Blue Earth Diagnostics receives positive CHMP o...

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]

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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 Axuminâ„¢ (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 Axumin^TM (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