) announced that the FDA has granted Breakthrough Therapy
Designation to its pipeline candidate, CTL019.
Novartis is evaluating CTL019, an experimental chimeric antigen
receptor (CAR) therapy, for the treatment of pediatric and adult
patients suffering from relapsed/refractory acute lymphoblastic
leukemia (r/r ALL).
CTL019 uses CAR technology to reprogram a patient's own T cells
to look for cancer cells which express specific proteins, called
CD19. Once reprogrammed, the T cells (called CTL019 after
reprogramming) are released into the patient's blood so as to
proliferate and bind to the targeted CD19+ cancer cells and destroy
The filing was submitted by the University of Pennsylvania's
Perelman School of Medicine. We note that the university has an
exclusive global agreement with Novartis to research, develop and
commercialize personalized CAR T cell therapies for the treatment
of cancers. The university is currently conducting phase I/II
trials on CTL019.
These studies are evaluating the activity and safety of CTL019
in patients with resistant or refractory CD19+ hematologic
malignancies, specifically pediatric and adult acute lymphoblastic
leukemia and chronic lymphocytic leukemia.
The designation from the FDA should expedite the development and
review of the candidate.The designation not only includes all of
the fast track program features but a more intensive FDA guidance
In order to focus on advancing innovative cell-based therapies,
including the development of CARs, Novartis has established the
Cell and Gene Therapies Unit. Moreover, Novartis holds the
worldwide rights to CARs which are being developed through the
collaboration with Penn for all cancer indications.
We are impressed by Novartis' efforts to realign its portfolio
in order to focus on its core business of pharmaceuticals, eye care
and generics. The acquisition of oncology products from
) and divestment of Vaccines business is a step in the right
direction. It will broaden Novartis' portfolio and enable it to
focus better on its core capabilities besides contributing
immensely to the top line. Margins are also expected to get a
Novartis, a large cap pharma, currently carries a Zacks Rank#3
(Hold). Some better-ranked large cap pharmas include
Johnson & Johnson
). Both the stocks carry a Zacks Rank #2 (Buy).
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