2009-11-24 07:08:01 -
London, November , 24, 2009
* CP-4126 is a novel, lipid-conjugated form of gemcitabine designed
by Clavis Pharma to improve treatment outcomes in patients with
pancreatic and other solid tumours
* Clavis Pharma to receive up to $380 million in staged payments,
including a $15 million signing fee, and tiered double-digit
royalties on sales
* Clovis Oncology fully responsible for the clinical development of
CP-4126
* Clovis Oncology to commercialise CP-4126 in the United States,
Europe, Canada, Central and South America
* Clavis Pharma retains an option to co-promote and share profits in
Europe
* Companies to collaborate on development of a companion diagnostic
test to identify patients likely to benefit most from CP-4126
treatment
Oslo, Norway, and Boulder, CO, USA. 24 November 2009
Clavis Pharma ASA (OSE: CLAVIS), the clinical stage oncology
focused pharmaceutical company, and Clovis Oncology, Inc., the
newly formed oncology company led by former Pharmion Corporation
executives, announced today an agreement for the further
development and commercialisation of the Clavis Pharma drug
candidate, CP-4126, currently in Phase II development in pancreatic
cancer. CP-4126 is a novel, patented, lipid-conjugated form of the
anti-cancer drug gemcitabine that has the potential to improve
treatment outcomes in a large subset of patients with pancreatic
cancer and certain other solid tumours.
Under the terms of the agreement, Clovis Oncology will take over
responsibility for product development and manufacturing of
CP-4126, and for filing of marketing approvals in the United
States, Europe, Canada, Central and South America and will be
responsible for commercialisation in those territories. Clavis
Pharma retains the option to co-develop and co-promote CP-4126 in
Europe.
Clavis Pharma will receive an upfront cash payment of $15 million
from Clovis Oncology and will be eligible to receive further
payments totalling up to $365 million on Clovis Oncology's
successful attainment of development, regulatory and sales
milestones. Clavis Pharma will receive tiered double-digit
royalties on all product sales in the licensed territories.
Under the terms of the agreement, the Companies are amending the
design of the ongoing Phase II study in pancreatic cancer to enroll
approximately 250 patients in an international, randomised,
comparative trial of CP-4126 versus gemcitabine with overall
survival as a primary endpoint.
In addition to evaluating survival in all patients, study results
will be analysed based on patient classification in relation to
their levels of expression of the hENT1 pancreatic tumour protein.
The hENT1 (human equilibrative nucleoside transporter 1) cell
membrane transporter is believed to be critical for gemcitabine
entry into tumor cells, whereas CP-4126 enters and kills tumour
cells in a hENT1-independent manner. Patients will be classified as
being hENT1-high or hENT1-low and particular emphasis will be given
to comparative overall survival in the hENT1-low population. Data
from this trial are expected in the first half of 2012.
Commenting on the deal, Geir Christian Melen, CEO of Clavis Pharma,
said:
"We are delighted to be working closely with the team at Clovis
Oncology, who will now be responsible for bringing our new and
improved anti-cancer product to market in the Americas and Europe.
They have substantial experience of successful cancer drug
development and marketing and will bring significant resources,
expertise and commitment to the conduct of the CP-4126 clinical
programme and achieving regulatory approvals in these major
markets.
"We view this agreement as an important validation of Clavis
Pharma's potential to generate multiple novel cancer drugs with
enhanced performance over existing therapeutics. This strategic
partnership for CP-4126, our second product under development, will
enable us to focus resources on developing our portfolio further
and provides great momentum towards our building a successful
oncology business."
Patrick Mahaffy, President and CEO of Clovis Oncology added:
"We are very enthusiastic about the potential for CP-4126.
Gemcitabine is the standard of care in pancreatic cancer, but
accumulating data suggest that a significant percentage of patients
may derive little benefit from its use because of low expression of
the hENT1 transporter that allows gemcitabine to enter tumour
cells. In vitro data demonstrate that CP-4126 overcomes this
resistance mechanism. We now have the opportunity to show that a
cytotoxic, which remains the backbone of cancer therapy, can become
an effective, targeted therapy in this large subset of patients.
Our development philosophy is to focus on providing meaningful
benefit to subset patient populations with unmet medical need and
we believe CP-4126 will do exactly that."
