Clovis Oncology (NASDAQ:CLVS) announced today that it has acquired EOS
(Ethical Oncology Science) S.p.A., a privately-held Italian
biopharmaceutical company developing a novel targeted therapy to treat
cancer. EOS owns the exclusive global (excluding China) development and
commercialization rights for lucitanib, an oral, dual-selective
inhibitor of the tyrosine kinase activity of fibroblast growth factor
(FGF) receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor
(VEGF) receptors 1-3 (VEGFR1-3). In 2012, EOS sublicensed lucitanib
rights in Europe and the rest-of-world (ROW) markets, excluding China,
to Les Laboratoires Servier (Servier). Clovis holds exclusive rights for
lucitanib in the U.S. and Japan, and will collaborate with Servier on
the global clinical development of lucitanib.
In an ongoing Phase I/IIa clinical study, lucitanib has demonstrated
multiple objective responses in FGF-aberrant breast cancer patients, and
objective responses have also been observed in patients with tumors
often sensitive to angiogenesis inhibitors, such as renal cell and
thyroid cancer. FGF-aberrations include amplification of the FGFR1 gene
as well as amplification of a region of chromosome 11q that contains
several FGF ligands, specifically FGF-3, -4 and -19.The initial
development program for lucitanib will focus on the approximately 25
percent of women with breast cancer who have FGF-aberrant disease.
FGFs and VEGFs each play a role in tumor growth and angiogenesis and
both are validated targets in oncology. Clovis believes lucitanib is
unique in its pattern of clinical inhibition of both FGFR and VEGFR
tyrosine kinases. As a result, lucitanib has potential to provide
benefit to cancer patients by simultaneously targeting two relevant
tumor growth pathways in selected patients identified by FGF
aberrations. In particular, Clovis believes FGF-aberrant tumors are
driven by both FGF and VEGF pathways, and that by inhibiting both,
lucitanib can provide more meaningful benefit than single pathway
inhibitors.
“We have been interested in lucitanib for some time and are pleased to
have acquired EOS to add this program to our portfolio,” said Patrick J.
Mahaffy, Clovis Oncology’s president and CEO. “It is highly consistent
with our focus on developing targeted therapies that provide meaningful
benefit to specific patient populations. We are extremely encouraged
with lucitanib’s 50 percent response rate seen to date in heavily
pre-treated targeted patients and we intend to develop it aggressively,
in collaboration with our partner Servier.”
Lucitanib Clinical Development
The first clinical trial of lucitanib was initiated in Europe in July
2010 and is currently ongoing at Institute Gustave-Roussy in Paris with
Professor Jean-Charles Soria and at Vall d’Hebron Institute of Oncology
in Barcelona with Professor Josep Tabernero. This trial is an
open-label, dose-escalation, Phase I/IIa study to determine the maximum
tolerated dose (MTD), recommended Phase II dose, efficacy,
pharmacokinetics and pharmacodynamics of lucitanib in adult patients
with advanced solid tumors.
Doses evaluated in the study ranged from 5mg to 30mg given once per day.
Twenty milligrams once per day was identified as the MTD. Overall, the
toxicity profile observed to date is consistent with what was expected
from preclinical studies and with VEGF inhibitors generally, with
hypertension, proteinuria, asthenia and subclinical hypothyroidism being
commonly observed. Other common treatment-related adverse events include
gastrointestinal symptoms such as diarrhea, abdominal pain, nausea and
vomiting.
Subsequent to MTD identification, a dose expansion phase was initiated
in defined populations expected to derive benefit from lucitanib, and
initial data show encouraging activity in patients who were either
FGF-aberrant or angiogenesis inhibitor-sensitive. Six of 12 evaluable
FGF-aberrant breast cancer patients achieved RECIST partial responses
and the median progression-free survival was 9.4 months in these 12
patients. These patients were heavily pre-treated, with at least three
or as many as 14 prior treatment regimens. Importantly, two of the
responders had previously failed to achieve a response with a selective
FGFR inhibitor. Responses were also observed in other tumor types.
