DGAP-News

MOLOGEN completes portfolio review: shift from research to product- and market-oriented company - Seite 2

focusing and resulting reduction of the preclinical product portfolio,
research activities previously carried out within the company will mostly
be discontinued. By implementing this strategy, MOLOGEN will reduce its
complexity and focus much more on the advanced product portfolio in order
to promptly generate greater added value for its shareholders. The
implementation of the new structure is expected to be completed by the end
of 2016.

Dr. Mariola Söhngen, CEO of MOLOGEN AG: "The 'Next Level' strategy will
define the goalposts for MOLOGEN's continued successful development. We
will focus on the company's value drivers, especially on the promising
cancer immunotherapy lefitolimod, for which we now plan to press on with
approval and market preparation activities in view of the mature stage of
development reached by the product. These are also important and value-
driving activities as regards the out-licensing of the product which we are
pursuing as a top priority. We are convinced that we will create real added
value for our shareholders with the implementation of this strategy."

Clear focus on lead product lefitolimod (MGN1703)
The target of the portfolio review was the analysis and evaluation of
MOLOGEN's product pipeline with regard to potentials and fit to the new
strategy. The main focus of MOLOGEN's activities in future will be on
continuing the four clinical trials with the immune surveillance
reactivator ("ISR") lefitolimod (MGN1703): the IMPALA, IMPULSE and TEACH
studies in the indications colorectal cancer, small-cell lung cancer and
HIV, and a combination study which is due to start shortly with the
immunotherapy Yervoy(R) (ipilimumab) in patients with advanced solid
tumors. In the case of lefitolimod, the focus is on completing patient
recruitment in the IMPALA study and, with a view to approval and market
preparation activities, on preparing to upscale production so that large
quantities of the compound can be produced in order to meet market demand.
There are plans to work with a specialist contract manufacturer for
production.

Lefitolimod (MGN1703) is part of the family of TLR9 agonists. In order to
be able to exploit the potential of this product group fully and to tap
additional market potential, MOLOGEN will also continue to invest in the
next-generation, currently still pre-clinical molecule of lefitolimod
(MGN1703), EnanDIM(R), which is also aimed at the indications cancer and
infectious diseases. As such, the bulk of available financial resources
will go into the further development of lefitolimod (MGN1703) and