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近日，美国食品药品管理局（FDA）批准尼洛替尼（nilotinib，商品名：Tasigna）用于新诊断的费城染色体阳性的慢性期慢性髓系白血病(PH+CP-CML)，“PH+CP-CML”是一种罕见的与基因变异相关的慢性渐进性血液与骨髓疾病。
Tasigna被认为通过阻滞一种能够引起白血病细胞生长的信号而发挥作用，最初于2007年10月被批准用于病情恶化、对其他治疗不耐受或耐药（包括伊马替尼（imatinib，商品名：Gleevec））的成人“Ph+CP-CML”患者，此次获批是将其适应症扩大至用于此类疾病的早期成年患者。Tasigna的此项新适应症是通过FDA加快审批程序获批，该程序允许FDA根据合理的临床受益预测结果，对目前尚无有效治疗严重疾病的治疗药物予以加快审批。
FDA药品审评与研究中心肿瘤药品办公室主任Richard Pazdur, M.D.说，“一旦临床证明对肿瘤耐受性治疗药物的有效性，那么对医药公司而言，继续开发这种药物用于早期肿瘤的治疗则十分重要，因为有可能会为患者提供有效的治疗途径。”
Tasigna的安全性、有效性已通过一项包含846名新诊断为“Ph+CP-CML”患者的临床试验得以证实。在疾病恶化或出现难以忍受的不良反应之前，患者分别接受Tasigna或Gleevec治疗，结果显示在12个月时，Tasigna组44%的患者达到主要终点即血流中慢性粒细胞白血病（CML）肿瘤细胞数量显著减少（出现主要分子学反应），在Gleevec组中该比率为22%。
在新诊断为CP-CML的患者中，最常见的非血液相关的不良反应是皮疹、瘙痒（瘙痒症）、头痛、恶心、疲劳以及肌肉痛（肌痛）。严重的血液相关的药物反应包括骨髓活性下降（骨髓抑制）、血液中血小板数量下降（血小板减少症）、抗感染的白细胞数量下降（嗜中性白血球减少症）以及贫血。
FDA批准的其它用于治疗CML的药品包括2001年5月获批的Gleevec和2006年6月获批的达沙替尼（dasatinib，商品名：Spryce）。
Tasigna®（尼洛）胶囊
最初美国批准：2007
诺华制药公司
适应症
新诊断的费城染色体阳性慢性髓细胞性白血病（Ph阳性慢性粒细胞白血病慢性期）的成年患者的治疗。研究正在进行，将需要进一步的数据，以确定长期的结果。
慢性期（CP）和加速阶段（AP）在之前的治疗包括伊马替尼耐药或不能耐受的成年患者的Ph +慢性粒细胞白血病的治疗。
剂量和用法
推荐剂量：初诊的Ph + CML-CP的：300毫克口服，每日两次。耐药或不能耐受的Ph + CML-CP的和CML-AP：400毫克口服，每日两次。
管理使用Tasigna相距约12小时，并不得采取与食品。
整个水吞下胶囊。不要食用前剂量和至少一个小时后至少2小时的食品。
血液学和非血液学毒性反应，药物相互作用，可能需要调整剂量。
较低的起始剂量建议在肝功能不全的患者（基线）。
剂型和优势
150毫克和200毫克硬胶囊剂
禁忌
低血钾，低血镁，或长QT综合征患者不要使用。
注意事项：
骨髓抑制：中性粒细胞减少，血小板减少和贫血有关。央行应该做的第2个月每2周，然后每月。预提剂量是可逆的。可能需要减少剂量。
QT间期延长：Tasigna的延长QT间隔。正确的低血钾或低血镁之前，管理和定期监测。 避免已知会延长QT间隔和强CYP3A4抑制剂的药物。 在肝功能不全的患者谨慎使用。获得心电图基线，开始后7天，并在此后定期，以及以下任何剂量调整。
突然死亡：已接受尼罗替尼耐药或不能耐受的Ph +慢性粒细胞白血病患者突然死亡的报告。心室复极异常可能是导致其发生。
血清脂肪酶升高：定期检查血清脂肪酶。脂酶海拔的情况下，伴随着腹部症状，中断剂量，并考虑采取适当的诊断，以排除胰腺炎。警告建议在胰腺炎病史的患者。
肝功能异常：使用Tasigna可能会导致胆红素，AST / ALT，碱性磷酸酶升高。定期检查肝功能检查。
电解质紊乱：使用Tasigna可以引起低血磷，低血钾，高血钾，低血钙，和低钠血症。纠正电解质异常之前开始使用Tasigna和治疗期间定期监测。
肝功能不全：尼罗替尼暴露增加肝功能受损的患者（基线）。在这些患者中，建议减少剂量和QT间期应密切监测。
药物相互作用：避免同时使用CYP3A4的强抑制剂或诱导。如果病人必须共同管理的一种强CYP3A4抑制剂，剂量减少，应考虑和QT间隔应密切监测。
食物影响：食物增加Tasigna的血药浓度。
避免进食前2小时和1小时后，剂量。
这些患者全胃切除术：更频繁地跟进应予以考虑。如果有必要，可考虑增加剂量。
妊娠时可能发生的管理，孕妇胎儿造成伤害。应建议妇女不成为孕妇服用Tasigna。
不良反应
最常见的非血液学不良反应（≥10％）患者在初诊的Ph + CML-CP的耐药或不能耐受
PH + CML-CP，或耐药或不能耐受pH值+ CML-AP为皮疹，瘙痒，头痛，恶心，疲劳，肌肉酸痛，鼻咽炎，便秘，腹泻，腹痛，呕吐，关节痛，发热，上尿路感染，背部疼痛，咳嗽和乏力。血液的药物不良反应包括骨髓抑制：血小板减少，中性粒细胞减少和贫血。
药物相互作用
使用Tasigna是抑制剂的CYP3A4，CYP2C8的，CYP2C9的，和CYP2D6。它也可能诱发CYP2B6，CYP2C8的和CYP2C9。因此，使用Tasigna可能会改变其他药物的血药浓度
CYP3A4抑制剂可能会影响血药浓度
