Novartis unveils promising new clinical data of key pipeline projects at the Goldman Sachs Healthcare Conference in Laguna Niguel
Zelnorm - New European landmark trial confirms long-term safety and demonstrates efficacy as intermittent therapy in patients with Irritable Bowel Syndrome
LAF237 - 52 week data show durability of glucose lowering effect as monotherapy and in combination with metformin
Enablex - Excellent safety profile confirmed with no QTc prolongation, data submitted to FDA
Prexige - TARGET study completed, data to be submitted to authorities in Q3
Zoledronic acid - 15 minute infusion more efficacious than daily oral treatment with current gold standard in Paget's disease
Laguna Niguel, 8 June 2004 - Novartis unveiled new data on key developmental projects today at the Goldman Sachs Healthcare Conference in Laguna Niguel. The company, which has gained market share and turned in above-market growth for the past nine quarters, announced clinical trial results for some late-stage pipeline compounds and in-market products.
James Shannon, Global Head of Clinical Development, commented, "We are pleased that our development activities are delivering strong data for key drugs including the European landmark trial data for Zelnorm, the durability of efficacy over 52 weeks shown with LAF237 and the safety profile of Enablex. We have made excellent progress in the first months of 2004 and our key projects are on track to meet our milestones in the 2004 to 2005 timeframe."
Top line results were revealed of a new landmark trial, involving more than 4 500 patients, which focused on the effect of Zelnorm (irritable bowel disease) after four weeks of treatment and again after a further four weeks of treatment in patients whose symptoms recurred. The results were highly statistically significant on both primary variables, overall relief of IBS symptoms and abdominal pain and discomfort. The data again confirmed efficacy, safety and tolerability, allowing for resubmission in the EU in 2004. In addition to this new data, Zelnorm for the use in chronic constipation was also discussed at the conference. This data is under review at the FDA, having been filed in October 2003. An FDA Advisory Committee is scheduled for 14 July.
LAF 237, an oral DPP4 inhibitor in Phase III, is the first in a highly attractive new class of compounds for type 2 diabetes. Most recent results of three-month and one-year phase II clinical studies showed a statistically and clinically significant sustained dose dependent reduction in HbA1c, both as monotherapy and in combination with metformin. In a Phase II trial (Study 2204), patients who were part of the metformin plus LAF237 treatment arm sustained an HbA1c level that was on average 1.1 percent lower than the group on metformin plus placebo at the end of 52 weeks of treatment. Glucose levels measured after 8-12 hours of fasting and those measured 1-2 hours after eating a meal were also reduced in patients taking metformin plus LAF237 versus continued therapy with metformin alone. The phase III clinical program for LAF237 is ongoing and filing is expected in 2006.
Further information was provided on two products under regulatory review, Prexige and Enablex. It was announced that the TARGET trial was completed for Prexige (COX II inhibitor for osteoarthritis, rheumatoid arthritis, and pain) and is currently being analyzed. Data from the TARGET trial, as well as data on the use of the medicine for osteoarthritis at a 100mg dose, will be supplied to regulatory authorities in the US and EU. Novartis confirmed that the MRP procedure in the EU is expected to start in the third quarter 2004 with resubmission in the US latest in early 2006. The QTc study on Enablex (overactive bladder) conducted in Q1 2004 illustrated the overall highly beneficial safety profile of Enablex by demonstrating that there is no increase in QT/QTc intervals underscoring the potential benefit of its M3 selectivity. The data address the question raised in the US approvable letter as part of the FDA's new QTc standards to evaluate anti-cholinergics drugs. Data have been supplied to the FDA in June for the US resubmission.
Zoledronic Acid (postmenopausal osteoporosis and Paget's disease) is currently the most advanced of several new Novartis drugs for osteoporosis. Data show that one 15-minute infusion of the intravenous bisphosphonate zoledronic acid more rapidly reduced the biochemical markers of bone turnover in patients with Paget's and also produced greater sustained efficacy at six months than was seen with the oral treatment risedronate (95% vs. 75% response rate respectively). This data was generated as part of the Zoledronic Acid HORIZON Clinical Development Program with approximately 10,000 patients worldwide, in more than 200 trial centers on four continents, one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. The Paget's file has been submitted to the CHMP in Europe in April and will be submitted to the FDA in Q4 2004.