Confirmation of the hENT1 hypothesis offers a promising and novel
enhancement to current treatments for patients with pancreatic
cancer," said Daniel D. Von Hoff, M.D., Physician in Chief,
Translational Genomics Research Institute and Clinical Professor of
Medicine at the University of Arizona. "This is an exciting new
concept that may enable both superior targeting of an established
drug, gemcitabine, as well as providing a new, rational treatment
option, CP-4126, to hENT1-low patients."
About CP-4126
CP-4126 is a new, patented, cytotoxic drug, consisting of an
anti-cancer nucleoside analogue coupled to a lipid chain. It was
generated using Clavis Pharma's proprietary Lipid Vector Technology
and has been designed to improve the therapeutic profile of
gemcitabine (Gemzar®) so that it can enter cancer cells without
requiring uptake by a specific transporter molecule. Gemcitabine is
the current standard treatment for advanced pancreatic cancer and
intravenous CP-4126 is currently being evaluated in a Phase II
clinical trial in this indication. Other potential indications for
CP-4126 are those currently treated with gemcitabine, including
lung, breast, ovarian and bladder cancer. An oral formulation of
CP-4126 is currently in a Phase I clinical trial in pancreatic
cancer.
It is estimated that pancreatic tumours in up to two-thirds of
patients have limited cellular uptake of gemcitabine, due to
deficient expression of the transport protein, hENT1 on the tumour
cell surface. In a number of independent studies of patients with
pancreatic cancer, a low level of hENT1 has been correlated with
poor outcomes after gemcitabine therapy. Published research has
also suggested that hENT1 levels predict outcome in lung cancer
patients treated with gemcitabine-containing chemotherapy. Due to
its different molecular design, CP-4126 is absorbed by cancer cells
independent of hENT1 levels, raising the prospect of a major
improvement in drug efficacy in the significant and potentially
poorly-served group of hENT1-low patients.
CP-4126 is currently being compared to gemcitabine in an
international, randomised, controlled Phase II trial in patients
newly diagnosed with advanced pancreatic cancer. Originally
designed by Clavis Pharma as a 120 patient study, Clovis Oncology
is altering the study design to increase enrolment to approximately
250 patients, randomising between gemcitabine and CP-4126, and
will use overall survival as its primary endpoint. Expression of
hENT1 in tumour tissue will be measured during the trial and
patients categorised into hENT1-high or hENT1-low groups prior to
final analysis, with primary emphasis on comparative overall
survival in the hENT1-low population.
This study is a well-powered, prospective test of two hypotheses:
(1) that low pancreatic tumour hENT1 expression is associated with
poor outcome after gemcitabine therapy, and (2) that CP-4126 will
have superior efficacy in hENT1-low patients compared with
gemcitabine. Data from this trial are expected in the first half
of 2012. As a key element of the clinical programme, a validated
companion molecular diagnostic test to reliably determine
pancreatic tumour hENT1 expression and enable patient
stratification will be developed by the two companies.
CP-4126 has been granted orphan drug status for the treatment of
pancreatic cancer in the European Union and is currently being
considered for a similar designation by the FDA in the US.
About Pancreatic Cancer
Pancreatic cancer presents a major unmet medical need due to the
poor survival outcomes and limited number of therapeutic options
available to patients. Approximately 37,000 new cases of
pancreatic cancer were recorded in the US in 2007. The 1-year and
5-year overall survival rates are estimated at 23% and 4%,
respectively. The majority of pancreatic cancer patients are
diagnosed with locally advanced (unresectable) or metastatic
disease. Median overall survival in these advanced patients is
4-10 months.
For Further Information Contact:
For Clavis Pharma For Clovis Oncology
Geir Christian Melen Anna Sussman / Breanna
Chief Executive Officer Burkart
+47 24 11 09 50 Scout Investor Relations
+47 91 30 29 65 (mob) +1 303 907 5358 or +1 303
geir.christian.melen@clavispharma.com 907 5162
anna@scoutir.com or
Gunnar Manum breanna@scoutir.com
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk
Investor Meeting and Conference Call
A meeting for investors, analysts and press will take place in Oslo
at 10.00 CET today, 24 November 2009 at Hotel Continental,
Stortingsgaten 24, Oslo, Norway.
An international conference call will take place at 12:00 CET -
details are given below.
Access the audio for the meeting by dialling the following and
quoting confirmation code 4956336:
+47 2415 9758 (from Norway)
+44 (0)20 7806 1966 (International)
For visuals click on the direct access link:
www.livemeeting.com/cc/premconfeurope/join?id=4956336&role=atten ..
