Syncona Ltd
Blue Earth
portfolio expansion, strong in market performance
2 May 2018
- Syncona portfolio company Blue Earth signs exclusive worldwide
license for radio-hybrid PSMA agent, rhPSMA-7, a novel, high
potential cancer imaging agent
- The move extends Blue Earth’s leadership position in the
radiopharmaceutical space; complementary to Axumin while offering
the potential for further growth and expanded patient management
options in biochemically recurrent prostate cancer
- Continued strong performance in the commercial launch of Axumin
in the US with strong growth in unit sales in fifth and sixth
trading quarters of 3700 and 5000 respectively
- Increase in Blue Earth valuation from £123.1m to £186.8m (9.7p
per share uplift)
rhPSMA-7 license
Syncona, a leading healthcare company focused on investing in
and building global leaders in life science, is pleased to note
that its portfolio company Blue Earth Diagnostics (Blue Earth) has
signed a license for radiohybrid PSMA-targeted agent, rhPSMA-7,
from Scintomics GmbH, Germany, a
specialist in radiopharmaceuticals and radiopharmaceutical
technologies.
The move expands Blue Earth’s oncology portfolio, representing
an opportunity to extend its leading position in prostate cancer
imaging, including potential new areas of high unmet need, such as
early stage primary prostate cancer patients. PSMA agents are
expected to play an important role in prostate cancer imaging in
the future, possessing favorable clinical attributes that support
broad application, and having the potential to support both
diagnostic and therapeutic applications. If approved, these
compounds would offer the possibility of ‘precision medicine’ for
men with prostate cancer.
The license includes the exclusive worldwide rights to a high
quality, broad family of Prostate Specific Membrane Antigen
(PSMA)-targeted radiohybrid agents for prostate cancer imaging,
together with an exclusive option to explore therapeutic uses. The
license has been funded directly by Blue Earth. Syncona has not
provided further funding to the business.
Blue Earth will be responsible for the further development of
the lead imaging compound 18F-rhPSMA-7 in a diagnostic
setting. It is currently in pre-clinical development, but has
already been utilised clinically under a German compassionate use
program in men with both primary and recurrent prostate cancer.
Blue Earth will also collaborate with Scintomics to identify
optimised therapeutic candidates for future development.
Blue Earth’s proven track record, and depth of expertise in the
rapid development and global commercialisation of
radiopharmaceuticals for cancer means it is very strongly placed to
develop the compound. Having secured approval by the Food and Drug
Administration (FDA) for Axumin in the
United States of America in May
2016, 18 months ahead of plan, and by the European Medicines
Agency in May 2017, the business has
extensive commercial infrastructure and know-how which will
optimise the speed of development and enhance commercial success.
Axumin commercial launch progress and
valuation update
Syncona also announces the continued strong performance of Blue
Earth’s first prostate cancer diagnostic agent, Axumin, following
its US commercial launch in August
2016. Since this time, it has performed strongly, with the
clinical utility of fluciclovine (18F) demonstrated by
positive change in patient management data.[1] Unit sales of Axumin
in the US have steadily increased over the first six quarters since
launch,[2] and were 3700 and 5000 in the last quarter of 2017 and
the first quarter of 2018 respectively. As a result of strong
growth, Blue Earth is now profitable.
Following a review by Syncona and third parties, which took
account of Axumin’s strong in-market performance and the licensing
of rhPSMA-7, Blue Earth’s valuation as at 31
March 2018 has been increased from £123.1m to £186.8m (9.7
per share uplift)
Iraj Ali, Syncona Partner and
Director of Blue Earth, said, “We are very encouraged by the
continued strong performance of Blue Earth and the momentum of
Axumin which has now been dosed in over 15,000 patients globally
and is showing clear patient utility. This performance demonstrates
the success of the Syncona strategy to take a hands-on approach to
developing high quality companies taking products all the way to
market.
“The move to secure rhPSMA-7, a novel, high-potential PSMA agent
with unique attributes, represents an exciting opportunity. We
believe this is one of the leading assets in the space which gives
Blue Earth the ability to extend its position in prostate cancer
diagnostics.”
Jonathan Allis, D. Phil., CEO of
Blue Earth Diagnostics, said, “This is a fantastic move for Blue
Earth and a natural extension of the portfolio,
as18F-rhPSMA-7 and Axumin have unique mechanisms that we
believe may ultimately allow physicians and their patients to
select the diagnostic agent most appropriate to each specific
clinical situation. PSMA agents are innovative compounds which have
potential utility in prostate cancer imaging and therapy. We expect
PSMA to play an important role in patient management in the
future.”
Syncona will report full year results on 14 June 2018.
