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 June 21, 2022
(Commission File No. 1-15024)
____________________
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: ☒ |
|
Form 40-F: ☐ |
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.
|
|
Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
https://twitter.com/novartisnews
|
MEDIA & INVESTOR RELEASE
Novartis plans to petition
the U.S. Court of Appeals for the Federal Circuit for further review to uphold validity of the Gilenya® (fingolimod) dosing
regimen patent
Ad hoc announcement pursuant to Art. 53 LR
Basel, June 21, 2022 — Today, Novartis
announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a new, negative decision regarding the validity of US Patent
No. 9,187,405, covering a dosing regimen for Gilenya. Novartis plans to file a petition seeking further review of this decision.
In August 2020, the U.S. District Court for the District
of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until
the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining Abbreviated
New Drug Application (ANDA) filer challenging this patent.
In January 2022, a three-judge panel of the CAFC issued
a decision upholding the validity of the dosing regimen patent. HEC filed a petition for rehearing with the CAFC, which today issued a
decision from a modified panel reversing its previous decision and now finding the patent invalid.
Novartis intends to vigorously defend the validity of
the patent and is considering all available options, including current plans to seek review of this decision by the full CAFC, a process
which may take several months.
Previously, Novartis entered into settlement agreements
with a number of ANDA filers. Those ANDA filers will be able to launch a generic version of Gilenya on an agreed upon date that is prior
to the expiration of the dosing regimen patent or earlier under certain circumstances. As the formal mandate closing the appeal process
has not been issued from the CAFC, the permanent injunction granted against HEC remains in place and Novartis believes that HEC and other
ANDA filers are not permitted to launch a generic version of Gilenya at this time.
Disclaimer
This press release
contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
Forward-looking statements can generally be identified by words such as “potential,” “can,”
“will,” “plan,” “may,” “could,” “would,” “expect,”
“anticipate,” “seek,” “look forward,” “believe,” “committed,”
“investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this
press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements.
Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this press release will be submitted or
approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any
guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products
could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results
and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends
toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and
requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the
particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the
effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues;
potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend
people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative
treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies
investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to
expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out
more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site
or required registration, please contact media.relations@novartis.com
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Amy Wolf | |
Meghan O’Donnell |
Novartis External Communications | |
Novartis Division Communications |
+41 79 576 0723 (mobile) | |
+41 61 324 9136 (direct) |
amy.wolf@novartis.com | |
+41 79 797 9102 (mobile) |
| |
meghan.odonnell@novartis.com |
Julie Masow
Novartis US External Communications
+1 862 579 8456
Julie.masow@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail:
investor.relations@novartis.com
Central |
|
North America |
|
Samir Shah |
+41 61 324 7944 |
Sloan Simpson |
+1 862 345 4440 |
Nicole Zinsli-Somm |
+41 61 324 3809 |
Alina Levchuk |
+1 862 778 3372 |
Isabella Zinck |
+41 61 324 7188 |
Parag Mahanti |
+1 973-876-4912 |
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.
|
Novartis AG |
|
|
|
|
|
|
|
|
|
Date: June 21, 2022 |
By: |
/s/ PAUL
PENEPENT |
|
|
Name: |
Paul Penepent |
|
|
Title: |
Head Group Financial Reporting and
Accounting |
Novartis (NYSE:NVS)
過去 株価チャート
から 3 2024 まで 4 2024
Novartis (NYSE:NVS)
過去 株価チャート
から 4 2023 まで 4 2024