Clavis Pharma and Clovis Oncology Extend Partnership and Sign New $205 Million Deal for the Development and Commercialisation of Anti-Cancer Agent CP-4126 in Asia and Rest of the World
(Thomson Reuters ONE) -
* New deal expands existing relationship to include global rights to CP-4126
* Clavis Pharma to receive up to $205 million in additional staged payments,
including a $10 million signing fee, and tiered double-digit royalties on
sales
Oslo, Norway, and Boulder, CO, USA. November 11, 2010
Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug discovery and
development company, and Clovis Oncology, Inc., announced today a new agreement
for the further development and commercialisation of CP-4126 (also known as CO-
101), which is 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 new agreement, Clavis Pharma will receive an upfront cash
payment of $10 million from Clovis Oncology for the expansion of the agreement
to include global rights and will be eligible to receive further payments
totalling $30 million for the successful attainment of development and
regulatory milestones in Asia and up to $165 million in sales milestones. This
is in addition to the upfront and milestone payments already agreed to in the
original license agreement. Clavis Pharma will receive tiered double-digit
royalties on all product sales globally.
This new deal expands the existing agreement between Clavis Pharma and Clovis
Oncology for the development and commercialisation of CP-4126 in the Americas
and Europe, which was signed in November 2009 (up to $380 million in milestone
payments plus royalties on sales).
As in the previous agreement, in collaboration with Clavis Pharma, Clovis
Oncology will be responsible for the clinical development and registration
filings in Asia and the rest of the world. Clavis Pharma will continue to fund
some development activities.
Clovis Oncology will now be responsible for the commercialisation of CP-4126
globally, while Clavis Pharma retains an option to co-promote in Europe.
Commenting on the deal, Olav Hellebø, CEO of Clavis Pharma, said:
"We are delighted to be extending our partnership with Clovis Oncology to Asia
for the development and commercialisation of our new and improved anti-cancer
product CP-4126. For Clavis Pharma, this new agreement represents an important
step forward to ensure that CP-4126 will be available to patients globally in
the shortest possible time. Clovis Oncology has the requisite expertise in
development, regulatory affairs and product commercialisation on a global level
to bring CP-4126 to market and we have already established a strong and
productive working relationship."
Patrick Mahaffy, President and CEO of Clovis Oncology added:
"We are very pleased to extend our relationship with Clavis to include global
rights to CO-101. We have established a strong collaboration with Clavis and
believe this allows us to develop the drug consistently in Japan, China, and
additional Asian and international markets. We are already planning the
development of our preclinical lung cancer compound in Asia so this expansion of
our agreement with Clavis is also highly complementary to our global development
and commercialisation strategy."
About CP-4126 (also known as CO-101) and Pancreatic Cancer
CP-4126 is a novel, patented, lipid-conjugated derivative of the anti-cancer
drug gemcitabine, developed using Clavis' lipid vector technology (LVT). It is
designed to improve upon the efficacy of gemcitabine by enabling the drug to
enter cancer cells without requiring the presence of transporter proteins. The
entry of gemcitabine into tumour cells has been shown to be dependent upon the
expression of specific membrane transporter proteins, particularly hENT1 (human
equilibrative nucleoside transporter 1). Gemcitabine is the current standard
treatment for advanced pancreatic cancer, and is also used in combination with
other chemotherapy agents for the treatment of other cancers, including non-
small cell lung, ovarian, gastro-intestinal and breast cancer.
It is estimated that due to deficient expression of the transport protein,
hENT1, at least 50% of patients with pancreatic tumours have limited cellular
uptake of gemcitabine and therefore respond poorly to treatment. This has been
confirmed in several studies of patients with pancreatic cancer where a low
level of the hENT1 biomarker has been correlated with poor outcomes after
gemcitabine therapy and high levels of hENT1 correlated with significant better
survival outcomes. Published research has also suggested that hENT1 levels
correlate with outcomes 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, which may lead to an
improvement in efficacy in the poorly-served group of hENT1-low patients.