Participating in the Meeting and Conference Call will be:
Geir Christian Melen, CEO, Clavis Pharma ASA
Keith McCullagh, Chairman, Clavis Pharma ASA
Patrick Mahaffy. President & CEO, Clovis Oncology Inc.
The presentation will be made available on www.clavispharma.com in
the Investors section from 09:00 CET. A webcast of the conference
call will be available from Clavis Pharma's website,
www.clavispharma.com for a period of 60 days.
About Clovis Oncology
Clovis Oncology is focused on acquiring, developing and
commercializing innovative anti-cancer agents in the US, Europe and
additional international markets. The company was founded in 2009
by former executives of Pharmion Corporation, a leading global
oncology company, which was acquired by Celgene Corporation in 2008
for $2.9 billion.
Earlier this year Clovis Oncology secured $146 million in start-up
financing from leading international healthcare-focused investors,
including Domain Associates, New Enterprise Associates (NEA),
Versant Ventures, Aberdare Ventures, Abingworth, Frazier Healthcare
Ventures, ProQuest Investments and the Company's management team.
While at Pharmion, the Clovis Oncology management team increased
revenues from zero to approximately $300 million, gained regulatory
approval for and launched the world's first epigenetic cancer drug,
Vidaza® (azacitidine), a DNA demethylating agent for the treatment
of Myelodysplastic Syndromes in the US and Europe, and gained
regulatory approval for Thalidomide for the treatment of multiple
myeloma in Europe and other international markets. Pharmion also
had a number of other oncology compounds under development,
including amrubicin for lung cancer.
The Company is headquartered in Boulder, Colorado, and has
additional offices in San Francisco, CA and London, UK.
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology focused
pharmaceutical company based in Oslo, Norway with a portfolio of
novel anti-cancer drugs in development. These potential breakthough
products are New Chemical Entities (NCEs) made using Clavis
Pharma's Lipid Vector Technology (LVT) chemistry to introduce new
properties to already established, commercially successful drugs.
Data generated suggests the resulting patentable NCEs offer
improved efficacy and reduced side effects through enhanced
pharmacokinetic properties, greater tissue penetration, altered
metabolism and, in certain cases, additional modes of action.
Clavis Pharma's has several drug candidates in formal development
studies:
* Elacytarabine, an improved form of Ara-C, a leukaemia drug -
about to commence a Phase III randomized, controlled
registration study in late-stage acute myeloid leukaemia;
* Intravenous CP-4126, an improved version of gemcitabine -
currently in a Phase II comparative study with gemcitabine for
the treatment of pancreatic cancer;.
* Oral CP-4126 - currently being evaluated in an escalating dose
Phase I study in solid tumours; and
* CP-4200, an azacitidine derivative - in preclinical development
for myelodysplastic syndrome (MDS), often a precursor to
myeloma or leukaemia.
Clavis Pharma intends to commercialise its products through
strategic alliances and partnerships with experienced oncology
businesses and, where and when commercially appropriate, by
establishing its own sales and marketing capabilities.
The shares of Clavis Pharma ASA are listed on the Oslo Stock
Exchange (ticker: CLAVIS). The largest shareholders of Clavis
Pharma include Neomed, Medical Venture Management and Braganza.
Disclaimer
The information contained herein shall not constitute an offer to
sell or the solicitation of an offer to buy, nor shall there be any
sale of the securities referred to herein in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration, exemption from registration or qualification under
the securities laws of any such jurisdiction.
This news release contains forward-looking statements and forecasts
based on uncertainty, since they relate to events and depend on
circumstances that will occur in the future and which, by their
nature, will have an impact on results of operations and the
financial condition of Clavis Pharma. There are a number of factors
that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements. Theses factors include, among other things, risks
associated with technological development, the risk that research &
development will not yield new products that achieve commercial
success, the impact of competition, the ability to close viable and
profitable business deals, the risk of non-approval of patents not
yet granted and difficulties of obtaining relevant governmental
approvals for new products.
No expressed or implied representations or warranties are given
concerning Clavis Pharma or the accuracy or completeness of the
information or projections provided herein, and no claims shall be
made by the recipient hereof by virtue of this Information
Memorandum or the information or projections contained herein. Any
representations or warranties made to an investor in Clavis Pharma
will be subject to separate sale and purchase agreements to be
negotiated between the parties. Clavis Pharma is a registered
trademark of Clavis Pharma ASA.
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