Blue Earth Diagnostics appoints IASON Sp. z o.o. to manufacture and distribute Axumin® (fluciclovine (18F)) in Poland

Published 25 Jun 2018

Blue Earth Diagnostics, and IASON Sp. a leading supplier of radiopharmaceuticals, announce an exclusive manufacturing and distribution agreements for the supply of Axumin® (fluciclovine ( 18F)) in Poland.

Blue Earth Diagnostics, a leading molecular imaging diagnostics company, and IASON Sp. z o.o., a leading supplier of radiopharmaceuticals, today announced that they have entered into exclusive manufacturing and distribution agreements for the supply of Blue Earth Diagnostics’ Positron Emission Tomography (PET) imaging product Axumin® (fluciclovine ( 18F)) in Poland. Under the terms of the agreements, IASON sp. z o.o., through their manufacturing site in Mszczonów, will bring Axumin to market in Poland. Axumin is indicated in Europe for use in 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. Blue Earth Diagnostics now has six manufacturing and distribution agreements for Axumin in place covering seventeen European countries.

Prostate cancer is the second most common cancer in Poland for men. The incidence of malignant prostate cancer has increased rapidly over the past three decades; about 14 000 new cases are diagnosed each year1 . While most primary prostate cancers can be successfully treated, the disease recurs in up to one-third of patients. In some patients, recurrent disease is detectable only by a rise in PSA levels, but often the anatomical location of the recurrence cannot consistently be identified by conventional imaging, limiting treatment guidance. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Following receipt of marketing authorization for Axumin from the European Commission on May 22, 2017, Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “We’re delighted to announce these agreements, which mark another significant step towards our goal of making Axumin commercially available across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin for clinicians and their patients. The agreements with IASON Sp. z o.o. will enable us to serve imaging centres and hospitals across Poland, where prostate cancer is a major concern for men and their families. We look forward to working with the team at IASON Sp. z o.o..”

Przemyslaw Kozanecki, President of IASON Sp. z o.o. said, “We are excited that IASON Sp. z.o.o has become a partner in Blue Earth Diagnostics’ European network for the production and distribution of Axumin, which promises to help improve the care of prostate cancer patients in Poland. We look forward to bringing our expertise, capabilities and reliability to support the launch of this new PET imaging agent in Poland.”

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization 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 recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially available product is Axumin® (fluciclovine F 18), a novel molecular imaging agent approved in the United States and European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. Blue Earth Diagnostics is backed by Syncona, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdiagnostics.com.

About IASON Sp. z o.o.

IASON Sp. z o.o. is the first commercial manufacturer and distributor of radiopharmaceuticals for Positron Emission Tomography (PET) in Poland, used in oncological, cardiological and neurological diagnostics. IASON manufactures and delivers to PET sites on a routine basis 18F- based radio-pharmaceuticals under EU permits both in Poland and abroad. Manufacturing facilities are located in Warsaw, Kielce and Mszczonów and fully meet GMP and national standards. IASON’s employees are one of the most experienced in the sector. IASON is a member of the Synektik Capital Group, listed on the Warsaw Stock Exchange. For more information please go to: www.synektik.com.pl

1. Data from: http://onkologia.org.pl/raporty downloaded 4 June 2018

This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.

Contacts:

Blue Earth Diagnostics (Europe)
Georgina Mowatt
Communications Manager
Tel: +44 (0) 7810 355 912
g.mowatt@blueearthdx.com

Blue Earth Diagnostics (US)
Priscilla Harlan
Vice President
Corporate Communications
Tel: + 781-799-7917
p.harlan@blueearthdx.com

IASON Sp. z o.o.
Przemyslaw Kozanecki
CEO
Tel: +48 663 927 511
pbkozanecki@synektik.com.pl

Media inquiries:

Sam Brown Inc. (for Blue Earth Diagnostics)
Mike Beyer
Tel: + 312-961-2502
mikebeyer@sambrown.com

Syncona Limited Disclaimer

Please read the below disclaimer carefully. You will be asked to accept these terms and conditions before proceeding.

The information on this website is directed only at persons who are shareholders in Syncona Limited (the “Company”) and is provided for their exclusive use and benefit.

Users of this website are responsible for observing all applicable laws and regulations in their relevant jurisdictions before proceeding to access the information contained herein. By proceeding to access the information, users are deemed to be representing and warranting that the applicable laws and regulations of their relevant jurisdiction allow them to do so. No information, materials or opinions contained on this website (“Materials”) constitute or would be deemed to constitute a recommendation or invitation in any jurisdiction to invest or otherwise deal in the shares of the Company (the “Shares”).

The website that you are seeking to access does not constitute an offer to buy or sell the securities mentioned in the website in any jurisdiction or jurisdictions in which such offers or sales are unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In particular, the securities mentioned in the website have not been and will not be registered under the United States Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or exemption from registration under the Securities Act and other securities laws. There will be no public offer of these securities in the United States. Offers and sales of these securities, and distribution of the related information, may also be subject to restrictions in other jurisdictions.

