NVS Discusses Data Readout Plans
Swiss pharmaceutical giant Novartis (NVS) recently announced that it intends to present key data from studies in patients suffering from hematologic diseases and breast cancer this December. The data, containing more than 140 abstracts, will be presented by Novartis at the American Society of Hematology (ASH) and the CTRC-AACR San Antonio Breast Cancer Symposium (:SABCS).
Hematology
An important readout from the Hematology segment will be the presentation of two-year, follow-up data from phase III trials of Jakavi (ruxolitinib). Jakavi is being developed for the treatment of myelofibrosis. We note that Novartis licensed Jakavi from Incyte Corporation (INCY) for the development and commercialization of the drug in ex-US markets.
The Hematology segment will also include two-year follow-up data from a study which is evaluating patients suffering from Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. The patients had switched to Novartis’ Tasigna after long-term treatment with the company’s other hematology drug Glivec to achieve a deeper molecular response.
Novartis will be presenting updated data on Exjade (deferasirox) as a treatment of non-transfusion-dependent thalassemia (NTDTY). We note that earlier in the month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (:EMA) had issued a positive opinion for approving Exjade for the NTDT indication. The company will also present new data from another study on the drug, where it is being developed for the removal of cardiac iron in Beta-thalassemia major. The Hematology segment also includes data presentation from other clinical trials on CTL019 (CART-19), PKC412 (midostaurin) and LBH589 (panobinostat), among others.
The hematology market currently has players like Abbott Laboratories (ABT).
Breast Cancer
Novartis is also engaged in research and development efforts for the treatment of breast cancer. The company currently has several candidates in this segment. Novartis will present data from a phase II clinical trial on Afinitor in combination with fulvestrant. The study is evaluating the combination in women suffering from HR+ advanced breast cancer who have progressed on a previous endocrine therapy.
Novartis will also present data from an additional phase II study on Afinitor in combination with Femara and from a phase III trial of Afinitor in combination with Pfizer Inc.’s (PFE) Aromasin. Novartis estimates that Afinitor has the potential to generate $2 billion alone in advanced breast cancer by 2017.
Other important data readouts in breast cancer studies include data from a pre-clinical data from LBH589, a phase I study of BYL719 and a phase III randomized study of PI3K inhibitor BKM120.
We remind investors that companies like Roche Holding (RHHBY) are already in the market targeting breast cancer.
Currently we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.
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