The extensive mega-trial program for Diovan, the number one ARB worldwide and the fastest growing top antihypertensive, was also discussed. This program is designed to document the medicine's efficacy, tolerability, cardio-protection and enhanced compliance. The next clinical results from the VALUE trial, evaluating morbidity and mortality in high risk patients with at least one additional risk factor for cardiovascular events, will be released at the European Society of Hypertension conference in June. Novartis recently launched a broad cardiovascular category management program, the most aggressive and comprehensive program ever introduced to educate and motivate patients to treat their elevated blood pressure, with more than 50,000 patients already enrolled.
Further outstanding new data from the MA-17 trial with Femara also were presented. They showed that Femara is the first hormonal therapy to significantly reduce distant metastases, or spreading of the cancer to other parts of the body, by 40% in postmenopausal women with early breast cancer in the extended adjuvant setting. Femara also reduced recurrence by 42% irrespective of nodal status and overall mortality by 39% vs. placebo in postmenopausal women with early breast cancer that had already spread to the lymph nodes by the time of diagnosis (called node-positive breast cancer). These data were the basis for global filings for the use of Femara in the extended adjuvant treatment of breast cancer in April 2004. Data from the BIG 198 trial in early adjuvant use of Femara vs. tamoxifen will become available in late 2004.
Novartis continues to excel in its development activities and was recently ranked number one by Center Watch in its relationships with European investigators. A total of 79 development projects fill the pipeline, of which 61 are in Phases II and III or in registration. They include 17 projects in cancer and 11 in cardiovascular medicine, two of Novartis' key growth areas. The number of projects in clinical development grew 44% between 2000 and 2003, with a significant increase in the mid- to late-stage clinical pipeline. Novartis led the industry over the past four years with 12 novel compounds that won approval in the US, confirming that Novartis is an industry leader in innovation. In addition, over the past three years, Novartis has succeeded in reducing the average development time by approximately 25%.
Based on the strength of the in-market product portfolio with limited patent exposure and the strong R&D pipeline, Novartis is on track to deliver above-market growth.
This release contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "to be submitted," "potential," "may," "will be," or similar expressions, or by express or implied discussions regarding potential future sales of existing products, potential new products or potential new indications for existing products, or by other discussions of strategy, plans or intentions. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There can be no guarantee that existing products will reach any particular sales levels, or that any new products will be approved for sale in any market, or that any new indications will be approved for existing products in any market. In particular, management's expectations could be affected by, among other things, uncertainties relating to product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the 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 described herein as anticipated, believed, estimated or expected. The Company 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.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Laguna Niguel, 8 June 2004 - Novartis unveiled new data on key developmental projects today at the Goldman Sachs Healthcare Conference in Laguna Niguel. The company, which has gained market share and turned in above-market growth for the past nine quarters, announced clinical trial results for some late-stage pipeline compounds and in-market products.
James Shannon, Global Head of Clinical Development, commented, "We are pleased that our development activities are delivering strong data for key drugs including the European landmark trial data for Zelnorm, the durability of efficacy over 52 weeks shown with LAF237 and the safety profile of Enablex. We have made excellent progress in the first months of 2004 and our key projects are on track to meet our milestones in the 2004 to 2005 timeframe."
Top line results were revealed of a new landmark trial, involving more than 4 500 patients, which focused on the effect of Zelnorm (irritable bowel disease) after four weeks of treatment and again after a further four weeks of treatment in patients whose symptoms recurred. The results were highly statistically significant on both primary variables, overall relief of IBS symptoms and abdominal pain and discomfort. The data again confirmed efficacy, safety and tolerability, allowing for resubmission in the EU in 2004. In addition to this new data, Zelnorm for the use in chronic constipation was also discussed at the conference. This data is under review at the FDA, having been filed in October 2003. An FDA Advisory Committee is scheduled for 14 July.
LAF 237, an oral DPP4 inhibitor in Phase III, is the first in a highly attractive new class of compounds for type 2 diabetes. Most recent results of three-month and one-year phase II clinical studies showed a statistically and clinically significant sustained dose dependent reduction in HbA1c, both as monotherapy and in combination with metformin. In a Phase II trial (Study 2204), patients who were part of the metformin plus LAF237 treatment arm sustained an HbA1c level that was on average 1.1 percent lower than the group on metformin plus placebo at the end of 52 weeks of treatment. Glucose levels measured after 8-12 hours of fasting and those measured 1-2 hours after eating a meal were also reduced in patients taking metformin plus LAF237 versus continued therapy with metformin alone. The phase III clinical program for LAF237 is ongoing and filing is expected in 2006.