Pancreatic cancer presents a major unmet medical need due to the poor survival
outcomes and limited number of therapeutic options available to patients.
Approximately 43,000 new cases of pancreatic cancer will occur in the US in
2010, with a similar number occurring in Europe. 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 unresectable locally advanced or
metastatic disease. Median overall survival in these advanced patients is 4-10
months. CP-4126 has been granted orphan drug designations for the treatment of
pancreatic cancer in the US and EU.
Clinical Development of CP-4126
Following the phase I study performed by Clavis Pharma, Clovis Oncology
initiated an international, randomised, Phase II trial of CP-4126 versus
gemcitabine in mid-2010, with overall survival as a primary endpoint. The trial
is progressing as planned with clinical sites opening and patient enrolment
ongoing in Europe, the US, South America and Australia. Results of this trial
are anticipated in 2012. While the trial is evaluating CP-4126 in patients who
express either high or low levels of the hENT1 biomarker, the primary analysis
will be overall survival in the hENT1-low population. If successful, Clovis
Oncology anticipates filing for marketing approval in the United States and in
the EU by year end 2012.
A new clinical trial with CP-4126 in second-line pancreatic cancer patients will
be initiated by the end of this year, and a retrospective observational study to
define the criteria for determining low/high hENT1 expression levels will begin
shortly as well.
Clovis Oncology has signed an agreement with Ventana Medical Inc., a subsidiary
of Roche, to develop and commercialise the novel hENT1 biomarker diagnostic
method as a companion diagnostic for CP-4126.
For Further Information Contact:
For Clavis Pharma For Clovis Oncology
Olav Hellebø Anna Sussman / Breanna Burkart
Chief Executive Officer Scout Investor Relations
+47 24 11 09 50 +1 303 907 5358 or +1 303 907 5162
olav.hellebo(at)clavispharma.com anna(at)scoutir.com or
breanna(at)scoutir.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum(at)clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma(at)citigatedr.co.uk
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 intends to target development
programs at specific subsets of cancer populations, and will simultaneously
develop diagnostic tools that direct a compound in development to the population
that is most likely to benefit from its use. The Company is currently
developing CO-101 which is in Phase 2 development for the treatment of
pancreatic cancer. The Company is collaborating with Ventana Medical Systems to
develop a hENT1 assay to identify patients likely to benefit from CO-101. The
Company is also developing an epidermal growth factor receptor (EGFR) mutant-
selective inhibitor (EMSI) which is currently in pre-clinical development for
non-small cell lung cancer (NSCLC) patients who express the T790M mutation along
with a companion diagnostic to identify patients with the T790M mutation.
The Company is headquartered in Boulder, Colorado, and has additional offices in
San Francisco and Cambridge, England.
For more information about Clovis Oncology, please visit the Company's website
at www.clovisoncology.com
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology discovery and drug development
company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in
development. These patented New Chemical Entities (NCEs) are novel, improved
versions of commercially successful drugs, made using Clavis Pharma's Lipid
Vector Technology (LVT) chemistry. Data generated suggests these potential
breakthrough products may 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, a leukaemia drug, currently in a randomized, controlled Phase
III study in late-stage acute myeloid leukaemia;
* CP-4126, is currently in a Phase II comparative study with gemcitabine for
the treatment of pancreatic cancer;
* CP-4200, an azacitidine derivative, in preclinical development for
myelodysplastic syndrome (MDS), a disease that is often a precursor to
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. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has
an option to co-promote CP-4126 in Europe.
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.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1461277]
Clavis Pharma partnering deal:
http://hugin.info/136972/R/1461277/400467.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Clavis Pharma ASA via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 11.11.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 48642
Anzahl Zeichen: 14451
contact information:
Town:
Oslo
Kategorie:
Business News
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