
Glivec contraindications, warnings and adverse events*
The majority of patients treated with Glivec experienced adverse events at some time. Most events were of mild to moderate grade and treatment was discontinued for adverse events only in 2% of patients in chronic phase, 3% in accelerated phase and 5% in blast crisis. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia.
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.
*Numbers indicate the range in percentages in four studies among patients with CML in blast crisis, accelerated phase and chronic phase.
The foregoing release contains forward-looking statements that can be identified by terminology such as “planned,” “planning,” “will,” or similar expressions, or by express or implied discussions regarding potential regulatory approvals of nilotinib or potential future sales of nilotinib, or regarding the long-term impact of a patient’s use of nilotinib. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with nilotinib to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that nilotinib will be approved for sale in any market. Nor can there be any guarantee regarding potential future sales of nilotinib. Neither can there be any guarantee regarding the long-term impact of a patient’s use of nilotinib. In particular, management’s expectations regarding nilotinib could be affected by, among other things, unexpected clinical trial results, including new clinical data, and additional analysis of existing nilotinib clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and other risks and factors referred to in the Company’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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