A broad Phase II program is being initiated to explore lucitanib in
multiple indications including a U.S. study in patients with
treatment-refractory FGF-aberrant breast cancer and a global study in
patients with metastatic squamous NSCLC. In parallel with these planned
Clovis-sponsored studies, a Servier-sponsored Phase II study of
lucitanib monotherapy in patients with advanced breast cancer will begin
enrolling this month. This ex-US study is expected to enroll
approximately 120 patients and will seek to determine whether the
activity of lucitanib is limited to a defined population of breast
cancer tumors with FGF-aberrations or if a more broadly defined
population may benefit as well.
If these Phase II monotherapy studies in breast cancer are successfully
completed, Clovis and Servier intend to pursue future development of
lucitanib as monotherapy and/or in combination with estrogen
antagonists. Other potential indications that may be considered for
development include squamous NSCLC, bladder, head and neck cancer, and
other solid tumors with FGF-aberrancies.
Clinical development of lucitanib in patients with FGF-aberrant tumors
will be accompanied by development of a diagnostic test designed to
identify a selected patient population most likely to benefit.
Composition of matter patent protection for lucitanib and a group of
structurally related compounds is issued in the United States and is
pending in Japan. In the United States, the composition of matter patent
will expire in 2030.
Financial Terms
Under the terms of the deal, Clovis is acquiring EOS for an up-front
payment of $200 million, which includes $190 million in Clovis common
stock (3,713,731 shares) and $10 million in cash. Clovis will pay an
additional $65 million in cash upon the initial approval of lucitanib by
the U.S. Food and Drug Association (FDA). Pursuant to the license
agreement with Servier, Clovis is entitled to receive up to €350 million
(approximately $470 million) upon the achievement of development and
commercial milestones, as well as royalties on sales of lucitanib in the
Servier territories. Clovis will also pay the EOS shareholders up to an
additional €115 million in cash (approximately $155 million) upon the
receipt by Clovis of certain of the milestone payments pursuant to the
Servier license agreement.
Clovis and Servier will collaborate on the development of lucitanib
pursuant to a mutually-agreed upon global development plan. Servier is
responsible for the initial €80 million (approximately $108 million) of
costs under the global development plan and costs above €80 million will
be shared equally between the companies.
Clovis intends to host an R&D Day and webcast for institutional
investors and analysts to detail its clinical development programs for
CO-1686, lucitanib and rucaparib next January in New York City.
Slide Presentation and Conference Call Details
Clovis will post a lucitanib slide presentation on the Company’s website
at www.clovisoncology.com
which can be accessed via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-presentations.
Clovis will also hold a conference call to discuss this announcement
Wednesday morning, November 20, 2013 at 8:30 a.m. ET. The conference
call and slide presentation will be simultaneously webcast on the
Company’s web site and archived for future review. Dial-in numbers for
the conference call are as follows: US participants 877 703 6110,
International participants 857 244 7309, passcode: 12815948.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops diagnostic tools that direct a
compound in development to the population that is most likely to benefit
from its use. Clovis Oncology is headquartered in Boulder, Colorado, and
has additional offices in San Francisco, California and Cambridge, UK.
About Servier
Servier is a privately-run French research-based pharmaceutical company.
Current therapeutic domains for Servier medicines are cardiovascular,
metabolic, neurological, psychiatric and bone and joint diseases, as
well as oncology. Servier is established in 140 countries worldwide with
over 20,000 employees and a 2012 turnover of €3.9
billion. Servier invests 25% of its turnover in R&D. More information is
available at: www.servier.com
To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve substantial risks and uncertainties
that could cause our clinical development programs, future results,
performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in our
clinical development programs, including the uncertainties inherent in
the initiation of future clinical trials, availability of data from
ongoing clinical trials, expectations for regulatory approvals, and
other matters that could affect the availability or commercial potential
of the drug product candidates because the relate to events, competitive
dynamics, and industry change and depend on economic circumstances that
may or may not occur in the future or may occur on longer or shorter
timelines than anticipated. Clovis Oncology does not undertake to update
or revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well as
risks relating to the business of the company in general, see Clovis
Oncology’s Annual Report on Form 10-K for the year ended December 31,
2012 and its other reports filed with the Securities and Exchange
Commission.
Copyright Business Wire 2013