CYP3A4诱导剂可能会影响血药浓度
在特殊人群中使用
性活跃的女性患者，应使用有效的避孕方法，在治疗过程中
如果不喂母乳
没有数据支持在儿科的使用
较低的起始剂量建议在肝功能不全的患者（基线）。
如何供应/贮存和处置
Tasigna(nilotinib)150 mg胶囊是红色不透明应明胶胶囊，1号大小黑色轴向印记“NVR/BCR”Tasigna (nilotinib)200 mg胶囊是淡黄色不透明应明胶胶囊，0号大小红色轴向印记“NVR/TKI”Tasigna胶囊在泡包装内供应。
150 mg
4泡纸盒包装(4×28粒)………………………….NDC 0078-0592-87
28粒胶囊泡……………………………………….NDC 0078-0592-51
200 mg
4泡纸盒包装(4×28粒) ………………………….NDC 0078-0526-87
28粒胶囊泡……………………………………….NDC 0078-0526-51
每个泡包装各含28胶囊，在早晨和傍晚各2粒间隔12小时共7天。
Tasigna (nilotinib)胶囊应贮存在25°C (77°F)；外出旅行允许15°–30°C (59°–86°F) [见美国药典控制室温]。
更新日期：01/2011
Tasigna® demonstrates rapid response as initial therapy in life-threatening form of leukemia
Tasigna now shows potential to become the treatment of choice for certain newly diagnosed patients with chronic myeloid leukemia
Two separate studies show rapid elimination of cancer cells in 96% of Tasigna patients and reduction of abnormal CML protein by six months
Larger front-line Phase III trial evaluating Tasigna vs. Gleevec® now fully accrued
East Hanover, December 8, 2008 /PRNewswire/ — New results from two separate trials demonstrate that Tasigna® (nilotinib) 200 mg capsules helps achieve rapid responses when used as initial therapy in newly diagnosed patients with a life threatening form of leukemia. The study results were presented today at the 50th Annual Meeting of the American Society of Hematology.
In both Phase II studies, 96% of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in early chronic phase achieved a complete cytogenetic response (CCyR) after six months of Tasigna treatment1,2. CCyR is defined as undetectable Philadelphia chromosome cells in a patient's bone marrow.
Although CCyR remains the primary goal of therapy, achieving major molecular response (MMR) may be a more sensitive predictor of long-term progression-free survival. In the two studies, 74%2 and 45%1 of patients treated with Tasigna exhibited MMR after six months. Tasigna was well tolerated in both studies.
"Newly diagnosed patients taking Tasigna experienced remarkable responses with minimal toxicity," said Jorge Cortes, MD, Professor of Medicine and Deputy Chair of Leukemia at the University of Texas MD Anderson Cancer Center in Houston. "These results indicate there is potential for patients to reach important clinical milestones faster."
