Novartis marks 30 year anniversary in transplantation and reinforces continued commitment to organ recipients at ESOT congress
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Novartis marks 30 year anniversary in transplantation and reinforces continued
commitment to organ recipients at ESOT congress
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* Novartis reaffirms continued innovation in transplant during anniversary
year of breakthrough therapy, ciclosporin
* TRANSFORM trial to be presented[1]: largest ever study of its kind,
evaluating Certican(® )(everolimus) in more than 2,000 kidney transplant
recipients, using innovative novel endpoint
* Breadth of data reinforces efficacy and safety profile of Certican and
ongoing commitment to improving transplant patients' lives in the long-term
Basel, September 4, 2013 - Demonstrating the strength of its ongoing commitment
to improve the lives of transplant patients through innovation, Novartis will
present 24 abstracts from its portfolio of transplant therapies at the 16(th)
congress of the European Society of Organ Transplantation (ESOT) in Vienna next
week. In the year that marks the 30(th) anniversary of ciclosporin, Novartis
will share its latest data addressing the long-term needs of transplant
patients[1],[2]. This includes the innovative TRANSFORM study design, a landmark
trial investigating long-term outcomes in kidney transplant recipients treated
with Certican[1].
"Having shaped the transplant landscape from the beginning with the discovery of
ciclosporin 30 years ago, we remain committed to developing innovative solutions
that advance the care of transplant patients," said Dr. Timothy Wright, Global
Head Development, Novartis Pharmaceuticals.
Novartis' discovery of the first calcineurin inhibitor (CNI), ciclosporin, was a
watershed moment in the history of organ transplantation[3]. Following its
approval 30 years ago, ciclosporin improved the one-year kidney graft survival
rate from around 50% to more than 80%[4] and CNIs remain the most effective and
widely used immunosuppressive agents in organ transplantation today[3].
About Certican and the TRANSFORM study[1]
The landmark TRANSFORM trial is an innovative long-term outcomes study with the
potential to change the treatment paradigm for preventing rejection in de novo
(first-time) kidney transplant recipients. For the transplant patient, it is no
longer just about surviving; it is about living a long and fulfilling life
thanks to improved outcomes (reduced risk of mortality and cardiovascular (CV)
events, and improved quality of life).
Novartis is committed to improving the lives of patients in the long-term
through investment in innovative clinical trials like TRANSFORM, which it is
hoped will be at the forefront of the next major evolutionary shift in
transplantation.
This global, Phase IV study, the largest ever in de novo kidney transplantation,
is designed to evaluate the short- and long-term benefits of Certican plus low
dose CNIs in kidney transplantation. The study of more than 2,000 patients will
investigate de novo Certican + low dose CNI versus Mycophenolic Acid (MPA) +
standard CNI, evaluating renal function and graft outcomes at 12- and 24-
months, as well as long-term outcomes up to five years.
The TRANSFORM trial is the first ever kidney transplantation study to evaluate
the short- and long-term patient outcome benefits using an innovative and novel
endpoint that combines renal function and graft outcome.
Novartis transplant portfolio highlights at ESOT, 8-11 September 2013
Certican in kidney transplant
* The HERAKLES study at 24 month: superior renal function in an everolimus-
based CNI-free regimen. O219, Guba, 10 September , 11:20 hrs CEST
* Safety of everolimus in kidney and liver transplantations: does the organ
matter? BO262, Kohler, 10 September, 16:05 hrs CEST
* Longer-term efficacy and safety of everolimus in de novo renal transplant
recipients. BO145, Watarai, 9 September, 16:20 hrs CEST
* 5-year follow-up on the ZEUS KTx trial: everolimus conversion after CNI
withdrawal. BO142, Lehner, 9 September, 16:05 hrs CEST
* HERAKLES at month 24: efficacy and safety of 3 different regimens in de novo
renal transplant patients. BO148, Lehner, 9 September, 16:35 CEST
* 12-month outcomes from EVIDENCE trial (Everolimus once-a-day regimen with
cyclosporine versus corticosteroid elimination) in adult kidney transplant
recipients. O193, Guarisco, 10 September, 8:20 hrs CEST
* Design of CRAD001A2314: a randomised study evaluating everolimus in
pediatric renal transplantation. P712, Tönshoff, 8 September, 18:15 - 19:30
hrs CEST
* Search for new endpoints for clinical trials of immunosuppressive drugs in
kidney transplantation. P312, Tedesco-Silva, 8 September, 18:15 - 19:30 hrs
CEST
* TRANSFORM trial design: effect of everolimus on long-term outcomes after
kidney transplantation. P308, Pascual, 8 September, 18:15 - 19:30 hrs CEST
* Outcome on renal function of everolimus conversion in maintenance KTx
patients: 4 years APOLLO trial. P271, Rhat, 8 September, 18:15 - 19:30 hrs
CEST
Certican in liver and non-kidney transplant
* Sustained better renal function with everolimus and reduced tacrolimus in
liver transplantation. BAC04 (Abstract Challenge Presentation) BAC - Best
