Aerocrine reaches multiple milestones in Asia, receives market approval in South Korea and Taiwan
SOLNA – 12 January 2012 – Aerocrine AB (OMX Nordic Exchange: AERO) announced that it’s product, NIOX MINO®, has received market approvals on the South Korean and Taiwanese markets. An approval is an important step towards receiving reimbursement for inflammation monitoring with the help of FeNO in asthma management.
KFDA, Korea Food & Drug Administration, decided on December 27, 2011 to give NIOX MINO market approval in South Korea. The approval means that Aerocrine now has the possibility to receive reimbursement from public as well as private health insurances on the South Korean market, which in the long term means that sales can start to grow. An application to obtain reimbursement has been submitted.
The decision of the market approval in Taiwan was taken by TFDA, Taiwan Food & Drug Administration, in early January 2012 and an application to obtain reimbursement has been submitted to the Taiwanese authorities. A decision on reimbursement application is expected to be communicated during late 2012.
- All progress on the Asian markets is important as the potential is very high there. Reimbursement in South Korea is totally dependent upon the decision by KFDA and therefore we are happy to have taken another step closer to achieving that. It will however not have any effect on our sales during 2012. Taiwan as such is not a significant market but we are of course glad to have received approval for one additional market, says Morten Gunvad, VP Commercial Operations Europe & Asia in Aerocrine.
Milestone in China
During the autumn 2011 Aerocrine also took one step further towards achieving reimbursement from the public health insurance system on the Chinese market. The Shanghai province (Canton), which is a key province both in regards to size as well as when it comes to embracing news, has decided that health providers can charge patients for the measurement of inflammation with the help of FeNO. This is an important milestone towards getting market access to the entire Chinese market. The decision means that Aerocrine, or FeNO measurement, has approval in seven out of 32 provinces: Henan, Shandong, Liaoning, Jiangsu, Zhejiang, Heilongjiang and Shanghai. The company expects that at least as many provinces will give their approval during 2012. At present CMA (Chinese Medical Association) is conducting a normal values clinical trial with 6 000 participants that is expected to be finalized in the end of 2012, after that Aerocrine expects that an application for national reimbursement can be submitted.
Asthma – a growing health care problem
Asthma is a fast growing health care problem which is caused by a chronic inflammation in the airways. From todays 300 million asthmatics worldwide the number of asthmatics is estimated to globally increase to between 400–450 million in 2025, according to the patient organization EFA (European Federation of Allergy and Airway Diseases).
For more information, contact:
Scott Myers, President & CEO, Aerocrine, Phone: +46 768 788 379
Morten Gunvad, VP Commercial Operations Europe & Asia, Aerocrine, Phone: +46 768 669 387
About Aerocrine
Aerocrine AB is a medical technology company focused on the improved management and care of patients with inflammatory airway diseases. As the pioneer and leader in the technology to monitor and manage airway inflammation, Aerocrine markets NIOX® Flex and NIOX MINO®. Both products enable fast and reliable management of airway inflammation and may therefore play a critical role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma. Aerocrine is based in Sweden with subsidiaries in the US, Germany and the UK. Aerocrine shares were listed on the Stockholm Stock Exchange on 15 June 2007. Aerocrine discloses the information provided herein pursuant to the Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 08:00 a.m. on January 12, 2012.