Further information was provided on two products under regulatory review, Prexige and Enablex. It was announced that the TARGET trial was completed for Prexige (COX II inhibitor for osteoarthritis, rheumatoid arthritis, and pain) and is currently being analyzed. Data from the TARGET trial, as well as data on the use of the medicine for osteoarthritis at a 100mg dose, will be supplied to regulatory authorities in the US and EU. Novartis confirmed that the MRP procedure in the EU is expected to start in the third quarter 2004 with resubmission in the US latest in early 2006. The QTc study on Enablex (overactive bladder) conducted in Q1 2004 illustrated the overall highly beneficial safety profile of Enablex by demonstrating that there is no increase in QT/QTc intervals underscoring the potential benefit of its M3 selectivity. The data address the question raised in the US approvable letter as part of the FDA's new QTc standards to evaluate anti-cholinergics drugs. Data have been supplied to the FDA in June for the US resubmission.
Zoledronic Acid (postmenopausal osteoporosis and Paget's disease) is currently the most advanced of several new Novartis drugs for osteoporosis. Data show that one 15-minute infusion of the intravenous bisphosphonate zoledronic acid more rapidly reduced the biochemical markers of bone turnover in patients with Paget's and also produced greater sustained efficacy at six months than was seen with the oral treatment risedronate (95% vs. 75% response rate respectively). This data was generated as part of the Zoledronic Acid HORIZON Clinical Development Program with approximately 10,000 patients worldwide, in more than 200 trial centers on four continents, one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. The Paget's file has been submitted to the CHMP in Europe in April and will be submitted to the FDA in Q4 2004.
The extensive mega-trial program for Diovan, the number one ARB worldwide and the fastest growing top antihypertensive, was also discussed. This program is designed to document the medicine's efficacy, tolerability, cardio-protection and enhanced compliance. The next clinical results from the VALUE trial, evaluating morbidity and mortality in high risk patients with at least one additional risk factor for cardiovascular events, will be released at the European Society of Hypertension conference in June. Novartis recently launched a broad cardiovascular category management program, the most aggressive and comprehensive program ever introduced to educate and motivate patients to treat their elevated blood pressure, with more than 50,000 patients already enrolled.
Further outstanding new data from the MA-17 trial with Femara also were presented. They showed that Femara is the first hormonal therapy to significantly reduce distant metastases, or spreading of the cancer to other parts of the body, by 40% in postmenopausal women with early breast cancer in the extended adjuvant setting. Femara also reduced recurrence by 42% irrespective of nodal status and overall mortality by 39% vs. placebo in postmenopausal women with early breast cancer that had already spread to the lymph nodes by the time of diagnosis (called node-positive breast cancer). These data were the basis for global filings for the use of Femara in the extended adjuvant treatment of breast cancer in April 2004. Data from the BIG 198 trial in early adjuvant use of Femara vs. tamoxifen will become available in late 2004.
Novartis continues to excel in its development activities and was recently ranked number one by Center Watch in its relationships with European investigators. A total of 79 development projects fill the pipeline, of which 61 are in Phases II and III or in registration. They include 17 projects in cancer and 11 in cardiovascular medicine, two of Novartis' key growth areas. The number of projects in clinical development grew 44% between 2000 and 2003, with a significant increase in the mid- to late-stage clinical pipeline. Novartis led the industry over the past four years with 12 novel compounds that won approval in the US, confirming that Novartis is an industry leader in innovation. In addition, over the past three years, Novartis has succeeded in reducing the average development time by approximately 25%.
Based on the strength of the in-market product portfolio with limited patent exposure and the strong R&D pipeline, Novartis is on track to deliver above-market growth.
This release contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "to be submitted," "potential," "may," "will be," or similar expressions, or by express or implied discussions regarding potential future sales of existing products, potential new products or potential new indications for existing products, or by other discussions of strategy, plans or intentions. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There can be no guarantee that existing products will reach any particular sales levels, or that any new products will be approved for sale in any market, or that any new indications will be approved for existing products in any market. In particular, management's expectations could be affected by, among other things, uncertainties relating to product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the 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 described herein as anticipated, believed, estimated or expected. The Company 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.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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