UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K dated November 1, 2016
(Commission File No. 1-15024)
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Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
____________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F:
Form 20-F: ☒
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Form 40-F: ☐
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
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Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
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MEDIA RELEASE
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COMMUNIQUE AUX MEDIAS
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MEDIENMITTEILUNG
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Novartis LEE011 (ribociclib) granted
FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer
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Priority Review based on Phase III MONALEESA-2 trial, which showed LEE011 plus letrozole, as initial treatment for advanced
breast cancer, significantly extended progression-free survival compared to letrozole alone
1
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Underscores potential of LEE011 plus letrozole as a new treatment option for advanced breast cancer; may lead to faster
access for US patients
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A marketing authorization application for LEE011 plus letrozole has also been accepted for review by the European Medicines
Agency (EMA)
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Basel, November 1, 2016 –
Novartis announced today that the US Food and
Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for filing and granted Priority Review for LEE011
(ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The NDA is based on a comprehensive clinical
package, including results of the Phase III MONALEESA-2 trial. The trial, which was presented at the European Society for Medical
Oncology (ESMO) 2016 Congress and published simultaneously in the
New England Journal of Medicine,
showed LEE011 plus letrozole
reduced the risk of progression or death by 44% (HR = 0.556, 95% CI: 0.429-0.720;
P
= 0.00000329) over letrozole alone,
significantly extending progression-free survival (PFS) across all patient subgroups
1
. The company also announced that
the EMA has accepted for review the marketing authorization application for LEE011 plus letrozole in the same patient population.
“These regulatory milestones, along with the FDA Breakthrough Therapy designation
granted in August, underscore the need for new treatment options for women living with HR+/HER2- advanced breast cancer,”
said Bruno Strigini, CEO, Novartis Oncology. “Priority Review allows a shorter review period compared with FDA standard
review in the US, helping us to potentially bring LEE011 plus letrozole to patients more quickly. We also are working diligently
with the EMA and other Health Authorities to bring this treatment to patients around the world as fast as possible.”
FDA Priority Review designation requires the agency to take action on an application
within six months of its filing date compared to ten months under standard review
2
. FDA grants Priority Review to applications
for new drug candidates that treat serious conditions, such as advanced breast cancer for which there is currently no cure, and
if approved, would provide a significant improvement in treatment safety or efficacy
2
.
About LEE011 (ribociclib)
LEE011 (ribociclib) is a selective cyclin dependent kinase
inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase
4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly. Targeting
CDK4/6 with enhanced precision may play a role in ensuring cancer cells do not grow uncontrollably.
LEE011 is not approved for any indication in any market at this time. LEE011 was developed
by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About the MONALEESA Clinical Trial Program
Novartis is continuing to assess LEE011 through the robust MONALEESA (
M
ammary
ON
cology
A
ssessment of
LE
E011’s
E
fficacy and
SA
fety) clinical trial program, which includes
MONALEESA-2, MONALEESA-3, and MONALEESA-7. These trials are evaluating LEE011 in multiple endocrine therapy combinations across
a broad range of patients, including men and premenopausal women.
MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter
global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone
in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer
1
.
The trial randomized 668 patients in a 1:1 ratio stratified by the presence of liver
and/or lung metastases at 223 clinical trial sites globally
1
. Patients received LEE011 600 mg/daily (three weeks on
and one week off), or placebo, in combination with letrozole 2.5 mg/daily.
The primary endpoint of the trial was PFS
1
. Secondary
endpoints included: overall survival, overall response rate, clinical benefit rate, health-related quality of life, safety and
tolerability
1
.
The MONALEESA-3 trial is evaluating LEE011 in combination with fulvestrant compared
to fulvestrant alone in men and post-menopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum
of one prior endocrine therapy.
The MONALEESA-7 trial is investigating LEE011 in combination with endocrine therapy
and goserelin compared to endocrine therapy and goserelin alone in pre-menopausal women with HR+/HER2- advanced breast cancer
who have not previously received endocrine therapy. Both MONALEESA-3 and MONALEESA-7 are fully enrolled.
About Advanced Breast Cancer
Up to one-third of patients with early-stage breast cancer
will subsequently develop metastatic disease
3
. Metastatic breast cancer is the most serious form of the disease and
occurs when the cancer has spread to other parts of the body, such as the brain, bones or liver
4
. Advanced breast cancer
comprises metastatic breast cancer (stage 4) and locally advanced breast cancer (stage 3)
4
. Survival rates for women
living with advanced breast cancer are lower than those for women with earlier stage disease. The 5-year relative survival rate
for stage 3 breast cancer is approximately 72%, while metastatic (stage 4) breast cancer has a 5-year relative survival rate of
approximately 22%
5
.
About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific advancements
for breast cancer patients and improving clinical practice in collaboration with the global community
6
. With one of
the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the
industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the
disease
6
.
Disclaimer
The foregoing release contains forward-looking statements that
can be identified by words such as “Priority Review,” “potential,” “may,” "Breakthrough
Therapy designation," “potentially,” “would,” "continuing," “evaluating,” “investigating,”
"will," “pipelines,” or similar terms, or by express or implied discussions regarding potential marketing
approvals for
LEE011, or regarding potential future revenues from LEE011 or other products in the Novartis breast cancer pipeline.
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 LEE011 will be submitted
or approved for sale in any market, or at any particular time. Nor can there be any guarantee that LEE011 or any other product
in the Novartis breast cancer pipeline will be commercially successful in the future. In particular, management's expectations
regarding LEE011 and the other products in the Novartis breast cancer pipeline 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; competition in general; global trends
toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing, safety or quality issues,
and other risks and factors referred to in Novartis AG's current Form 20-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 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 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately
USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately
118,000 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.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
References
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1.
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Hortobagyi G, Stemmer S, Burris H,
et al. First-line ribociclib plus letrozole for postmenopausal women with HR+, HER2-,
advanced breast cancer: First results from the Phase III MONALEESA-2 study. Presented
at the European Society for Medical Oncology (ESMO) Congress, October 8, 2016, Copenhagen,
Denmark (abstract # LBA1_PR)
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2.
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FDA. Priority Review. Available at
http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Accessed October 19, 2016.
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3.
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O’Shaughnessy J. Extending survival
with chemotherapy in metastatic breast cancer. The Oncologist. 2005;10 (Suppl 3):20–29.
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4.
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American Cancer Society. How do you
determine the stage of breast cancer? Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-staging.
Accessed May 10, 2016.
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5.
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American Cancer Society. Breast cancer
survival rates, by stage. Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage.
Accessed July 7, 2016.
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# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com
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Julie Masow
Novartis Oncology Media Relations
+1 862 778 7220 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com
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Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central
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North America
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Samir Shah
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+41 61 324 7944
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Richard Pulik
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+1 212 830 2448
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Pierre-Michel Bringer
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+41 61 324 1065
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Sloan Pavsner
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+1 212 830 2417
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Thomas Hungerbuehler
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+41 61 324 8425
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Isabella Zinck
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+41 61 324 7188
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Media release (PDF): http://hugin.info/134323/R/2053164/768466.pdf
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Novartis AG
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Date: November 1, 2016
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By:
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/s/ PAUL PENEPENT
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Name:
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Paul Penepent
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Title:
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Head Group Financial Reporting and Accounting
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