Aerocrine reaches multiple milestones in Asia, receives market approval in South Korea and Taiwan


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

 

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