-- Amendment enhances productive year with
CABOMETYX™ regulatory approvals and commercial
launches in the United States and European Union
-- Exelixis to receive $10 million upfront
payment, with subsequent regulatory and commercial
milestones
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY)
today jointly announced an amendment to the exclusive collaboration
and licensing agreement for the commercialization and continued
development of cabozantinib, to include commercialization rights in
Canada for Ipsen where Ipsen has an established business
(Mississauga, Ontario). Signed in February 2016, the original
agreement gave Ipsen exclusive commercialization rights for current
and potential future cabozantinib indications outside of the United
States, Canada and Japan. Following the amendment, Exelixis
maintains exclusive rights for cabozantinib in the United States
and Japan, and is continuing discussions with potential partners
for commercial rights in Japan.
Under the terms of the amendment, Exelixis will receive a $10
million upfront payment. Exelixis is eligible to receive regulatory
milestones, for the approvals of cabozantinib in Canada for
advanced renal cell carcinoma (RCC) after prior treatment, for
first-line RCC, and advanced hepatocellular carcinoma (HCC), as
well as additional regulatory milestones for potential further
indications. In line with the prior transaction between the
parties, the agreement also includes commercial milestones and
provides for Exelixis to receive tiered royalties on Ipsen’s net
sales of cabozantinib in Canada.
“Exelixis and Ipsen have made significant progress together
since signing our collaboration and licensing agreement in
February, and considering the substantial business resources that
Ipsen has in Canada, amending the terms to grant Ipsen Canadian
rights is a natural next step,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer of Exelixis. “Over the past
nine months, CABOMETYX received regulatory approval for advanced
RCC in the United States as well as the European Union, where Ipsen
recently began launching the product. Our collaboration with Ipsen
is strong, and we look forward to continued progress as they pursue
approval and commercialization in Canada.”
David Meek, Chief Executive Officer of Ipsen, said, “Gaining
commercial rights for CABOMETYX in Canada expands our geographic
footprint and strengthens our Oncology franchise in North America,
one of our key geographic regions and main drivers of growth. This
announcement follows numerous advancements in the CABOMETYX
program, including the recent approval in Europe. We are now
focused on a successful European launch and are pleased to offer
advanced renal cell carcinoma patients a new treatment option
supported by a strong clinical profile. We look forward to continue
working with our partner Exelixis to advance the cabozantinib
program.”
CABOMETYX was approved in the European Union (EU) on September
9, 2016 for the treatment of RCC in adults following prior vascular
endothelial growth factor (VEGF)-targeted therapy. Ipsen is
currently initiating the launch of CABOMETYX in the EU. The
regulatory filing in Canada is expected in 2017, with regulatory
approval anticipated in early 2018.
About CABOMETYX™
CABOMETYX is the tablet formulation of cabozantinib. Its targets
include MET, AXL and VEGFR-1, -2 and -3. In preclinical models,
cabozantinib has been shown to inhibit the activity of these
receptors, which are involved in normal cellular function and
pathologic processes such as tumor angiogenesis, invasiveness,
metastasis and drug resistance.
CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The
recommended dose is 60 mg orally, once daily.
On April 25, 2016, the FDA approved CABOMETYX tablets for the
treatment of patients with advanced renal cell carcinoma who have
received prior anti-angiogenic therapy. On September 9, 2016, the
European Commission approved CABOMETYX tablets for the treatment of
advanced renal cell carcinoma in adults who have received prior
vascular endothelial growth factor (VEGF)-targeted therapy in the
European Union, Norway and Iceland.
About Exelixis’ Exclusive Licensing Agreement with
Ipsen
In February 2016, Exelixis granted Ipsen exclusive
commercialization rights for current and potential future
cabozantinib indications outside of the United States, Canada and
Japan. On 20 December 2016, Exelixis granted Ipsen the commercial
and development rights for cabozantinib in Canada. As provided in
their agreement, Exelixis and Ipsen are also collaborating on the
development of cabozantinib for current and potential future
indications.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical group with
total sales exceeding €1.4 billion in 2015. Ipsen sells more than
20 drugs in more than 115 countries, with a direct commercial
presence in more than 30 countries. Ipsen’s ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its fields of expertise cover oncology, neurosciences and
endocrinology (adult & pediatric). Ipsen’s commitment to
oncology is exemplified through its growing portfolio of key
therapies improving the care of patients suffering from prostate
cancer, bladder cancer and neuro-endocrine tumors. Ipsen also has a
significant presence in primary care. Moreover, the Group has an
active policy of partnerships. Ipsen's R&D is focused on its
innovative and differentiated technological platforms, peptides and
toxins, located in the heart of the leading biotechnological and
life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford,
UK; Cambridge, US). In 2015, R&D expenditure totaled close to
€193 million. The Group has more than 4,600 employees worldwide.
Ipsen’s shares are traded on segment A of Euronext Paris (stock
code: IPN, ISIN code: FR0010259150) and eligible to the “Service de
Règlement Différé” (“SRD”). The Group is part of the SBF 120 index.
Ipsen has implemented a Sponsored Level I American Depositary
Receipt (ADR) program, which trade on the over-the-counter market
in the United States under the symbol IPSEY. For more information
on Ipsen, visit www.ipsen.com.
