Novartis announces an exclusive global licensing and research collaboration with Regenerex, leveraging a novel cell platform to broaden presence in the cell therapy space
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Novartis International AG /
Novartis announces an exclusive global licensing and research collaboration with
Regenerex, leveraging a novel cell platform to broaden presence in the cell
therapy space
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* Research collaboration advances company goal to deliver an innovative
portfolio of novel cell therapy therapeutics for conditions with a high
unmet need
* Strategic research collaboration enlarges scope of the Novartis novel cell
therapy portfolio with the potential to build expertise and synergies across
the programs
* For kidney transplantation this has the potential to induce immunological
tolerance, resulting in long-term graft survival without the need for
lifelong immunosuppression
Basel, September 6, 2013 - Novartis today announced that it has entered into an
exclusive global licensing and research collaboration agreement with Regenerex
LLC, a biopharmaceutical company based in Louisville, Kentucky, for use of the
company's novel Facilitating Cell Therapy (FCRx) platform. The hematopoietic
stem cell-based FCRx platform has been investigated in kidney transplantation to
induce stable immunological tolerance, resulting in graft survival without the
need for lifelong immunosuppression. This collaboration reaffirms the Novartis
commitment to transplant. Beyond transplant, Regenerex's novel platform
potentially has curative potential for multiple underserved diseases and will be
investigated in the rescue of serious genetic deficiencies such as inherited
metabolic storage disorders and hemoglobinopathies.
"As the field of biomedicine sits on the cusp of a new transformation, we are
excited to announce this agreement which supports the Novartis leadership
position in cell therapy," said Dr. Timothy Wright, Global Head Development,
Novartis Pharmaceuticals. "Thirty years ago, Novartis developed ciclosporin,
which changed transplantation treatment paradigms and enabled countless lives to
be saved. Now, this collaboration, along with our internal cell therapy assets,
has the potential to transform medicine once again through innovation."
FCRx will broaden the current Novartis cell therapy portfolio, which includes
two novel cell therapy platforms initially being investigated in hematological
malignancies. HSC835 is a novel cell therapy approach that enables an expanded
single umbilical cord blood derived hematopoietic stem cell transplant in
patients with limited treatment options. HSC835 is currently in a Phase II
trial in patients with high-risk hematological malignancies. A second cell
therapy product, CTL019 is a chimeric antigen receptor T cell therapy currently
in Phase II development in acute lymphoblastic leukemia (ALL) and chronic
lymphocytic leukemia (CLL).
About FCRx
FCRx is a novel allogeneic hematopoietic stem cell based therapy platform that
also contains facilitating cells derived from a donor. The platform supports the
development of tolerance, or "bone marrow chimerism," in transplant recipients,
providing a better side effect profile than current human hematopoietic stem
cell transplantation protocols. Chimerism may eventually render the recipient
tolerant to cell, tissue or organ transplants from the same donor, thereby
enabling transplant patients to discontinue immunosuppressive medications after
building stable immunological tolerance. Results from a Phase II study in 15
kidney transplant recipients are extremely encouraging with six patients fully
withdrawn from immunosuppression without loss of engraftment, and a further two
with planned full withdrawal at 1 year[1]. Currently, solid organ transplant
recipients must take immunosuppressive drugs for life to prevent rejection.
This approach may also allow for treatment of inherited metabolic diseases like
metachromatic leukodystrophy or sickle cell disease.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "goal," "potential," "commitment," "potentially," "will,"
"on the cusp," "being investigated," "may," "eventually," "encouraging,"
"planned," or similar expressions, or by express or implied discussions
regarding potential approvals for the FCRx platform, HSC835 or CTL019, or
regarding potential future revenues from such products. 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 to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that the FCRx
platform, HSC835 or CTL019 will be approved for use or sale in any market, or at
any particular time. Nor can there be any guarantee that such products will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding such products could be affected by, among
other things, unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing 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; unexpected manufacturing issues; 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
Novartis 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, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Barbara Duci
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 0285 (direct)
+41 79 593 4202 (mobile) +41 79 701 7982 (mobile)
eric.althoff(at)novartis.com barbara.duci(at)novartis.com
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Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
References
[1] Leventhal J, Abecassis M, Miller J. Gallon L, Ravindra K, Tollerud DJ,
King B, Herzig G, Herzig R, Ildstad ST. Chimerism and tolerance without
GVHD or engraftment syndrome in HLA-mismatched combined kidney and
hematopoietic stem cell transplantation. Science Translational Medicine
2012 Mar 7; 4(124): 124ra28.
Media release (PDF):
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Source: Novartis International AG via Thomson Reuters ONE
[HUG#1727596]
Unternehmensinformation / Kurzprofil:
Datum: 06.09.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 294112
Anzahl Zeichen: 10492
contact information:
Town:
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Kategorie:
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