Gleevec® (imatinib mesylate) tablets* is the standard treatment for Ph+ CML and rapidly transformed the treatment of CML when it was introduced in 2001. An ongoing Phase III trial called ENESTnd (Evaluating Nilotinib Efficacy in Clinical Trials of Newly Diagnosed Ph+ CML Patients) is evaluating Tasigna vs. Gleevec in newly diagnosed patients and is now fully accrued. Data from ENESTnd will be reported once available.
"Building on the wealth of scientific and clinical knowledge we have gained with Gleevec, Novartis strives to continually uncover novel approaches to help Ph+ CML patients achieve the best long-term outcomes," said David Epstein, President and CEO, Novartis Oncology.
Tasigna is a tyrosine kinase inhibitor approved for the treatment of adult Ph+ CML patients in the chronic or accelerated phases who are resistant or intolerant to prior treatment including Gleevec. Tasigna was specifically designed to inhibit Bcr-Abl, the key cause and driver of Ph+ CML and its mutations. The Philadelphia chromosome is found in nearly all patients with CML.
Study results
The first study, conducted by the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA), is an ongoing, open-label, single-stage, multicenter Phase II clinical trial, designed to evaluate the therapeutic efficacy and safety of Tasigna 800 mg/day as a first-line treatment. Seventy-three patients with newly diagnosed Ph+ CML in early chronic phase are enrolled in the trial. After six months of treatment, 96% of patients had achieved CCyR2.
In addition, 74% of patients achieved MMR, defined as Bcr-Abl/Abl ratio < 0.1%. The percentage of patients achieving this level of response rapidly increased after one month of treatment. Adverse reactions were manageable with dose adaptations. The incidence of any Grade 2 and 3 non-hematologic adverse events decreased considerably between months one to three and months four to six2.
The second study, conducted by researchers at MD Anderson Cancer Center, is an ongoing Phase II clinical trial investigating the efficacy and safety of Tasigna as initial therapy for patients with CML-CP (chronic phase). The current analysis, which includes data from 48 patients, shows that nearly all evaluable patients (96%) achieved CCyR. By six and 12 months, 45% and 52% of patients achieved MMR, respectively. Adverse reactions were manageable with temporary treatment interruptions or dose reductions1. Notably, there was no marked incidence of severe fluid retention or effusions, side effects commonly observed with other drugs of this class.
About Tasigna
Tasigna (nilotinib) capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. Tasigna has been approved in more than 50 countries. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Please see Important Safety Information, including Boxed Warning below.
Tasigna important safety information
WARNING: QT PROLONGATION AND SUDDEN DEATHS
TASIGNA prolongs the QT interval. Sudden deaths have been reported in patients receiving nilotinib. TASIGNA should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to TASIGNA administration and should be periodically monitored. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. Use caution in patients with hepatic impairment. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments. |
Myelosuppression
Treatment with Tasigna is associated with Grade 3/4 neutropenia, thrombocytopenia, and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months, then monthly thereafter as clinically indicated. Myelosuppression with Tasigna was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction.
QT prolongation
Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.
Sudden deaths
There were sudden deaths reported in the safety population and the expanded access program. Ventricular repolarization abnormalities may have contributed to their occurrence.
Elevated serum lipase
Caution is recommended in patients with history of pancreatitis. Check serum lipase periodically.
Liver function abnormality
Serum bilirubin and hepatic transaminases
The use of Tasigna may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase. Check hepatic function tests periodically.
Electrolyte abnormalities
Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hyponatremia and hypocalcemia. Correct electrolyte abnormalities prior to initiating Tasigna and monitor periodically during therapy.
Hepatic impairment
Metabolism of Tasigna is mainly hepatic. Tasigna has not been investigated in patients with hepatic impairment. Caution is recommended in these patients and QT interval should be monitored closely.
Drug interactions
The concomitant use of QT prolonging drugs and strong inhibitors or inducers of CYP3A4 should be avoided as they may affect serum concentration of Tasigna.
Concomitant strong CYP3A4 inhibitors
The concomitant use of strong CYP3A4 inhibitors should be avoided (including, but not limited to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted. If interruption of treatment with Tasigna is not possible, patients who require treatment with a drug that prolongs QT or strongly inhibits CYP3A4 should be closely monitored for prolongation of the QT interval, and a dose reduction to ½ the daily dose is recommended (400 mg once daily). If the strong inhibitor is discontinued, a washout period should be allowed before Tasigna is adjusted upward to the indicated dose. Close monitoring for prolongation of the QT interval is indicated for patients who cannot avoid strong CYP3A4 inhibitors. Grapefruit products and other foods that are known to inhibit CYP3A4 should also be avoided.