About Exelixis
Exelixis, Inc. (Nasdaq:EXEL) is a biopharmaceutical company
committed to the discovery, development and commercialization of
new medicines with the potential to improve care and outcomes for
people with cancer. Since its founding in 1994, three medicines
discovered at Exelixis have progressed through clinical development
to receive regulatory approval. Currently, Exelixis is focused on
advancing cabozantinib, an inhibitor of multiple tyrosine kinases
including MET, AXL and VEGF receptors, which has shown clinical
anti-tumor activity in more than 20 forms of cancer and is the
subject of a broad clinical development program. Two separate
formulations of cabozantinib have received regulatory approval to
treat certain forms of kidney and thyroid cancer and are marketed
for those purposes as CABOMETYX™ tablets (U.S. and EU) and
COMETRIQ® capsules (U.S. and EU), respectively. Another
Exelixis-discovered compound, COTELLIC® (cobimetinib), a selective
inhibitor of MEK, has been approved in major territories including
the United States and European Union, and is being evaluated for
further potential indications by Roche and Genentech (a member of
the Roche Group) under a collaboration with Exelixis. For more
information on Exelixis, please visit www.exelixis.com or follow
@ExelixisInc on Twitter.
Ipsen - Forward Looking Statement
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes," "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations. Moreover,
the targets described in this document were prepared without taking
into account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons.
The Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favourable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Other risks and uncertainties include
but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the Group's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the Group’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to the Group’s activities and financial results. The
Group cannot be certain that its partners will fulfil their
obligations. It might be unable to obtain any benefit from those
agreements. A default by any of the Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to
update or revise any forward looking statements, targets or
estimates contained in this press release to reflect any change in
events, conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers.
The risks and uncertainties set out are not exhaustive and the
reader is advised to refer to the Group’s 2014 Registration
Document available on its website (www.ipsen.com).
Exelixis – Forward Looking Statement
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
receipt of a $10 million upfront payment; Exelixis’ eligibility to
receive regulatory milestones for the approvals of cabozantinib in
Canada for advanced RCC after prior treatment, for first-line RCC,
and advanced HCC, as well as additional regulatory milestones for
potential further indications; the potential receipt of tiered
royalties on Ipsen’s net sales of cabozantinib in Canada; Ipsen’s
continued progress toward the pursuit of approval and
commercialization of cabozantinib in Canada; the expectation that
the regulatory filing in Canada for cabozantinib in advanced RCC
will be in 2017, with regulatory approval anticipated in early
2018; Exelixis' commitment to the discovery, development and
commercialization of new medicines with the potential to improve
care and outcomes for people with cancer; Exelixis’ focus on
advancing cabozantinib; and the continued development of
cobimetinib. Words such as “will,” “eligible,” “potential,”
“further,” “look forward,” “expected,” “anticipated,” “committed,”
“focused,” or other similar expressions identify forward-looking
statements, but the absence of these words does not necessarily
mean that a statement is not forward-looking. In addition, any
statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements. These forward-looking statements are
based upon Exelixis’ current plans, assumptions, beliefs,
expectations, estimates and projections. Forward-looking statements
involve risks and uncertainties. Actual results and the timing of
events could differ materially from those anticipated in the
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation: the complexities
and challenges associated with regulatory review and approval
processes; Exelixis’ dependence on its relationship
with Ipsen, including, the level of Ipsen’s investment in the
resources necessary to successfully commercialize cabozantinib in
Canada and other territories where it is approved; the degree of
market acceptance of CABOMETYX and the availability of coverage and
reimbursement for CABOMETYX; the risk that unanticipated
developments could adversely affect the commercialization of
CABOMETYX; Exelixis’ ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; risks
related to the potential failure of cabozantinib to demonstrate
safety and efficacy in clinical testing; Exelixis’ dependence on
its relationship with Genentech/Roche with respect to
cobimetinib and Exelixis’ ability to maintain its rights under the
collaboration; Exelixis’ dependence on third-party vendors;
Exelixis’ ability to protect the company’s intellectual property
rights; market competition; changes in economic and business
conditions, and other factors discussed under the caption “Risk
Factors” in Exelixis’ quarterly report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on November
3, 2016, and in Exelixis’ future filings with the SEC. The
forward-looking statements made in this press release speak only as
of the date of this press release. Exelixis expressly
disclaims any duty, obligation or undertaking to release publicly
any updates or revisions to any forward-looking statements
contained herein to reflect any change in Exelixis’ expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
Exelixis, the Exelixis logo, COMETRIQ and
COTELLIC are registered U.S. trademarks, and CABOMETYX is a U.S.
trademark.
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version on businesswire.com: http://www.businesswire.com/news/home/20161220006162/en/
Exelixis
ContactsFinancial Community:Susan Hubbard,
650-837-8194Executive Vice President, Public Affairs and Investor
Relationsshubbard@exelixis.comMedia:Lindsay Treadway,
650-837-7522Director, Public Affairs and Advocacy
Relationsltreadway@exelixis.comorIpsen
ContactsFinancial Community:Eugenia Litz, +44 (0)
1753 627721Vice-President, Investor
Relationseugenia.litz@ipsen.comMedia:Didier Véron, +33 (0)1
58 33 51 16Senior Vice-Preìsident, Public Affairs and
Communicationdidier.veron@ipsen.comorAdditional Ipsen ContactsFinancial
Community:Côme de La Tour du Pin, +33 (0)1 58 33 53 31Investor
Relations
Managercome.de.la.tour.du.pin@ipsen.comMedia:Brigitte Le
Guennec, +33 (0)1 58 33 51 17Corporate External Communication
Managerbrigitte.le.guennec@ipsen.com
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