Companies will partner on promotion and further development of the product for metastatic colorectal cancer in North America, Europe and Japan
In a separate agreement Novartis also obtains exclusive rights to expand development of PTK787 to age-related macular degeneration and potentially other ophthalmic diseases
Basel, January 25, 2005 - Novartis Pharma AG announced today that it has executed a commercialization agreement with Schering AG, Germany, for the investigational agent PTK787, known by Schering AG as ZK222584. PTK787 is an oral angiogenesis inhibitor, which Novartis and Schering AG have been jointly researching and co-developing since 1995.
Under the commercialization agreement, the companies will partner on promotion and further development of the product all oncology indications including metastatic colorectal cancer in all major markets. The value of the agreement to Schering and Novartis is designed to be equal based on the co-promotion terms and territory allocations. Novartis will lead North American co-promotion activities and Schering will lead European co-promotion activities with both companies sharing co-promotion activities equally in Japan. Novartis will exclusively promote the product in Asia (excluding Japan) and Middle East. Schering will exclusively promote PTK787 in Latin America, Africa and Australia.
PTK787 is currently in phase III clinical trials for metastatic colorectal cancer. Initial results are expected in the second quarter of 2005, and filing planned for the second half of 2005. Two phase III trials have enrolled approximately 2,000 patients with metastatic colorectal cancer at more than 200 centers around the world.
"This agreement will further optimize the commercialization and future development activities for this potential breakthrough cancer medicine. Our collaboration has enabled us to effectively move PTK787 through clinical trials and now working closely together in the world's major regions should allow us to most effectively reach physicians and patients once the medicine is commercialized," said David Epstein, CEO of Specialty Medicines and president of Novartis Oncology."
In a separate agreement with Schering, Novartis has obtained exclusive rights to develop PTK787 for the treatment of "wet" age-related macular degeneration (AMD). Under the agreement, Novartis will obtain full global and exclusive developmental and commercialization rights to PTK787 in ophthalmics. Novartis will pay an upfront fee, milestone payments and royalties on ophthalmics sales. Additional details of the agreement were not disclosed.
"The wet AMD market is expected to show strong market growth over the next 10 years, fueled by increased patient diagnosis and referrals with the entry of new competitors," said Epstein. "With PTK787, we are excited to explore the full potential of this next-generation compound and continue to lead innovation in the treatment of retinal diseases."
Phase III Study for Treatment of Colorectal Cancer
PTK787 is currently in Phase III development for metastatic colorectal cancer, with first results expected in Q2 2005 from the CONFIRM I trial, which is evaluating the safety and potential efficacy benefit of once-daily oral treatment with PTK787 in combination with the FOLFOX-4 regimen compared to FOLFOX-4 alone in previously untreated patients with metastatic colorectal cancer. A second trial, CONFIRM 2 is evaluating the safety and potential survival benefit of once-daily oral treatment with PTK787 in combination with the FOLFOX-4 regimen compared with FOLFOX-4 alone in patients with metastatic colorectal cancer who have progressed after irinotecan-based chemotherapy The CONFIRM trials started in January 2003 and enrollment was completed in July 2004.
PTK787 is currently in Phase III development for metastatic colorectal cancer, with first results expected in Q2 2005 from the CONFIRM I trial, which is evaluating the safety and potential efficacy benefit of once-daily oral treatment with PTK787 in combination with the FOLFOX-4 regimen compared to FOLFOX-4 alone in previously untreated patients with metastatic colorectal cancer. A second trial, CONFIRM 2 is evaluating the safety and potential survival benefit of once-daily oral treatment with PTK787 in combination with the FOLFOX-4 regimen compared with FOLFOX-4 alone in patients with metastatic colorectal cancer who have progressed after irinotecan-based chemotherapy The CONFIRM trials started in January 2003 and enrollment was completed in July 2004.
According to the World Health Organization, in 2000 there were almost 940,000 cases of colorectal cancer worldwide, almost 65% of which were in the more developed countries. The Colorectal Cancer Network reports that in the United States only lung cancer is responsible for more cancer-related deaths.
Contraindications and Adverse Events
PTK787 treatment has been generally well tolerated in more than 1,000 patients with up to 24 months of uninterrupted treatment and the side effects that have been observed are generally mild to moderate. The most frequently reported adverse events were nausea; fatigue, vomiting, and dizziness and the majority of these were mild to moderate. In the Phase I/II trial, the adverse event profile for the group of patients treated with PTK787 in combination with FOLFOX-4 was generally similar to that reported for the FOLFOX-4 regimen alone. PTK787 should not be administered to women who are pregnant or lactating or to anyone not practicing adequate contraception.
PTK787 treatment has been generally well tolerated in more than 1,000 patients with up to 24 months of uninterrupted treatment and the side effects that have been observed are generally mild to moderate. The most frequently reported adverse events were nausea; fatigue, vomiting, and dizziness and the majority of these were mild to moderate. In the Phase I/II trial, the adverse event profile for the group of patients treated with PTK787 in combination with FOLFOX-4 was generally similar to that reported for the FOLFOX-4 regimen alone. PTK787 should not be administered to women who are pregnant or lactating or to anyone not practicing adequate contraception.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "will participate," "potentially," "will lead," "will," "expected," "will obtain," "will pay," "to explore the full potential," or similar expressions, or by discussions regarding the potential that PTK787 will be approved for marketing, or regarding any potential revenues from PTK787. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with PTK787 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that PTK787 will be approved for sale in any market. In particular, management's expectations regarding commercialization of PTK787 could be affected by, among other things, uncertainties relating to clinical trials; new 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; as well as 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 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
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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Lisa Richert
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