The website that you are seeking to access is not directed at and may not be viewed by or distributed to persons:

  • in the United States or who are U.S persons (as defined in Rule 902 under the Securities Act);

or

  • located in a jurisdiction where it is not lawful to access the materials.

The Materials are provided on an “as is” and “as available basis” and do not purport to be full or complete. The Company and its affiliates believe that the source of the Materials is reliable however they cannot and do not guarantee, either expressly or implicitly, and accept no liability for, the accuracy, validity, timeliness, merchantability or completeness of any information or data (whether prepared by the Company, its affiliates or by any third party) for any particular purpose or use or that the information or data will be free from error. The Company and its affiliates do not undertake any responsibility for any reliance which is placed by any person on any statements or opinions which are expressed herein. Neither the Company, nor any of its affiliates, directors, officers or employees will be liable or have any responsibility of any kind for any loss or damage that any person may incur resulting from the use of this information.Nothing contained in this website constitutes financial, investment, legal, tax or other advice and is not to be relied on in making an investment or other decision. You should obtain relevant and specific professional advice before making any investment decision.

The Materials on this website are provided for your personal use and informational purposes only and are subject to change without notice. The Company has the right to suspend or withdraw the provision of all or any of the website of the Materials without prior notice at any time.

The value of investments mentioned in this site, and the income from them may go down as well as up and investors may not get back the amount invested. Information on past performance, where given, is not a guide to future performance. Changes in rates of exchange between currencies may cause the value of investments to decrease or increase.
The Company is a registered closed-ended collective investment scheme registered pursuant to the Protection of Investors (Bailiwick of Guernsey) Law, 1987, as amended (the ‘‘POI Law’’) and the Registered Collective Investment Scheme Rules 2008 (the ‘‘CIS Rules’’) issued by the Guernsey Financial Services Commission (the ‘‘GFSC’’). Neither the GFSC nor the States of Guernsey Policy Council take any responsibility for the financial soundness of the Company or for the correctness of any of the statements made or opinions expressed with regard to it.

Copyright

Copyright of all images and text in this website is owned by or licensed to the Company or one of its affiliates unless otherwise noted. You may imprint, copy, download or temporarily store extracts from this website for your personal information and use. Any other use is prohibited unless you first request and obtain the prior written consent of the Company. You may not alter or otherwise make any changes to any material that you print or download from this website, including, without limitation, removing any identifying marks or legends from such material. In particular, you may not copy or use any part of this website on any other website, or link any other website to this website, without the prior written permission of the Company. You may not use the website for any purpose which is unlawful, abusive, libellous, obscene or threatening.

No Warranty

The Materials contained in this website are provided without any warranty of any kind, either expressed or implied, to the fullest extent permissible pursuant to applicable law. Neither the Company nor its affiliates assume any responsibility for the uninterrupted availability of this website or warrant that it will be error-free, that defects will be corrected, or that this website or the servers that make it available will be free of viruses or other harmful components.

Liability Waiver

You agree that under no circumstances, including, but not limited to, negligence, shall the Company or any of its affiliates be liable for any special or consequential damages that result from the access or use of, or the inability to access or use, the Materials on this website. This does not exclude or restrict any duty or liability that the Company has to its customers under the regulatory system in the United Kingdom or Guernsey.

Privacy Policy

This policy sets out what the Company and its affiliates do with any personal information collected from this website.

Any personal information collected from this website will be processed in accordance with relevant data protection laws.

You may use the public areas of this website without providing the Company or its affiliates with any personal information and the Company and its affiliates do not monitor or collect any personal information through your access to the public areas of this website. The Company and its affiliates do not use cookies to collect information but may gather other anonymous information to assist in improving the services.

If you chose to provide the Company and its affiliates with personal information, this information will only be used for the purposes of the service that you have requested. The Company and its affiliates will not sell or transfer any personal information to third parties without your permission, other than as required by law.

The Company and its affiliates are not responsible for the content or privacy policies of websites to which this website may link.

The Company and its affiliates are committed to protecting your personal information but in the event that the system is infiltrated by unauthorised third parties the Company and its affiliates will not be liable for any resulting misuse of personal information.

Linked Sites

The Company has not reviewed any website linked to this website and is not responsible for the contents of off-site pages or any other websites linked or linking to this website. If you follow any links from this website you do so at your own risk.

Links to this website may not be established without the prior written consent of the Company.

Governing Law

The terms and conditions of this legal notice shall be governed by and construed in accordance with the laws of Guernsey. Users of this website agree that any dispute or action arising out of or relating to these terms or any user’s use of this website shall be commenced only in the courts located in Guernsey, and users of this website hereby consent and submit to the exclusive jurisdiction of such courts for the purposes of any such dispute or action.

By accessing Materials on this website you agree to be bound by the foregoing limitations.