Abstract Challenge, Saliba, 9 September, 11:40 hrs CEST
* mTOR inhibition and evolution of urinary protein excretion in non-renal
transplant recipients. O192, Junge, 10 September, 08:10 hrs CEST
* Efficacy and safety of everolimus-facilitated tacrolimus reduction versus
standard tacrolimus. O277, De Simone, 10 September, 17:20 hrs CEST
* A rational approach to quantify the mTOR treatment effect in liver
transplant recipients. O194, Junge, 10 September, 08:30 hrs CEST
* The PROTECT Study: sustained superior renal function in liver transplant
recipients after 35 months with everolimus monotherapy vs. calcineurin
inhibitor-based therapy. O275, Sterneck, 10 September, 17:00 hrs CEST
* Early calcineurin inhibitors avoidance improves renal function in de novo
heart transplant recipients: the results of a randomized controlled trial
(SCHEDULE trial) O076, Gude, 9 September, 11:40 hrs CEST
* Long-term therapy with everolimus in heart transplant recipients: two-years
results of the CERTIC Registry. O195, Brusa, 10 September, 8:40 hrs CEST
* Cardiovascular events with de novo use of everolimus in heart transplant
recipients. O073, Potena, 9 September, 11:10 hrs CEST
* Early vs delayed everolimus introduction in heart transplantation: analysis
of safety on the first 100 patients of the EVERHEART study. BO225, Boffini,
10 September, 16:15 hrs CEST
* Design of the H2307 study: everolimus with reduced tacrolimus in living
donor liver transplantation. P571, Junge, 8 September, 18:15 - 19:30 hrs
CEST
* Design of H2305: a prospective study evaluating everolimus in pediatric
liver transplantation. P717, Ganschow, 8 September, 18:15 - 19:30 hrs CEST
Pipeline and additional data
* Drug-drug interaction assessment to guide optimal use of hepatitis c
antivirals with immunosuppressants. P066, Barve, 8 September, 18:15 - 19:30
hrs CEST
* Efficacy and safety of the pkc-inhibitor sotrastaurin in de novo liver
transplant recipients. O278, Pascher, 8 September, 19:30 hrs CEST
* Progression of fibrosis in HCV+ liver transplant recipients treated with
cyclosporine or tacrolimus. O279, Nevens, 10 September, 17:40 hrs CEST
About Certican (everolimus)
Everolimus is one of the most-extensively studied immunosuppressants in solid
organ transplantation with more than 10,000 transplant recipients enrolled in
Novartis-sponsored clinical trials worldwide[5]. Under the trade name
Certican(®), it is approved in more than 90 countries to prevent organ rejection
for renal and heart transplant patients, and in addition, is approved in the EU
and other countries worldwide to prevent organ rejection for liver transplant
patients. In the U.S., under the trade name Zortress(®), the drug is approved
for the prophylaxis of organ rejection in adult patients at low-moderate
immunologic risk receiving a kidney transplant, and is also approved in adult
patients following a liver transplant.
Everolimus is also available from Novartis in different dosage strengths and for
different uses in non-transplant patient populations under the brand names
Afinitor(®) and Votubia(®). It is also exclusively licensed to Abbott and
sublicensed to Boston Scientific for use in drug-eluting stents.
Not all indications are available in every country. As an investigational
compound, the safety and efficacy profile of everolimus has not yet been
established outside the approved indications. Because of the uncertainty of
clinical trials, there is no guarantee that everolimus will become commercially
available for additional indications anywhere else in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "continued," "commitment," "ongoing," "will,"
"committed," "potential," "hope," "designed to," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for everolimus or regarding potential future revenues from everolimus. 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 everolimus to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that everolimus will be approved for any additional
indications or labeling in any market. Nor can there be any guarantee that
everolimus will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding everolimus 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;
unexpected manufacturing issues; 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
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.
References
[1] Pascual J, Chadban S, Citterio F et al. TRANSFORM trial design: Effect of
everolimus on long-term outcomes after kidney transplantation. Abstract
presented at: 16(th) European Society of Organ Transplantation Congress, Vienna,
Sept 2013.
[2] Watarai Y. Longer-term efficacy and safety of everolimus in de novo renal
transplant recipients. Abstract presented at: 16(th) European Society of Organ
Transplantation Congress, Vienna, Sept 2013.
[3] Rush D. The impact of calcineurin inhibitors on graft survival. Transplant
Rev (Orlando) 2013 Jul;27(3):93-5. doi: 10.1016/j.trre.2013.04.003. Epub 2013
Jun 3.
[4] Calne RY. "It can't be done". Lasker-DeBakey Clinical Medical Research
Award. Nature Med 2012;18(10):xxii-xxv.
[5] Novartis Pharma AG, Data on File.
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Datum: 04.09.2013 - 07:05 Uhr
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News-ID 293186
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