[ENDS]
Enquiries
Syncona Ltd
Siobhan Weaver
Tel: +44 (0) 20 7611 2031
+44 (0) 7921 822 994
Tulchan Communications
Martin Robinson
Lisa Jarrett-Kerr
Tel: +44 (0) 207 353 4200
Copies of this press release and other corporate
information can be found on the company website at:
www.synconaltd.com
This announcement includes
information that is inside information as defined in Article 7 of
the Market Abuse Regulation (EU) No.596/2014. The person
responsible for arranging for the release of this announcement on
behalf of Syncona Ltd is [John
Bradshaw, Chief Financial Officer], SIML.
Forward-looking statements – this
announcement contains certain forward-looking statements with
respect to the portfolio of investments of Syncona Ltd. These
statements and forecasts involve risk and uncertainty because they
relate to events and depend upon circumstances that may or may not
occur in the future. There are a number of factors that could cause
actual results or developments to differ materially from those
expressed or implied by these forward-looking statements and
forecasts. Nothing in this announcement should be construed as a
profit forecast.
About Syncona:
Syncona is a leading FTSE250 healthcare company focused on
investing in and building global leaders in life science. Our
vision is to deliver transformational treatments to patients in
truly innovative areas of healthcare while generating superior
returns for shareholders. Our current investment portfolio consists
of seven high quality companies in life science and a leading range
of fund investments.
We seek to partner with the best, brightest and most ambitious
minds in science to build globally competitive businesses. We are
established leaders in gene therapy, cell therapy and advanced
diagnostics, and focus on delivering dramatic efficacy for patients
in areas of high unmet need.
Our fund investments represent a productively deployed evergreen
funding base which enables us to take a long term approach to
investing in life sciences as we target the best new opportunities
and support our existing portfolio companies to grow and
succeed.
Syncona is aligned with two of the premium charitable funders in
UK science, the Wellcome Trust, original founder of Syncona, and
Cancer Research UK, both of which are significant shareholders in
our business. We make a donation of 0.3% of Net Asset Value
to a range of charities each year.
About Blue Earth Diagnostics
Blue Earth Diagnostics is a molecular imaging diagnostics
company focused on the development and commercialisation of novel
PET imaging agents to inform clinical management and guide care for
cancer patients in areas of unmet medical need. Formed in 2014,
Blue Earth Diagnostics is led by recognised experts in the clinical
development and commercialisation of innovative nuclear medicine
products.
Blue Earth Diagnostics’ first approved and commercially
available product is Axumin® (fluciclovine
18F), a novel molecular imaging agent approved in
the United States and Europe for use in PET imaging to detect and
localize prostate cancer in men experiencing suspected biochemical
recurrence. Blue Earth Diagnostics is funded by Syncona Limited, an
investment company listed on the London Stock Exchange (LON: SYNC).
For more information, visit: www.blueearthdx.com.
About rhPSMA-7
rhPSMA-7 was invented at the Technical University of
Munich, Germany, where it has been
utilized clinically in the diagnostic imaging of men with both
primary and recurrent prostate cancer. 18F-rhPSMA-7
consists of a prostate-specific membrane antigen (PSMA) receptor
ligand, which attaches to and is internalized by prostate cancer
cells, and is labeled with the 18F radioisotope for PET imaging.
rhPSMA-7 and other “rh” compounds, can also be labeled with the
radioisotope 177Lu for therapeutic use.
Scintomics’ unique theranostic “rh” technology allows for the
efficient labelling of PSMA-targeted agents with imaging
radioisotopes, such as 18F or 68Ga, or therapeutic radioisotopes
such as 177Lu. Depending on the type of radioisotope attached, the
resulting radiopharmaceutical may be used either as an imaging
agent to locate prostate cancer cells in the body or as a
therapeutic which targets cancer cells with high energy radiation.
These innovative compounds offer the possibility of “precision
medicine” for men with prostate cancer.
About Axumin® (fluciclovine
(18F))
Axumin (fluciclovine (18F)) injection is a novel
product indicated for use in positron emission tomography (PET)
imaging to identify suspected sites of prostate cancer recurrence
in men. Recurrence of prostate cancer is suspected by an increase
in prostate specific antigen (PSA) levels following initial
therapy. PET imaging with Axumin may identify the location and
extent of such recurrence.
Axumin was developed to enable visualisation of the increased
amino acid transport that occurs in many cancers, including
prostate cancer. It consists of a synthetic amino acid that is
preferentially taken up by prostate cancer cells compared with
surrounding normal tissues, and is labeled with the radioisotope
18F for PET imaging.
Fluciclovine 18F was invented at Emory University in Atlanta, Ga. USA, with much of the fundamental
clinical development work carried out by physicians at Emory
University’s Department of Radiology and Imaging Sciences.
Axumin is the first product commercialised by Blue Earth
Diagnostics. The molecule is being investigated by Blue Earth
Diagnostics for other potential cancer indications, such as
glioma.
[1] FALCON Change in Management study demonstrated that 61.2% of
patients had their treatment path changed following an Axumin
scan.
[2] First 6 quarters of units sold respectively are: 200, 800,
1800, 2500, 3700 and 5000 to March 31
2018.