East Hanover, NJ, October 2, 2009 – Novartis has been awarded the prestigious Prix Galien USA award for best pharmaceutical product, the pathfinding drug Gleevec® (imatinib mesylate) tablets*. A molecularly targeted treatment, Gleevec is the therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST)1.
Considered “the pharmaceutical industry’s Nobel Prize,” the Prix Galien – also known as the Galen Prize – is awarded for pharmaceutical science that improves the human condition2. The Prix Galien USA is judged by an exceptional awards committee that includes seven Nobel Laureates3. Novartis had previously won the Prix Galien International Prize for Gleevec in 20024.
“Nominees for the Prix Galien USA stand apart from other drugs and technologies in the marketplace for the amount of research and level of skill that was invested in the development of these products that improve lives,” said Gerald Weissmann, M.D., Prix Galien USA committee chair, NYU School of Medicine research professor of medicine, director of the Biotechnology Study Center, and editor-in-chief of The FASEB Journal.
Gleevec has received approval for eight diseases so far, including becoming the only post-surgery treatment of adult patients following complete surgical removal of KIT+ GIST.
Gleevec validated an emerging paradigm in oncology, in which cancers are defined by genetic abnormalities and therapies are developed that target events critical to the development of disease. When the drug was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Ph+ CML in 2001, the regulatory review set the record for the fastest approval of any cancer drug to date5.
“It is a great honor for Gleevec to be the winner of such a significant award,” said David Epstein, CEO & President, Novartis Oncology. “Before Gleevec, oncologists dreamed of targeted, precise therapies but few believed them possible. Now, nearly a decade since its first approval, Gleevec has more than fulfilled its promise – triggering an intensive search for targets in other serious diseases and stimulating the development of new targeted therapies.”
Seven years after the start of a landmark ongoing Phase III clinical trial, nearly nine out of ten (86%) patients taking Gleevec are alive, the longest overall survival of patients with newly diagnosed Ph+ CML6. For patients with KIT+ GIST, Phase III research used for regulatory approvals showed that 98% of Gleevec patients remained tumor-free one year after surgery7.
The Prix Galien award was created in France by pharmacist Roland Mehl, who sought to promote the pharmaceutical success of his country. Since then, this accolade has spanned across Europe and Canada and was introduced in the US in 2007. It recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines, and is now considered the highest accolade for pharmaceutical research and development8.
Since 1970, Novartis has received 22 national Prix Galien awards in nine countries for innovative therapies such as Rimactan®, Parlodel®, Sandimmune®, Sandostatin®, Simulect® and Visudyne®9. In 2002, Novartis received an international Prix Galien prize for Gleevec4. Research related to the discovery and preclinical work on Gleevec has garnered additional prizes including the Bruce F. Cain Award from the American Association for Cancer Research (AACR); the Warren Alpert Foundation Scientific Prize, awarded by Harvard Medical School; and the 2009 Lasker-DeBakey Clinical Medical Research Award.
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 the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha (IFN-a) therapy; adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL); adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements; adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with c-KIT mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase–negative or unknown; adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP); patients with KIT (CD117)–positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as ”so far,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Gleevec, regarding the long-term impact of a patient’s use of Gleevec, or regarding potential future revenues from Gleevec. 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 Gleevec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gleevec will be approved for any additional indications or labeling in any market. Neither can there be any guarantee regarding the long-term impact of a patient’s use of Gleevec. Nor can there be any guarantee that Gleevec will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Gleevec could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including actions or delays by the European Commission; 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
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, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.us.novartis.com.
