TARRYTOWN, N.Y., June 22, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today provided details of the
royalty it receives on any sales of canakinumab (ACZ885), an
anti-IL1β antibody. Under a 2009 agreement with Novartis, Regeneron
receives a royalty on worldwide net sales of canakinumab; the
royalty rate starts at 4 percent and reaches 15 percent when
canakinumab annual sales exceed $1.5 billion. The royalty
applies to currently approved indications for Ilaris®,
and any potential sales for future indications, including related
to the positive Canakinumab Anti-inflammatory Thrombosis Outcomes
Study (CANTOS) results announced by Novartis earlier
today.
Regeneron has not reviewed the CANTOS data and cannot predict
whether the study will result in new indications or sales in the
future. Regeneron is not involved in the development and regulatory
process for canakinumab.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led by physician-scientists for nearly 30
years, our unique ability to repeatedly translate science into
medicine has led to six FDA-approved treatments and over a dozen
product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary VelociSuite®
technologies, including VelocImmune® which yields
optimized fully-human antibodies, and ambitious initiatives such as
the Regeneron Genetics Center, one of the largest genetics
sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This news release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the impact (if any) of the
agreement with Novartis discussed in this news release on
Regeneron's business, operating results, and financial condition;
the impact (if any) of the Canakinumab Anti-inflammatory Thrombosis
Outcomes Study (CANTOS) discussed in this news release on the
development and commercialization of Ilaris®
(canakinumab); the nature, timing, and possible success and
therapeutic applications of Regeneron's products, product
candidates, and research and clinical programs now underway or
planned; the likelihood and timing of possible regulatory approval
and commercial launch of Regeneron's late-stage product candidates;
unforeseen safety issues resulting from the administration of
products and product candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron's product candidates in clinical trials; determinations
by regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's products and product candidates; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products, research and clinical programs, and business, including
those relating to patient privacy; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
products and product candidates; coverage and reimbursement
determinations by third-party payers, including Medicare and
Medicaid; the ability of Regeneron to manufacture and manage supply
chains for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties to
perform filling, finishing, packaging, labelling, distribution, and
other steps related to Regeneron's products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its sales
or other financial projections or guidance and changes to the
assumptions underlying those projections or guidance; the potential
for any license or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, Teva Pharmaceutical Industries Ltd.,
and Novartis (or their respective affiliated companies, as
applicable), to be cancelled or terminated without any further
product success; and risks associated with intellectual property of
other parties and pending or future litigation relating thereto,
including without limitation the patent litigation relating to
Praluent® (alirocumab) Injection, the permanent
injunction granted by the United States District Court for the
District of Delaware that, if
upheld on appeal, would prohibit Regeneron and Sanofi from
marketing, selling, or commercially manufacturing Praluent in
the United States, the outcome of
any appeals regarding such injunction, the ultimate outcome of such
litigation, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the United States
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2016 and its
Form 10-Q for the quarterly period ended March 31, 2017. Any forward-looking statements
are made based on management's current beliefs and judgment, and
the reader is cautioned not to rely on any forward-looking
statements made by Regeneron. Regeneron does not undertake any
obligation to update publicly any forward-looking statement,
including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts
Regeneron:
Media
Relations
Alex
Bowie
Tel: 1 (914)
847-3407
Mobile: +1 (202)
213-1643
alexandra.bowie@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.