Concomitant strong CYP3A4 inducers
The concomitant use of strong CYP3A4 inducers should be avoided (including, but not limited to, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital). Patients should also refrain from taking St John's Wort. If patients must be co-administered a strong CYP3A4 inducer, the dose of Tasigna may need to be increased, depending on patient tolerability. If the strong inducer is discontinued, the Tasigna dose should be reduced to the indicated dose. Tasigna is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and UGT1A1. Since warfarin is metabolized by CYP2C9 and CYP3A4, it should be avoided if possible. Tasigna inhibits human P-glycoprotein. If Tasigna is administered with drugs that are substrates of Pgp, increased concentrations of the substrate are likely and caution should be exercised. Tasigna may also induce CYP2B6, CYP2C8, and CYP2C9. Therefore, Tasigna may alter serum concentration of other drugs.
Food effects
Food increases blood levels of Tasigna. Patients should avoid food 2 hours before and 1 hour after taking dose.
Lactose
Since the capsules contain lactose, Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or of glucose-galactose malabsorption.
Pregnancy
Fetal harm can occur when Tasigna is administered to a pregnant woman. Women should be advised not to become pregnant when taking Tasigna.
Adverse reactions
In chronic phase patients, the most commonly reported adverse reactions (>10%) were rash (33%), pruritus (29%), nausea (31%), fatigue (28%), headache (31%), constipation (21%), diarrhea (22%), and vomiting (21%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (28%), neutropenia (28%), elevated lipase (15%), and hyperglycemia (11%). In accelerated phase patients, the most commonly reported adverse reactions (>10%) were rash (28%), pruritus (20%), and constipation (18%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (37%), neutropenia (37%), anemia (23%), and elevated lipase (17%). Other serious adverse reactions included pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, and pyrexia (Grade 3/4: 2%).
Dose adjustments or modifications
Tasigna may need to be temporarily withheld and/or dose reduced for QT prolongation, hematological toxicities that are not related to underlying leukemia, clinically significant moderate or severe nonhematologic toxicities, laboratory abnormalities, or concomitant use of strong CYP3A4 inhibitors. With concomitant use of strong CYP3A4 inducers, the dose of Tasigna may need to be increased, depending on patient tolerability.
Other patients in whom Tasigna should be used with caution
Tasigna should not be used during pregnancy. Sexually active female patients should use effective contraception during treatment. Women should not breast feed while taking Tasigna. There are no data to support the use of Tasigna in pediatric patients. Use with caution in patients with hepatic impairment.
About Gleevec
Gleevec® (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy.
Gleevec important safety information3
Fetal harm can occur when administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.
Severe (NCI Grades 3/4) lab abnormalities – including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (>1%-33%), and hepatotoxicity (approx 5%)—and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced phase studies (where the dosage was 600 mg/day), and is more common in the elderly.
Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. 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.
Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of patients. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).
A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment. Patients with moderate renal impairment (CrCL = 20-39 mL/min) should receive a 50% decrease in the recommended starting dose and increased as tolerated. Doses greater than 600 mg are not recommended in patients with mild renal impairment (CrCL = 40-59 mL/min). For patients with moderate renal impairment doses greater than 400 mg are not recommended. Gleevec should be used with caution in patients with severe renal impairment.
Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, acute respiratory failure, and GI perforation.
Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several post marketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.
Consider potential toxicities-specifically liver, kidney, and cardiac toxicity, and immunosuppression from long-term use.
Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored, in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include ketoconazole, acetaminophen, warfarin, erythromycin, and phenytoin. (Please see full Prescribing Information for other potential drug interactions.)
For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron.
Common side effects of Gleevec tablets
The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%-49%), and rash and related terms (36%-47%)*†.
Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.
Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.
Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.
*Numbers indicate the range of percentages in 4 studies among adult patients, with newly diagnosed Ph+ CML, patients in blast crisis, accelerated phase, and in the chronic phase after failure of interferon-alpha therapy.
†For more detailed study information please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "suggesting," "may," "commitment," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Tasigna, the long-term impact of a patient's use of Tasigna or regarding potential future revenues from Tasigna. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Tasigna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Tasigna will be approved for any additional indications or labeling in any market. Nor can there be any guarantee regarding the long-term impact of a patient's use of Tasigna. Neither can there be any guarantee that Tasigna will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Tasigna could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG'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 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 Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The Company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world.
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