Clovis Oncology Acquires EOS (Ethical Oncology Science) S.p.A. to Gain Rights to Lucitanib, a Unique Dual-Selective Phase II

  Clovis Oncology Acquires EOS (Ethical Oncology Science) S.p.A. to Gain
  Rights to Lucitanib, a Unique Dual-Selective Phase II FGFR/VEGFR Inhibitor

  *50 percent response rate seen in heavily-pretreated FGF-aberrant breast
    cancer patients
  *Activity observed in other solid tumors with FGFR/VEGFR pathway activation
  *Servier partnership to fund majority of lucitanib R&D expenditures over
    the next 2-3 years
  *Adds third compound to portfolio with focus on patient selection and
    companion diagnostics

Business Wire

BOULDER, Colo. -- November 19, 2013

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

Servieris a privately-run French research-based pharmaceutical company.
Current therapeutic domains forServiermedicines are cardiovascular,
metabolic, neurological, psychiatric and bone and joint diseases, as well as
oncology.Servieris established in 140 countries worldwide with over 20,000
employees and a 2012 turnover of €3.9 billion.Servierinvests 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 December31, 2012 and its other reports filed
with the Securities and Exchange Commission.

Contact:

Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
 
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