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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
* 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 GBP83.5
million to GBP109.01 million adding GBP25.5 million (3.9p per share) to Syncona
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
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 GBP109.01
million, a GBP25.5 million (3.9p per share) uplift to the last published
valuation of GBP83.5 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
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."|
|Good to see that along with a Capital Mkts Day they've launched a proper website today, as befits a ftse 250 investment company.
|Promoted into ftse 250, with effect from mon 20th.
|Is 9% of nav:
BURLINGTON, Mass. and OXFORD, England February 7, 2017 – Blue Earth Diagnostics, a molecular imaging diagnostics company, and Siemens’ PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., announce the increasing number of radiopharmacies offering Blue Earth Diagnostics’ Axumin (fluciclovine F 18) PET imaging agent through PETNET’s national network.
|First fact sheet post enlargement and remit change:
Historical info on Syncona pre BACIT merger:
hTtp://sixthelementcapital.com/index.php/portfolio (aka The Pioneer Fund)|
|Use other thread|
|New MYRN threads have been set up - see links below:
For all those interested in following this stock perhaps you should migrate across. Thanks.|
|Annual results tomorrow. Judging by the recent share price performance the market is not expecting much. We shall see.|
|Good Start !|
|Hopefully the upward momentum can be maintained.
I thought we would have heard something more about their Twitter rollout to the emerging markets. Perhaps more will be forthcoming with the release of the annual results on 20th March.|
|Looking Good !|
|ZURICH, Switzerland 6th March, 2014 Myriad Group AG (SIX: MYRN), the company creating and connecting communities across mobile and TV, today announces that Myriad Updates (MU), including its Facebook for USSD service, has successfully launched with Meditel Morocco, a major operator in the Orange Group.
Facebook for USSD is now available to subscribers in 20 countries worldwide. Since its launch, over 20 million unique visitors have connected to the service. Facebook for USSD at Meditel has been a tremendous success. Meditel's track record of innovation and its desire to democratise access to Facebook made MU an obvious choice to let all subscribers connect to the social network.
Myriad Updates is a ubiquitous, text‐based social mobile messaging service that provides users with simple, low‐cost access to a range of services over USSD that include social networking and messaging. Accessible on any mobile device, subscribers can easily connect to services like Facebook without needing to purchase a data plan, upgrading to a new mobile phone or even downloading an app on their device.
Stephen Dunford, CEO of Myriad Group, commented: "We are delighted to be able to support Meditel Morocco as the operator brings new ways to connect to mobile Internet services to its subscribers in an affordable way. Myriad Updates enables mobile users to join the world's largest online social networking communities at minimal cost. Its popularity is certainly underlined by the rapid subscriber uptake in Morocco."
Reda Salmane, Product Marketing Manager at Meditel, commented: "Myriad's Facebook for USSD service is the perfect answer to the requirements of the Moroccan market. It meets the needs of our large Facebook users community who are still mostly using feature phones and rarely have internet access on their devices. We are proud of our partnership with Myriad who took our particular needs into account when customising the service ahead of its deployment."
Myriad delivers consumer applications, messaging solutions, and embedded software to leading OEMs, mobile operators, and pay TV providers worldwide.
Our messaging services deliver instant messaging and social networking to tens of millions of users in Latin America, Asia and Africa. Working with some of the world's most successful mobile phone operators, Myriad's market leading chat application, MSNGR, enables consumers to connect to friends and family for free across feature phones as well as smartphones. Our Updates service, provided over USSD, enables users without data plans to connect to the social networks and chat services they want to reach in a simple and affordable way. In many cases, Myriad's services are providing users with their first experience of the Internet.
Our market proven and innovative connected home solutions are found in billions of mobile phones and tens of millions of set-top boxes and Blu-ray players.|
|It is about time Stephen Dunford & Co. gave shareholders something to cheer about. To date senior management appears to have been a bit uninspiring.|
|We are exhibiting at Barcelona next week.|
|Our messaging services deliver email, instant messaging and social networking to tens of millions of users in Latin America, Asia and Africa. Working with some of the world's most successful mobile phone operators, Myriad's market leading services enable consumers to connect to Internet services they want to reach in simple and affordable ways. In many cases, Myriad's services are providing them with their first experience of the Internet.|
|The price tag Facebook has just put on WhatsApp shows the immense value in instant messaging. Hopefully this will give MYRN's share price a boost.|
|Having taken advantage of last year's rights offer I do hope the upward momentum is maintained. Also the recent volume seems to be encouraging.|
|Myriad Doing Well !
2.5p Soon IMO !|
|one to watch ...phenomenal growth play if executed as envisaged by the management.|