THIS ANNOUNCEMENT CONTAINS INSIDE
INFORMATION FOR THE PURPOSE OF ARTICLE 7 OF THE MARKET ABUSE
REGULATION (EU) NO.596/2014 AND IS NOT FOR RELEASE, PUBLICATION OR
DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO
OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A
VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH
JURISDICTION
Syncona
Blue Earth
Diagnostics achieves positive CHMP opinion on Axumin
24 March 2017
- Axumin receives positive opinion from the European Medicines
Agency’s Committee for Medicinal Products for Human Use, a key
milestone in securing European approval
- Positive progress in the USA
market following the commencement of sales of Axumin in
August 2016
- Syncona’s investment in Blue Earth Diagnostics written up from
£83.5 million to £109.01 million adding £25.5 million
(3.9p per share) to Syncona Ltd’s NAV
Syncona Ltd (“Syncona”), is pleased to note the announcement by
its portfolio company Blue Earth Diagnostics Limited (“Blue Earth”)
that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) has issued a positive opinion
recommending that Axumin be granted marketing authorisation in the
European Union. Syncona holds a 90 per cent interest in the share
capital of Blue Earth.
The recommendation is for Axumin (fluciclovine 18F)
use in Positron Emission Tomography (PET) imaging to detect
recurrence of prostate cancer in adult men with a suspected
recurrence based on elevated blood prostate specific antigen (PSA)
levels after primary curative treatment. This is an area of
significant unmet need.
A CHMP positive opinion is a key step in achieving approval to
sell Axumin in the European Union. The opinion on Axumin will now
be reviewed by the European Commission, which has the authority to
approve medicines for the European Union. The final decision is
expected in the coming months and would be applicable to all
European Union member states as well as in Iceland, Liechtenstein and Norway.
Axumin was approved by the Food and Drug Administration (FDA) in
the United States of America in
May 2016, and sales commenced in
August 2016.Since this time the business has continued to make good
strategic and commercial progress in the region.
The positive opinion of the CHMP, coupled with good progress in
the USA, has resulted in Syncona’s
investment in Blue Earth being written up to £109.01
million, a £25.5 million (3.9p per share) uplift to the last
published valuation of £83.5 million.
Syncona Investment Management partner and Blue Earth director
Iraj Ali, said, “In the three years
since formation Blue Earth has successfully delivered to the US
market a product with the potential to transform how patients with
recurrent prostate cancer are treated. It is now a significant step
closer to doing the same in Europe, which is testament to the efficacy of
the product, hard work of the team and the strength of Syncona’s
long term partnership model.”
Blue Earth chief executive, Jonathan
Allis, said, “The CHMP’s positive recommendation for Axumin
is a major advance for Blue Earth. We now look forward to working
with our commercial manufacturing and distribution associates to be
ready to make Axumin widely available to doctors and their patients
across Europe.”
[ENDS]
Enquiries
Syncona Ltd
Siobhan Weaver
Tel: +44 (0) 20 7611 2031
+44 (0) 7921 822 994
J.P. Morgan Cazenove
William Simmonds
James Mitford
Tel: +44 (0) 207 742 4000
Tulchan Communications
Doug Campbell
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
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.
Notes to Editors:
About Syncona
Syncona is a leading life science investment company seeking to
deliver transformational treatments to patients in innovative areas
of healthcare while generating attractive returns for
shareholders.
We seek to partner with the best, brightest and most ambitious
minds in science, providing them with the capabilities and
investment they need to transform their ideas into commercial
businesses and patient treatments. We focus on technologies with
the potential to deliver dramatic results in areas of high unmet
medical need.
Our hybrid structure combines our life science investment team
with a market leading fund of fund portfolio which generates
attractive returns while providing a source of capital to invest in
the best life science opportunities over time. This capital
efficient model enables us to take a long term approach as we
support our portfolio companies to grow and succeed. Syncona
Investment Management Limited is Syncona’s management
subsidiary.
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
Syncona. 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 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 AxuminTM (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.
About the Committee for Medicinal
Products for Human Use (CHMP)
CHMP is the European Medicines Agency's (EMA) committee
responsible for human medicines.
The CHMP plays a vital role in the authorisation of
medicines in the European Union (EU). In the centralised
procedure, the CHMP is responsible for:
- conducting the initial assessment of EU-wide marketing
authorisation applications;
- assessing modifications or extensions (‘variations’) to an
existing marketing authorisation;
- considering the recommendations of the the
Agency's Pharmacovigilance Risk Assessment Committee on
the safety of medicines on the market and when necessary,
recommending to the European Commission changes to a medicine’s
marketing authorisation, or its suspension or withdrawal from the
market.
More information about the CHMP can be found here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp
More information about the EMA process to approve a product can
be found here:
https://ec.europa.eu/health/authorisation-procedures-centralised_en
1 At exchange rates on 23
March 2017