Novartis highlights clinical advances at ASH 2015, underscoring leadership in hematology research
November 30, 2015
EAST HANOVER, N.J., Novartis will demonstrate the strength of its research program and portfolio at the 57th American Society of Hematology (ASH) Annual Meeting. Presentations will highlight data across leukemias, lymphomas and myelomas as well as supportive care, including key findings in rare and difficult-to-treat patient populations, in addition to personalized cell therapies. The ASH Annual Meeting will be held December 5-8 in Orlando, Florida.
"We pride ourselves in our drive for new science and innovation, and look forward to bringing this promise to life at ASH through the results of our latest hematology research," said Bruno Strigini, President, Novartis Oncology. "We will be presenting encouraging overall survival data for both investigational and approved products, underscoring our commitment to improve and extend people's lives."
A key focus in hematology for Novartis is developing therapies for rare and difficult-to-treat patient populations. The acute myeloid leukemia (AML) community in particular is in need of new treatment options as the general therapeutic strategy has remained unchanged for more than 25 years1,2. Further, about one-third of AML patients harbor a FLT3 mutation, which is associated with poorer prognoses than in those without the mutation3,4. To this end, key data on PKC412 (midostaurin) from the following two studies will be presented:
Novartis and the University of Pennsylvania's Perelman School of Medicine have an exclusive global collaboration to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies for the investigational treatment of cancers. New data on investigational CART therapy CTL019, as well as cell processing technology will be presented at ASH including:
Novartis will share new research for pipeline compound ABL001, a small molecule designed to inhibit BCR-ABL. ABL001 is different from Gleevec® (imatinib mesylate)* and Tasigna® (nilotinib) as it binds to a unique region of BCR-ABL, forcing a conformational change that disables the protein's active site. As part of Novartis' ongoing commitment to chronic myeloid leukemia (CML) research, ABL001 represents the company's evolving science and is being investigated in Phase I trials:
Novartis will also be presenting safety and efficacy data, including long-term studies, at ASH from its approved hematological treatments:
Jakavi® (ruxolitinib)**
Tasigna (nilotinib)
Farydak® (panobinostat)
In addition, Sandoz, a Novartis company and the global leader in biosimilars, will present data from PROTECT 2, one of their pivotal Phase III trials investigating use of their proposed pegfilgrastim biosimilar in patients with chemotherapy-induced neutropenia.
Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.
For full prescribing information, including approved indications and important safety information about marketed products, please visit
http://www.pharma.us.novartis.com/info/products/products.jsp.
Because PKC412 (midostaurin), CTL019 and ABL001 are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that PKC412 (midostaurin), CTL019 and ABL001 will ever be commercially available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "investigational," "investigating," "proposed," "will," "drive," "look forward," "promise," "encouraging," "commitment," "focus," "being investigated," "yet," or similar terms, or by express or implied discussions regarding potential marketing approvals for PKC412, CTL019, ABL001 or proposed biosimilar pegfilgrastim, or regarding potential new indications or labeling for Gleevec, Tasigna, Jakavi or Farydak, or regarding potential future revenues from such products and investigational compounds. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that PKC412, CTL019, ABL001 or proposed biosimilar pegfilgrastim will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that Gleevec, Tasigna, Jakavi or Farydak will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products and investigational compounds will be commercially successful in the future. In particular, management's expectations regarding such products and investigational compounds could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality issues, and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. 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 Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives. We offer a broad range of medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions. 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 innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
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*Known as Glivec® (imatinib) outside the US, Canada and Israel.
**Jakavi is a registered trademark of Novartis AG in countries outsidethe United States. Jakafi is a registered trademark of Incyte Corporation. Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outsidethe United States.
References
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