Regeneron Announces Potential Additional Royalty Stream Related to EU Approval
for Ilaris® (canakinumab) in Patients Suffering Acute Gouty Arthritis Attacks
Who Cannot Gain Relief From Current Treatments
Regeneron receives 4% to 15% royalty on sales of Ilaris
TARRYTOWN, N.Y., March 4, 2013
TARRYTOWN, N.Y., March 4, 2013 /PRNewswire/ --Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced that it will receive an additional potential
royalty stream now that the European Commission (EC) has approved Novartis'
llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty
arthritis who suffer frequent attacks, and whose symptoms cannot or should not
be managed with current treatment options. Ilaris is the first biologic
approved in the European Union (EU) for symptomatic pain relief in a gouty
arthritis indication, and is administered in a single, subcutaneous injection
of 150 mg.^1
Under a June 2009 agreement with Novartis, Regeneron receives royalties on
worldwide sales of Ilaris. The overall royalty rate in the agreement starts
at 4% and reaches 15% when annual sales exceed $1.5 billion. In 2012,
Regeneron reported full year Ilaris royalties of $2.8 million.
In the EU, Ilaris is specifically indicated for the symptomatic treatment of
adult patients with frequent gouty arthritis attacks (at least 3 attacks in
the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs)
and colchicine are contraindicated, are not tolerated, or do not provide an
adequate response, and in whom repeated courses of corticosteroids are not
appropriate.^1Ilaris is a registered trademark of Novartis AG.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in
Tarrytown, New York that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other
areas of high unmet medical need, including hypercholesterolemia, rheumatoid
arthritis, asthma, and atopic dermatitis. For additional information about
the company, please visit www.regeneron.com.
Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance of
Regeneron, and actual events or results may differ materially from these
forward-looking statements. These statements concern, and these risks and
uncertainties include, among others, 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 possible success
of Ilaris in the European Union and resulting royalty stream; unforeseen
safety issues resulting from the administration of products and product
candidates in patients; the likelihood and timing of possible regulatory
approval and commercial launch of Regeneron's late-stage product candidates;
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; competing drugs and
product candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance of Regeneron's products and
product candidates; the ability of Regeneron to manufacture and manage supply
chains for multiple products and product candidates; coverage and
reimbursement determinations by third-party payers, including Medicare and
Medicaid; 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 and Bayer HealthCare,
to be canceled or terminated without any further product success; and risks
associated with third party intellectual property and pending or future
litigation relating thereto. 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, 2012. 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, unless required by law.
 Ilaris [prescribing information]. Surrey, UK: Novartis Pharmaceuticals UK
Media Relations Investor Relations
Peter Dworkin Michael Aberman, M.D.
Tel: 1 (914) 847-7640 Tel: 1 (914) 847-7799
SOURCE Regeneron Pharmaceuticals, Inc.
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