ALK-Abelló

Legal Proceedings Report • Sep 21, 2017

Copenhagen, 2017-09-21 19:39 CEST (GLOBE NEWSWIRE) --

ALK’s 2017 full-year guidance remains unchanged.

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the French
National Agency for Medicines and Health Products Safety (ANSM) has issued an
injunction against ALK, linked to needed upgrades of the quality system at its
manufactoring facility in Vandeuil, France.

The injunction follows the identification by ALK of an environmental
contamination (not a product contamination) in the facility’s sterile
production area where injectable SCIT products and skin prick tests for the
French market are manufactured. As a result, ALK has temporarily stopped
production in the sterile area and halted the release of all products
manufactured there.

ALK and ANSM have been in close dialogue, with the authority carrying out an
inspection of the facility in September. In its injunction, the ANSM instructs
ALK to make a series of quality improvements to the entire facility,
predominantly a strengthening of the environmental monitoring and deviation
handling. Furthermore, as a precautionary measure, and in agreement with ANSM,
ALK has initiated a recall of all injectable SCIT products released from the
affected area since March 2017, regardless of the fact that routine testing of
product quality did not reveal any effect from the environmental contamination.
The SCIT products that are recalled were only distributed in France. The
manufacturing facility in France also produces SLIT-drops, mainly for the
French market. SLIT-drops are not affected by the recall.

ALK’s President and CEO, Carsten Hellmann, says: "We are already investing
heavily in equipment upgrades, new systems, digitalisation, and a strengthening
of Quality Assurance and Quality Control efforts at our production sites, and
the injunction shows that we need to continue these investments. We are
committed to rigorously improving the systems and ensuring that we have
meticulous training and education in place for our people."

A plan of action to address ANSM’s instructions is now being put in place and
manufacturing in the sterile area will restart once adequate corrective
measures have been implemented and verified by the authority. The temporary
halt in production will lead to SCIT products and skin prick tests being in
short supply until the situation is fully remedied. ALK has informed patients
and prescribers in France accordingly.

The products that are affected by the temporary production suspension represent
less than 0.5 percent of ALK’s total, global revenue. At this stage, ALK
expects only a limited, negative spill-over effect on sales of other products.
Hence, ALK expects that the suspension will have a slightly negative effect on
its full-year revenue. Furthermore, ALK expects extra costs associated with the
needed upgrade of the quality system. However, ALK’s 2017 full-year guidance
remains unchanged.

                             ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy
prevention, diagnosis and treatment. ALK is a world leader in allergy
immunotherapy – a treatment of the underlying cause of allergy. The company has
approximately 2,300 employees, with subsidiaries, production facilities and
distributors worldwide. ALK has entered into partnership agreements with Torii,
Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets
in Japan, Russia, and South-East Asia, and Australia and New Zealand,
respectively. The company is headquartered in Hørsholm, Denmark, and listed on
Nasdaq Copenhagen. Find more information at www.alk.net.